Objectives To evaluate the performance of direct-to-consumer pulse oximeters under clinical conditions, with arterial blood gas measurement (SaO2) as reference standard. Design Cross-sectional, validation study. Setting Intensive care. Participants Adult patients requiring SaO2-monitoring. Interventions The studied oximeters are top-selling in Europe/USA (AFAC FS10D, AGPTEK FS10C, ANAPULSE ANP 100, Cocobear, Contec CMS50D1, HYLOGY MD-H37, Mommed YM101, PRCMISEMED F4PRO, PULOX PO-200 and Zacurate Pro Series 500 DL). Directly after collection of a SaO2 blood sample, we obtained pulse oximeter readings (SpO2). SpO2-readings were performed in rotating order, blinded for SaO2 and completed <10 min after blood sample collection. Outcome measures Bias (SpO2–SaO2) mean, root mean square difference (ARMS), mean absolute error (MAE) and accuracy in identifying hypoxaemia (SaO2 ≤90%). As a clinical index test, we included a hospital-grade SpO2-monitor (Philips). Results In 35 consecutive patients, we obtained 2258 SpO2-readings and 234 SaO2-samples. Mean bias ranged from −0.6 to −4.8. None of the pulse oximeters met ARMS ≤3%, the requirement set by International Organisation for Standardisation (ISO)-standards and required for Food and Drug Administration (FDA) 501(k)-clearance. The MAE ranged from 2.3 to 5.1, and five out of ten pulse oximeters met the requirement of ≤3%. For hypoxaemia, negative predictive values were 98%–99%. Positive predictive values ranged from 11% to 30%. Highest accuracy (95% CI) was found for Contec CMS50D1; 91% (86–94) and Zacurate Pro Series 500 DL; 90% (85–94). The hospital-grade SpO2-monitor had an ARMS of 3.0% and MAE of 1.9, and an accuracy of 95% (91%–97%). Conclusion Top-selling, direct-to-consumer pulse oximeters can accurately rule out hypoxaemia, but do not meet ISO-standards required for FDA-clearance Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.

中文翻译：

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与同步动脉血氧饱和度或临床级脉搏血氧仪相比，流行脉搏血氧仪的性能：重症监护患者的横断面验证研究

目的 以动脉血气测量 (SaO2) 作为参考标准，评估临床条件下直接面向消费者的脉搏血氧仪的性能。设计横断面验证研究。设置重症监护。参与者 需要监测 SaO2 的成年患者。干预措施 所研究的血氧仪在欧洲/美国最畅销（AFAC FS10D、AGPTEK FS10C、ANAPULSE ANP 100、Cocobear、Contec CMS50D1、HYLOGY MD-H37、Mommed YM101、PRCMISEMED F4PRO、PULOX POcurate00DL 系列） . 在采集 SaO2 血样后，我们立即获得了脉搏血氧仪读数 (SpO2)。SpO2 读数按轮换顺序进行，对 SaO2 不知情，并在血样采集后 10 分钟内完成。结果测量偏差 (SpO2–SaO2) 均值、均方根差 (ARMS)、识别低氧血症的平均绝对误差 (MAE) 和准确度 (SaO2 ≤90%)。作为临床指标测试，我们包括了医院级 SpO2 监测器（飞利浦）。结果 在连续 35 名患者中，我们获得了 2258 个 SpO2 读数和 234 个 SaO2 样本。平均偏差范围从 -0.6 到 -4.8。所有脉搏血氧仪均不符合国际标准化组织 (ISO) 标准设定的 ARMS ≤ 3% 要求以及食品和药物管理局 (FDA) 501(k) 许可要求。MAE 范围从 2.3 到 5.1，十个脉搏血氧仪中有五个满足≤3% 的要求。对于低氧血症，阴性预测值为 98%–99%。阳性预测值范围为 11% 至 30%。Contec CMS50D1 的准确度最高 (95% CI)；91% (86–94) 和 Zacrate Pro 系列 500 DL；90% (85–94)。医院级 SpO2 监护仪的 ARMS 为 3。0% 和 MAE 为 1.9，准确度为 95% (91%–97%)。结论 畅销、直接面向消费者的脉搏血氧仪可以准确排除低氧血症，但不符合 FDA 批准所需的 ISO 标准 数据可根据合理要求提供。与研究相关的所有数据都包含在文章中或作为补充信息上传。