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The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion.

The pulse oximeter, Model OHT60 and OXH78, consists of probe, electronic circuits, and display and plastic enclosures, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a professional healthcare facility or home conditions when physician follow-up and operated by a physician. This medical device can be reused. Not for continuously monitoring.

SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The measurement principle of Pulse oximeter is based on the absorption spectrum characteristics of hemoglobin and oxyhemoglobin in red and infrared regions, and the empirical formula of data is established by using ' Lambert Beer ' law. The working principle of the instrument adopts photoelectric blood oxygen detection technology combined with volume pulse recording technology, The specific process is as follows: Firstly, the infrared light emitting at 660 nm and the near-infrared light emitting at 905 are used to irradiate the finger and the measurement data are obtained by the infrared receiver tube. Secondly, the obtained measurement data were calculated and processed by electronic circuits and microprocessors to obtain the blood oxygen saturation and pulse rate, and the calculation results were displayed on the screen.

The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA alkaline batteries.

The Model OHT60 and OXH78 have the same critical components and its materials and means of power supply, PCB layout and Software are little different.

The provided text describes the 510(k) summary for a Pulse Oximeter (Models OHT60, OXH78). This document primarily details the device's technical specifications, non-clinical testing, and a clinical study to demonstrate its accuracy against a predicate device. It does not describe a study involving an AI component or a multi-reader multi-case (MRMC) comparative effectiveness study, as the device is a standalone hardware product (pulse oximeter).

Therefore, I will focus on the acceptance criteria and the study that proves the device meets those criteria based on the information available for this specific medical device.

Device Name: Pulse Oximeter (Model OHT60, OXH78)
Intended Use: Spot-checking oxygen saturation and pulse rate in adults, reusable device, for use with the finger in professional healthcare facilities or home conditions with physician follow-up. Not intended for use under motion.

Acceptance Criteria and Reported Device Performance

The primary performance criterion for this pulse oximeter is its accuracy in measuring SpO2. The relevant standard cited is ISO 80601-2-61:2017. This standard typically specifies the acceptable accuracy (Root Mean Square, ARMS) for pulse oximeters over a defined SpO2 range.

Table 1: Acceptance Criteria and Reported Device Performance (SpO2 Accuracy)

Note: While the predicate device had an SpO2 accuracy of ±2% and the subject device has ±3%, the document states "The SpO2 measurement range and accuracy is a little different, but they are within the limits of the specified range of the standard ISO 80601-2-61 and FDA guidance for Pulse Oximeters. The different has no effect on substantive equivalence." This implies that the ±3% for the subject device is within the acceptable range defined by the standard and FDA guidance.

Study Details to Prove Device Meets Acceptance Criteria

The study described is a clinical accuracy study for the pulse oximeter.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 12 healthy adult volunteer subjects.
   • Data Provenance: Clinical study conducted at Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, China (implied from the submitter's country and study location). The study was prospective as it involved inducing fractional inspiration O2 (FiO2) control tests and obtaining arterial blood samples.
   • Subject Demographics: Ages 21-42 years, 46-75 kg, 150-180 cm. Included 4 males and 8 females, with varying skin pigmentations (4 subjects with Fitzpatrick V, VI, and 8 subjects with Fitzpatrick I ~ Fitzpatrick IV).

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • The ground truth for SpO2 (SaO2) was established by an arterial blood gas analyzer (CO-OXIMETER), which is a laboratory instrument. Experts were involved in conducting the clinical study, drawing arterial blood, and operating the analyzer, but the ground truth itself is an instrumental measurement, not expert consensus reading of images or similar. The document does not specify the number or specific qualifications of medical professionals involved in operating the CO-OXIMETER or conducting the clinical measurements beyond being part of the clinical study team at the hospital.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truth (SaO2) was obtained directly from an arterial blood gas analyzer, not through human interpretation requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done. This device is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic imaging tool that would typically involve human readers.

5. If a Standalone (algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence, the clinical study assessed the "standalone" performance of the pulse oximeter device itself by comparing its SpO2 readings directly against the functional oxygen saturation (SaO2) from the arterial blood gas analyzer. The device provides a direct measurement, not an output that requires further human interpretation for its primary function.

6. The Type of Ground Truth Used:

   • Outcomes Data/Physiological Measurement: The ground truth used was functional oxygen saturation (SaO2) measured by an arterial blood gas analyzer (CO-OXIMETER) from stable arterial blood samples. This is considered a gold standard for blood oxygen measurement.

7. The Sample Size for the Training Set:

   • The document does not specify a separate "training set" in the context of machine learning. The device is a hardware product relying on established physiological principles (spectrophotometry, photoplethysmography) and empirical formulas, not a "learnable" AI algorithm in the contemporary sense that would require a distinct training set for model development. The clinical study data (12 subjects) described is the test set used for validation of the device's accuracy.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as a distinct training set for an AI model is not described or relevant for this type of device. The underlying principles and empirical formulas are based on general scientific and medical knowledge, rather than specific data training.

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