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The oCare Wrist Pulse Oximeter, Model Pro 100, is a wrist-worn device indicated for use in noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The intended measuring site of this device is the wrist skin surface. It is intended for spot-checking or continuous monitoring of adult patients during no motion conditions, in hospital-type facilities, and home environments.

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a wrist-worn device for noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate. The intended measuring site of this device is the lateral side of wrist and slightly above the wrist bone (ulnar styloid processus).

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a watch-like device with a reflectance pulse oximetry sensor located at the bottom of the watch case and on top of the wrist. The reflectance pulse oximetry sensor includes three light emitting diodes (LEDs) of red, infrared and green wavelength and one photodiode light detector placed next to each other. Light beams are emitted from LEDs through the skin to the arteriolar bed of the tissue. Changes in light absorption during the pulsing cycle are measured by the photodiode light detector as scattered lights are reflected back from the pulsating arteriolar bed. The functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate are measured by the well-established non-invasive pulse oximetry technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood during the arterial pulsing. The maximum optical output power is less than 2 mW.

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a single-patient use, non-sterile pulse oximeter. It is available in one configuration as a standalone device with a wrist pulse oximeter and a detachable watchband for wearing the pulse oximeter on the wrist.

The oCare™ Wrist Pulse Oximeter, Model Pro 100 is a compact and light weight device which consists of a reflectance pulse oximetry sensor, a color graphic OLED display, a lithium ion polymer rechargeable battery, a memory, an analog and digital unit, a microprocessor and an operating software.

The provided text describes the performance data for the oCare™ Wrist Pulse Oximeter, Model Pro 100, focusing on its accuracy in measuring functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The exact number of human subjects is not explicitly stated. The text mentions "human subjects screened for this testing" and "each human subject," implying multiple individuals, but a specific number (e.g., n=X) is not provided.
• Data Provenance: The study was conducted at an "independent research university hospital." The subjects were "health, male, female, no-smoking and light to dark-skinned adult subjects of 20-40 years of age."
  • Country of Origin: Not explicitly stated, but the submission is from Taiwan Biophotonic Corporation, suggesting the study might have been conducted in Taiwan or an affiliated institution.
  • Retrospective or Prospective: Prospective. The study "was designed in accordance with ISO 80601-2-61" to "verify the SpO2 accuracy" where hypoxia was induced in a "stair-stepped manner" and arterial blood samples were taken simultaneously. This indicates a pre-planned, forward-looking study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The text does not indicate that human experts were used to establish ground truth for the device's performance. The ground truth for SpO2 was established invasively using co-oximetry with arterial blood samples. Therefore, this section is not applicable in the context of expert review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 accuracy was established through direct
invasive measurement (co-oximetry) of arterial blood samples, not through human
adjudication of medical images or observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. This study focused on the standalone accuracy of the pulse oximeter device against an invasive gold standard (co-oximetry), not on evaluating how human readers (e.g., clinicians) perform with or without AI assistance. The device is a diagnostic tool, not an AI-assisted diagnostic aid for clinicians.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was performed. The "Clinical Studies" section describes a study testing the oCare™ Wrist Pulse Oximeter's accuracy in measuring SpO2 directly against a gold standard (co-oximetry with arterial blood samples). This is a purely algorithmic/device performance evaluation without any human interpretation of the device's output being part of the primary performance metric.

7. The Type of Ground Truth Used

The ground truth used for SpO2 accuracy was invasive functional oxygen saturation of arterial hemoglobin (% SaO2) analyzed by the co-oximetry method with arterial blood samples taken simultaneously.

8. The Sample Size for the Training Set

Not applicable. The device is a pulse oximeter that uses well-established non-invasive pulse oximetry technology (based on light absorption by hemoglobin) and does not appear to employ machine learning that would require a "training set" in the conventional sense (e.g., for AI model development). Its operation is based on physiological principles and signal processing, not a data-driven learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention or indication of a "training set" for this
device's underlying technology.

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