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The SPO PulseOx 5500 Pulse Oximeter is indicated for use for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, medical facilities, home care, transport and sub-acute environment.

The SPO PulseOx 7500 Pulse Oximeter, a small, wrist-worn device, is indicated for use in measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, sub-acute and sleep study environments.

The SPO PulseOx pulse oximeter devices monitor the oxygen saturation levels in the blood using pulse oximetry, i.e., changes in light intensity as the light is reflected back from human tissue. Two different wavelengths (in the visible and infrared wavelength) are used. Comparisons between the standard signal and the variances can be used to calculate the oxygen saturation of arterial blood. The SPO PulseOx pulse oximeter devices are based on the reflective method whereby the sensor is located on one side of the relevant body part so as to measure the necessary parameters.

The main components of the SPO pulse oximeter devices are a sensor block, analog block, controller, LCD display and battery.

Here's a breakdown of the acceptance criteria and the study information for the PulseOx 5500 Finger Device and PulseOx 7500 WristWatch Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list quantitative acceptance criteria in a table format for performance. Instead, it states that:

• Bench Studies: "Tests results showed that the devices perform within their specification and according to the requirements of FDA Draft Guidance Document of the Non-Invasive Pulse Oximeter."
• Software Validation: "Software Validation according to the IEC60601-1-4 standard and the FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices."
• Electrical Safety & EMC: "Test results showed that the PulseOx device meet the requirements of these standards [IEC 60601-1 and IEC 60601-1-2]."
• Environmental Testing: "The PulseOx device will undergo environmental and mechanical testing in accordance With FDA Reviewer Guidance for Premarket Notification Submissions; November 1993; With I DA Reviewer Gallanov Tor Free Branch; Division of Cardiovascular, Respiratory and Neurological Devices."
• Clinical Studies: "results show a sufficient correlation to the Gold Standard."

While it doesn't provide specific numerical criteria or results, the general acceptance criterion implied for all tests is "meets specifications/requirements of relevant standards and FDA guidance."

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

The document provides limited detail on the clinical study sample sizes and provenance.

• Clinical Studies: "The performance of the PulseOx devices was validated by three clinical studies."
  • A comparison of PulseOx, Masimo/Radical and Arterial Blood Sampling.
  • A comparison of PulseOx 5500/7500 models to Masimo/Radical.
  • A comparison of accuracy of a reflectance pulse oximeter in comparison to a standard pulse oximeter in adult patients.
• Meta-analysis: A meta-analysis was performed comparing PulseOx devices to blood sampling results (Gold Standard).

Sample Size: Not explicitly stated for any of the clinical studies or the meta-analysis.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The applicant's address is in Kfar Saba, ISRAEL, but this doesn't confirm the study location.

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

This information is not provided in the document. The ground truth for pulse oximetry accuracy is typically established by arterial blood gas (ABG) analysis, not by human expert interpretation of oximeter readings.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device performance study. Adjudication is typically used for subjective assessments (e.g., image interpretation) where multiple experts might disagree. Pulse oximetry accuracy is compared against a quantitative "gold standard" (arterial blood gas analysis).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human performance (e.g., radiologists reading images). The PulseOx device is a standalone diagnostic tool, not an AI-assisted diagnostic aid for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, a standalone performance assessment was conducted. The clinical studies and meta-analysis described compare the PulseOx devices' readings (algorithm-only output) directly against established standards (e.g., arterial blood sampling, other predicate oximeters).

7. The Type of Ground Truth Used

• Arterial Blood Sampling (ABG) for Oxygen Saturation: The document explicitly mentions "Arterial Blood Sampling" and refers to "Gold Standard" in relation to blood sampling results for the meta-analysis. This is the accepted gold standard for determining actual arterial oxygen saturation.
• Predicate Oximeters: Comparisons were also made against other legally marketed pulse oximeters (Masimo/Radical, a "standard pulse oximeter"). While not a "ground truth" in the strict sense of direct physiological measurement, these serve as a comparative standard for substantial equivalence demonstrations.

8. The Sample Size for the Training Set

• This information is not provided in the document. The document describes premarket notification for a medical device and typically focuses on performance validation rather than the internal development or training of algorithms that might have occurred during the device's design phase.

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

• This information is not provided in the document, as it pertains to the device's internal development process, which is often proprietary and not detailed in 510(k) summaries unless explicitly called out by FDA guidance for specific types of algorithmic devices.

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