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The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users. The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. The device is not intended to be the sole method of checking the physical health of a subject.

Vital Signs is a software-only medical device (SaMD) that provides non-contact pulse rate and breathing rate (chest wall movements) data derived from video, without the need for contact devices to be attached to the patient or bed.

The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy rooms within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient spot heart rate and breathing rate data from the analysis of this video data, once the user has followed a workflow to initiate the system's data analysis.

The provided FDA 510(k) clearance letter and summary for the Oxehealth Vital Signs device (K251200) does not contain the detailed acceptance criteria and study information requested.

The document primarily focuses on:

• Regulatory clearance: Stating the device is substantially equivalent to a predicate device (K211906).
• Device description: Explaining its non-contact vital signs monitoring capabilities using video.
• Intended use: Specifying its application in single occupancy rooms within healthcare settings for adults 18+ who do not require critical care.
• Technological characteristics: Highlighting it is a software-only medical device (SaMD) and that the main difference from the predicate is the operating system.
• Non-clinical performance: Listing applied standards related to risk management, software lifecycle, and cybersecurity, and explicitly stating that EMC, electrical safety, biocompatibility, or mechanical safety testing was not performed due to the nature of the device.

Therefore, I cannot fully complete the requested table and study description based on the provided text. The document relies on a comparison to a predicate device (K211906) and refers to a "Substantial Equivalence document" (27. VS.DOC.748) which would likely contain the performance data.

However, based on the information available, I can make some inferences and structure the answer as requested, clearly indicating where information is not present.

Acceptance Criteria and Device Performance

Due to the general nature of the provided FDA summary, specific numerical acceptance criteria for vital sign accuracy are not explicitly stated in this document. The summary asserts substantial equivalence to a predicate device (K211906). Typically, performance claims for vital signs monitors are made against established accuracy standards (e.g., ISO 80601-2-61 for pulse oximetry, though this is a different technology, the principle of a measurement standard applies).

The document states: "Proprietary software-controlled algorithms are used to derive patient spot heart rate and breathing rate data from the analysis of this video data..." and "Based on the comparison to the predicate devices and performance characteristics, the Oxevision Vital Signs is substantially equivalent to the currently legally marketed device Oxevision Vital Signs predicate for the US (K211906)." This implies that the device performance is considered equivalent to the predicate, and whatever performance criteria were met by the predicate device are assumed to be met by this device.

Table 1: Hypothetical Acceptance Criteria and Reported Device Performance (Based on Inferences, Actual Data Not Provided)

Study Details Proving Acceptance Criteria (Information Not Provided in Document)

The provided FDA 510(k) summary focuses on the regulatory clearance and substantial equivalence rather than a detailed performance study report. The document refers to "27. VS.DOC.748 - Oxevision Vital Signs Device 510(k) - Substantial Equivalence document" which is the likely place for the detailed study results needed to assess acceptance criteria.

Based only on the provided text, the following details are not available:

1. Sample size used for the test set and the data provenance: No information on the number of subjects (patients) or video recordings used for performance testing. Data provenance (country of origin, retrospective/prospective) is also not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. For vital signs, ground truth would typically be established by a reference medical device (e.g., ECG for heart rate, capnography for breathing rate) rather than expert consensus on video.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as ground truth for vital signs is usually objective measurements from reference devices.

4. 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: Not applicable. This device is a standalone software for automated vital sign measurement, not an AI-assisted diagnostic tool for human readers to interpret.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, this is implicitly confirmed. The device is described as "software assessing video footage... Proprietary software-controlled algorithms are used to derive patient spot heart rate and breathing rate data..." This strongly indicates standalone algorithm performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for vital signs devices, the ground truth is typically obtained from concurrent measurements using a clinically validated reference standard medical device (e.g., a medical-grade ECG monitor for pulse rate, a capnograph or respiratory belt for breathing rate).

7. The sample size for the training set: Not provided.

8. How the ground truth for the training set was established: Not provided. Similar to the test set, it would likely be established using reference medical devices.

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