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The Vital Signs device is intended for noninvasive spot measurement of pulse rate and breathing rate 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 system is intended for use by appropriately trained staff and should not be used by untrained users.

The Vital Signs device is indicated for use on subjects 12 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.

The subject device is the next generation device of the predicate (K211906).

Vital Signs is a software-only medical device (SaMD) that provides retrospective monitoring of non-contact pulse rate and respiratory rate 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 respiratory rate data from the analysis of this video data, once the user has followed a workflow to initiate the system's data analysis.

Improvements to the device compared to the predicate are as follows:
• 24 hour trends
• Expansion of intended population from 18 years and older → 12 years and older
• Widened respiratory rate range from 8-31 bpm → 8-39 bpm

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for the Oxehealth Vital Signs Device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document specifies the acceptance criteria as "designed accuracy targets" and concludes that "all of the different subgroups were within the stated performance metrics... for both the MAD and 95% CI." The "MAD" here refers to Mean Absolute Difference, which is equivalent to Mean Absolute Error (MAE) in this context.

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

• Sample Size: 30 subjects
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involved subjects performing "a variety of activities reflecting real-world behavior, under a variety of environmental conditions similar to those expected in the intended environment," suggesting a prospective clinical validation study.

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

• Number of Experts: One physician for manual annotation of the capnogram output.
• Qualifications: "physician blinded to both device outputs." Further specific qualifications (e.g., years of experience, specialization) are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "manually-annotated by a physician blinded to both device outputs." This indicates a single expert review for the primary ground truth, not a multi-reader consensus process like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided document. The study focuses on comparing the device's measurements against gold-standard reference devices, not on human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the described clinical performance study clearly evaluates the standalone performance of the Vital Signs device (algorithm only, as it's a SaMD) by comparing its output directly against reference devices (FDA-cleared finger pulse oximeter for heart rate and capnogram for respiratory rate). Human-in-the-loop performance is not part of this evaluation.

7. Type of Ground Truth Used

• Ground Truth:
  • Pulse Rate: FDA-cleared finger pulse oximeter. This is a gold standard reference device.
  • Respiratory Rate: Capnogram, "manually-annotated by a physician blinded to both device outputs." This is described as "the accepted gold standard for respiratory rate validation."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified in the provided document. The document describes the device as "the next generation device of the predicate (K211906)" and states, "The subject device algorithm is identical to the predicate device. It uses the same methods of Vital sign detection and the same Machine Learning techniques as the predicate device (K211906)." This suggests that any training would have been conducted for the predicate device, or for a prior version of the algorithm, but details are not given here.

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

• Ground Truth for Training Set: Not specified in the provided document. As mentioned above, the algorithm is stated to be identical to the predicate, with no details on its training provided in this 510(k) summary.

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