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The Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.

Discovery 1 is a portable non-invasive Hemodynamic Blood Pressure Monitor powered by an internal rechargeable lithium polymer battery. It contains a pulse wave probe incorporating two LEDs, which can collect the pulse wave to the device.

The provided document describes the FDA 510(k) clearance for the Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor. Here's a breakdown of the acceptance criteria and the study details:

1. A table of acceptance criteria and the reported device performance

Note: The document explicitly states that the subject device's blood pressure accuracy of ±5 mmHg and pulse rate accuracy of ±2% or ±2 bpm (whichever is greater) meet the requirements of the ISO 81060-2: 2013 standard, and the full claimed range has been verified. The differences in specific ranges and accuracy benchmarks between the predicate and subject device were addressed and deemed not to raise safety or effectiveness issues.

2. Sample size used for the test set and the data provenance

The document states that clinical accuracy was assessed according to ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.

• Sample Size for Test Set: The ISO 81060-2: 2013 standard typically requires a minimum of 85 subjects for clinical validation studies for non-invasive sphygmomanometers. While the exact number of subjects is not explicitly stated in this document, adherence to the standard implies this or a similar sample size was used for the clinical accuracy testing.
• Data Provenance: Not explicitly stated in the provided text. It's common for such studies to be conducted in a controlled clinical environment, but the country of origin is not mentioned. The study is prospective as it's a clinical validation study performed to evaluate the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ISO 81060-2: 2013 standard, which the device adhered to for clinical accuracy, details requirements for observers during manual reference measurements. Typically, this would involve at least two trained observers measuring blood pressure using a standard auscultatory method. Their qualifications would be as trained clinical professionals experienced in taking manual blood pressure measurements. Specific details on the number or qualifications of these experts are not provided in this document, but their involvement is implied by compliance with the standard.

4. Adjudication method for the test set

For clinical validation studies following ISO 81060-2: 2013, if the initial two observers have discrepancies in their measurements, a third independent observer often adjudicates or a defined protocol for resolving discrepancies is followed. The document does not explicitly state the adjudication method, but adherence to ISO 81060-2 implies a standard protocol for reconciling differences in observer measurements.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in this document, nor is there any discussion of human readers improving with AI assistance. The device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool involving human readers.

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

Yes, the clinical accuracy study described, adhering to ISO 81060-2, is a standalone performance assessment of the device's algorithm. The device itself (Discovery 1) is an automated system for measuring blood pressure; its performance is compared directly to a reference standard (manual measurement), without involvement of human-in-the-loop for measurement interpretation. The device's output is the final measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical accuracy study was established by reference measurements performed by trained observers using a validated method (typically auscultation), as prescribed by the ISO 81060-2 standard. This falls under the category of expert consensus/reference standard measurement.

8. The sample size for the training set

The document does not provide information on the sample size used for the training set. This is typical for 510(k) summaries, which focus on the validation of the final product. The device operates on a principle of hemodynamics and pulse wave analysis, likely developed using a dataset, but details of that developmental dataset are not included here.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for any training set was established. As mentioned above, the 510(k) summary focuses on the validation of the final device against a recognized clinical standard.

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