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The RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions.

Biofeedback Device

The provided document is limited in detail regarding specific acceptance criteria and a detailed study report. However, based on the available information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "clinical testing in the OTC setting" and a "clinical study," but does not provide the number of participants.
• Data Provenance: Not explicitly stated, but the submission is from InterCure Ltd. in Lod, Israel. Without further information, it's difficult to confirm geographical origin. The study appears to be prospective as it "demonstrated a safe, clinically significant, reduction in high blood pressure with use of the RESPeRATE over a period of 8 weeks."

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The RESPeRATE is a biofeedback device, not an image analysis or diagnostic AI tool that would typically involve human "readers." Therefore, an MRMC comparative effectiveness study involving human readers is not applicable to this device. The study focused on the device's direct effect on blood pressure and user's ability to use it without physician guidance.

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

The RESPeRATE is a biofeedback device that requires user interaction. While it likely contains internal algorithms for guiding breathing and monitoring, its performance is inherently human-in-the-loop. The clinical study evaluated the device's performance when used by individuals, demonstrating its effect as an adjunctive treatment and its usability in an OTC setting. Therefore, a purely standalone algorithm test (without human interaction) is not applicable in the context of this device's intended use.

7. The Type of Ground Truth Used

The ground truth appears to be based on clinical outcomes data, specifically:

• Measurement of blood pressure reduction over an 8-week period.
• Observation and assessment of the user's ability to properly use the device in an OTC setting without physician guidance.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set. It refers to "clinical testing" and a "clinical study" which seem to encompass the evaluation of the device's performance.

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

As no separate training set is mentioned, this information is not provided. The clinical study mentioned would have served to establish the efficacy and safety for the device itself.

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