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The Heart Seat is a replacement for a standard toilet seat that is indicated for use in a home environment. The Heart Seat is intended to be used for measuring, reviewing and storing non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) and heart rate (HR) in adults of at least 22 years of age with weight ranging from 90 to 350 pounds. Data from the Heart Seat are collected whenever the seat is used and are automatically uploaded to the Casana Cloud where they can be viewed by the healthcare provider. The Heart Seat is not intended for continuous monitoring.

The Heart Seat™ is a prescription use remote monitoring system built into a toilet seat. It is intended for physiological monitoring in the home setting. The device and platform are tools intended to support clinicians by providing them with data to help them better manage patients. Monitored users (or Patients) sit on the seat for their data to be captured and sent to the cloud. Clinical users interact with the clinical cloud-based application that provides the patient measurements.

Here's a summary of the acceptance criteria and the studies that prove the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample sizes for the test set and data provenance:

• Heart Rate Validation Study:
  • Sample Size: 117 healthy subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but it was a clinical study conducted by Casana. Given the FDA submission, it's likely US-based, and it was prospective.
• SpO2 Clinical Validation Study:
  • Sample Size: 13 subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but it was a clinical study conducted by Casana. Given the FDA submission, it's likely US-based, and it was prospective.
• BioID Validation Study:
  • Sample Size: 125 subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but it was a clinical study conducted by Casana. Given the FDA submission, it's likely US-based, and it was prospective.

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

• Heart Rate Validation Study: The ground truth was established by a 3-lead ECG device. No human experts are mentioned for establishing ground truth from this reference device.
• SpO2 Clinical Validation Study: The ground truth would typically be established by a co-oximeter for fractional oxygen saturation (as per ISO 80601-2-61), which is a reference medical device. While human experts (e.g., clinicians) would operate the equipment and monitor the subjects, the ground truth itself is derived from the reference device, not expert consensus.
• BioID Validation Study: The ground truth for subject identity would be established by the actual identity of the user as confirmed during the study setup, not by experts adjudicating data.

4. Adjudication method for the test set:

• Heart Rate Validation Study: Not applicable in the traditional sense of expert adjudication. The device's measurements were quantitatively compared against a 3-lead ECG device (the reference standard).
• SpO2 Clinical Validation Study: Not applicable in the traditional sense of expert adjudication. The device's measurements were quantitatively compared against a reference co-oximeter or similar device as per the ISO standard.
• BioID Validation Study: Not applicable. The determination of "true match" or "true non-match" is based on the enrolled individual's identity, not expert adjudication of the algorithm's output.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The studies described focus on the standalone performance of the device against a reference standard or its ability to correctly identify users. These are not studies evaluating human reader performance with or without AI assistance.

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

• Yes, standalone performance studies were done.
  • The Heart Rate Validation study evaluated the Heart Seat's HR measurements directly against a 3-lead ECG.
  • The SpO2 Clinical Validation study evaluated the Heart Seat's SpO2 measurements against a reference standard.
  • The BioID Validation study assessed the algorithm's ability to identify users without human intervention in the identification process itself.

7. The type of ground truth used:

• Heart Rate Validation Study: The ground truth was established using an independent reference medical device (3-lead ECG device).
• SpO2 Clinical Validation Study: The ground truth was established using an independent reference medical device (e.g., co-oximeter), as required by ISO 80601-2-61:2017 for pulse oximeter equipment.
• BioID Validation Study: The ground truth was based on the confirmed identity of the actual subject using the seat.

8. The sample size for the training set:

• The document does not provide information on the sample size used for the training set for any of the algorithms (SpO2, HR, or BioID). The described studies are all validation studies.

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

• The document does not provide information on how the ground truth for the training set was established, as it only details the validation studies, not the development or training phases.

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