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K Number
K230996
Device Name
Pursuant Health Kiosk (G1.D5)
Manufacturer
Pursuant Health
Date Cleared
2024-01-04

(272 days)

Product Code
DXN,QZP
Regulation Number
870.1130
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Pursuant Health Kiosk is intended to be used by the general public so that a user can measure their own blood pressure, pulse rate, and weight. Additionally, the kiosk can capture digital images of an adult user's retina without the use of a mydriatic agent. It is not a diagnostic device and only furnishes retinal images that users can send to their personal physician or other healthcare professional.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the Pursuant Health Kiosk (G1.D5). It confirms the device's substantial equivalence to legally marketed predicate devices. However, this document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document lacks the following:

  1. A table of acceptance criteria and reported device performance: This information is typically found in the technical specifications, verification and validation reports, or performance studies submitted with the 510(k) application, not in the clearance letter itself.
  2. Sample size used for the test set and data provenance: The letter does not describe any specific test sets, their sizes, or their origin (e.g., country, retrospective/prospective).
  3. Number of experts used to establish ground truth and their qualifications: This detail is part of the clinical or performance study design, which is not included in the clearance letter.
  4. Adjudication method for the test set: Not mentioned in the clearance letter.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study details: The letter does not discuss any MRMC studies, effect sizes, or human reader improvement with AI assistance.
  6. Standalone (algorithm-only) performance: The letter does not provide this information.
  7. Type of ground truth used: This detail would be in the study design, not the clearance letter.
  8. Sample size for the training set: The letter does not discuss the training of any algorithms or associated sample sizes.
  9. How ground truth for the training set was established: Not mentioned.

In summary, this document is a regulatory clearance letter, not a detailed technical or clinical study report. Therefore, it is impossible to extract the requested information from the provided text. To answer these questions, one would need access to the actual 510(k) submission, including the performance data, validation studies, and possibly clinical study reports, which are not part of this clearance letter.

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).