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K Number
K122076
Device Name
PERSONAL HEALTH CENTER (PHC)
Manufacturer
ADFLOW HEALTH NETWORKS INC
Date Cleared
2013-04-15

(273 days)

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

The ADFLOW Personal Health Center (PHC) is indicated for and consists of

    1. A Blood Pressure Monitor (BPM) that is used for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides blood pressure and heart rate data to the users, who are advised to consult a physician.
    1. a Body Composition Monitor (BCM) that is used as a body fat analyzer that estimates the percent body fat (%BF), percent lean body mass (%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis).

The PHC is intended for healthy subjects between 8 and 92 years.

Device Description

The ADFLOW Personal Health Center (PHC) consists of a Blood Pressure Monitor (BPM) and a Body Composition Monitor (BCM). The BPM measures blood pressure and heart rate. The BCM estimates percent body fat, percent lean body mass, and percent total body water using bioelectrical impedance analysis (BIA).

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the ADFLOW Personal Health Center. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a product's technical documentation or clinical study results.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It briefly mentions the "Indications for Use" for the Blood Pressure Monitor (BPM) and Body Composition Monitor (BCM) components, but does not provide any specific acceptance criteria or study data demonstrating the device meets those criteria.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
  2. Sample size used for the test set and the data provenance: Not available.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
  4. Adjudication method for the test set: Not available.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available.
  6. If a standalone performance study was done: Not available.
  7. The type of ground truth used: Not available.
  8. The sample size for the training set: Not available.
  9. How the ground truth for the training set was established: Not available.

This document serves as an FDA clearance letter, not a detailed technical or clinical study summary. To obtain the information you're looking for, you would typically need to consult a different type of document, such as the 510(k) submission summary, a clinical study report, or the device's technical specifications.

§ 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).