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K Number
K042768
Device Name
MEDICOMPASS CONNECT
Manufacturer
IMETRIKUS, INC.
Date Cleared
2005-02-22

(140 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
K040086
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

MediCompass Connect serves as an interface or a gateway between personal monitoring devices and a general purpose personal health management database. Monitoring devices that can interface to the MediCompass Connect include, but are not limited to:

  • Blood glucose monitor
  • Blood pressure cuffs I
  • Insulin pumps
  • Spirometers
  • . Scales

MediCompass Connect is designed for professional healthcare settings and home use.

Device Description

MediCompass Connect is a system that transmits data from personal monitoring devices using standard communication methods such as telephone lines or wireless, or transmits data by using a PC that has a connection to the Internet. MediCompass Connect transmits the data from a personal monitoring devices, such as a blood pressure cuff, to a remote general-purpose personal health management database.

  • Blood pressure cuffs .
  • . Blood glucose meters
  • Insulin pumps .
  • Spirometers .
  • . Scales
AI/ML Overview

This document is a 510(k) premarket notification for the MediCompass Connect device, which is a data transfer system for personal monitoring devices. It outlines the regulatory classification, a comparison to a predicate device, and the list of devices it is validated to work with. However, it does not contain the specific acceptance criteria or the results of a study that prove the device meets such criteria.

Therefore, I cannot populate the table or provide details for most of your questions based only on the provided text. The document is primarily a regulatory submission for substantial equivalence rather than a detailed performance study report.

Here's what I can infer and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

  • Acceptance Criteria: Not specified in this document. This document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative performance criteria related to accuracy or clinical effectiveness.
  • Reported Device Performance: Not provided. The document lists which devices MediCompass Connect is validated for use with, implying functional compatibility, but does not present data on its performance (e.g., data transfer success rate, speed, or accuracy of data transmission) against any set criteria.

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

  • Sample Size: Not specified.
  • Data Provenance: Not specified.

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

  • Not applicable as no specific test set or ground truth establishment relevant to device performance is described.

4. Adjudication method for the test set:

  • Not applicable.

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:

  • Not applicable. This device is a data transfer system, not an AI-powered diagnostic tool involving human readers.

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

  • Not explicitly stated. The "validation for use with" section (page 4) suggests functional testing for compatibility, but not a standalone performance study in the sense of an algorithm's diagnostic accuracy.

7. The type of ground truth used:

  • Not applicable as no specific ground truth for performance evaluation is mentioned. The ground truth for this type of device would likely be accurate data transfer, which would be verified through functional testing rather than expert-established ground truth.

8. The sample size for the training set:

  • Not applicable, as this device does not appear to involve machine learning or AI that would require a training set in the typical sense. It is a data transfer system.

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

  • Not applicable.

What information is provided regarding the device's assessment:

  • Predicate Device: Health Buddy® with BuddyLink (K040086) (Page 3).
  • Comparison: MediCompass Connect is stated to be "substantially equivalent" to the predicate device for general-purpose personal health management information communication (Page 4).
  • Validated Devices: A list of 27 personal monitoring devices (blood glucose monitors, blood pressure monitors, insulin pumps, spirometers) from various brands (Roche, Bayer, Abbott, LifeScan, Becton, Dickinson, and Company, HDI, A&D Medical, Omron Healthcare) that MediCompass Connect is validated to work with (Page 4). This indicates functional compatibility testing, but the details of this testing (e.g., how many tests per device, success rate, specific metrics) are not included in this summary.

§ 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).