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The Brocomfort Health Manager is a software for local home PC or Laptop in a non clinical environment to collect historical data from defined peripheral devices The software will receive, store and display measurements from home use diagnostic medical devices such blood pressure meter and a body composition analyser The data will not be used for medical diagnosis It is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgement

The Brocomfort Health Manager is a software for local home PC or Laptop in a non clinical environment HM can manage up to 8 users With the HM the Biocomfort devices can be bound with the USB-Dongle from Biocomfort After the devices are bound and programmed with HM, the user can measure with the devices

The provided text is a 510(k) summary for the Biocomfort Health Manager 2.0, a software device intended to collect, store, and display measurements from home-use diagnostic medical devices. The document explicitly states the device's intended use and makes comparisons to a predicate device (Confidant 2.5) to establish substantial equivalence.

However, this document does not contain information on acceptance criteria for device performance or a study demonstrating the device meets those criteria. The "SE Discussion" section compares the new device to a predicate device on various characteristics, but this is to establish substantial equivalence based on functional and operational similarities and differences, not performance metrics against specific acceptance criteria.

Therefore, many of the requested items cannot be answered from the provided text.

Based on the available information:

1. Table of acceptance criteria and reported device performance:
* Not Available. The document does not specify any performance acceptance criteria or report device performance against such criteria. The discussion focuses on comparing the new device's features and intended use to a predicate device to establish substantial equivalence, not on quantitative performance metrics.

2. Sample size used for the test set and data provenance:
* Not Applicable / Not Available. No performance testing with a specific test set is described. The 510(k) summary focuses on establishing substantial equivalence through feature comparison with a predicate device.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
* Not Applicable / Not Available. Since no performance study is described, there's no mention of a test set or ground truth established by experts.

4. Adjudication method for the test set:
* Not Applicable / Not Available. No performance study or test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
* No. An MRMC study was not mentioned. The device is software for managing data from home-use devices, not an interpretative AI that would typically be involved in such a study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not Applicable / Not Available. The document describes a software device that collects, stores, and displays data. It does not describe an "algorithm" in the sense of an interpretative AI requiring standalone performance testing. The comparison is feature-based against a predicate.

7. The type of ground truth used:
* Not Applicable / Not Available. No performance ground truth is mentioned as no explicit performance study is detailed.

8. The sample size for the training set:
* Not Applicable / Not Available. Software for data management (not a machine learning algorithm requiring training on data to make predictions) is being described. Therefore, a training set is not pertinent to this submission type.

9. How the ground truth for the training set was established:
* Not Applicable / Not Available. (See point 8).

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