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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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The tenso-comfort BPM 105 /BPM 205 is a wrist non-invasive blood pressure device which is intended for use in measuring blood pressure and pulse rate in adult patient population. The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard. The model version BPM 105 is equipped with a radio module to transmit the measurement data to a PC. The device is not intended for neonatal use.

The non-invasive wrist blood pressure meter BPM105 and BPM205 determine the arterial blood pressure by means of the oscillometric blood pressure measuring method. With this method the pressure fluctuations are measured, which develop when depressing pulse-cyclic blood pulses in the compressed arteria under the blood pressure cuff put on. The blood pressure apparatus in the model variant BPM105 is equipped with a radio module, with which the transmission of the stored measured values on a PC is optionally possible (radio interface for PC and software is offered as accessory).

Here's a summary of the acceptance criteria and the study information for the tenso-comfort BPM 105 / 205 device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the tenso-comfort BPM 105 / 205 focus on its measurement accuracy compared to established standards for non-invasive blood pressure devices.

Note: The document explicitly states "The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard." This implies that the device's accuracy was compared against auscultatory measurements, which is a standard method for validating blood pressure monitors.

Study Information

The provided 510(k) summary does not include a detailed report of a specific clinical study proving the device meets the acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device, the TaiDoc Clever TD-3018A (K051703), which presumably has already undergone such validation.

The substantial equivalence discussion indicates that the measurement accuracy of the tenso-comfort BPM 105 / 205 is claimed to be equivalent to that of the predicate device.

Given the information provided, many of the requested details about a specific validation study are absent. However, based on what is available, we can infer the following:

2. Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The document refers to the oscillometric method referring to the auscultatory method as the reference standard, implying such testing would have been done.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For validation against an auscultatory method, it would typically involve trained medical professionals taking blood pressure measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated.
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 standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The listed accuracy metrics for Pressure and Pulse are for the device's performance directly, without human intervention in the measurement process (beyond operating the device). The device's oscillometric method is an algorithm that directly provides the blood pressure and pulse readings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for blood pressure measurement is stated as the "auscultatory method as the reference standard." This typically involves measurements taken by trained healthcare professionals using a stethoscope and sphygmomanometer.
8. The sample size for the training set: Not applicable and not mentioned. This is a measurement device, not an AI model that requires a training set in the conventional sense. The "training" of such a device refers to its design and calibration processes.
9. How the ground truth for the training set was established: Not applicable for a training set in the context of an AI model. For the device's design and calibration, the reference standard would be the auscultatory method.

In summary, the 510(k) summary primarily demonstrates substantial equivalence to a predicate device by comparing technical specifications and intended use. While it states the device operates under the oscillometric method with reference to the auscultatory standard for accuracy, the specific details of a dedicated clinical validation study for this device (tenso-comfort BPM 105 / 205) are not provided in this document. Such studies would have been performed for the predicate device and the new device would be expected to perform similarly given the equivalence argument.

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