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The Vignet TeleHealth Manager is an accessory software application that is intended to be used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Vignet Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.

The Vignet TeleHealth Manager does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.

The Vignet TeleHealth Manager is a software system that collects patient physiological data such as blood pressure and blood sugar levels for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols. This data is also available to the patient for viewing purposes and as an aid in maintaining wellness regimens.

The provided text describes a "Telemedicine System" called "Vignet TeleHealth Manager", which is a software application. The document states that the device is substantially equivalent to a predicate device and "no new issues of safety, performance, technology or intended use were identified" after "extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis".

However, the document does not provide a specific table of acceptance criteria with reported device performance metrics, nor does it outline a study in the conventional sense (e.g., clinical trial with specific endpoints, statistical analysis, etc.) for performance evaluation of the software itself.

Based on the provided text, here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

No explicit table of acceptance criteria with reported quantitative performance metrics (e.g., accuracy, sensitivity, specificity, data integrity rates) is provided for the Vignet TeleHealth Manager software itself. The document mentions "performance requirements and criteria established in accordance with application of EN14971 risk analysis" and states that "no new issues of safety, performance, technology or intended use were identified" after "extensive bench testing." This implies that the device met internal performance and safety criteria, but these are not quantified or detailed in the submission.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The "extensive bench testing" mentioned is for a software application focused on data collection, recording, and transmission, rather than an algorithm performing diagnostic or predictive functions on a dataset. There is no mention of a "test set" in the context of patient data for performance evaluation in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. As noted above, there is no "test set" of patient data for which a ground truth would need to be established by experts for this software.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as there is no "test set" of patient data and no algorithmic output requiring adjudication.

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

No. This device is a "Telemedicine System" software for data collection and transmission, not an AI or diagnostic algorithm intended to assist human readers (e.g., radiologists, pathologists). Therefore, an MRMC study is not relevant to its function as described.

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

No. The device is a "software system that collects patient physiological data... for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention." It explicitly states: "The Vignet TeleHealth Manager does not measure, interpret or make any decisions on the data that it conveys." Therefore, there is no "algorithm" in the sense of a decision-making model whose standalone performance would be evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. There is no ground truth involved in the evaluation of this software as it does not interpret data or make decisions. Its function is to accurately collect, record, and transmit physiological information.

8. The sample size for the training set

Not applicable. This is a software application for data management, not a machine learning or AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of software application.

Summary of what the document does state about performance and testing:

The Vignet TeleHealth Manager is a software application. Its performance was assessed through:

• Extensive bench testing: This was conducted "to performance requirements and criteria established in accordance with application of EN14971 risk analysis."
• Safety assessment: No electrical safety or electromagnetic testing was required because it is a software application.
• Outcome of testing: "no new issues of safety, performance, technology or intended use were identified."
• Conclusion: The device is concluded to be substantially equivalent to the identified predicates based on these assessments.

The performance criteria in this context would likely relate to the software's ability to:

• Successfully connect with listed external biometric devices.
• Accurately collect physiological data from these devices.
• Correctly record and store the collected data.
• Reliably transmit the data to a remote secure server.
• Ensure data integrity during collection, storage, and transmission.
• Provide accessibility to stored data for healthcare professionals and patients.
• Maintain security and privacy of health information.

However, the specific quantitative metrics used to evaluate these aspects during "extensive bench testing" are not detailed in the provided document.

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