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CareConsole is intended to be used in conjunction with biometric health care measuring devices, mobile applications, and questionnaires to collect and store data, and for clinician-scheduled monitoring at home and/or in medical facilities. The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications, alerts, and reports can be generated and data can be securely viewed by healthcare professionals, authorized caregivers, and patients. Clinicians would then determine how and when to best treat their patients in response to the notifications, alerts, and biometric data. For use by individuals 12 years and older who do not have an emergency health care condition.

· Data can be sent via intranet networks, the internet, landline telephones, and other mobile devices.

· The software supports communication between patients and clinicians, caregivers, or researchers, such as through bidirectional audio and video e-visits, telephone calls, and mobile text messages.

CareConsole is intended for use in capturing remote patient monitoring data from non-invasive remote monitoring devices and to provide remote hospital-at-home level of care where determined necessary by a health care professional. CareConsole is not intended for use in emergency situations or by a patient in an acute care medical facility.

The CareConsole ("CareConsole") is a software only device. CareConsole enables clinicians and patients to conduct bidirectional audio-video conversations and collects patient-reported outcomes and self-care activities via assessment questionnaires. Biometric measurements, using third party devices, can be taken by the patient while being observed over videoconference by a clinician who is located remotely, or measurements can be made by the patient at any time, without being observed by a clinicians can also use CareConsole to exchange messages with patients by text or telephone.

The system is indicated when health professionals wish to directly interact with patients via video, voice and/or text, and/or view reports of medical parameters collected from patients with non-acute conditions using remote biometric measuring devices and questionnaires. The AMC system is not intended for use in emergency situations.

The provided text describes the regulatory clearance of the AMC Health CareConsole, a software-only device for remote patient monitoring. However, it does not contain specific details about acceptance criteria, the methodology of a study proving the device meets those criteria, or performance metrics from such a study.

The document mainly focuses on:

• Regulatory information: FDA clearance, regulation numbers, product codes, and general controls.
• Device description and intended use: How CareConsole functions (collects, stores, and transmits biometric data, facilitates communication) and its target users (individuals 12+, not for emergency situations).
• Predicate devices comparison: It asserts the substantial equivalence of the CareConsole to its predicate devices in terms of intended use and technological specifications, mainly through a comparison table.
• Compatibility with third-party devices: A list of integrated biometric devices.
• General statement on performance: Mentions that "validation and verification testing were performed under the company's Design Control Process" and "The testing has confirmed the device's conformity with specifications."

Therefore, based only on the provided text, I cannot complete the requested information about acceptance criteria and detailed study results. The document states that performance validation was done to meet regulatory requirements but does not provide the specifics of that validation.

Here's what I can extract or infer, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing: Specific quantitative acceptance criteria or performance metrics (e.g., accuracy percentages, latency times, success rates for data transmission, etc.). The document states that testing confirmed conformity but doesn't provide the results of that conformity testing.

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

• Missing: No information on specific sample sizes for any test sets.
• Data Provenance: Not specified (e.g., country of origin). The document implies the data is gathered remotely from patients using the system. It states "The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information." and lists various third-party devices, suggesting data would come from these sources. It's unclear if a specific "test set" with a defined provenance was used for a formal clinical performance study, or if "testing" refers to internal software validation.
• Retrospective/Prospective: Not specified.

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

• Missing: The document does not describe a study involving expert readers/evaluators for establishing ground truth, as it is a data aggregation and communication platform, not an AI diagnostic imaging device. The "ground truth" here would relate to the successful and accurate transfer, storage, and display of biometric data. The closest mention of experts is "Clinicians," "healthcare professionals," and "authorized caregivers" who view the data.

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

• Missing: Not applicable or not described, as the device is not an imaging AI requiring multiple reader 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:

• Missing: Not applicable. The CareConsole is a data management and communication system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or implied.

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

• Partially Addressed/Inferred: The device is "software only." Its primary function is automated data collection, transmission, storage, and presentation. Thus, its core performance is "standalone" in terms of these automated processes. The "human-in-the-loop" aspect comes in with clinicians viewing the data and interacting with patients, but the device's fundamental data handling is algorithmic. However, there are no specific standalone performance metrics provided (e.g., "algorithm achieved X% accuracy in data transmission"). The document states the "testing has confirmed the device's conformity with specifications."

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

• Inferred: For a device like CareConsole, the "ground truth" would likely be the accuracy and integrity of the data captured from the third-party devices, its faithful transmission, secure storage, and correct display. This would typically be verified against the direct output of the connected biometric device or a known, verified standard. There's no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the device's technical performance.

8. The sample size for the training set:

• Missing: No information provided about a training set, as this is a traditional software system, not described as a machine learning/AI model that typically requires a distinct training set. The "testing" mentioned refers to software verification and validation.

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

• Missing: Not applicable, as no training set for an AI model is described.

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The AMC Health VitalCaregiving System II ("VitalCaregiving System II") is intended to be used in conjunction with biometric measuring devices, mobile applications and questionnaires to collect and store data, and for clinician scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications/alerts and reports can be generated and data can be securely viewed by authorized caregivers and patients. Clinicians would then determine how and when to respond to the alerts/notifications and biometric data. For use by adults 18 years and older who do not have an acute care or emergency health care condition.

• Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices.
  • The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging.

The VitalCaregiving System II is not intended for use in emergency situations or by a patient in an acute care medical facility and is not for active patient monitoring.

The AMC Health VitalCaregiving System II ("VitalCaregiving System II") is a software only device. VitalCaregiving System II enables clinicians and patients to conduct bidirectional audio-video conversations and collects patient-reported outcomes and self-care activities via assessment questionnaires. Biometric measurements using third party devices can be taken by the patient while being observed over videoconference by a clinician who is located remotely, or measurements can be made by the patient at any time, without being observed by a clinician. Clinicians can also use VitalCaregiving System II to exchange messages with patients by text or telephone.

The system is indicated when health professionals wish to directly interact with patients via video, voice and/or text, and/or view reports of medical parameters collected from patients with non-acute conditions using remote biometric measuring devices and questionnaires. The AMC system is not intended for use in emergency situations.

The provided document is a 510(k) summary for the AMC Health VitalCaregiving System II. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a dedicated study proving performance against those criteria. As such, much of the requested information about a specific study proving the device meets acceptance criteria is not present.

However, I can extract information related to how performance was generally validated.

Here's the breakdown of available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, etc. Instead, it states that the device's performance was evaluated by confirming its conformance with specifications through "software verification and validation testing."

The "Performance" section (page 11) states:
"The Vital Caregiving System II is a software only device and the validation and verification testing were performed under the company’s Design Control Process. This device meets all necessary software verification requirements in 21 CFR 820.3(z) and (aa) and 820.30(f) and (g), as described in "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." The testing has confirmed the device's conformance with specifications."

Essentially, the acceptance criterion implicitly is "conformance with specifications" and the reported performance is "testing has confirmed conformance." There are no quantitative metrics or specific performance thresholds provided in this document.

The "Comparison Table" (page 5) compares the subject device with predicate devices across various functional characteristics. While not a performance metric table, it demonstrates that the subject device either matches or extends the capabilities of the predicates, implying that its performance in these functional areas is at least equivalent.

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

This information is not provided in the document. The document refers to "software verification and validation testing" but does not specify the sample size of any data used for these tests, nor its provenance (country of origin, retrospective/prospective).

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

This information is not provided in the document. The document refers to "conformance with specifications" but does not detail how "ground truth" might have been established for any data used in testing.

4. Adjudication method for the test set

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not done or at least not reported in this document. The device is a "software-only device" for data storage, collection, and transmission, and also facilitates communication and e-visits. It is not an AI-assisted diagnostic or interpretive tool where "human readers improve with AI vs without AI assistance" would be a relevant metric.

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

The document describes the "VitalCaregiving System II" as a "software only device." The performance reported is that "The testing has confirmed the device's conformance with specifications." This implicitly describes the standalone performance of the software in terms of its ability to collect, store, transmit, and display data as per its design. However, there are no specific standalone performance metrics (e.g., accuracy of data transmission, latency) provided.

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

The document does not explicitly state the "type of ground truth" used for testing. Given that it's a data collection and transmission system, the "ground truth" would likely relate to the accurate capture, storage, and transmission of biometric data from connected devices, and the correct functioning of communication features. This would typically be validated against expected output values or successful communication logs, rather than clinical 'ground truth' in the diagnostic sense.

8. The sample size for the training set

This information is not provided in the document. As this is a 510(k) for a data management and communication system built upon established technology, it's unlikely to involve a "training set" in the machine learning context. The validation focuses on software engineering principles and functional testing.

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

This information is not provided in the document. (Refer to point 8).

In summary, the provided document is a regulatory submission focused on substantial equivalence and compliance with software validation requirements. It does not contain the detailed clinical or performance study information typically associated with AI/ML diagnostic devices, which would require specific acceptance criteria, test sets, and reader studies. The "study" mentioned generally refers to internal "software verification and validation testing" demonstrating adherence to design specifications and regulatory guidelines for software.

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