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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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The AMC SYSTEM is indicated when a physician wants to periodically measure data of chronically-ill home r nt reason it me monitoring devices connected via wired or wireless facilities to a central station, where parts can be generated and viewed via a Web browser by authorized personnel (e.g. physicians, care givers, and patients). The system is not intended to provide real-time data or real-time monitoring.

The AMC System receives data from cleared home measurement devices via an intermediary organization, stores the information in databases, and produces reports for patients and physicians that can be viewed on the Internet by means of secure transmission methods. The AMC system has no direct interface with patients or patients' measuring devices.

The AMC system performs no diagnosis. It stores the received data in the patient's file as received from intermediate organizations, and generates reports in the form of diagrams, data sheets, histograms and scatter diagrams (where applicable).

The AMC system allows the patient and his doctor to access the patient's data via the Internet by use of secured password-protected access codes. These codes (User name and password) are assigned by the AMC system ..

This document is a 510(k) summary for the AMC System by Advanced Monitored Caregiving Inc. It describes a central station for home medical parameters measurement devices and a transtelephonic digital transmission system.

Based on the provided text, the AMC System is a data management and reporting system; it does not perform any diagnosis or have a direct interface with patients or measurement devices. Because of this, the submission indicates that no clinical tests were required. The 510(k) submission highlights that "The AMC system uses the same technology as the predicate devices, and thus no clinical tests are required. All home measurement devices are FDA-cleared." This implies that the device's performance does not rely on a direct clinical evaluation.

Given the information, the following points can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Software Validation Testing	Undergone extensive validation testing
   Interface Compatibility	Interfaces with intermediary organizations are all tested for compatibility
   Equivalence to Predicate Devices	Uses the same technology as legally marketed predicate devices, ensuring equivalent safety and efficacy.

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

   • Not applicable/Not mentioned, as no clinical tests were required.

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

   • Not applicable/Not mentioned, as no clinical tests were required.

4. Adjudication method for the test set:

   • Not applicable/Not mentioned, as no clinical tests were required.

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/Not mentioned. The device is a data management system, not an AI-assisted diagnostic tool.

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

   • Not applicable/Not mentioned for standalone clinical performance. The "algorithm" (software) underwent non-clinical validation.

7. The type of ground truth used:

   • For software validation, the 'ground truth' would be defined by predefined functional and performance specifications. For regulatory clearance, the ground truth for equivalence was the legally marketed predicate devices.

8. The sample size for the training set:

   • Not applicable/Not mentioned. No machine learning training set is indicated.

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

   • Not applicable/Not mentioned. No machine learning training set is indicated.

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