(119 days)
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:
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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. -
Sample size used for the test set and the data provenance:
- Not applicable/Not mentioned, as no clinical tests were required.
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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.
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Adjudication method for the test set:
- Not applicable/Not mentioned, as no clinical tests were required.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable/Not mentioned. No machine learning training set is indicated.
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How the ground truth for the training set was established:
- Not applicable/Not mentioned. No machine learning training set is indicated.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).