(344 days)
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
| Acceptance Criteria (Inferred from general statements) | Reported Device Performance (Explicitly Stated / Inferred from "conformity") |
|---|---|
| Conformity with specifications (Functional, Performance) | "The testing has confirmed the device's conformity with specifications" |
| Meeting software verification requirements (21 CFR 820.3(z) and (aa) and 820.30(f) and (g)) | Device meets these requirements as described in "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." |
| Data acquisition from third-party devices | "Established pathways for each gateway to extract data from the medical device and input it into AMC's cloud-based data center." |
| Secure data transmission via Internet | "Used an encrypted transport technology with redundant, private connections between the network providers and AMC's cloud-based data center." |
| Secure data storage/access for patient info | "Patient's information is available in a number of tabular and graphical views, providing a detailed analysis of the data." |
| Patient engagement features (messaging, e-visits) | "Provides for interactive eVisits between patient/caregiver and clinician. Generates alerts, notifications, reports and dashboards." |
| Data integration with 3rd party applications | "Securely transfers patient information to 3rd party applications, such as electronic personal health records (PHR) and electronic data capture (EDC)." |
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).