(53 days)
Confidant 2.5 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health.
Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.
Confidant 2.5 does not provide diagnosis of any disease or medical condition.
Confidant 2.5 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
Confidant 2.5 is not intended for emergency calls or for transmission of any real-time alarms or timecritical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.
Confidant 2.5 is intended for over-the-counter use.
Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.
Confidant 2.5 currently supports several models of glucose meters, noninvasive blood pressure cuffs and weight scales.
The provided text describes the Confidant 2.5 system, its intended use, and its equivalence to predicate devices, but it does not contain information about specific acceptance criteria or an explicit study proving performance against those criteria.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:
- Same supported monitoring devices
- Same operating features
- Same fundamental technology
The "Discussion of functional and safety testing" section (page 2) states:
"Testing of Confidant 2.5 included electrical safety and EMC testing of the Confidant Connector component; software testing of the Confidant Collector and Confidant Server components; and low-level, device compatibility testing with each of the supported monitoring devices. The test results demonstrate that Confidant 2.5 is in compliance with the applied standards and that it performed within its specifications and functional requirements."
This general statement asserts that the device met its specifications and functional requirements, but it does not define what those specifications or functional requirements were (i.e., the acceptance criteria), nor does it provide details about the study methodology, sample sizes, or outcome metrics.
Therefore, I cannot populate the requested table or answer most of the questions as the specific details are not present in the provided text.
Here's what can be inferred or explicitly stated based on the text, with the understanding that key details for many points are missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific criteria not defined in the document | "Confidant 2.5 is in compliance with the applied standards and that it performed within its specifications and functional requirements." |
| Electrical Safety & EMC | Compliance with applied standards. |
| Software functionality | Performed within specifications and functional requirements. |
| Device compatibility with supported monitoring devices | Compatibility testing demonstrated performance within specifications and functional requirements. |
2. Sample sized used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., 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
- Number of experts: Not applicable, as this device primarily involves data collection and messaging, not interpretation requiring expert ground truth in the traditional sense (e.g., for image analysis or diagnosis). The testing described is functional and safety-oriented.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Not applicable, as the testing described is functional and safety-oriented, not involving subjective interpretation 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, an MRMC comparative effectiveness study was not done. The device is a data collection and messaging system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The software testing of the Confidant Collector and Confidant Server components could be considered a form of standalone performance evaluation for the algorithmic aspects (e.g., data processing, message generation). However, specific metrics, methodology, and results for "standalone performance" in a quantitative sense (like accuracy, sensitivity, specificity) are not provided. The conclusion statement vaguely refers to "performance testing."
7. The type of ground truth used
- For electrical safety, EMC, and device compatibility, the "ground truth" would be established by relevant engineering standards and physical verification methods. For software, it would be its design specifications and functional requirements. There is no mention of expert consensus, pathology, or outcomes data in the context of this device's testing.
8. The sample size for the training set
- Not applicable. This document describes a traditional medical device (data collector/messenger) and its testing for 510(k) clearance, not an AI/ML-based diagnostic device that typically involves training data sets. While it selects messages based on "currently submitted and recent historic data," this refers to patient data for operational use, not a separate "training set" for model development in the context of a performance study.
9. How the ground truth for the training set was established
- Not applicable, as no training set (in the AI/ML context) is described.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).