(76 days)
Confidant 2.0 is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. Confidant 2.0 is to be used only upon prescription of a licensed physician or other authorized healthcare provider.
Confidant 2.0 is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention.
Confidant 2.0 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 2.0 is an accessory device that collects data from a range of supported measurement devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Confidant 2.0 currently supports several models of glucose meters, non-invasive blood pressure cuffs and weight scales.
The Confidant 2.0 device is a physiological transmitter and receiver that collects and transmits medical measurements to a healthcare provider and provides educational and motivational messages to the patient.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific, quantifiable acceptance criteria such as accuracy thresholds, sensitivity, or specificity. Instead, the evaluation focuses on "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to legally marketed predicate device (The Hermes System K050929) | Confidant 2.0 provides equivalent functionality to The Hermes System K050929. |
| Additional Device Support | Confidant 2.0 supports six models of off-the-shelf glucose meters (vs. 1 for predicate), two models of blood pressure cuffs (vs. 1 for predicate), and two models of weight scales (vs. 1 for predicate). |
| Battery Powered Data Converter | Confidant 2.0 uses a battery-powered serial to Bluetooth data converter (vs. AC powered for predicate). |
| Safety and Effectiveness | An extensive collection of tests was conducted and successfully completed, and Confidant Inc. concluded that the device presents no new concerns about safety and effectiveness. The FDA concurred with substantial equivalence. |
| Intended Use | The device's intended use, as stated, is to collect and transmit medical measurements and provide educational/motivational messages to out-of-hospital patients, upon prescription. It is not for emergency calls, real-time alarms, automated treatment decisions, or as a substitute for direct medical supervision. The device performed within this intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "usability and pilot studies" and "software unit, integration, system and load/performance testing," but it does not specify the sample size for any test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for a test set. This type of device (physiological transmitter and receiver) primarily focuses on data collection and transmission functionality, rather than diagnostic interpretation that would typically require expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since the document does not describe a clinical study or a test set requiring interpretation, there is no mention of an adjudication method.
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
There is no indication of an MRMC comparative effectiveness study being conducted. The device is not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "stand-alone" performance of the Confidant 2.0 device itself was implicitly evaluated through "software unit, integration, system and load/performance testing." This testing would assess the device's functionality (data collection, transmission, message delivery) without direct human intervention in the core operational loop. However, the exact methodology and results are not detailed beyond "successfully completed."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device, the "ground truth" for the functional and safety testing would likely involve:
- Successful transmission and reception of data: Verifying that measurements are accurately collected from supported devices and transmitted to the database server.
- Correct message delivery: Confirming that educational and motivational messages are delivered to the patient as intended based on configured parameters.
- System stability and performance: Ensuring the device operates reliably under various conditions.
The document does not explicitly state "ground truth" based on expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic or prognostic devices.
8. The sample size for the training set
The document does not mention a training set or its sample size. The device functions as a data collection and transmission system, not a machine learning model that typically requires a distinct training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, there is no information on how its ground truth would have been established.
§ 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).