(58 days)
Confidant 2.6 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 2.6 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 communication 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, via cell-phone or personal computer. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data.
Confidant 2.6 does not provide diagnosis of any disease or medical condition.
Confidant 2.6 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 2.6 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 2.6 is intended for over-the-counter use.
Confidant 2.6 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 communication 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, via cell-phone or personal computer. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data. Confidant 2.6 currently supports several models of glucose meters, a non-invasive blood pressure cuffs and a weight scale.
Here's an analysis of the provided text regarding the Confidant 2.6 System, focusing on acceptance criteria and supporting studies:
The provided 510(k) summary for the Confidant 2.6 System primarily focuses on demonstrating substantial equivalence to a predicate device (Confidant 2.5, K072698) rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/algorithm.
Therefore, much of the requested information (like specific performance metrics for an AI, sample sizes for training/test sets, expert qualifications, MRMC studies, stand-alone performance, and detailed ground truth establishment) is not present in this document because the device is a data collection and messaging system, not an AI for diagnosis or interpretation of medical images/signals.
However, I will extract what is available and indicate when information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Functional Performance | - Compliance with applied standards. |
- Performance within specifications and functional requirements. | "The test results demonstrate that Confidant 2.6 is in compliance with the applied standards and that it performed within its specifications and functional requirements." |
| Device Compatibility | - Compatibility with supported home monitoring devices (glucose meters, blood pressure cuffs, weight scales), including new devices like the OMNIS glucose meter. | "low-level, device compatibility verification for the OMNIS glucose meter."
"Confidant 2.6 currently supports several models of glucose meters, a non-invasive blood pressure cuffs and a weight scale." |
| Technological Equivalence| - Same types of supported monitoring devices as predicate. - Same operational features as predicate.
- Same fundamental technology as predicate. | "Confidant 2.6 utilizes the same technology as the predicate device (Confidant 2.5, K072698) including: The same types of supported monitoring devices, The same operational features, The same fundamental technology." |
| Safety and Effectiveness | - As safe and effective as the legally marketed predicate device. | "it is our conclusion that Confidant 2.6 is as safe, as effective and performs as well as the legally marketed predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in the context of typical AI/algorithm evaluation (e.g., number of patients, images, or data points). The testing described is "functional performance testing of the new PC Interface software component, and low-level, device compatibility verification for the OMNIS glucose meter." This suggests hardware/software integration and basic functionality checks rather than a clinical performance study with a patient data test set.
- Sample size for test set: Not specified beyond general "testing" of the PC Interface and OMNIS glucose meter.
- Data provenance: Not specified. Given the nature of the device (collects data from home monitoring devices and sends messages), the "data" being tested would likely be simulated or actual readings from these monitoring devices to verify correct transmission and message generation. It's not a study on patient outcomes or disease detection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable/Not provided. The Confidant 2.6 System is not an AI diagnostic device that requires expert-established ground truth for medical conditions. Its function is to collect data, transmit it, and generate pre-defined motivational messages based on that data. The "ground truth" for its testing would involve verifying that the data is transmitted correctly and that the appropriate messages are triggered under specific data conditions, which does not require medical experts for truth establishment in the traditional sense.
4. Adjudication Method for the Test Set
Not applicable/Not provided. Since there's no expert clinical ground truth being established for diagnostic accuracy, there's no need for an adjudication method. Testing would involve engineering validations (e.g., does data transfer correctly, are messages generated as expected).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is used to assess the diagnostic performance of a system (often an imaging CADx system) by comparing multiple human readers with and without AI assistance on multiple cases. The Confidant 2.6 is a data collection and messaging system, not a diagnostic AI that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device's core functionality is standalone in terms of data collection and message generation. However, it's not an "algorithm only" device in the sense of making diagnostic or treatment decisions. It automates information flow and feedback messages, but explicitly states: "Confidant 2.6 does not provide diagnosis of any disease or medical condition." and "Confidant 2.6 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment."
The performance evaluation described ("functional performance testing of the new PC Interface software component, and low-level, device compatibility verification for the OMNIS glucose meter") is essentially a standalone test of its stated functions.
7. The Type of Ground Truth Used
For the described testing, the "ground truth" would be:
- Expected data transmission: Verification that data from home monitors is accurately received by the server.
- Expected message generation: Verification that the system generates the correct pre-defined feedback messages based on the received data, according to its internal logic.
- Compatibility verification: That the device successfully interfaces with and collects data from specified home monitoring devices (e.g., OMNIS glucose meter).
This is a form of functional/technical validation rather than medical ground truth (e.g., pathology, outcomes).
8. The Sample Size for the Training Set
Not applicable/Not provided. The Confidant 2.6 is not an AI device developed using machine learning that requires a "training set" in the conventional sense. It's a rules-based system that processes data and generates messages based on pre-programmed logic rather than learning from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As there is no training set mentioned, this information is not relevant to the described device.
§ 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).