(97 days)
The MediCompass® Connect serves as an interface or a gateway between personal monitoring devices and a general-purpose personal health management database. The MediCompass Connect collects physiologic measurements and retrospectively monitors vital signs from defined personal monitoring devices and transmits the data to a central database server, using standard communication technologies. MediCompass Connect is designed for professional, personal and home use.
MediCompass Connect is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.
MediCompass® Connect is a telehealth gateway to upload biometric data from personal health monitoring devices, including glucose monitors, insulin pumps, blood pressure monitors, digital spirometers, pulse oximeter, PT/INR meter, activity monitor/pedometer, and weight scales. The system conveniently transfers data via a standard phone line or Internet-enabled personal computer using the MetrikLink® connectivity hub, or connection directly to mobile devices via wireless technology.
After connectivity is activated by a health care professional, patients can connect their monitoring device to MediCompass Connect using MetrikLink, adapters or compatible cables provided for their specific medical device and model. The data captured from the personal monitoring medical devices is transferred securely to the MediCompass database or other secure online database, then to the health care provider's remote general purpose health management database.
MediCompass Connect does not provide diagnosis of any disease or medical condition, nor is it 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.
MediCompass Connect is not intended for emergency use 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.
The provided text describes the MediCompass® Connect, a telehealth gateway. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular performance metrics.
The document mainly focuses on:
- Regulatory information: Device classification, predicate devices, and FDA substantial equivalence determination.
- Device description: How it functions as an interface to transfer biometric data.
- Indications for Use: The intended purpose of the device.
- Performance Testing (High-level): A brief statement saying "Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of MediCompass Connect... The results of all performance testing were acceptable and demonstrated performance as intended."
Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth, and expert involvement for a specific study proving device performance cannot be extracted from this document.
Here's how to address each point based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in the document) | "The results of all performance testing were acceptable and demonstrated performance as intended." |
| Functionality as a data transfer gateway | Demonstrated in performance testing. |
| Reliability of data transfer | Demonstrated in performance testing. |
| Connectivity with listed personal monitoring devices | Demonstrated in performance testing (implied by "support the connection of additional personal medical devices"). |
| Secure data transfer to database | Implied by device description ("data captured... is transferred securely to the MediCompass database"). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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)
- This information is not applicable as the document does not describe a study involving expert-established ground truth for diagnostic or clinical performance. The device is a data transfer gateway, not a diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; no clinical study or diagnostic performance evaluation described.
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 MRMC study was done. This device is not an AI diagnostic tool and does not involve human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- A "standalone" performance testing for the device's function as a data gateway was done, as stated: "Verification and validation testing activities were conducted to establish the performance, functionality and reliability characteristics of MediCompass Connect... The results of all performance testing were acceptable and demonstrated performance as intended." However, no quantitative standalone performance metrics (e.g., accuracy of data transfer, speed, error rate) are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The concept of "ground truth" as typically used in diagnostic or AI studies is not directly applicable here. The device's function is data transfer. Its "ground truth" would likely involve successful transfer of data identical to the source, without corruption or loss. The text does not detail how this "ground truth" for data integrity was established during testing.
8. The sample size for the training set
- Not applicable. This device is a hardware/software system for data transfer, not an AI model that requires a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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).