(94 days)
The FORA TeleHealth System is intended for use by patients remotely in combination with a variety of monitoring devices upon the prescription of healthcare professionals The system serves as the communication link between the FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center
The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results. home users and healthcare professionals can do health management effectively
The FORA TeleHealth System may not be used as a substitute for direct medical intervention or emergency care Interpretation of the information collected and transmitted requires clinical judgment by an appropnate healthcare professional
This system is to be used or prescribed on the order of a physician
FORA TeleHealth System serves as the communication link between FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center
The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results, home users and healthcare professionals can do health management effectively
The provided document is a 510(k) summary for the FORA TeleHealth System. It outlines the device's intended use, comparison to predicate devices, and concludes that it demonstrates satisfactory performance. However, it lacks detailed information regarding specific acceptance criteria and the comprehensive study results that would typically be found in a performance evaluation report.
Based on the information given, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document states, "Testing of FORA TeleHealth System and user evaluation indicate that the system meets the acceptable criteria." However, it does not explicitly list the acceptance criteria or provide specific performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in the document) | "the system meets the acceptable criteria" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The general statement "Testing of FORA TeleHealth System and user evaluation" does not give details about the test set's sample size or its provenance.
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 provided. The document makes no mention of experts or how ground truth was established for any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. There is no mention of adjudication methods.
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
A multi-reader multi-case comparative effectiveness study is not mentioned. The device is described as a communication link for existing monitoring devices, not an AI diagnostic tool that would typically involve human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm is not explicitly mentioned in the context of the device's function. The "FORA TeleHealth System" is primarily a data transmission and review system, not an algorithm that performs standalone diagnoses or measurements. The "testing" likely refers to the system's ability to accurately transmit data from compatible devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used for any testing. Given the system's function as a data relay, the "ground truth" would likely relate to the accuracy of data transmission and display, rather than medical diagnoses.
8. The sample size for the training set
This information is not applicable/not provided. The FORA TeleHealth System is a data transmission and review system. It's not described as a machine learning or AI-based diagnostic tool that would typically have a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as above.
§ 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).