(34 days)
The Personal Telemedicine is intended to be used solely as a monitorium device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, and to listen to the patient's heart and lung sounds.
The PTM 1 consists of a blood pressure meter, a telephonic stethoscope and a speaker/microphone circuit. Both the blood pressure meter and telephonic stethoscope have been cleared by FDA. Neither device has been altered for use with the PTM 1. Instead, they have been placed in a common enclosure for the convenience of the patient. The principal differences between the PTM 1 and the PTS are: (1) the removal of the videophone; (2) the addition of the speaker/microphone circuitry, and (3) the modification of the enclosure.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for American Telecare, Inc.'s Personal Telemedicine Module, focusing on its substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request for the following information:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily discusses the device's intended use, its components (blood pressure meter, telephonic stethoscope, and speaker/microphone circuit), and justifies its substantial equivalence by highlighting that its core components were previously cleared by the FDA and the modifications do not raise new safety or effectiveness concerns. It mentions that the company "has conducted testing which demonstrates the compatibility of this device in the new enclosure," but provides no details about this testing, its criteria, or results.
§ 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).