(444 days)
The American TeleCare, Inc. Personal Telemedicine System (PTS) is intended to be used to transmit medical information between a patient at one location, typically in their home, and a medical practitioner at another location, typically a home care nurse at a central nursing station. Information is transmitted over normal residential telephone lines and utilizes two-way video and voice communication.
The PTS is typically used in home health care situations as an augment to home care nursing.
In essence, the PTS allows a medical practitioner to make a "video-visit" TM to the patient rather than a physical visit. In this "video-visit," the medical practitioner can conduct many of the same diagnostic tests that would be performed in a physical visit.
The Personal Telemedicine System (PTS) is an assembly of medical products, each of which was previously cleared by the FDA for commercial distribution to patients for their in home use. These products are assembled into a housing which incorporates a videophone and speakerphone and thereby allows a medical practitioner to communicate directly with a patient in a remote location, both verbally and visually, to perform an examination.
Use of the PTS begins by either the medical practitioner placing a call to the patient's videophone or the patient pushing the "CALL" button on the PTS unit to notify the medical practitioner to call them. The medical practitioner then determines the patient's status through questions and answers, through visual examination via the videophone, and through use of the medical products. Visual examination is enhanced by the patient placing themselves in relation to the camera portion of the videophone and by use of a specially made magnifying lens placed in front of the camera portion of the videophone. The medical practitioner walks the patient through use of the medical products and the results of each test are presented verbally to the medical practitioner.
The medical products in the PTS unit are being used for the same purposes for which they received 510(k) clearance. The unit as a whole, however, has never been submitted to the FDA for clearance.
Here's an analysis of the provided text regarding the Personal Telemedicine System (PTS), focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain specific acceptance criteria or quantitative performance data in a format that lends itself to this table. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than a stand-alone performance study with defined criteria and results.
Instead, the document asserts:
- The constituent medical devices within the PTS "were previously cleared by the FDA for commercial distribution to patients for their in home use."
- "The medical products in the PTS unit are being used for the same purposes for which they received 510(k) clearance."
- The PTS, as an assembly, allows "a medical practitioner to communicate directly with a patient in a remote location, both verbally and visually, to perform an examination."
- This enables the medical practitioner to "conduct many of the same diagnostic tests that would be performed in a physical visit."
Therefore, the "acceptance criteria" are implicitly that the integrated system functions as intended for telemedicine, leveraging the existing clearances and functionalities of its components. The "reported device performance" is the assertion that it achieves this without new safety or effectiveness concerns.
| Acceptance Criteria (Inferred from Text) | Reported Device Performance |
|---|---|
| Ability to transmit medical information (video/voice) between patient and practitioner. | Achieved via integration of previously cleared medical and communication products. |
| Functionality of integrated medical devices for their intended use. | Each component device maintains its original 510(k) cleared intended use. |
| Communication over normal residential telephone lines | Explicitly stated. |
| Allows practitioner to perform examinations remotely | Stated as the primary function ("video-visit"™). |
| System operates safely using standard household energy sources. | Explicitly stated (compared to predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not describe a specific test set, sample size, or data provenance (country of origin, retrospective/prospective) for a clinical study to evaluate the PTS as a whole. The submission relies on the prior clearances of its individual components.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No specific study requiring expert-established ground truth for the PTS as an integrated system is described in this summary.
4. Adjudication Method
Not applicable. No study or ground truth establishment process requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The summary does not mention an MRMC study comparing human readers with and without AI assistance. The PTS is a communication system, not an AI diagnostic tool.
6. Standalone Performance (Algorithm Only)
Not applicable. The PTS is an integrated communication and medical device system involving human interaction, not a standalone algorithm. Its performance is tied to its functional components and the human practitioner's use.
7. Type of Ground Truth Used
Not applicable in the context of a new efficacy study for the PTS. The "ground truth" for the individual components of the PTS would have been established during their initial 510(k) clearances, likely through a combination of performance testing, clinical data, and comparison to predicate devices. For the PTS itself, the ground truth is its ability to facilitate remote medical consultation using these pre-cleared components as intended.
8. Sample Size for the Training Set
Not applicable. The PTS is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set is mentioned or implied for this device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).