(80 days)
The Digital Personal Telemedicine Module is intended to be used solely as a monitoring device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds.
The Digital Telemedicine Module ("Digital PTM") and the predicate devices listed above have the same intended use and principles of operation and very similar technological characteristics. Specifically, both the Digital PTM and the Personal Telemedicine Module ("PTM") consist primarily of a blood pressure meter, a telephonic stethoscope, and a speaker/microphone circuit; these three components are placed in a common housing but are not interconnected by hardware or software.
The provided text describes the 510(k) submission for American TeleCare's Digital Personal Telemedicine Module (K973873). The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel claim.
Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in the provided document. The submission is primarily a comparison to existing, already cleared devices.
Here's what can be extracted and inferred based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K964554) in: | The Digital PTM and the predicate devices have same intended use and principles of operation, and very similar technological characteristics. |
| - Intended Use | "intended for use as monitoring devices, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds." |
| - Principles of Operation | "Operation of either device consists of: 1) connecting the device to a video system; 2) establishing voice/video communication; 3) establishing communication between the sending and receiving units of a telephonic stethoscope; 4) obtaining a blood pressure and pulse reading; and 5) obtaining and transmitting to heart or lung sounds." |
| - Technological Characteristics | "Digital PTM... consist primarily of a blood pressure meter, a telephonic stethoscope, and a speaker/microphone circuit; these three components are placed in a common housing but are not interconnected by hardware or software." |
| - Not raising new questions of safety or effectiveness due to modifications. | "bench testing and clinical studies demonstrate that these modifications do not adversely affect the quality of the transmitted signal." |
(Note: The "acceptance criteria" here are implied by the substantial equivalence framework. The text doesn't explicitly state quantitative performance acceptance criteria for a new claim.)
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical studies" for the telephonic stethoscope component but does not provide details on sample size, data provenance (country of origin), or whether these studies were retrospective or prospective. It is likely these were comparison studies to ensure the signal quality wasn't degraded, rather than studies designed to establish stand-alone clinical accuracy against a ground truth.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not provided in the document. The general nature of the device (a remote monitoring module for a healthcare professional) suggests that a traditional MRMC study for diagnostic performance improvement with AI assistance would not be applicable, as it's not an AI-powered diagnostic device. The device facilitates data transmission for human review.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is described as a "monitoring device" where a "health care professional can... communicate with the patient" and "listen to the patient's heart and lung sounds." This inherently implies human-in-the-loop operation, as the device's function is to transmit data to a professional.
7. The Type of Ground Truth Used
The document mentions "bench testing and clinical studies" demonstrating that modifications "do not adversely affect the quality of the transmitted signal" for the telephonic stethoscope. This implies the ground truth for these studies would likely be the signal quality of the predicate device (CareTone II) or an objective measure of acoustic fidelity, rather than clinical outcomes or pathology for a diagnostic claim (since it's explicitly stated "Neither device is intended to be used for diagnostic purposes").
8. The Sample Size for the Training Set
This information is not provided in the document. As the device is primarily a hardware module for transmitting data, and not a machine learning algorithm, the concept of a "training set" as it relates to AI/ML devices is not applicable here.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. See point 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).