(56 days)
The 3MTM Littmann® TeleSteth Online Auscultation System is intended to provide and control the real time data transfer of body sounds between two 3M Littmann Electronic Stethoscopes Model 3200 over a data network. Patient body sounds may be remotely evaluated in real-time or in store-and-forward mode. The 3M Littmann TeleSteth Online Auscultation System can be used on any person undergoing a physical assessment.
The 3MTM Littmann® TeleSteth Online Auscultation System, used together with the 3MTM Littmann® Model 3200 Electronic Stethoscope (K083903), allows healthcare professionals to share heart, lung and other body sounds with colleagues located across the globe using the internet or a private data network. When operational, 3MTM Littmann® TeleSteth Online Auscultation System software is physically located on a data network server and on each clients PC (see Figure 1 below). Functionally, software that is located on a clients PC establishes a wireless (Bluetooth) communications connection with a 3MTM Littmann® Model 3200 electronic stethoscope on one side and the designated network server (internet or private data network) on the other. When connected in such a way the 3MTM Littmann® Model 3200 electronic stethoscope can transmit heart, lung, and other body sounds through the clients PC to the server using secured and encrypted digital communications. Data sent to the server in such a way can then be sent on to a remotely located client PC where it can be listened to in real time (data streaming mode) by a second 3MTM Littmann® Model 3200 Electronic Stethoscope, or the sound data may be stored on the server database where it can be retrieved and listened to at a later point in time (store and forward mode).
The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) Premarket Notification for the 3M Littmann TeleSteth Online Auscultation System, primarily focusing on establishing substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or describe a study proving the device meets the criteria. The document explicitly states: "Information provided in this 510(k) submission shows that the 3M™ Littmann® TeleSteth Online Auscultation System is substantially equivalent in terms of intended use, composition, physical properties and technological characteristics compared to the predicate device, the 3M™ Littmann® Scope-to-Scope Software System (K101834). There are no new questions of safety or effectiveness." This indicates that the approval was based on equivalence, not on independent performance studies with detailed acceptance criteria.
To address the specific points of your request based on the absence of this information in the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not provided in the document.
- Reported Device Performance: Not provided in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the document. No specific test set or study data is mentioned.
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):
- Not applicable as no test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no test set or adjudication process is 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:
- Not applicable. The device is a system for transferring body sounds, not an AI diagnostic tool that assists human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as the device is a communication system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no studies involving ground truth are described.
8. The sample size for the training set:
- Not applicable as no training set or machine learning components are mentioned for this device.
9. How the ground truth for the training set was established:
- Not applicable as no training set or ground truth establishment process is described.
§ 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).