(94 days)
The Smart Wireless Stethoscope enables amplification, filtering, and transmission of auscultation sounds from the heart, lungs, bowel, arteries, and veins. A medical professional at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The device is intended for use on pediatric and adult patients. The device is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.
The proposed smart wireless stethoscope is made of a Bluetooth® stethoscope and a companion medical mobile application that runs on a smartphone or a tablet. The stethoscope picks human body sounds with an acoustic structure that is similar to the chest piece of a traditional stethoscope. Then the sounds are converted to electrical audio signals by a microphone in the device. The electrical audio signals are further processed and transmitted through Bluetooth® protocol. The device has three models STEMO300, STEMO500 and STEMO700. All the three models can work with the companion app running on a smartphone or tablet. When they work this way, the stethoscope transmits audio to the app and the sounds can be further processed in the app. The app provides functions such as amplification, filtering, recording, sharing, etc. STEMO500 and STEMO700 have an ambient noise cancelling option while STEMO300 not. Unlike STEMO300 or STEMO500, STEMO700 has an option to directly transmit audio to paired Bluetooth earphones.
The provided text is a 510(k) summary for the "Smart Wireless Stethoscope (Model: STEMO300, STEMO500, STEMO700)". This document details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, a regulatory pathway for medical devices in the US.
However, it explicitly states:
"No clinical test is submitted in this 510(k)."
This means that the document does not contain information about acceptance criteria or a study proving the device meets those criteria through clinical performance. The FDA clearance for this device was based on demonstrating substantial equivalence to a legally marketed predicate device, rather than on new clinical effectiveness studies.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or training set.
- Data provenance for the test set or training set.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness study or its effect size.
- Standalone performance study.
- Type of ground truth used.
- How ground truth for the training set was established.
The document focuses on:
- Biocompatibility Testing: Conducted according to ISO10993-1, including Cytotoxicity, Sensitization, and Irritation tests.
- Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ANSI IEEE C63.27-2017, and AAMI TIR69:2017/(R2020).
- Software Verification and Validation Testing: Conducted according to FDA guidance for software in medical devices.
These tests are primarily focused on safety and technical performance standards, not on clinical performance against specific acceptance criteria for diagnostic accuracy or effectiveness in a clinical setting.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.