(149 days)
SKEEPER is an electronic stethoscope that collects, fitters, and amplifies the sound of a person's heart, lungs, and abdomen. It is intended for use by professional users in clinical environments or by lay users in non-clinical environments. It is not intended for self-diagnosis.
SKEEPER is an electronic stethoscope used to collect and measure the sounds inside the body, and it consists of an electronic stethoscope (SM-300) and a mobile application (SKEEPER PRO APP).
When the diaphragm at the bottom of the SM-300 is lightly attached to the body part to be measured, such as the heart, lungs, or abdomen, the diaphragm vibrates due to the sound inside the human body and generates a sound. This sound is collected using a microphone and converted into an electrical signal. After that, the electrical signal is filtered and amplified for each frequency band set according to the measurement site, amplified, and output to earphones or transmitted to the SKEEPER APP installed on the mobile platform, and then the sound is output the earphone or speaker of the corresponding platform.
The SKEEPER PRO APP graphs the waveform of the sound received by the SM-300. It also stores and plays back sound data and analyzes heart rate.
The provided text is a 510(k) summary for the SKEEPER electronic stethoscope. It describes the device, its intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence. However, it does not contain the detailed acceptance criteria, device performance, or information about specific studies (like a multi-reader multi-case study, standalone performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth establishment) as requested in your prompt.
Specifically, the document states:
- "Clinical Data was not required to demonstrate the substantial equivalence." This indicates that no clinical study was performed.
- Non-clinical data provided includes electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, wireless coexistence, and bench testing. These typically involve engineering and performance specifications but not diagnostic accuracy or comparative effectiveness in a clinical context.
Therefore, I cannot provide the requested information from the given text as it does not contain details about:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical utility.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods.
- Multi-reader multi-case comparative effectiveness study or standalone performance.
- Types of ground truth used for such studies.
- Sample size for the training set or how ground truth was established for it.
§ 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.