(77 days)
The i-Stethos Link Electronic Stethoscope is intended for the purpose of electronically amplifying and listening to biological sounds, such as those produced by the heart, lungs, arteries and veins, and other internal organs and systems. The i-Stethos Link may also be used to display the heart rate, which is calculated as the number of heartbeats per minute.
In addition, the i-Stethos Link is equipped with an analog I/O port to interface with external devices such as a computer and to accept input from other compatible devices such as the biological sound monitor (BSM) sensor or another i-Stethos Link.
The i-Stethos Link Electronic Stethoscope is indicated for use under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope.
The i-Stethos Link Electronic Stethoscope is not intended as a substitute for medical care or for diagnosis and treatment by unlicensed or unqualified persons.
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The provided document is a 510(k) premarket notification letter for the i-Stethos Link Electronic Stethoscope. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific performance acceptance criteria, detailed study designs, or results from such studies (like multi-reader multi-case studies, standalone performance, training sets, or adjudication methods). It is primarily a regulatory clearance document.
Therefore, I cannot provide the requested information from the given text.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Results from a multi-reader multi-case comparative effectiveness study.
- Standalone performance data.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.