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The TransMedica Model 100 Digital Electronic Stethoscope uses a piezoelectric element to convert chest wall motion into electrical impulses. It employs a coupling medium to conduct chest wall motions directly onto the transducer. It also uses a second transducer to detect ambient room noises and special circuitry to reverse the phase of these signals for cancellation. The device uses a general purpose digital computer to process, store, and display sound recordings, specifically Amplitude versus Time (Time Series = Strip Chart).
The provided text describes the TransMedica Model 100 Digital Electronic Stethoscope, focusing on its safety and effectiveness. However, it does not contain any acceptance criteria or a study that proves the device meets specific performance criteria. The document explains the design principles and technological advancements of the stethoscope compared to traditional ones, and how it aims to improve sound detection and reduce noise. It details the transducer, common mode rejection, engineered gain curves, and data display functionalities.
Therefore, I cannot provide the requested information about acceptance criteria and the associated study because the provided text does not include this information.
To answer your request, I would need a document that:
- Clearly states specific performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio improvement of a certain dB level) as "acceptance criteria."
- Describes a study conducted to evaluate the device against these criteria, including methodologies, results, and statistical analyses.
§ 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.