(104 days)
For listening and amplification of sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to intensify the acoustical sounds of the device.
American Diagnostic Corporation's number 656 Electronic Stethoscope indications for use as an electronic stethoscope which will electronically amplfy sounds associated with the heart, arteries, veins and other internal organs. American Diagnostic intends to provide this device for use by healthcare providers and not for use by the general public.
ADC #656BK Electronic Scope
Basic design is identical in both operation and functionality to the Graham-Field Healthcare Products, Labtron Electronmax (510(k) K961857). The main amplifying chestpiece is identical to the Graham-Field Healthcare Products stethoscope in design, function and performance. The headset assembly is identical to one used on numerous other ADC stethoscopes (510(k) 935544).
The provided documentation for the ADC 656 Electronic Stethoscope does not include specific acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Graham-Field Healthcare Products Electronic Stethoscope Model: Labtron Electromax, 510(k) number: K961857).
Here's an breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics are provided in these documents. The submission relies on demonstrating that the ADC 656 Electronic Stethoscope is functionally and operationally identical to its predicate device.
2. Sample sized used for the test set and the data provenance
No test set or associated sample size is mentioned for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no performance study with a test set and ground truth establishment is described.
4. Adjudication method for the test set
Not applicable.
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. This device is an electronic stethoscope, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, and its function involves human operation. There is no mention of an "algorithm only" performance.
7. The type of ground truth used
Not applicable, as no performance study is detailed.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Device's Approval Process (based on the provided text):
The ADC 656 Electronic Stethoscope gained clearance through the 510(k) pathway by demonstrating substantial equivalence to a predicate device.
- Rationale for Substantial Equivalence: The submission states that the basic design, operation, functionality, and the main amplifying chestpiece are identical to the predicate device (Graham-Field Healthcare Products, Labtron Electromax, K961857). The headset assembly is also noted as being identical to one used on numerous other ADC stethoscopes (510(k) 935544).
- Non-Clinical Testing: The submission mentions that testing information substantiating safety and effectiveness was conducted in accordance with FDA's guidelines "Reviewer Guidance for PMN Submission" and DCRND outlining electrical, mechanical, and environmental performance standards. However, the specific results or details of these tests are not included in the provided excerpt.
- Clinical Testing: The document explicitly states "Non-Applicable" for clinical tests performed. This is common for devices seeking 510(k) clearance where substantial equivalence can be demonstrated through non-clinical data and comparison to a legally marketed predicate device.
In essence, the "study" that proves the device meets requirements is the demonstration of its likeness to a previously cleared device, backed by non-clinical engineering and performance tests (though details of these specific tests are not given beyond their adherence to FDA guidelines). The FDA's clearance letter (K012304) confirms that based on the provided information, the device was found to be substantially equivalent to the predicate.
§ 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.