Search Results

The Meditron Stethoscope System is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies sounds from the bodys internal organs, mainly the heart and respitatory and circulatory organs. It provides computer-aided recordings of these sounds and stores these recordings along with other appropriate patient information.

The Meditron stethoscope system is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It consists of four major components: electronic stethoscope (thestethoscope), distributor (thedistributor), connector (thecomnector), and CD software (theanalyzer). Thestethoscope amplifies sounds from the body's internal organs, mainly the heart and respiratory and circulatory organs, without introducing signals or energy into the body. Thedistributor is a co-listening device that has been specially developed for teaching purposes as it permits up to six persons to listen to the patient at the same time. Thedistributor can also be used during maternity check-ups to permit the physician and expectant mother to simultaneously listen to the sounds. Theconnector (connection box and cables) links thedistributor to the sound card of a personal computer (PC). Theanalyzer is a Microsoft Windows-based CD software application supplied with theconnector and is designed to provide computeraided recordings with the electronic stethoscope and to store these recordings along with other appropriate patient information.

The provided 510(k) summary for the Meditron Stethoscope System primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical testing. It explicitly states that clinical study information was not submitted for the purpose of demonstrating substantial equivalence.

Therefore, based on the provided document, the following answers reflect this lack of clinical study data to prove acceptance criteria:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criterion	Reported Device Performance
   Not applicable	No clinical acceptance criteria or performance data are provided, as no clinical study was conducted for this purpose.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   No clinical study data was submitted for demonstrating substantial equivalence. Therefore, no test set size or data provenance is available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   No clinical study data was submitted for demonstrating substantial equivalence. Therefore, no information on experts or ground truth establishment is available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   No clinical study data was submitted for demonstrating substantial equivalence. Therefore, no adjudication method is described.

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:
   No clinical study data was submitted for demonstrating substantial equivalence, and the device is an electronic stethoscope system, not explicitly framed as an AI-assisted diagnostic tool for human readers in this document. Therefore, no MRMC study or effect size is reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No clinical study data was submitted for demonstrating substantial equivalence. While the device includes "computer-aided recordings," the submission does not describe a standalone algorithm performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   No clinical study data was submitted for demonstrating substantial equivalence. Therefore, no ground truth type is specified.

8. The sample size for the training set:
   No clinical study data was submitted for demonstrating substantial equivalence, and no machine learning model training is described for a diagnostic purpose requiring such a set.

9. How the ground truth for the training set was established:
   No clinical study data was submitted for demonstrating substantial equivalence, and no machine learning model training is described for a diagnostic purpose.

Summary of Clinical Data Absence:

The Meditron Stethoscope System's 510(k) submission (K991367) explicitly states: "Clinical study information was not submitted for the purpose of demonstrating substantial equivalence to legally marketed electronic stethoscopes."

Instead, substantial equivalence was primarily demonstrated through:

• Comparison of Indications for Use: The Meditron system's indications were consistent with predicate devices and the FDA classification regulation (21 CFR 870.1875(b)).
• Non-Clinical Testing: Biocompatibility, environmental testing (climatic, mechanical, enclosure protection), and electromagnetic compatibility (EMC) tests were conducted according to international standards (ISO-10993, IEC, CISPR, EN). These tests confirmed that product specifications were met and that differences in technological characteristics did not raise new safety or effectiveness concerns.

Therefore, the acceptance criteria for this specific substantial equivalence determination were met through non-clinical performance and a comparison of device characteristics and intended use to legally marketed predicate devices, rather than through a clinical study demonstrating diagnostic performance.

Ask a specific question about this device