Search Results

Ask a specific question about this device

Indications: This instrument is indicated for use with a compatible trumpet valve during endoscopic surgery for facilitating the removal of gallstones.

The stone extractor has a nominal diameter of 0.392", a tube length of 13.0" and has a scoop 0.6" long. The surface of the stone extractor is polished on the proximal 3.0" and matte finished on the remaining 10.0". The stone extractor is fabricated from 304 stainless steel.

The provided text is a 510(k) summary for a medical device (Stone Extractor) submitted in 1997. This type of submission relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting new clinical studies with defined acceptance criteria and performance metrics typically associated with AI/software devices today.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, or AI performance metrics. The text focuses on comparing the new device's physical attributes and intended use to a legally marketed predicate device.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission is a comparison of attributes to a predicate device, not a performance study against predefined criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or clinical study is described.
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): Not applicable. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process 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: Not applicable. This device is a physical stone extractor, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical stone extractor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established as there is no performance study.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

The 510(k) summary explicitly states its purpose is to demonstrate "Substantial Equivalence" based on a comparison of device attributes and intended use. The provided table compares specific attributes of the submitted device to a predicate device, showing identical or similar specifications (e.g., material, dimensions, reusability, sterility). This comparison is the "study" for a 510(k) of this nature. The FDA's letter (K971123) confirms substantial equivalence, which allows the device to be marketed.

Ask a specific question about this device