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These instruments are intended for use by qualified surgeons or physicians to provide access to the patient's body and allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

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This document is a 510(k) clearance letter from the FDA for the KSEA Endotip System. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML-based devices.

The document discusses the substantial equivalence of the KSEA Endotip System (an endoscopic instrumentation system) to previously marketed devices. This type of clearance is based on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not on specific performance metrics established through acceptance criteria and a detailed study like those for AI/ML algorithms.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

Here's what can be gathered, and why other sections cannot be answered:

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

   • Not Applicable. This document does not describe performance metrics or acceptance criteria for an AI/ML algorithm. It's a clearance letter for a medical instrument system based on substantial equivalence.

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. This document does not refer to a test set for an AI/ML algorithm.

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. This document does not refer to ground truth for an AI/ML algorithm.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not Applicable. This document does not refer to adjudication for an AI/ML algorithm.

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 document concerns a physical endoscopic instrument system, not an AI/ML tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

   • Not Applicable. This document concerns a physical endoscopic instrument system, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Applicable. This document does not refer to ground truth for an AI/ML algorithm.

8. The sample size for the training set

   • Not Applicable. This document does not refer to a training set for an AI/ML algorithm.

9. How the ground truth for the training set was established

   • Not Applicable. This document does not refer to ground truth for an AI/ML algorithm.

In summary: The provided FDA 510(k) clearance letter is for the KSEA Endotip System, which is an endoscopic instrument system. The regulatory pathway for this type of device (510(k) substantial equivalence) does not typically involve the detailed performance studies, acceptance criteria, test sets, or ground truth establishment relevant to AI/ML algorithms, which are the focus of your questions.

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