(29 days)
The Sugita AVM Microclip Applier is exclusively designed to place Sugita AVM Microclips during surgical procedures.
The Sugita AVM Microclip Applier has a spring handle design with a ratchet. The Sugita AVM Microclip Applier serves to open and close the Sugita AVM Microclips. Using the Sugita AVM Microclip Applier, the Sugita AVM Microclips are removed from their packaging and applied, repositioned or removed from the target tissue. The Sugita AVM Microclip Applier has no function of its own and may only be used in combination with the Sugita AVM Microclips. The Sugita AVM Microclip Applier has the same design and materials as the clip applier in the K960037. The body of the Sugita AVM Microclip Applier is manufactured from stainless steel and the jaws are manufactured from Elgiloy, a cobalt-chromium-molybdenum alloy.
The provided document is a 510(k) summary for the Sugita AVM Microclip Applier (K221524). It details the device, its intended use, and its comparison to a predicate device. However, it does not describe an acceptance criteria table, a study proving device performance against acceptance criteria, or any of the detailed study information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance.
The document focuses on demonstrating substantial equivalence to a predicate device (Aesculap Slim Clip Applier, K211572) based on similar indications for use, materials, design, and technological characteristics. The only "performance testing" mentioned is non-clinical sterilization and cleaning validation, which supports updated instructions for use, not a clinical performance study using patient data.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a type of performance study that was not conducted or reported here.
Here's what can be extracted and a clear indication of what is not present in the document based on your request:
1. A table of acceptance criteria and the reported device performance
Information Not Available: The document does not provide a table of acceptance criteria or reported device performance against such criteria. The submission focuses on demonstrating substantial equivalence through comparison of design, materials, and intended use, along with validating sterilization and cleaning parameters.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Information Not Available: No clinical test set or patient data was used for performance evaluation as described in this document. The "tests" performed were non-clinical validation of sterilization and cleaning parameters.
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)
Information Not Available: No clinical test set requiring expert ground truth establishment was conducted or reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information Not Available: No clinical test set requiring adjudication was conducted or reported.
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
Information Not Available: This device is a mechanical surgical applier, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Information Not Available: This device is a mechanical surgical applier, not an algorithm. Therefore, standalone algorithm performance is not applicable and was not assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information Not Available: No clinical ground truth was established as no clinical studies were performed for this 510(k) submission.
8. The sample size for the training set
Information Not Available: No training set was used as this is not an AI/machine learning device. The "training" for this submission would involve the development and validation of manufacturing processes, sterilization, and cleaning instructions.
9. How the ground truth for the training set was established
Information Not Available: No training set or associated ground truth, in the context of AI/machine learning, was established. The "ground truth" for the non-clinical validations would be successful completion of specified sterilization and cleaning cycles according to established scientific and regulatory standards.
§ 882.4175 Aneurysm clip applier.
(a)
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.(b)
Classification. Class II (performance standards).