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Found 3 results
510(k) Data Aggregation
(89 days)
The Christoudias Slim Tip Electrode Insert is indicated for laparoscopic surgical procedures where controlling small bleeding vessels with coagulation would be advantageous.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Christoudias Slim Tip Electrode Insert." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods typical for AI/ML device evaluations. Such details are usually found in the 510(k) submission summary or the actual study reports, not in the clearance letter itself.
Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on the provided text.
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(65 days)
Fracture fixation of long bone diaphysis (tibia, humerus, femur) and fracture reduction at metaphyseal and epiphyseal levels.
Pediatric Intramedullary Nail
This FDA letter acknowledges the substantial equivalence of the "MacMed Paediatric Intramedullary Nail" (K991877) to legally marketed predicate devices, thereby allowing its commercialization. However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
The letter is solely a regulatory approval based on the comparison to existing devices, not a review of clinical or performance data as would be found in a study report. Therefore, I cannot provide the requested information from this document.
To answer your questions, you would need access to the original 510(k) submission (K991877) from InnerVision®, Inc., which would have included the technical and performance data supporting their claim of substantial equivalence.
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(88 days)
The Christoudias Gauze Dissector is indicated for laparoscopic general surgical procedures where blotting small bleeders and/or sponging tissue in a visible, atraumatic world be advantageous.
Christoudias Gauze Dissector (Laparoscopic Hand Instrument)
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Christoudias Gauze Dissector (Laparoscopic Hand Instrument)". This type of document is a notification of intent to market a device based on substantial equivalence to a legally marketed predicate device.
It does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, or AI-related effectiveness studies.
Therefore, I cannot extract the requested information from the provided text. The document confirms that the FDA reviewed the device and determined it is substantially equivalent, allowing the manufacturer to market it, but it does not detail the specific performance studies that might have been conducted by the manufacturer to establish this equivalence, nor does it refer to AI assistance.
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