Search Results

The Summit Patella Plating System is indicated for use in surgical stabilization of patella fractures during open reduction internal fixation (ORIF) procedures in adults. Each system includes a plate, screws, surgical suture, and instruments that are provided in a sterile procedure kit and intended for single use.

The Endeavor Orthopaedics Summit Patella Plating System is a plating system used for fixation of patella fractures. The system includes implants and ancillary instruments needed for open reduction internal fixation (ORIF) of a patella fracture, packaged together in a single use sterile procedure kit. The kit provides a patella plate, locking screws, nonabsorbable sutures with needles and surgical instrumentation required for preparation of fracture fragments, manipulation/reduction of the patella, provisional fixation, plate placement and definitive fixation to the dorsal surface of the patella. The system is intended for single use, by a licensed orthopedic surgeon.

This FDA 510(k) clearance letter pertains to a medical device, the Summit Patella Plating System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on human expert performance or large-scale clinical trials.

Therefore, much of the requested information regarding acceptance criteria and study details (especially those related to AI, human readers, ground truth establishment for large datasets, and clinical performance) is not applicable or not available in this document.

However, I can extract the information that is present and indicate where the requested information is not provided.

Acceptance Criteria and Device Performance (Non-Clinical)

The document states that non-clinical testing was performed, and the results met acceptance criteria. However, the specific quantitative acceptance criteria are not detailed in this document. Instead, it makes a general statement about the device performing "as intended" and acceptance criteria being met.

Detailed Study Information:

1. Sample size used for the test set and the data provenance:

   • This document describes non-clinical bench testing for a physical medical device (patella plating system), not an AI/software device that would use a test set of data in the typical sense.
   • Therefore, information about a test set sample size, country of origin, retrospective/prospective data is not applicable/provided. The "test set" would refer to the physical prototypes or samples tested.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Since this is non-clinical bench testing of a physical implant system, the concept of "ground truth" derived from human experts in a diagnostic or image interpretation context is not applicable/provided. Ground truth would conceptually relate to the established physical properties or mechanical performance, typically measured by engineering and materials science experts.

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

   • Not applicable/provided. Adjudication methods are relevant for human expert review of cases (e.g., medical images for ground truth establishment), not for the direct measurement of mechanical properties or biocompatibility of a physical device.

4. 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, an MRMC comparative effectiveness study was not done. This is a clearance for a physical orthopedic implant system, not an AI software device intended to assist human readers. Therefore, an effect size of human improvement with AI assistance is not applicable/provided.

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

   • No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm. Therefore, information about standalone algorithm performance is not applicable/provided.

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

   • For the non-clinical testing, the "ground truth" would be established through engineering standards, material specifications, and validated test methods measuring mechanical strength, durability, biocompatibility, and sterility. This is not explicitly detailed but inferred from the description of non-clinical testing. It's not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable/provided. This describes the clearance of a physical medical device, not an AI system that undergoes training.

8. How the ground truth for the training set was established:

   • Not applicable/provided. This describes the clearance of a physical medical device, not an AI system.

Ask a specific question about this device