(90 days)
The Duracon® Conversion Metal Backed Patella is intended to be used with Duracon® femoral and tibial components as part of a total knee system. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Specifically, this patellar component is intended to replace the articular surface of the natural patella in primary or revision total knee scenarios.
The Duracon® Conversion Metal Backed Patella is intended to be a revisable The patellar component will be made available with the polyethylene component. insert assembled to the metal backing. Separate polyethylene patellar inserts will be made available so the physician can intraoperatively replace excessively worn polyethylene to a well-fixed metal patellar baseplate.
The Duracon® Conversion Metal Backed Patella is intended to be implanted using bone cement.
The Duracon® Conversion Metal Backed Patella is intended to be used with Duracon® femoral and tibial components as part of a total knee system. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Specifically, this patellar component is intended to replace the articular surface of the natural patella in primary or revision total knee scenarios.
The Duracon® Conversion Metal Backed Patella is intended to be a revisable The patellar component will be made available with the polyethylene component. insert and the metal backing. Separate polyethylene patellar inserts will be made available so the physician can intraoperatively replace polyethylene to a well-fixed metal patellar baseplate.
The Duracon® Conversion Metal Backed Patella is intended to be implanted using bone cement.
This document (K972752) is a 510(k) summary for a medical device called the Duracon® Conversion Metal Backed Patella, not a study report. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or clinical study results in the manner requested.
A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical studies. The "testing presented to address the FDA guidance document on Semi-Constrained Cemented Total Knee Prostheses" would refer to mechanical and/or bench testing, not clinical studies involving human subjects or AI algorithms.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, study design, and performance metrics as they would typically be found in a clinical study report for an AI/ML powered device. This document describes a traditional medical device (a knee implant) and its regulatory pathway.
The relevant information from the provided text is that the device is "substantially equivalent to other legally marketed devices" and that "Testing was presented to address the FDA guidance document on Semi-Constrained Cemented Total Knee Prostheses." This indicates the device's equivalence was established through a comparison to existing devices and likely through non-clinical (e.g., mechanical) testing, not through the type of performance study you are asking about.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.