(60 days)
The Klassic® Knee System is intended for prosthetic replacement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NID): avascular necrosis and osteoarthritis
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
The Klassic® Femur with Aurum®, is being introduced as a line extension for use with the Klassic® Knee System for cemented implantation during total knee arthroplasty. The Klassic® Femur with Aurum® is manufactured from Titanium alloy (Ti6Al4V per ASTM F136) with a titanium nitride surface.
The provided text is a 510(k) Premarket Notification for a Knee Joint Prosthesis (Klassic® Knee System). It details the device's indications for use, its classification, and a comparison to predicate devices, particularly focusing on a new line extension, the Klassic® Femur with Aurum®.
This document does not contain any information regarding AI/ML device performance testing, clinical studies with human readers, or ground truth establishment relevant to AI/ML systems. The "acceptance criteria" discussed are likely related to the mechanical and biocompatibility performance of the knee implant, not an AI/ML algorithm's diagnostic accuracy.
Therefore, I cannot provide an answer based on the prompt's request for AI/ML device performance without the presence of such information in the provided text.
The closest relevant sections in the provided text are:
- Non-Clinical Bench Testing and Engineering analyses: These were performed to evaluate the physical properties of the Klassic® Femur with Aurum® (e.g., strength of coating, fatigue, wear, stability, contact stress, range of motion, patella-femoral resistance). This refers to the mechanical integrity and function of the physical implant, not an AI algorithm.
- LAL testing requirements for orthopedic implants: This refers to Limulus Amebocyte Lysate testing for bacterial endotoxins, a biocompatibility test, not an AI algorithm's performance.
To answer your request, the input text would need to describe a study evaluating an AI/ML algorithm's performance, including details such as:
- Acceptance criteria for algorithm metrics (e.g., sensitivity, specificity, AUC).
- Test set characteristics (sample size, data provenance, image types).
- Ground truth establishment (number and qualifications of experts, adjudication methods).
- Human reader studies (MRMC design, effect sizes of AI assistance).
- Standalone algorithm performance.
- Training set details (sample size, ground truth methodology).
§ 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.