(77 days)
The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): . 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, Porous and the Klassic® Tibial Baseplate, Porous, are being introduced as line extensions for use with the Klassic® Knee System for uncemented implantation during total knee arthroplasty. The Klassic® Femur, Porous is manufactured from Cobalt-Chromium-Molybdenum alloy and features a cobalt chrome porous sintered coating for uncemented biologic fixation. The Klassic® Tibial Baseplate, Porous is manufactured from Titanium alloy and features a titanium porous sintered coating for uncemented biologic fixation.
This document is a 510(k) premarket notification for the Klassic® Femur, Porous and Klassic® Tibial Baseplate, Porous, knee prosthetic components. It focuses on demonstrating substantial equivalence to previously cleared devices, rather than providing details of a clinical study with acceptance criteria and device performance as typically seen for AI/Software as a Medical Device (SaMD) products.
Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable or available within this type of regulatory submission. This submission primarily relies on engineering analyses and non-clinical testing to demonstrate equivalence in terms of material, design, and function.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
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Not Applicable in the traditional sense for this submission. This document describes a new version of an existing medical device (knee implant components) and aims to prove its substantial equivalence to predicate devices, not to report performance against specific clinical acceptance criteria in a clinical trial. The "performance" here refers to mechanical and material properties.
Acceptance Criteria (Implied from testing) Reported Device Performance (Summary of results) Tibial-Femoral Stability Characteristics Evaluated and deemed substantially equivalent Stress Distributions and Range of Motion Evaluated and deemed substantially equivalent Patella-Femoral Resistance to Lateral Subluxation and Surface Stress Distribution Evaluated and deemed substantially equivalent Tibial Modular Disassembly Characteristics Evaluated and deemed substantially equivalent Adherence to ASTM F1800 Compliant Adherence to FDA Guidance (1994) Compliant LAL testing requirements Compliant
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission does not involve human clinical "test sets" or patient data in the typical sense. The testing performed is non-clinical (engineering analyses and material testing) on the physical devices.
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)
- Not Applicable. No experts were used to establish ground truth from patient data for this submission. The "ground truth" for mechanical testing is established by engineering standards and validated testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication was involved as this is not a study assessing diagnostic accuracy or clinical outcomes based on human interpretation.
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
- Not Applicable. This document is not for an AI/SaMD product. No MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This document is not for an AI/SaMD product. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" (or basis of comparison) for the mechanical and material testing is established by validated engineering standards (e.g., ASTM F1800) and FDA guidance documents for orthopedic implants, in comparison to the performance of predicate devices.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth establishment for this type of device.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.