(121 days)
The Klassic™ Knee System is intended for prosthetic replacement with the use of bone cement 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 consists of two categories of devices: an implantable knee prosthesis and the various instruments needed to perform the surgery and implant the femoral, tibial and patellar components. The Klassic "Knee System allows for simple surgical use and addresses the needs of a wide patient population. The System also has streamlined instrumentation.
The Klassic™ Knee System is a cemented total knee joint replacement system intended for use in primary knee surgery. The System is a semiconstrained design and both the medial and lateral collateral ligaments must be intact. The Klassic" Knee System utilizes a symmetrical design, eliminating the need for left/right orientations. The patellofemorotibial prosthesis includes a metal femoral component, a tibial component consisting of a polyethylene tibial bearing fixed to a metal tibial baseplate, a polyethylene patellar component, a polyethylene dome extension, and a metal tibial insert set screw. The implantable components are provided sterile and are intended for single-use only in a single patient.
The Cobalt Chromium alloy (CoCr) femur has a symmetric design and is available in six sizes for cemented application to accommodate replacement of either left or right knees.
The Titanium alloy tibial baseplate has a symmetric design and is available in six sizes for cemented application. The tibial baseplate has a modular design to assemble with the tibial insert with a snap-in locking mechanism that is secured with the Titanium allov tibial insert set screw. The System includes two types of tibial inserts which can be used in cruciate retaining and cruciate sacrificing procedures. Both types of tibial inserts have a symmetric design, are composed of ultrahigh molecular weight polyethylene (UHMWPE) and are available in six sizes and four thicknesses (10-16mm). The System also includes a patella composed of UHMWPE which is available in four sizes. Additionally, the System includes a dome extension composed of UHMWPE that connects to the bottom of the tibial baseplate and is available in one size. The UHMWPE material has been utilized in previously cleared devices.
The provided text is a 510(k) Summary for the Klassic™ Knee System, an orthopedic implant. It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, but does not contain details about acceptance criteria, a specific study proving those criteria were met, or information related to AI/algorithm performance.
Therefore, I cannot populate the requested table and sections with the information provided. The document focuses on demonstrating substantial equivalence through bench testing, not on clinical performance or AI algorithm validation with performance metrics like sensitivity, specificity, or reader studies.
Here's a breakdown of why each point cannot be addressed based on the provided text:
- Table of acceptance criteria and the reported device performance: Not present. The document mentions "Extensive bench testing was conducted... to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate devices." It lists aspects tested (Fatigue, Disassembly, Stability, Contact area and stress distributions, Range of motion, Biocompatibility, Sterilization and cleaning validations, Packaging and shelf life) but does not provide specific acceptance values or performance results.
- Sample size used for the test set and the data provenance: Not applicable as it's bench testing, not a clinical study on a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is relevant for diagnostic or AI-assisted devices, not for an orthopedic implant's bench testing.
- Adjudication method: Not applicable.
- 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 device is an implant, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of AI/diagnostic ground truth. For an orthopedic implant, "ground truth" would relate to engineering specifications and performance standards met in bench testing.
- The sample size for the training set: Not applicable as there is no AI algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a medical device (a knee implant) demonstrating its equivalence to existing predicate devices through physical and mechanical testing, not a study evaluating the performance of a diagnostic algorithm or AI system.
§ 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.