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K Number
K210829
Device Name
Persona Revision Knee System Femoral Metaphyseal Cones
Manufacturer
Zimmer, Inc.
Date Cleared
2021-05-18

(60 days)

Product Code
JWH,MBH
Regulation Number
888.3560
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
K181947
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is indicated for patients with severe knee pain and disability due to:

  • Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

  • Collagen disorders, and/or avascular necrosis of the femoral condyle.

  • Post-traumatic loss of joint confi guration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

  • Moderate valgus, varus, or flexion deformities.

  • The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augments are indicated for cemented use only.

Device Description

The purpose of this submission is to obtain clearance for the changes/proposed changes made to the Persona Revision Knee System femoral metaphyseal cones post their original 510(k) submission/clearance. The Persona Revision Knee System femoral metaphyseal cones are intended to fill distal femoral cavitary bone defects during knee arthroplasty.

AI/ML Overview

This FDA document is a 510(k) clearance letter for the Persona® Revision Knee System Femoral Metaphyseal Cones. It confirms that the device is substantially equivalent to a previously cleared predicate device.

The document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the way you've outlined for an AI/ML medical device. This is because the Persona Revision Knee System Femoral Metaphyseal Cones are a mechanical orthopedic implant, not an AI/ML imaging or diagnostic device.

For a mechanical device like this, "acceptance criteria" and "performance studies" are typically related to:

  • Biocompatibility: Ensuring the materials are safe for implantation.
  • Mechanical Testing: Verifying the strength, fatigue life, and wear characteristics of the implant components under simulated physiological loads. This often involves standardized tests (e.g., ISO standards) and sometimes finite element analysis (FEA).
  • Sterilization Validation: Confirming the chosen sterilization method is effective.
  • Design Verification and Validation: Ensuring the device meets its design specifications and user needs.

The provided text only briefly mentions that:

  • Finite Element Analysis (FEA) was used to predict peak stress under physiological loading. This is a common non-clinical method for evaluating the mechanical performance of orthopedic implants.

Therefore, I cannot populate your requested table and information points as they are designed for AI/ML device evaluations, and this document pertains to a traditional mechanical medical device.

Here's why each of your requested points cannot be answered from the provided text:

  1. Table of acceptance criteria and reported device performance: Not applicable for an AI/ML device; for this mechanical device, specific mechanical test results and acceptance criteria are not detailed in this summary document.
  2. Sample size for test set and data provenance: No test set of data (like images or patient records) for an algorithm is mentioned.
  3. Number of experts and qualifications for ground truth: No ground truth established by experts for algorithmic performance is relevant here.
  4. Adjudication method: Not applicable as there's no diagnostic output to adjudicate.
  5. MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic tool.
  6. Standalone performance: Not applicable, as there is no algorithm that performs independently.
  7. Type of ground truth: Not applicable, as there's no diagnostic task involving ground truth.
  8. Sample size for training set: Not applicable, as there is no AI algorithm to train.
  9. How ground truth for training set was established: Not applicable.

§ 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.