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K Number
K030301
Device Name
UNICONDYLAR FEMORAL COMPONENT
Manufacturer
SMITH & NEPHEW, INC.
Date Cleared
2003-02-25

(27 days)

Product Code
JWH
Regulation Number
888.3560
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Unicondylar Femoral Components are indicated for restoring either compartment of a knee that has been affected by the following:

    1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
    1. correction of functional deformity;
    1. revision procedures where other treatments or devices have failed; and
    1. treatment of fractures that are unmanageable using other techniques.
      The Unicondylar Femoral Components are single use only and are intended for implantation with bone cement.
Device Description

The Unicondylar Femoral Components are designed for use with tibial components of the Genesis I Knee System. The Unicondylar Femoral Components are metal alloy devices processed via a proprietary oxidation process.

AI/ML Overview

This document is a 510(k) summary for the Smith & Nephew, Inc. Unicondylar Femoral Components, a Class II medical device (Knee joint femorotibial metal/polymer/non-constrained cemented prosthesis).

The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, sensitivity, specificity, or other statistical measures.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is very similar to devices already legally marketed in terms of design, indications, and material composition.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the specific questions related to sample size, ground truth, expert opinions, or MRMC studies, as these types of studies were not presented in this 510(k) submission.

Here's a breakdown of what the document does state regarding "proof" of the device's suitability:

1. A table of acceptance criteria and the reported device performance:

  • Not applicable. The document does not provide a table with acceptance criteria or reported device performance in the manner typically seen for new diagnostic algorithms or complex clinical outcome studies.

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. No clinical test set data is provided. The submission relies on mechanical testing and comparison to predicate 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 ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not applicable. No test set adjudication is described.

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 device is a physical implant (femoral component for knee surgery), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

  • Not applicable. No ground truth for a clinical study is provided. The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set:

  • Not applicable. No training set for an algorithm is described.

9. How the ground truth for the training set was established:

  • Not applicable. No training set ground truth establishment is described.

Summary of the provided information related to device performance and safety:

The document states:

  • Mechanical Data: "A review of the mechanical test data indicated that the Unicondylar Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."
  • Substantial Equivalence: The primary method of demonstrating safety and effectiveness is through substantial equivalence. "The substantial equivalence of the Unicondylar Femoral Components is substantiated by its similarities in design features, overall indications, and material composition as existing components distributed by Smith & Nephew, Inc."

In essence, the "study" proving the device meets "acceptance criteria" is the demonstration of substantial equivalence to previously approved devices, supported by mechanical testing that confirms the device's ability to withstand in vivo loading. No clinical trials or performance studies with human subjects are detailed in this 510(k) summary.

§ 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.