The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.

Device Description

The Metagen All Poly Acetabular Cup System is a family of acetabular components designed for use in total hip arthroplasty, that are manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the predicate devices.

AI/ML Overview

This document, K96403, is a 510(k) summary for the "Metagen All Poly Acetabular Cup System." It describes a medical device, its intended use, and argues for its substantial equivalence to previously marketed devices.

However, this document *does not contain any information regarding:

Acceptance criteria for a study.
A study that proves the device meets acceptance criteria.
Device performance metrics (like sensitivity, specificity, AUC).
Sample sizes for test or training sets.
Data provenance (country, retrospective/prospective).
Number or qualifications of experts for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
Type of ground truth used.
How ground truth was established.

This K96403 document is a regulatory submission for a physical medical device (an acetabular cup for hip replacement), not an AI/ML-based diagnostic or imaging device. Therefore, the questions you've asked, which are typically relevant to the validation of AI/ML algorithms, are not applicable to the content provided in this specific K96403 summary.

The document primarily focuses on demonstrating substantial equivalence in terms of design, materials, and intended use to predicate devices, rather than presenting a performance study against specific acceptance criteria.

Summary

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K96403

Summary of Safety and Effectiveness

for

Metagen All Poly Acetabular Cup System

This safety and effectiveness summary for the Metagen All Poly Acetabular Cup System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.

1. Submitter: Metagen, LLC Origen Center 428 Technology Drive East Menomonie, WI 54751
  Contact Person: Wesley Johnson Telephone: (715) 232-4880 Fax: (715) 235-9370

Date Prepared: October 3, 1996

Tradename: Metagen All Poly Acetabular Cup System Total Hip Prosthesis, Acetabular Component Common Name: Classification Name: Acetabular Component of Hip Joint, Hip Joint Metal/Polymer, Semi-Constrained Cemented Prosthesis (888.3350)

3. Predicate or legally marketed devices which are substantially equivalent:

. Orthomet All-Poly Acetabular Cup (Orthomet)
Charnley/Elite Plus All Poly Cups (DePuy) ●
StelKast All Poly Cup (StelKast) .

4. Description of the device:

5. Intended Use:

The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

There are no significant differences between the Metagen All Poly Acetabular Cup and the systems currently being marketed, which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, material and intended use.

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.