EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED

• K Number: K033634
• Device Name: EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
• Manufacturer: CENTERPULSE ORTHOPEDICS, INC.
• Date Cleared: 2004-09-15 ( 301 days)
• Product Code: KWA
• Regulation Number: 888.3330
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K974728 , K001526 , K002379 , K003363 , K993438 , K980513

Intended Use

The 32mm Epsilon Metasul Acetabular Insert and Metasul Femoral Head are intended for use in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., . avascular necrosis, osteoarthritis, and inflammatory joint disease (JJD), e.g., rheumatoid arthritis:
• those patients with failed previous surgery where pain, deformity, or dysfunction . persists:
• . revision of previously failed hip arthroplasty.

Device Description

The Epsilon Metasul 32mm Acetabular Insert is a hemispherically shaped design, composed of an outer component manufactured from polyethylene (UHMWPE) (in compliance with ASTM F648) which is thermo-mechanically bonded to a wrought hotforged CoCr alloy metallic inlay (in compliance with ISO 5832-12). The Epsilon Metasul Acetabular Insert is designed for use only with a Metasul femoral head component, as a metal-on-metal system. The body's natural synovial fluid lubricates the metal surfaces. The Epsilon Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes designed to mate with Converge® Acetabular Shells, sizes 53mm to 81mm (in 2mm increments).

The Epsilon Metasul 32mm Insert has what is commonly referred to as a "polysandwich" design. The inner diameter, which forms the bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and thermomechanically bonded into the polyethylene liner, which is then locked into the Converge acetabular shell via the proven snap mechanism. On the hooded inserts, the face of the polyethylene outer diameter incorporates a 20° overhang of polyethylene extending superiorly from the midpoint of the insert face. This hood feature is designed to provide additional resistance to subluxation and instability.

The 32mm Metasul® Modular Femoral Head is manufactured from Protasul-21WF (wrought forged CoCrMo, in compliance with ISO 5832-12). The design incorporates a 12/14 Morse-type female taper and a beveled face that allows for easier reduction of the hip intraoperatively. This femoral head component is offered in both a standard and an eccentric version, and is designed specifically to articulate with Centerpulse Orthopedics acetabular inserts having a Metasul® Inlav.

AI/ML Overview

The provided 510(k) Premarket Notification for the 32mm Epsilon Metasul Acetabular Insert and 32mm Metasul Femoral Head does not contain acceptance criteria or study results in the format requested.

This document is a regulatory submission for a medical device that demonstrates substantial equivalence to predicate devices. It focuses on device description, intended use, and comparison to existing products, rather than presenting a performance study with specific acceptance criteria and results.

Here's why the requested information is not available in the provided text:

• Type of Submission: This is a 510(k) premarket notification. For many Class II and Class III devices (like this one, which is Class III), substantial equivalence can be demonstrated through design comparisons, materials, and indications for use, without requiring extensive clinical performance studies to define acceptance criteria or measure performance against them in the same way an AI/software device would.
• Device Type: The device is a total hip replacement system component (metal-on-metal hip prosthesis). Its "performance" isn't measured by metrics like sensitivity, specificity, or object detection rates. Instead, performance is related to mechanical properties, biocompatibility, and clinical outcomes that are generally assessed through long-term follow-up and post-market surveillance.
• Content Focus: The document emphasizes:
  • Predicate Devices: Identifying similar devices already on the market.
  • Device Description: Detailed explanation of materials, design, and dimensions.
  • Intended Use: Specifying the patient conditions it's designed to treat.
  • Basis of Substantial Equivalence: Arguing that it's "substantially equivalent" to predicate devices based on design features, materials, and indications for use.

Therefore, I cannot populate the requested table and answer the following questions based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

In summary, the provided document is a regulatory submission for a physical medical device (hip implant components) focused on substantial equivalence, not a performance study for, for example, an AI algorithm that would typically have the requested performance metrics and study design details.

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.