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The Implex Cross-Linked Polyethylene Acetabular Components are intended to be used with the below listed, legally marketed Implex Acetabular Component Replacement Systems to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads:

1. The Implex HEP (Hedrocel) Acetabular Cup, cemented & cernentless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
2. The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
3. The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10 ° and 20° face angle options.
4. The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.

Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads:

1. The Implex HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
2. The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
3. The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10° and 20° face angle options.
4. The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.

The raw material being utilized in the manufacture of both the subject and predicate devices remains as direct and sheet compression molded ultrahigh molecular weight polyethylene (UHMWPE) conforming to ASTM F-648. The modifications to the manufacturing process of this polyethylene will be introduced to create a higher cross-linked polyethylene.

Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for Implex Cross-Linked Polyethylene Acetabular Components, focusing on wear claims. It does not describe a medical device that uses AI or goes through typical clinical study acceptance criteria as might be expected for software-based diagnostic devices. Instead, it concerns the physical properties of a medical implant and its performance in in-vitro testing.

Therefore, many of the requested categories for AI/software-based devices (like test set size, expert ground truth, MRMC study, training set, etc.) are not applicable to this submission. I will address the relevant information that can be extracted.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set: The "test set" in this context refers to the physical samples of the acetabular components undergoing wear simulation.
  • Sample Size: Not explicitly stated as a number of individual components. The text mentions "the same acetabular components (28 mm/52 mm ID/OD, with polyethylene thickness of 9.5 mm)" for sheet compression molded and "polyethylene thickness was 8.2 mm for the tested DCM components." It implies that specific configurations were tested. A specific count of components tested is not provided, which is common for material testing.
  • Data Provenance: The testing was "in-vitro hip wear simulation testing." It's laboratory-based, not patient-derived or country-specific in the sense of clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. For mechanical wear testing of an implant, the "ground truth" is established by the physical testing methodology itself (e.g., gravimetric wear rate measurements) and adherence to established standards (e.g., use of ASTM F-648 for UHMWPE). This does not involve human expert consensus or interpretation of data in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human experts (e.g., in image interpretation). This is a physical, objective test.

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 is a hardware implant, not an AI diagnostic device. No human readers or AI assistance are involved in interpreting the wear test results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a hardware implant. The "standalone performance" is its physical wear characteristics during the in-vitro simulation.

7. The Type of Ground Truth Used

• Objective Physical Measurement / Performance Standard. The ground truth for the wear claims is based on:
  • Gravimetric wear rate measurements from in-vitro hip wear simulation tests.
  • Comparison to specified "current" Implex products and the "Charnley 'Gold Standard'" (a benchmark for hip prostheses).
  • Material conformity to ASTM F-648.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device; there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study:

The study proving the device meets the acceptance criteria (primarily concerning reduced wear) was an in-vitro hip wear simulation testing performed under multiaxial hip joint simulation for 5 million cycles.

• Conditions:
  • Femoral Head: Super-finished Implex 28 mm Co-Cr-Mo femoral head.
  • Acetabular Component: Corresponding to a shell OD of 52 mm.
  • Lubricant: Bovine calf serum.
  • Cycle Count: 5 million cycles.
  • Polyethylene Thickness: 9.5 mm for sheet compression molded components; 8.2 mm for direct compression molded (DCM) components.

The results showed significant reductions in gravimetric wear rates for both sheet compression molded and direct compression molded cross-linked polyethylene compared to existing Implex products and the Charnley 'Gold Standard'. The manufacturer explicitly states a disclaimer: "The results of such in-vitro hip wear simulation tests have not been shown to correlate with clinical wear mechanisms." This is an important caveat regarding the interpretation of these in-vitro results.

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