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The P.C.A.® System Inserts (previously cleared in K921384) are intended to be used with P.C.A.® Acetabular Shells, and Howmedica femoral stems and heads in cementless primary or cemented primary/revision total hip arthroplasty.

The Premise® Hip Acetabular Components (previously cleared in K912426) are intended to be used with Howmedica femoral stems and heads in comented primary or revision total hip arthroplasty.

The Osteolock™ Inserts (previously cleared in K903362), and the System 12® inserts (previously cleared in K951114 and K951115), when used with the Osteolock™ and Vitalock® Shells, are intended to be used with Howmedica femoral stems and heads in cemented primary of revision total hip arthroplasty.

SEE ADDITIONAL PAGE LABELED DURATION WEAR CLAIMS

Duration™ Stabilized UHMWPE - Hip Components

The provided document describes wear claims for Howmedica's Duration™ Stabilized UHMWPE hip components and does not present acceptance criteria or a study design in the typical format for medical device performance evaluation against specific metrics like sensitivity, specificity, or accuracy. Instead, it describes a series of in vitro wear simulation tests demonstrating a reduction in volumetric wear compared to conventionally gamma-sterilized components.

Therefore, the requested information cannot be fully provided as it pertains to a different type of performance evaluation (e.g., diagnostic accuracy of an AI device vs. material wear properties of an implant). However, I can extract and structure the information presented regarding the wear tests.

Here's an attempt to structure the available information, noting where specific requested fields are not applicable or estimable from the provided text:

Acceptance Criteria and Device Performance (Wear Claims)

Given the nature of the document detailing material wear claims, the "acceptance criteria" are implicitly a demonstrable reduction in volumetric wear compared to the conventionally sterilized counterpart. The reported device performance is the percentage reduction in volumetric wear.

Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms." This is a crucial disclaimer for interpreting these results.

Study Details (as inferrable from the provided text):

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify the exact number of hip components (samples) used in each test (e.g., N=3 per group). It refers to "a hemispherical cup" or "neutral acetabular inserts," implying at least one test article for each condition, but standard practice usually involves multiple samples for statistical validity.
   • Data Provenance: The data is from in vitro laboratory tests. The document mentions "Howmedica's" tests and an "independent laboratory test." This indicates the data is from manufacturer-sponsored and potentially third-party laboratory experiments, not from human patients or clinical trials.
   • Retrospective or Prospective: These are prospective laboratory experiments designed to assess wear characteristics under controlled conditions.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For material wear testing, "ground truth" is typically established by direct measurement of material loss (e.g., gravimetric or profilometric methods) in a controlled laboratory setting, not by expert consensus or interpretation in the way one would assess clinical images or outcomes. The "ground truth" here is the measured volumetric wear.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods (like 2+1) are used for resolving disagreements among human readers or experts, which is not relevant to automated laboratory measurements of material wear.

4. 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 document describes in vitro mechanical testing of a medical implant material, not a study involving human readers or AI assistance.

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

   • Not Applicable. This is not an algorithm-based device. It's a physical implant, and the assessment is of its material properties in a simulator.

6. The type of ground truth used:

   • The "ground truth" for these tests is the direct, quantifiable measurement of volumetric wear of the UHMWPE components under simulated physiological loading conditions. This is obtained through laboratory techniques (e.g., gravimetric analysis and density measurements to calculate volume loss).

7. The sample size for the training set:

   • Not Applicable. This is not a machine learning or AI context where "training sets" are used. The material properties are inherent to the manufactured product, and performance is tested directly.

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

   • Not Applicable. See point 7.

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