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The DePuy Duraloc Acetabular Cup Liners are to be used with the DePuy Duraloc Acetabular Cup System's metal acetabular shells to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

The DePuy Duraloc Acetabular Liners are manufactured from ultra high molecular weight polyethylene (UHMWPE) and are available in two designs. standard and Charnley Bore (CB), Both designs are available in two styles, a neutral and 10° lip, with an inner diameter (I.D.) of 22.225mm and are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 48mm-74mm. The Duraloc liners are locked into the Duraloc metal acetabular shells with a metal wire locking ring supplied with the shells.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured as requested.

It's important to note that the provided text is a 510(k) summary for a medical device (DePuy Duraloc® Acetabular Cup System - Enduron Liner). 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed new performance study against specific acceptance criteria for a novel device. Therefore, many of the requested fields related to a performance study will be "Not Applicable" or "Not Provided" in this context.

Acceptance Criteria and Device Performance Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This submission is based on demonstrating substantial equivalence through design and material comparison, not a performance study involving a test set of data.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth for a performance study is not relevant to a substantial equivalence demonstration based on design, material, and intended use comparison.

4. Adjudication method for the test set

• Not applicable.

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 component of a hip prosthesis, not an AI-powered diagnostic or assistive tool for human readers.

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

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

7. The type of ground truth used

• Not applicable. For a substantial equivalence claim, the "ground truth" is largely the established safety and effectiveness of the predicate devices based on their prior clearances and clinical history.

8. The sample size for the training set

• Not applicable. No training set is relevant for this type of device and submission.

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

• Not applicable.

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The DePuy Duraloc Acetabular Cup Liners are intended to be used with the Duraloc System Acetabular Cups to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

The subject DePuy Duraloc Acetabular Cup Liners are polyethylene acetabular cup liners which are available with 28mm or 32mm inner diameters, and with a neutral or a 10° lip. The 28mm liners are available in sizes to fit Duraloc metal acctabular shells with outer diameters of 48-74mm. The 32mm liners are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 52-74mm. The Duraloc polyethylene liners are locked into the Duraloc metal shells with a metal wire locking ring which is supplied with the metal shells. The subject polyethylene liners are identical in design to the acetabular cup liners cleared with the Modified DePuy Acetabular Cup System and the DePuy Modified AML+ Acetabular Cup System. The only difference between the subject Duraloc polyethylene liners and those that have been previously cleared by FDA is that the subject liners are manufactured from crosslinked polyethylene which has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to oxidation compared to gamma radiation sterilized standard UHMWPE.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to DePuy Inc. regarding their Duraloc® Acetabular Cup System. It confirms that the device is substantially equivalent to previously marketed devices and can be brought to market.

The information provided includes:

• Device name and intended use.
• Company contact information.
• Regulatory classification and product codes.
• A brief description of the device's design and its manufacturing from crosslinked polyethylene.
• The FDA's finding of substantial equivalence based on the provided submission.

However, it does not include any details on:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
• Whether a multi-reader, multi-case comparative effectiveness study was done, or any effect sizes of human readers with/without AI assistance.
• Whether a standalone algorithm performance study was done.
• The type of ground truth used.
• Sample size for the training set or how ground truth for the training set was established.

This type of information is typically found in design validation reports or clinical study summaries, which are not part of this particular FDA correspondence. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive performance studies in all cases.

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