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The DePuy ASR™ XL Modular Acetabular Cup System is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head and neck.
4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty.
5. Certain cases of ankylosis.
   Porous-coated DePuy ASR™ XL Modular Acetabular Cups are indicated for cementless application.
   The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component.
   The DePuy ASR™ XL Modular Acetabular Cup System is compatible with DePuy ASR™ femoral components.

The subject DePuy ASR™ XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one-piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups.
Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acctabular cups will be compatible with DePuy ASR™ femoral components.
The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The ASR Uni femoral heads (sizes 39mm through 55mm) were cleared in the DePuy ASR™ Modular Acetabular Cup System, K040627.
The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy.

The provided text is a 510(k) Summary for a medical device (DePuy ASR™ XL Modular Acetabular Cup System). It focuses on establishing substantial equivalence to previously cleared devices rather than detailing a study with acceptance criteria and device performance as typically seen in diagnostics or AI/software device submissions. Therefore, the requested information cannot be fully extracted from this document in the manner described.

Here's an analysis based on the available text:

Acceptance Criteria and Study Details for DePuy ASR™ XL Modular Acetabular Cup System

The provided document describes a 510(k) premarket notification for a medical device, the DePuy ASR™ XL Modular Acetabular Cup System. This type of submission primarily aims to demonstrate substantial equivalence to devices already legally marketed, rather than presenting a detailed study with specific performance acceptance criteria like those for diagnostic algorithms or AI.

The document indicates that the submission is a "line extension of the acetabular cup components" and that "minor revisions are being made to the Indications for Use and the Instructions for Use (IFU) to minimize the necessity for multiple IFUs and to update the contents to reflect current practice. The subject device does not raise any new issues of safety or effectiveness."

Because this is a Class III implantable device, the "acceptance criteria" largely revolve around demonstrating that the new sizes (64mm-70mm) and slight modifications do not introduce new safety or effectiveness concerns compared to existing predicate devices. This is typically achieved through design analysis, material composition verification, and sometimes mechanical testing, rather than a clinical study comparing performance metrics against specific quantitative targets.

Therefore, most of the specific questions about acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable to this type of regulatory submission and information is not present in the provided text.

Here's what can be extracted:

Table of Acceptance Criteria and Reported Device Performance

Not applicable in the format requested for this type of device and submission. The "acceptance criteria" are implied by the FDA's acceptance of "substantial equivalence" based on similarities in "design, material composition and intended use/indications for use" with predicate devices. No quantitative performance metrics are reported in this summary.

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • Not applicable / Not provided. This submission relies on demonstrating substantial equivalence to predicate devices through design and material comparisons, not a clinical trial with a "test set" in the context of diagnostic performance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   • Not applicable / Not provided. No "ground truth" establishment in this context, as it's not a diagnostic or AI device performance study. The "ground truth" for orthopedic implants relates to their long-term clinical performance and safety, which is established over years of post-market surveillance.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   • Not applicable / Not provided.
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 / Not provided. This is an orthopedic implant, not an AI or imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable / Not provided. This refers to a medical device's physical components, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   • Not applicable / Not provided. (See point 2).
7. The sample size for the training set:
   • Not applicable / Not provided. There is no "training set" in the context of this device.
8. How the ground truth for the training set was established:
   • Not applicable / Not provided.

In summary: The provided 510(k) summary focuses on regulatory clearance through substantial equivalence, which is a different pathway than studies validating the performance of diagnostic algorithms or AI-powered devices against explicit acceptance criteria. The information requested (table of criteria, sample sizes, expert involvement, etc.) is standard for such performance studies but is not contained within this type of 510(k) documentation.

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