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The subject Constrained Liner is intended to be used with the DePuy Pinnacle® metal acetabular shells, DePuy Modular M femoral heads and Self-centering™ (bipolar) femoral heads to resurface the acetabular socket in cementless total hip arthroplasty.

The Pinnacle® Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.

The DePuy Pinnacle® Constrained Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6A1-4V). The liner component articulates with a metal femoral head of an appropriate diameter.

The Pinnacle® Constrained Acetabular Liner mechanically constrains the femoral head within the ID of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.

The subject DePuy Pinnacle® Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized facechanging orientation and have inner diameters (ID) compatible with Self-Centering™ (bipolar) femoral heads within the 40mm - 44mm size range. The liners are identical in design to those cleared in K052079 on October 21, 2005. The compatible components are being extended in this submission to include DePuy Modular M femoral heads (cleared in K060031 on January 31, 2006) within the 40mm - 44mm size range.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy Pinnacle® Constrained Acetabular Liner:

The provided 510(k) summary (K071117) does not describe a study to prove acceptance criteria in the traditional sense of a clinical trial or performance study with acceptance metrics. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested fields related to a specific study (sample size, experts, ground truth, MRMC study, standalone performance, training set) cannot be directly extracted from this document, as such a study was not the basis of clearance.

Here's the information that can be gleaned, with explanations for missing parts:

Acceptance Criteria and Study for DePuy Pinnacle® Constrained Acetabular Liner (K071117)

This 510(k) submission (K071117) asserts substantial equivalence to predicate devices rather than presenting a performance study with defined acceptance criteria and tested device performance. The "acceptance criteria" here are implicitly met by demonstrating that the device is identical or substantially similar to previously cleared devices in terms of design, materials, manufacturing, and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This submission did not involve a test set for performance evaluation in the typical sense. Substantial equivalence was demonstrated by comparing design specifications and intended use against already cleared devices.

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

• Not applicable. No expert ground truth establishment for a test set was described.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method was described within this summary.

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 physical medical implant (acetabular liner), not an AI/software device that would involve human readers or AI assistance.

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

• Not applicable. This is a hardware device; no algorithm-only performance was assessed.

7. The type of ground truth used:

• Not applicable. The submission does not refer to ground truth data in the context of a performance study. "Ground truth" in this context is established by the prior clearance of the predicate devices and the demonstration that the current device is identical or substantially equivalent.

8. The sample size for the training set:

• Not applicable. This is a hardware device; no training set for an algorithm was used.

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

• Not applicable. No training set was used.

Summary Explanation:

The K071117 submission is a 510(k) premarket notification that seeks clearance based on "substantial equivalence." This regulatory pathway allows manufacturers to market a new device if it is as safe and effective as a legally marketed "predicate device." A key aspect of proving substantial equivalence is demonstrating that the new device has the same technological characteristics (or different characteristics that do not raise new questions of safety or effectiveness) and the same intended use as a predicate device.

In this specific case, the applicant states that:

• The DePuy Pinnacle® Constrained Acetabular Liner is identical to a previously cleared version (K052079).
• The DePuy Modular M femoral head (which the liner is now compatible with) is identical to a previously cleared version (K060031).
• The articulation/combination of these two components is substantially equivalent to a different predicate device (K043058) based on similarities in design, intended use, material, and manufacturing.

Therefore, the "acceptance criteria" were met by establishing these direct identifcations or substantial equivalences to already approved devices, rather than through a de novo performance study. The "study" referenced is the comparative analysis against the predicate devices' specifications and clearance information.

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