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The modification does not alter the intended use of the predicate systems as cleared in the referenced premarket notifications. The subject ADM and ADM/MDM Acetabular Inserts are sterile, single-use devices intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. These devices are intended to be used only with currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.

The indications for use for total hip arthroplasty include:

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis: l )
• 2. Rheumatoid arthritis:
• 3. Correction of functional deformity:
• 4. Revision procedures where other treatments or devices have failed:
• 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• 6. Dislocation risks

The ADM and MDM Systems are intended for cementless use only.

The Restoration® Anatomic Dual Mobility (ADM) and Modular Dual Mobility (MDM) Systems utilize Duration® and X3® Polyethylene Acetabular Inserts that retain a femoral head. The outer diameter of the insert articulates on the inner surface of either the polished ADM Acetabular Cup or, for certain sizes of inserts, the MDM Acetabular Liner. The Duration® and X30 polyethylene inserts therefore function as a dual mobility device as there are two articulating surfaces.

The provided submission is a 510(k) summary for the Restoration® Anatomic Dual Mobility™ and Modular Dual Mobility™ Systems Duration® and X3® Acetabular Inserts. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical trials. Therefore, much of the requested information cannot be extracted from this document as it pertains to clinical study results.

Here's a breakdown of what can be inferred and what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through engineering and risk analysis, and laboratory testing.

• Device comparison (intended use, materials, operational principles)
• Engineering and risk analysis
• Laboratory testing (Wear, lever-out and pull out force testing, and range of motion analysis) |

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

The document states: "Clinical Testing: Clinical testing was not required for this submission." This indicates there was no clinical "test set" in the context of a traditional clinical study with human subjects. The "test set" for demonstrating substantial equivalence consisted of laboratory tests on the device itself.

• Sample Size: Not specified as it refers to laboratory testing, not human subjects.
• Data Provenance: Laboratory testing.

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

Not applicable. There was no clinical ground truth established by experts for a patient test set as clinical testing was not performed.

4. Adjudication method for the test set

Not applicable, as there was no clinical test set requiring adjudication.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

For the laboratory testing, the "ground truth" would be the measured physical and mechanical properties of the device, compared against known industry standards, design specifications, and the performance of predicate devices. This is a technical "ground truth" rather than a clinical one.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of machine learning. The design and validation of the device were based on engineering principles and knowledge, not data-driven training.

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

Not applicable. Without a training set, this question is not relevant.

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