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The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Congenital hip dysplasia.
• · Acute traumatic fracture of the femoral head or neck.
• · Certain cases of Ankylosis.
• · Dislocation of the hip.
• · Correction of functional deformity.
• · Revision of failed joint reconstruction or treatment.
• · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

Note

· The Modular Shell, Uncemented Stem and Taper Uncemented Femoral Stem are intended for press-fit, uncemented use only.

· The Cemented stem is intended for cemented use only.

This 510k is intended to add a Modular Liner made from Vitamin E containing HXLPE (E-XLPE) to the Libertas™ - Hip Replacement System and Libertas™ Acetabular Hooded Liner cleared under K180973 and K183365, respectively. These Modular Liners are designed to be used with the Libertas components already cleared under K180973. These are available in different sizes i.e. MA, MB, MD, MF, MH, MJ, MK and different variants for each size Viz, neutral offset, "+4 mm offset", "Elevated wall", "10° Oblique", "15° Oblique" and "+4 mm offset 10° Oblique".

This looks like a 510(k) summary for a medical device called the Libertas™ E-XLPE Modular Liner, which is a component for hip replacement systems. The document states that the device is substantially equivalent to previously cleared predicate devices.

However, the provided text does not contain information about a study proving the device meets acceptance criteria in the way typically seen for AI/ML-powered medical devices. The "Non-clinical Performance data" section describes a series of mechanical and material tests for the physical hip implant component, not a clinical study or AI/ML performance evaluation.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training set details, or ground truth establishment).

Here's an analysis of what is present in relation to "acceptance criteria" and "proof":

Analysis of Provided Information Regarding Acceptance Criteria and Proof

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical and material testing, which is the standard pathway for many Class II medical devices like this hip implant component. The "acceptance criteria" are implicitly tied to meeting the performance standards of these established predicate devices and the relevant ASTM/ISO standards.

The "study that proves the device meets the acceptance criteria" refers to the set of non-clinical bench tests listed.

1. A table of acceptance criteria and the reported device performance

Since this is a mechanical device, the "acceptance criteria" are the passing criteria for the referenced ASTM and ISO standards for properties like axial disassembly, offset pull-out, torque-out disassembly, impingement, range of motion, and material characteristics. The document states that these tests were "conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence," implying that the device met the acceptance criteria defined by these standards. However, the specific quantitative results of these tests and the exact thresholds for acceptance are not provided in this summary.

Implied Acceptance Criteria and Reported Performance (Based on available info):

2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical bench tests on physical devices, not a test set of data like in AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context refers to the results of the bench tests against established standards, not expert adjudication of medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests would be the measured physical and material properties meeting the specifications outlined in the referenced ASTM and ISO standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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