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The PLUS EPF Acetabular Cup is intended for all types of arthrosis. such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.

The PLUS EPF Cup is a cementless acetabular cup, which was designed with a triple-radius profile. The advantages are 1) minimal bone resection, 2) press-fit with physiological load transfer through the peripheral zone of the acetabulum, thus ensuring good primary stability without the need for screw fixation and 3) optimal osseous integration due to good primary stability.

The provided text describes a 510(k) summary for the PLUS EPF Acetabular Cup, a cementless total hip prosthesis. It outlines the device's characteristics, indications, contraindications, and performance data used to establish substantial equivalence. However, it does not detail specific acceptance criteria in a quantitative manner, nor does it describe a study that proves the device meets such criteria with numerical thresholds.

Instead, the document states: "In all tests the PLUS EPF Cup was comparable to, or exceeded, cementless competitive acetabular cups." This implies a comparative study was performed against predicate devices, with the acceptance criteria being that the PLUS EPF Cup performs at least as well as or better than the predicate cups in the measured biomechanical properties.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size (number of cups tested) for each biomechanical test. It mentions comparing "four cups of other leading manufacturers to the PLUS EPF Cup," which suggests that for each test, at least one PLUS EPF Cup was compared against four predicate cups. However, the exact number of replicates for each type of cup is not specified.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective, as it involves testing manufactured devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable and not provided. The "ground truth" for these biomechanical tests would be the physical measurements themselves, not expert opinion.

4. Adjudication Method for the Test Set

This information is not applicable and not provided as the tests are objective biomechanical measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The described studies are biomechanical tests of the device itself, not studies involving human readers or clinical outcomes.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the studies described are standalone performance tests of the device's physical properties. They do not involve human intervention in the measurement process, aside from operating the testing equipment.

7. The Type of Ground Truth Used

The ground truth used was objective physical measurements (forces) obtained from biomechanical testing.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This type of device (hip prosthesis) does not typically involve a "training set" in the context of machine learning or AI. The biomechanical tests are for performance validation.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. There is no concept of a "training set" or "ground truth for a training set" in the context of these device performance tests.

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