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The use of the Implex A-240 HEP Acetabular Cup System is indicated for: a) Total Hip Replacement in severely disabled joints as a result of degenerative arthritis or avascular necrosis; b) Secondary revision of a previously unsuccessful acetabular component; c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results; d) Fracture dislocation of the hip, or irreducible fractures in which adequate fixation cannot be obtained; e) Non-union of femoral neck or head fractures; and f) Salvage of a failed primary or secondary total or hemi hip.

Implex A-240 HEP Acetabular Cups are available in OD sizes from 40 mm to 72 mm (in 2 mm increments), and with 4 possible ID size options (22 mm, 26 mm, 28 mm, and 32 mm). Implex A-240 HEP Acetabular Cups are to be implanted using the Implex Acetabular Cup Instrumentation System.

The provided text is a 510(k) Summary for a medical device (Implex A-240 HEP Acetabular Cup System) seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the new device is as safe and effective as a previously cleared device, rather than defining and proving arbitrary acceptance criteria for a novel device through a clinical study.

Therefore, many of the requested categories for acceptance criteria and study design are not applicable in this context. The document describes a comparison to a predicate device, not a de novo study against defined performance metrics for a completely new technology.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

Since this is a submission for substantial equivalence based on material and design similarity, explicit numerical acceptance criteria and a "reported device performance" table in the sense of a clinical trial are not present. Instead, the "acceptance criteria" can be inferred as demonstrating that the Implex A-240 HEP Acetabular Cup System is substantially equivalent to the predicate device, the Implex A-230 Porous Acetabular Cup System, Non-Cemented, in terms of intended use, safety, and effectiveness.

The "study" conducted to prove this equivalence is a series of "Testing conducted to characterize the materials and the Performance Data of the device under defined laboratory conditions."

Table of Equivalent Performance (Inferred from Substantial Equivalence Claim):

Specific Study Details (Not Applicable/Inferred for a 510(k) Submission)

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

   • Test Set Sample Size: Not applicable for a 510(k) material/performance characteristics study. The testing would involve samples of the device material and components, not a patient test set.
   • Data Provenance: Laboratory conditions. (Country of origin and retrospective/prospective are not relevant for material characterization).

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

   • Not applicable. Ground truth in the context of clinical outcomes or expert interpretation is not relevant for material and performance characterization in a laboratory setting. Material properties are established through standardized tests.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This refers to clinical data adjudication, which is not described.

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. This device is an acetabular cup, not an AI or imaging diagnostic tool.

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

   • Not applicable. This device is an acetabular cup, not an algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Material properties and mechanical performance metrics (e.g., strength, stiffness, fatigue resistance) as determined by established engineering and materials science standards.

7. The sample size for the training set:

   • Not applicable. This type of study does not involve a "training set" in the machine learning sense. The "training" for such a device would be the extensive research and development leading to its design and manufacturing processes, which are not detailed here.

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

   • Not applicable. See point 7. For material design, "ground truth" would be established through established scientific principles, industry standards, and material characterization techniques.

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