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The Stryker Modular Hip is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available Howmedica Osteonics acetabular components, V40 femoral heads, C-Taper Alumina heads when used with the V40/C-Taper Adaptor and the Biolox® Delta Universal Taper Heads and sleeves.

The indications for use of total hip replacement prostheses include:

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

The Stryker Modular Hip System is intended for cementless use only.

Howmedica Osteonics is introducing a modular hip prosthesis. The basic design of the Stryker Modular Hip System is similar to other total hip systems commercially distributed such as the Profemur® Total Hip Modular Neck System, Wright Medical Technology, Inc. and other Howmedica Osteonics' hip systems such as the Secur-Fit HA Stem, the Accolade C and TMZF HA Stems and the Citation TMZF HA Stem.

The subject hip is a composed of a modular stem with a modular neck intended for cementless, press-fit application. It is designed for use with currently available Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.

The provided text is a 510(k) summary for the Stryker Modular Hip System. It describes the device, its intended use, indications, and claims substantial equivalence to predicate devices based on design, materials, and operational principles, supported by mechanical testing.

However, the provided text does not contain any information about specific acceptance criteria or a study demonstrating device performance against those criteria in a clinical or statistical sense. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study with quantified metrics.

Therefore, I cannot provide the requested table or answer most of the questions about a performance study, as the information is not present in the given document.

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

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

• Cannot be provided. The document states that the device is "substantially equivalent" to predicate devices based on mechanical testing, but it does not specify any quantitative acceptance criteria (e.g., specific thresholds for wear, fatigue life, or clinical outcome measures) or numerical results from such tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document mentions "mechanical testing" was performed to establish substantial equivalence but does not specify sample sizes, data provenance, or whether the study was retrospective or prospective. It is highly likely that any "test set" in this context would refer to device components undergoing lab-based mechanical tests, not a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. There is no mention of human expert involvement in establishing "ground truth" for a test set. The evaluation focuses on mechanical properties, which are typically assessed through laboratory measurements and engineering standards.

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

• Cannot be provided. This concept is not applicable to the type of information presented. The document describes a medical device's mechanical testing for regulatory clearance, not a clinical study involving human assessment.

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

• Cannot be provided. This document is not about AI or diagnostic imaging. It describes a hip prosthesis.

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

• Cannot be provided. This document is not about an algorithm. It describes a hip prosthesis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth," in the context of this document, would be based on engineering standards and mechanical test results confirming the physical properties and performance characteristics of the hip prosthesis components. For example, fatigue strength, tensile strength, wear rates, etc., compared to established benchmarks for hip implants. However, specific metrics are not detailed.

8. The sample size for the training set

• Not applicable / Cannot be provided. This concept is for AI/machine learning models. The document describes a physical medical device.

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

• Not applicable / Cannot be provided. This concept is for AI/machine learning models. The document describes a physical medical device.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Stryker Modular Hip System to already marketed predicate devices based on design, materials, indications for use, and a general statement about mechanical testing. It does not provide the detailed performance metrics, acceptance criteria, or study design information typically associated with a clinical or performance study as implied by your questions, which are more relevant to AI or diagnostic device evaluations.

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