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Exeter X3 RimFit Cup: The indications for use for total hip arthroplasty include: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or madequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. The Exeter X3 RimFit Cup is intended for cemented use only.

Exeter V40 Femoral Stem: The indications for use for total and hemi hip arthroplasty 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 Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The subject Exeter X3 RimFit Cup sterilized by ethylene oxide (EtO) is referred to throughout this submission as the Exeter X3-EtO RimFit Cup. The subject Exeter X3-EtO RimFit Cup is a modified version of the predicate Exeter X3 RimFit Cup and features an alternate terminal sterilization method with EtO, an additional polyethylene resin consolidation method (conventional method which meets the specifications of ASTM F648), an alternate cement spacer material in Acrylic Resin Colacryl® TS2270 PMMA, minor dimensional changes related to flange diameter and blow hole locations, and newly introduced Magnetic Resonance (MR) Conditional labeling. The geometry and design of the subject Exeter X3-EtO RimFit Cup is similar to the predicate Exeter X3 RimFit Cup. There are minor modifications to the flange diameter and blow hole locations between the subject Exeter X3-EtO RimFit Cup and predicate Exeter X3 RimFit Cup. The alternate terminal sterilization method and polyethylene resin consolidation method were previously cleared for Stryker Orthopaedics knee devices in K173849 and Stryker Orthopaedics hip devices in K182468. The alternate cement spacer material was previously cleared in K191414. The MR Conditional labeling was previously cleared in K171768.

The subject Exeter X3 RimFit Cup sterilized via gas plasma (GP) is referred to throughout this submission as the Exeter X3-GP RimFit Cup and has device designs identical to the predicate Exeter X3 RimFit Cup in terms of design and geometry. In comparison to the predicate Exeter X3 RimFit Cup, the only change to the subject Exeter X3-GP RimFit Cup is that the labeling is updated to add MR Conditional information. The MR Conditional language was previously cleared in K171768.

The subject Exeter V40 Femoral Stem is a modified version of the predicate Exeter V40 Femoral Stem in that the stem component is packaged with two polymethyl methacrylate (PMMA) centralizers that are manufactured from an alternate PMMA material (Acrylic Resin Colacryl® TS2270 PMMA). The alternate PMMA material was previously cleared in K191414. The subject device is identical to the predicate device in terms of design and geometry. The labeling for the subject device maintain the MR Conditional designation that was previously cleared in K171768 and K174399 (certain sizes of Exeter V40 Femoral Stem only).

This document, K193429, is a 510(k) premarket notification for hip replacement devices (Exeter V40 Femoral Stem, Exeter X3 RimFit Cup). It does not describe an AI/ML powered device or a study involving human readers or expert ground truth establishment for a diagnostic output. Instead, it focuses on demonstrating substantial equivalence of modified conventional medical devices to legally marketed predicate devices through non-clinical bench testing, material testing, biocompatibility evaluation, sterilization validation, and MRI compatibility analysis.

Therefore, many of the requested criteria related to AI/ML device performance, reader studies, and ground truth establishment are not applicable.

Here's an attempt to address the applicable parts of your request based on the provided document:

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

The document outlines non-clinical testing to demonstrate substantial equivalence, rather than a clinical performance study with acceptance criteria for a diagnostic output. The "acceptance criteria" here are implicitly tied to the successful completion and positive results of the listed non-clinical tests, demonstrating the modified devices meet established standards and are safe and effective.

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Sizes: The document does not specify exact sample sizes for each non-clinical test (e.g., how many material samples were tested, how many centralizers). This level of detail is typically found in the full test reports referenced by these summaries.
• Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Stryker Orthopaedics/Howmedica Osteonics Corp). The document doesn't specify the country of origin for the data, but the company is based in Mahwah, New Jersey, USA. All data would be prospective in the sense that these tests were conducted specifically for this submission.

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

• Not Applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic output. The "truth" in this context is determined by the physical, chemical, and mechanical properties of the device as measured by standardized engineering and material science tests.

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

• Not Applicable. This is not a study involving human readers or subjective interpretations 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 document is for a conventional hip implant and does not involve AI/ML or comparative effectiveness studies with human readers.

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

• Not Applicable. This document is for a conventional hip implant and does not involve an algorithm.

7. The type of ground truth used:

• The "ground truth" for the non-clinical tests is established by objective, quantitative measurements against recognized industry standards (e.g., ASTM, ISO) and FDA guidance documents. Examples include:
  • Material properties (e.g., tensile strength, wear rates)
  • Biocompatibility assessments (e.g., cytotoxicity, sensitization)
  • Sterilization effectiveness (e.g., sterility assurance level)
  • Mechanical performance (e.g., centralizer retention force)
  • MRI compatibility (e.g., induced heating, image artifact).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML product; therefore, there is no training set mentioned or implied.

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

• Not Applicable. As there is no training set for an AI/ML product, this question is not relevant.

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