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The Foundation 8mm Forged Cemented Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used with cement with acetabular components or with unipolar heads.

The proximal body of the Foundation™ Non-Porous Stem is trapezoidal in cross-sectional geometry and tapers proximal to distal and lateral to medial. The proximal body has one rib on the anterior and posterior surfaces that run the length of the proximal body. Polymethylmethacrylate "buttons" are placed on the anterior, lateral and medial surfaces of the proximal body to assure that the implant is centered in the metaphseal region of the femur with a 1.5 mm cement mantle. The proximal body of the femoral stem is grit blasted to a surface of 4-6 u. This device is fabricated from forged CoCrMo alloy.

The distal portion of the stem is conical in shape. It necks down at the distal end to receive a flanged PMMA canal centralizer. This centralizer assures that the distal stem is centered in the femoral canal and helps to maintain a even cement mantle around the distal stem. The Foundation 8mm Forged Cemented Stem has a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 135°.

The provided text is a 510(k) summary for a medical device called the "8mm Forged Cemented Stem." This document describes the device, its intended use, and its basis for substantial equivalence to a predicate device. It also briefly mentions testing results. However, it does not contain a detailed study design or comprehensive acceptance criteria typically found for AI/ML-driven medical devices.

Based on the provided information, I can extract what is available regarding acceptance criteria and supporting evidence. Please note that many of the requested fields (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable because this is a traditional medical device (a hip stem) and not an AI/ML diagnostic or prognostic tool.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This is a mechanical orthopedic implant, not an AI/ML algorithm requiring a dataset of patient images or clinical data. The "test set" in this context refers to mechanical testing of the physical device.

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 the context of AI/ML, refers to clinically validated diagnoses or outcomes. For this device, "ground truth" would be the engineering specifications and performance limits for mechanical components, which are typically established through engineering standards and validated through laboratory testing, not expert clinical consensus on a test set.

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

• Not Applicable. This is not a clinical study involving human readers or expert adjudication of diagnostic findings.

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

• No. This is a mechanical implant device, not an AI-assisted diagnostic tool.

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

• Not Applicable. This device is a physical hip stem, not an algorithm. Its "standalone" performance refers to its mechanical integrity under specified load conditions, which was tested.

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

• For mechanical devices (like this hip stem), the "ground truth" is typically defined by:
  • Engineering Specifications and Standards: Material properties (e.g., CoCrMo alloy), geometric dimensions (e.g., 135° neck/stem angle, specific tapers, centralizer designs), surface finishes (e.g., 4-6 µ grit blast).
  • Biomechanical Performance Requirements: Ability to withstand specific loading conditions for a defined number of cycles (e.g., 450 lbs for 5M cycles).
  • Functional Equivalence: Demonstrated similarity in design principles and intended function to legally marketed predicate devices, implying similar safety and effectiveness.

8. The sample size for the training set

• Not Applicable. This is a mechanical orthopedic implant, not an AI/ML algorithm requiring a training dataset.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for it.

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