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The Global Press-fit Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because of: 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 non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended for cementless use.

The Global Press-fit stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. It is available is sizes ranging from 9mm to 17mm. The body tapers proximal to distal in the lateral and frontal planes, and lateral to medial in the sagittal plane resulting in a tri-planar wedge geometry that is conducive to axial and rotational stability. The distal stem is conical in shape with sharp splines to enhance rotational stability. Stems larger than 11mm have a coronal slot in the distal third to aid in the reduction of thigh pain. A Morse type taper is used to attach modular femoral heads. The stem is available with neutral, and right and left anteverted necks. No calcar collar is present on this stem. The proximal lateral shoulder of the stem has a threaded hole for insertion and extraction tools. The proximal body of the stem has a circumferential porous coating of sintered CP titanium beads (ASTM F67). The femoral heads utilized with the Global Press-fit Hip are machined from wrought CoCrMo alloy (ASTM F799). They are available in 22mm, 28mm diameters. The 22mm heads have two neck lengths, while the 28mm and 32mm heads have five neck lengths.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Global Press-fit Hip as requested.

Based on the provided text, the "study" conducted for the Global Press-fit Hip is primarily an engineering analysis comparing its strength to predicate devices, rather than a clinical trial with human subjects or a diagnostic algorithm performance study.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text does not specify a distinct "test set" in the traditional sense of a clinical or retrospective data set. The evaluation was primarily an engineering analysis, likely involving a limited number of physical prototypes or computational models for the mechanical strength comparison. No human subject data (prospective or retrospective) is mentioned.
• Data Provenance: Not applicable in the context of an engineering comparison of device characteristics. There's no country of origin for "data" as it pertains to patient information.

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

• Experts: The document does not mention the use of experts to establish "ground truth" for a test set of data in a diagnostic or clinical performance context. The expertise would lie with the engineers who conducted the material and mechanical comparisons.
• Qualifications: Not specified.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" requiring adjudication in the sense of expert review for ground truth. The comparison method was an engineering analysis.

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, an MRMC comparative effectiveness study was not done. This submission is for a medical device (hip implant), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on established engineering standards, material specifications (ASTM), and comparative mechanical performance against legally marketed predicate devices. It relies on:
  • Published ASTM standards: For material composition.
  • ISO 7206-4 standard: For mechanical strength testing of femoral components.
  • Known characteristics of predicate devices: For comparison of geometry, materials, and manufacturing processes.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. There is no "training set" and therefore no ground truth was established for it.

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