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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
. Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
. Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The proposed Novation Splined RDD Press-Fit Femoral Stem is a modification of the predicate Novation 12/14 Splined Press-Fit Femoral Stems cleared through premarket notification #K042842. Both products share the same intended use and basic fundamental scientific technology and differ only in the proposed reduced distal crosssectional diameter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech® Novation Splined RDD Femoral Stems:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantifiable acceptance criteria (e.g., "flexural strength must be > X MPa") or detailed performance results in the format of a table. Instead, it relies on a qualitative statement regarding substantial equivalence.

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

The document does not provide any information about a "test set" in the context of clinical or performance testing with a specific sample size. The evaluation appears to be based on "engineering evaluations."

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (since no clinical or performance test data is detailed).

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

The document does not mention using experts to establish ground truth for a test set. The evaluation is described as "engineering evaluations," implying analysis by engineers, rather than medical experts interpreting test results.

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

Since there is no mention of an expert panel or a test set generating subjective interpretations, there is no adjudication method described.

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:

This type of study is not applicable to the information provided. The device described is a medical implant (femoral stem for hip replacement), not an AI-assisted diagnostic tool or image analysis software. Therefore, there's no mention of AI or human readers improving with AI assistance.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the performance characteristics of the predicate device, against which the modified device's "engineering evaluations" were compared.

• Type of Ground Truth: Performance metrics of the predicate device (Novation 12/14 Press-Fit Femoral Stems #K042842), presumably derived from its original clearance process and existing data or design specifications. The document states "Engineering evaluations were conducted to verify that the performance of the proposed Novation Splined RDD Femoral Stems would be adequate for anticipated in vivo use." This implies comparison to established performance standards or expectations for such devices, likely informed by the predicate.

8. The Sample Size for the Training Set:

This is not applicable as the document describes a physical medical device (femoral stem) and engineering evaluations, not a machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the same reason as point 8.

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