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The Unitrax® Modular Unipolar System is intended to be used with a Howmedica Osteonics hip stem. When assembled to a hip stem, the resultant component functions in Ostcomes imp stem. "When assemmooprosthesis. The endoprosthesis is used as a hemia shillial for the following indications: femoral neck fractures, idiopathic avascular necrosis and non-unions.

The Unitrax® component is a unipolar head that accepts a neck adjustment adaptor or sleeve. The neck adjustment sleeve is then assembled to the trunnion of the desired Howmedica Osteonics femoral stem. The design modification to the unipolar head involves a reduction in the wall thickness and removal of the inner "ribs". The manufacturing process modification involves changing the size 45mm components from machined to cast parts which results in a material change from ASTM F1537 to ASTM F75. The modified component is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process in 510(k) #K902365. The Unitrax® Modular Unipolar Heads are manufactured from Vitallium® (CoCr) Alloy which conforms to ASTM standards F75 (cast) and F1537 (wrought). The intended use of the modified Unitrax® Modular Unipolar Heads is identical to that of the unmodified Unitrax® Modular Unipolar Heads.

This submission describes design, manufacturing process, and material modifications to the Unitrax® Modular Unipolar System, a unipolar hip implant component. The information provided does not contain details about acceptance criteria, device performance, or a study that uses statistical measures to evaluate performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and material verification, rather than clinical performance or AI/software validation.

Therefore, many of the requested fields cannot be answered directly from the provided text.

Here's the breakdown of what can be extracted and what is not available, based purely on the provided text:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for device performance (e.g., accuracy, sensitivity, specificity). The acceptance criteria implicitly revolve around demonstrating substantial equivalence to the predicate device through design, material, and manufacturing process changes, and possibly mechanical testing (though specific results are not detailed).
• Reported Device Performance: No quantitative performance metrics are reported. The document states:
  • "The modified component is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process in 510(k) #K902365."
  • "The intended use of the modified Unitrax® Modular Unipolar Heads is identical to that of the unmodified Unitrax® Modular Unipolar Heads."

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

• Sample Size for Test Set: Not specified. This document is a 510(k) summary for modifications to an existing device, and such submissions often rely on bench testing (mechanical, material, etc.) rather than clinical test sets with human subjects, unless a major change in safety/effectiveness is suspected.
• Data Provenance: Not specified. Likely involves in-house laboratory testing of the device components.
• Retrospective or Prospective: Not applicable as no clinical study or human data is mentioned.

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)

• Not applicable. This device is a mechanical implant; ground truth would relate to material properties and mechanical performance, established through engineering standards and testing, rather than expert interpretation of data.

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

• Not applicable. No expert adjudication process is described as there is no clinical data or expert interpretation involved in the substantial equivalence argument presented.

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 is a hip implant, not an AI or imaging device. No human readers or AI assistance are part of this device or its evaluation in the provided text.

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

• Not applicable. This is a hip implant, not an algorithm or software device.

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

• The ground truth in this context would likely be engineering standards and specifications (e.g., ASTM standards for materials, recognized test methods for mechanical strength, fatigue, etc.) that the modified device components must meet to demonstrate substantial equivalence and safety/effectiveness. No clinical ground truth (pathology, outcomes) is mentioned.

8. The sample size for the training set

• Not applicable. No training set is involved as this is not a machine learning or AI device.

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

• Not applicable. No training set or associated ground truth.

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