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Total hip replacement procedures for:

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
• Revision procedures where other treatments have failed
  The device is intended for insertion without bone cement. It is a single use implant.
  To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.

Biomet Titanium Low Profile Screws are available in 5.0mm and 6.5mm diameters in lengths from 15mm to 70mm. The 5.0mm screws are for use in screw holes on the rim of an acetabular shell whereas the 6.5mm screws are designed for use in the dome of an acetabular shell. Each screw has a self-tapping point.

This document is a 510(k) premarket notification for a medical device (Titanium Low Profile Screws) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel study with acceptance criteria and performance data in the way a clinical trial for a new drug or a completely novel device might.

Therefore, the requested information elements related to specific study designs for "acceptance criteria" and "device performance" (especially relating to AI or software, which this device is not) are not present in this document.

However, I can extract information related to how substantial equivalence was established, which serves a similar purpose in the 510(k) pathway.

Here's a breakdown of the available information:

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

   • Not Applicable (N/A): This document does not present acceptance criteria or reported device performance in the form of a study comparing the new device against specific performance metrics. Instead, the "acceptance criteria" for a 510(k) submission are based on demonstrating "substantial equivalence" to a legally marketed predicate device.
   • "Performance" implicitly refers to being equivalent to the predicate. The document states: "Biomet's Low Profile Screws are substantially equivalent to acetabular screws depicted with the following competitive acetabular systems: Trilogy Acetabular System - Zimmer (510(k) K934765) and Arthopor Acetabular System - Joint Medical Products Corp. (510(k) K955511)."
   • The "performance" implies that the new device shares the same intended use, indications for use, and technological characteristics (e.g., material, dimensions, self-tapping point) as the predicate devices, and therefore is expected to perform similarly with the same associated risks.

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

   • N/A: There is no "test set" in the context of a clinical performance study described. This 510(k) focuses on demonstrating substantial equivalence primarily through comparison of design, materials, and intended use to predicate devices, without presenting data from a standalone clinical study involving a test set.

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)

   • N/A: No experts were used to establish ground truth for a test set, as no such study is presented. The "expertise" involved in the 510(k) process is the regulatory review by the FDA (e.g., Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices).

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

   • N/A: No adjudication method is mentioned as there is no test set or expert review process described in a clinical study context.

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

   • N/A: This device (Titanium Low Profile Screws) is a physical implant, not an AI or software-based device. Therefore, an MRMC study or AI-related effectiveness is not relevant or included.

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

   • N/A: As above, this is a physical implant, not an algorithm or software.

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

   • N/A: The concept of "ground truth" (as typically used in studies evaluating diagnostic accuracy or AI performance) is not applicable here. The "truth" in a 510(k) submission for substantial equivalence is that the device is comparable in fundamental scientific technology and performance to a legally marketed predicate device.

8. The sample size for the training set

   • N/A: There is no "training set" as this is not a machine learning or data-driven software device.

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

   • N/A: Not applicable for the reasons stated above.

In summary, this 510(k) submission demonstrates substantial equivalence of a physical medical implant (Titanium Low Profile Screws) to existing predicate devices (Zimmer Trilogy Acetabular System and Joint Medical Products Corp. Arthopor Acetabular System). It does not involve a clinical study with an "acceptance criteria" table or elements related to AI, software performance, or specific sample sizes for test/training sets as might be seen for a novel diagnostic or AI-powered device.

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