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The BioPro Bipolar Head is intended for use in combination with a BioPro PSL femoral stem for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
• Femoral neck and trochanteric fractures of the proximal femur
• Osteonecrosis of the femoral head
• Revision procedures where other devices or treatments for this indications have failed

Device Description

The BioPro Bipolar Head consist of a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell and UHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outer diameters ranging from 38-60mm, in 1mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38-42 mm) have an inner diameter that mates with a 22mm diameter femoral head; the larger bipolar heads (43-60mm) have an inner diameter that mates with a 28mm diameter femoral head. The BioPro Bipolar Head may be used in conjunction with a BioPro PSL femoral stem (K872535 and K871462) for hemiarthroplasty.

AI/ML Overview

This is a 510(k) summary for a medical device, specifically a hemi-hip prosthesis. The information provided heavily emphasizes that the device is "substantially equivalent" to predicate devices, and therefore no new clinical studies were performed to establish its performance or meet acceptance criteria derived from clinical data.

Here's a breakdown based on your request, highlighting the relevant sections and the absence of clinical data:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission relying on predicate devices, there aren't explicit "acceptance criteria" for a new study to meet, nor "reported device performance" in terms of clinical outcomes. Instead, the "acceptance criteria" are implied by the performance of the predicate devices and the successful completion of specific non-clinical tests.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Push-out strength within range of legally marketed bipolar designs.	Push-out and lever-out strengths were within the range of legally marketed bipolar designs.
Lever-out strength within range of legally marketed bipolar designs.	(Addressed above)
Material Durability:
Locking ring spring should maintain function after heat exposure.	Locking ring spring storage heat tolerance test (150 deg. F) was conducted and presumably passed, as the device was deemed substantially equivalent. (No specific performance metric provided, but implied successful completion).
Sterilization Efficacy:
ETO sterilization provides sterility assurance level.	ETO sterilization validation 10^6 was performed and presumably passed, as the device was deemed substantially equivalent. (No specific performance metric provided, but implied successful completion).
Equivalence to Predicate Device:
Identical to predicate device (K082705) with specified modifications.	The BioPro Bipolar Head is identical to the BioPro Bipolar head cleared in K082705 with the specified exceptions (modified UHMWPE retaining ring and added retaining spring). The device is also stated to be identical to the Omni Life Science Bipolar head 510k 100151 and manufactured to the same standards and technical drawings.
No change in Indications for Use from predicate.	The indications have not changed from the predicate. (Listed in "Indications for Use" section: primary or revision hemiarthroplasty for femoral neck/trochanteric fractures, osteonecrosis, revision procedures where other treatments failed).

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

Sample Size: Not applicable in the context of clinical data. For the non-clinical tests (push-out, lever-out, heat tolerance, sterilization), the specific sample sizes are not provided in this summary.
Data Provenance: The "study" here is a series of non-clinical, benchtop tests. The data provenance is from laboratory testing conducted by or for the device manufacturer, BioPro, Inc. There is no clinical data provenance from human subjects.

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

Not applicable. No clinical test set with ground truth established by experts was used. The evaluation relies on engineering principles and comparison to predicate device specifications.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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 device is a physical implant (hemi-hip prosthesis), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study involving human readers or AI was performed or is relevant.

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

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

7. The Type of Ground Truth Used

Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be established engineering standards, material specifications, and the performance characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of clinical data or machine learning for this device. The device design and testing are based on established engineering principles and comparison to predicate devices.

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

Not applicable. As there was no training set, there was no ground truth for it to be established. The basis for the device's design and assessment is its substantial equivalence to previously cleared devices, supported by non-clinical testing demonstrating comparable mechanical and material properties.

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