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The BioPro Bipolar Head is intended for use in combination with a BioPro femoral stem for uncemented primary or revision arthroplasty 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 these indications . have failed.

The BioPro Bipolar Head consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have with a iiim ater that mates with a 28 mm diameter femoral head. The BioPro Bipolar an infor diamotor that may be a BioPro femoral stem (K882146) for arthroplasty.

The provided text describes a 510(k) premarket notification for the BioPro Bipolar Head, a medical device. This type of notification focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way a new, high-risk device might.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance
   As a 510(k) submission, the primary "acceptance criterion" is demonstrations of substantial equivalence to predicate devices, not performance against specific clinical or technical benchmarks (beyond material properties and design specifications). The document provides a detailed comparison table (Table 1 in section 5. Predicate Device Comparison) between the BioPro Bipolar Head and predicate devices (Ortho Development Pivot Bipolar Head and PLUS Orthopedics PLUS Bipolar Prosthesis).

   Feature	BioPro Bipolar Head	Ortho Development Pivot Bipolar Head	PLUS Orthopedics PLUS Bipolar Prosthesis
   510(k) Number	Pending	K050966	K982447
   FDA Product Code	KWY	KWY	KWY
   DESIGN: Head-Liner-Shell	CoCr-UHMWPE-CoCr	CoCr-UHMWPE-CoCr	CoCr-UHMWPE-CoCr
   DESIGN: Head Outer Diameter	38 to 60 mm in 1 mm increments	38 to 60 mm in 1 mm increments	43 to 60 mm in 1 mm increments
   DESIGN: Self-aligning	Yes	Yes	Yes
   DESIGN: Liner Inner Diameter	22.225 or 28 mm	22.225 or 28 mm	28 mm
   DESIGN: Liner-Head Assembly	Head snap-fit into bipolar liner	Head snap-fit into bipolar liner	Head held in by retention ring
   DESIGN: UHMWPE retention ring	Yes	Yes	Yes
   MATERIALS: Outer shell	Cobalt chromium (ASTM F75)	Cobalt chromium (ASTM F75)	Cobalt chromium (ASTM F75)
   MATERIALS: Liner & retention ring	UHMWPE (ASTM F648), EtO sterilized (not highly crosslinked)	UHMWPE (ASTM F648), gamma sterilized (not highly crosslinked)	UHMWPE (ASTM F648), EtO sterilized (not highly crosslinked)

   Acceptance Criteria Implied: The device is considered to meet "acceptance criteria" if its design, materials, and intended use are substantially equivalent to the predicate devices. The table above shows that the BioPro Bipolar Head is largely identical in design and materials to its predicates, with minor differences (e.g., sterilization method for UHMWPE, range of outer diameters compared to one predicate), which were presumably deemed not to raise new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   This document describes a 510(k) submission, which is typically based on mechanical testing, material characterization, and comparison to predicate devices, rather than a clinical "test set" from patient data. There is no mention of a clinical study or a "test set" in the context of patient data for performance evaluation in this document. The data provenance would be laboratory testing data for material properties and design specifications, not patient data.

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. As this is a 510(k) submission for a physical medical device, there is no "ground truth" establishment by experts in the context of interpreting medical images or clinical outcomes from a test set of data. The "experts" involved would be engineers and material scientists validating the device's physical properties and designers ensuring substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable. There is no clinical "test set" and therefore 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
   Not applicable. This device is a hip implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This device is a hip implant, not an algorithm. Its performance is evaluated through material testing and mechanical simulations if needed, and comparison to predicate devices.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
   Not applicable in the AI/diagnostic sense. For a device like this, "ground truth" relates to compliance with material standards (e.g., ASTM F75 for Cobalt chromium, ASTM F648 for UHMWPE) and design specifications, established through laboratory testing and engineering principles. The "truth" is that the materials meet stated specifications and the device performs its intended mechanical function in a manner equivalent to previously approved devices.

8. The sample size for the training set
   Not applicable. This document does not describe a clinical study or an AI algorithm that would require a training set.

9. How the ground truth for the training set was established
   Not applicable. No training set is mentioned in the document.

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