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The J-FX Bipolar Head is indicated for use in partial hip replacement procedures for patients suffering severe pain and disability due to:

• femoral fracture
• avascular necrosis of the femoral head
• osteoarthritis
• other abnormalities:
  • where the major pathology affects the femoral head,
  • where the acetabular cavity is normal and not deformed or weakened, and
  • where acetabular replacement is not required or desirable.

The J-FX Bipolar Head is composed of an Co-Cr-Mo alloy shell (ASTM F75) and a ultra-high-molecular weight polyethylene (UHMWPE) liner. The liner is a three piece design consisting of a bearing insert, inner retaining ring and an outer locking ring. The bearing insert and inner retaining ring provide the bearing surface for the femoral hip head while the locking ring holds the liner assembly in place in the shell.

The outer diameter of the metal shell varies in size from 38 through 58 mm in 1 mm increments for use with the 22.225 mm UHMWPE liner. For the 28 mm UHMWPE liner, the size range for the metal shell is 42 through 58 mm in 1 mm increments. A 60 mm metal shell is also available for use with both the 22.225 mm and 28 mm UHMWPE liner.

Five sizes of polyethylene liners are available for the 22.225 mm J-FX Bilpolar head and four sizes for the 28 mm J-FX Bipolar head. With this availability of liner sizes, the mating of the full range of outer shell sizes are met. The polyethylene thickness ranges from 4.1 to 12.1 mm for the 22.225 mm head and 3.7 to 9.2 mm for the 28 mm head.

This document describes the J-FX Bipolar Head, a medical device for partial hip replacement. It is a 510(k) premarket notification. Therefore, the information provided below will largely focus on demonstrating substantial equivalence rather than detailed studies to prove novel acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

For 510(k) submissions, the “acceptance criteria” and “device performance” are primarily demonstrated through comparison to a legally marketed predicate device. The key acceptance criterion is substantial equivalence in terms of indications for use, technological characteristics (materials, design), and performance (implied by the same materials and function).

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

This is a 510(k) premarket notification for a Class II device. There is no explicit "test set" in the traditional sense of a clinical trial for this submission. Substantial equivalence is primarily established through:

• Comparison of device specifications to the predicate device.
• Bench testing to ensure material properties and mechanical performance meet established standards for similar devices. While not explicitly detailed in the provided text, such testing would have been part of the full submission, but it's not a "test set" with patient data.

Therefore, information on "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) related to patient data is not applicable in this summary as no such clinical study data is presented for direct evaluation of the J-FX Bipolar Head's performance in a patient population. The focus is on design and material equivalence to a device already proven safe and effective.

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

Not Applicable. As no clinical "test set" with patient data requiring ground truth establishment is described in this 510(k) summary, this information is not relevant. The "ground truth" for demonstrating substantial equivalence is the existence and established performance of the predicate device, recognized by the regulatory body.

4. Adjudication Method for the Test Set

Not Applicable. See point 2 and 3. No clinical test set requiring adjudication is detailed.

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 mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic system. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

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

Not Applicable. This is a mechanical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device (P.F.C.® Bipolar Hip System), which was cleared under premarket notifications K945793 and K931655. The J-FX Bipolar Head establishes its own "truth" of safety and effectiveness by demonstrating direct equivalence in materials, indications, and function to this already approved device.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware medical device. The concept of a "training set" as understood in machine learning or AI is not relevant here. The design and manufacturing process would involve engineering principles and quality control, not a "training set" of data.

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

Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this device, there is no ground truth to establish for it. The "ground truth" for the device's design and manufacturing is adherence to material standards (e.g., ASTM F75 for Co-Cr-Mo alloy) and general Good Manufacturing Practices (GMP).

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