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The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

The BiPolar-i is intended for use in the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement,
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
• Revision of failed partial hip replacements in which the acetabulum does not require replacement

The BiPolar-i is indicated for cementless use only.

The BiPolar-i is a preassembled bipolar head comprised of an ultra-high molecular weight polyethylene (UHMWPE) liner and a highly polished cobalt-chromium alloy (CoCr) outer shell. The BiPolar-i is used in combination with a 22mm or 28mm CoCr modular head (dependent on the BiPolar i size) and compatible hip stem, both supplied separately. When assembled, the modular head is maintained captive and articulates within the UHMWPE liner. The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. The BiPolar-i is intended for use with a Corin femoral head and hip stem prosthesis with a compatible 12/14 taper connection and is designed to articulate in the patient's natural acetabulum.

The provided document is a 510(k) summary for the Corin BiPolar-i, a hip joint femoral (hemi-hip) metal/polymer prosthesis. This document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, intended use, and non-clinical testing. It explicitly states that clinical testing was not necessary for this particular submission.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not available within this document because a clinical study of the device's performance against pre-defined acceptance criteria was not conducted or reported for this 510(k) submission.

This type of submission relies heavily on non-clinical testing to demonstrate that the new device performs as safely and effectively as legally marketed predicate devices, rather than establishing numerical performance metrics against acceptance criteria from a clinical trial.

However, I can provide the non-clinical testing information that was conducted:

1. Acceptance Criteria and Device Performance (from non-clinical testing):

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical human test set was used. This refers to non-clinical laboratory testing. The document does not specify the sample sizes used for each non-clinical test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical human test set requiring expert ground truth was used.

4. Adjudication method for the test set: Not applicable, as no clinical human test set was used.

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 hip prosthesis, 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 physical hip prosthesis, not an algorithm.

7. The type of ground truth used: For the non-clinical testing, the "ground truth" is defined by the requirements and test methodologies outlined in the referenced ASTM and ISO standards, and the performance of the predicate device. For BET, it's the absence of bacterial endotoxins.

8. The sample size for the training set: Not applicable, as no training set for an algorithm was used.

9. How the ground truth for the training set was established: Not applicable, as no training set for an algorithm was used.

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The Bencox Bipolar Cup system is intended for cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis;

c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques;

d. Patients with failed previous surgery where pain, deformity, or dysfunction persists;

e. Revision of previously failed hip arthroplasty.

The BENCOX Bipolar Cup System is a cementless, metal-on-polyethylene bearing hip system for hip arthroplasty. It consists of components, Femoral stem -BENCOX ID Stem; Femoral head - BENCOX Metal Head; Acetabular system -BENCOX Bipolar Cup (Shell; Insert; Lock Ring & PE ring) and BENCOX Hip Instrumentation.

The Bencox ID Stem is manufactured from titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and has a proven titanium plasma spray coating with pure titanium conforming to ASTM F1580-07, Standard Specification for Titanium and Ti-6 Al-4 V Alloy Powders for Coatings of Surgical Implants with about two decades of clinical experience

Bencox Metal Head components are manufactured from cobalt-chromiummolybdenum alloy conforming to ASTM F1537, Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539).

The BENCOX Bipolar Cups are provided as the preassembled cup (CoCr shell + PE Liner) and PE ring is assembled by the user (surgeon). The shell is made of Cobaltchromium-molybdenum alloy conforming to ASTM F75-07, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants. The PE liner and locking ring is made of Ultra-high molecular weight polyethylene conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants.

Bencox Bipolar Cup System components are sterilized by gamma irradiation.

The provided document is a 510(k) Premarket Notification for a medical device, the BENCOX Bipolar Cup System. This type of document is centered on demonstrating substantial equivalence to legally marketed predicate devices, not on proving performance against specific acceptance criteria for a new AI/software-driven medical device.

Therefore, the document does not contain any information related to:

• A table of acceptance criteria and reported device performance (in the context of AI/software).
• Sample sizes for test sets or data provenance for AI/software.
• Number of experts and their qualifications for establishing ground truth for AI/software test sets.
• Adjudication methods for AI/software test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for AI/software.
• Sample size or ground truth establishment for a training set of an AI/software device.

Explanation:

The 510(k) Premarket Notification process for devices like the BENCOX Bipolar Cup System focuses on bench testing (performance testing) and material characterization to demonstrate that the new device is as safe and effective as a legally marketed predicate device. The performance tests mentioned (ISO standards like 7206-4, 7206-9, etc., and ASTM standards like F1147, F1044, etc.) are mechanical and material tests specific to orthopedic implants, assessing aspects like fatigue strength, wear, and corrosion resistance.

The document explicitly states the basis for substantial equivalence:

• Same intended use
• Same operating principles
• Same basic designs
• Same materials
• Similar packaging and sterilization

This is a traditional medical device submission, not one for an AI or software as a medical device (SaMD), which would require clinical performance data against specific metrics and ground truth.

In summary, the requested information regarding AI/software device acceptance criteria, study design, and ground truth establishment is not present in this document because it describes a mechanical orthopedic implant, not an AI/software medical device.

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