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• Non-inflammatory 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 technique

The Renovis Bipolar Hip System includes a bipolar head and 22 mm femoral heads. The Renovis Bipolar heads are offered in a range of inner and outer dimensions from 39 to 65 mm to fit either 22 or 28 mm femoral heads. Renovis already has FDA clearance for a 28 mm femoral head (K112897). The bipolar head is a sub-component of a hip replacement construct where it assumes the function of the natural femoral head and is combined with a femoral head and hip stem. It consists of a highly polished CoCr alloy outer shell and a polyethylene insert. The ultra-highmolecular weight polyethylene (UHMWPE) insert is comprised of an inner liner and a locking ring. The bipolar head has two articulation surfaces: the outer CoCr head articulates with the patient's natural acetabular cartilage and the inner UHMWPE liner articulates with the femoral head assembled to the femoral stem. The modular CoCr alloy femoral head, is held in place within the bipolar head by a retaining ring that is pre-assembled into the polyethylene insert. The bipolar heads and femoral heads are gamma sterilized. The system is offered with the full instrumentation required for the procedure.

Here's a breakdown of the acceptance criteria and study information for the Renovis Bipolar Hip System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria in terms of compliance with specific ASTM and ISO standards for material properties, testing methods, and sterilization. It does not provide specific numerical acceptance criteria (e.g., minimum force for disassembly) or corresponding numerical performance values from the testing. Instead, it makes a general statement of successful compliance.

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

The document only states that the device "successfully undergone ASTM performance testing." It does not specify the sample size used for the mechanical testing (e.g., number of bipolar heads tested for disassembly force). The data provenance is not explicitly mentioned but implies laboratory testing, not clinical data, and therefore, country of origin is not relevant in this context.

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

This information is not applicable as the evaluation is based on in-vitro performance testing against engineering standards, not on clinical interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on in-vitro performance testing against engineering standards, not on clinical interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This document describes the premarket notification for a medical device (hip prosthesis) based on substantial equivalence, which primarily relies on engineering performance testing and comparison to predicate devices, not clinical effectiveness studies of human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to this medical device submission. The "device" in this context is a physical hip prosthesis, not an algorithm or AI system. The performance testing described is mechanical, in-vitro testing.

7. Type of Ground Truth Used

The "ground truth" for this submission is established by engineering standards and specifications (ASTM and ISO). The device's components and overall system are tested against the requirements outlined in these standards.

8. Sample Size for the Training Set

There is no training set for this device submission as it is a physical medical device (hip prosthesis) and not an AI/algorithm-based product.

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

This question is not applicable as there is no training set mentioned or implied for this physical medical device.

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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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