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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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The M²a™/C²a™ Acetabular System is intended for cemented or non-cemented use in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Revision procedures where other treatment or devices have been unsuccessful
5. Treatment of non-union, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

The M²a™/C²a™ Acetabular System consists of a titanium outer acetabular shell with a cobalt alloy metallic liner for metal articulation.

The acetabular shells are hemispherical in shape to closely match the natural acetabulum. Two screw holes in the dome allow for additional fixation by the use of screws. The outer surface of the shells are covered with Biomet's plasma sprayed coating.

The metallic cobalt alloy bearing liner fits into the outer shell by means of a taper similar to the taper used for the attachment of a modular head to a femoral stem. The metallic liners articulate with cobalt alloy modular heads.

The provided text describes a 510(k) submission for the M²a™/C²a™ Acetabular System, a metallic hip implant. This document is a premarket notification to the FDA for a medical device and therefore does not contain acceptance criteria or a study demonstrating device performance in the context of AI/ML or diagnostic accuracy studies.

The key information from the document related to testing is:

• Non-Clinical Testing: None provided
• Clinical Testing: None provided.

This indicates that the device's substantial equivalence was claimed based on its technological characteristics being similar or identical to legally marketed predicate devices, rather than through new non-clinical or clinical studies. This is a common pathway for 510(k) clearances, especially for devices where the fundamental technology is well-established.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance because this type of information is not present in the provided 510(k) summary. These types of details are more common in PMAs (Premarket Approval applications) or specific studies related to a device's diagnostic accuracy or clinical outcomes, which is not the nature of this document.

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