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This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
3. Correction of function deformity;
4. Revision procedures where other treatments or devices have failed;
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.

There are two purposes in current submission, the fist one is to expand the Indications for Use of two cleared products: U2 Hip System (K111546) and Femoral Heads, +2.5 & +7.5 mm Offset (K122504), which have been expanded to a population with similar demographic, diagnosis and prognosis as the original. The second purpose of this submission is to reword the statement of Indications for Use of six cleared "UNITED" hip products including U1 Hip System (K994078), U2 Hip Stem, Ti porous coated (K003237), U2 Acetabular Cup and Femoral Head (K022520), U2 Acetabular Component (K050262), U2 Hip Stem and Ti Plasma Spray (K062978) and U2 Acetabular Cup, Plasma Spray (K121777). Through this submission, the Indications for Use of above listed devices are unified as one version, and the components, materials, design, processing methods, sterilization methods, biocompatibility, safety and effectiveness of above listed devices are unchanged by this submission.

The provided text describes a 510(k) summary for the "U2 Hip System, Expanded Indications for Use". This document focuses on establishing substantial equivalence to previously cleared predicate devices for the indications for use of a hip implant system, rather than proving the performance of a newly designed device through explicit acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established is not applicable in this context.

Here's why and what the document does provide:

• Type of Device: This is a hip prosthesis (total hip replacement system).
• Regulatory Pathway: This is a 510(k) premarket notification. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics (design, materials, packaging, sterilization) and intended use, rather than conducting new clinical performance studies against specific acceptance criteria for a novel device.
• Purpose of the Submission:
  1. Expand Indications for Use: For two existing products (U2 Hip System K111546 and Femoral Heads K122504) to include a similar patient demographic, diagnosis, and prognosis.
  2. Reword/Unify Indications for Use: For six other cleared "UNITED" hip products to a single, unified version.
• Basis for Substantial Equivalence: The submission states that the components, design, materials, packaging, and sterilization method of the "U2 Hip System - Expanded Indications for Use" are identical to cleared predicate devices. The only difference is the integration of indications for use.
• Non-Clinical and Clinical Testing: The document explicitly states:
  • "Non-clinical laboratory testing is not provided as a basis for substantial equivalence."
  • "Clinical Testing None provided as a basis for substantial equivalence."

Conclusion:

This submission does not contain information about a study designed to prove the device meets specific acceptance criteria in the manner requested because it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices. The performance and safety of the device are implicitly linked to the predicate devices it is compared against, not to new performance data generated for this specific submission.

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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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