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BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System is intended for Cementless use in 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 total hip arthroplasty

The subject BENCOX Mirabo Z cup Cortinium shares key design features, materials, Indications for Use statements, geometry, and compatibility with other Corentec acetabular components marketed under the brand names BENCOX Mirabo Cup System and BENCOX Mirabo Z Cup Cortinium.

The BENCOX Mirabo Z cup Cortinium is similar to the predicate devices BENCOX Mirabo Z Cup Cortinium cleared under K210614 and Bencox Mirabo Cups cleared under K220468, K172806, K162127, K120924 with respect to material - Titanium alloy (ASTM F136), and coated by pure titanium powder (ASTM F1580) through an additive manufacturing process, design, locking system, manufacturing (without coating processes), packaging and sterilization. This submission is only for the inclusion of specification of BENCOX Mirabo Z Cup Cortinium with external diameter 50mm.

The manufacturing process including additive manufacturing is identical to the predicate. The subject 50mm acetabular shell is thinner than the predicate 50mm shells but it is not thinner than other sized shells in the predicate submission. Otherwise, the geometry of the features is identical to the predicate.

The subject devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation to legally marketed device cleared under K120924, K162127, K172806, K220468 and K210614.

The provided text describes a 510(k) submission for a hip joint prosthesis, not an AI/ML medical device. Therefore, it does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The document is a clearance letter from the FDA for a new size (50mm diameter acetabular cup) of an existing hip implant device, the BENCOX Mirabo Z Cup Cortinium. The submission focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical testing of the physical properties and performance of the implant.

Consequently, I cannot extract the information required in your request regarding acceptance criteria and a study for an AI/ML device. The document mentions tests like "Wear Testing as per ISO 14242-1 and 14242-2," "Cup Deformation as per ISO 7206-12," and "Shell Fatigue Testing as per ASTM F3090," which are standard tests for orthopedic implants. However, these are mechanical and material tests, not performance metrics for an AI/ML algorithm.

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Bencox M Stem Lateralized & Bencox Mirabo Cup System of Bencox Total Hip 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 total hip arthroplasty

1. Bencox M Stem Lateralized: (Sterile)
   Similar to predicate device cleared under K152084. Bencox M Stem Lateralized is a double tapered wedge shaped stem intended for press-fit partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Femoral Head (metal and ceramic) and used with Bencox Acetabular Cups which are already cleared. When used in partial hip arthroplasty Bencox M Stem Lateralized is coupled to a Femoral Head and used with Bencox Bipolar Cup. Bencox M Stem Lateralized is made of Ti6AI4V alloy conforming to ASTM F136. The proximal half of the stem is plasma sprayed coating of pure titanium as per ASTM F1580. The materials, design, manufacturing and sterilization is essentially same as Bencox M Stem cleared under K152084 and is available in 13 sizes with CCD angle of 132°.

2. Bencox Mirabo Cup System: (Sterile)
   The Bencox Mirabo Cup System is a Cementless hip acetabular system (Metal on Poly Liner or Ceramic on Poly Liner) for hip arthroplasty. It consists of the following components:

• Acetabular Cup - Bencox Mirabo Cup
• Acetabular Liner Bencox Mirabo PE Liner
• Hole Plugs – Dome hole (same as cleared in K120924 & K150007)
• Bone Screw Bencox Bone Screw (same as cleared in K120924 & K150007) .

Acetabular Cup: Bencox Mirabo Cup
The Bencox Mirabo Cup Spec. Inclusion is essentially same as Bencox Mirabo Cup cleared under K120924 with respect to materials, design, locking system, manufacturing and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameters 56, 70, 72 & 74 mm.

Acetabular Liner: Bencox Mirabo PE Liner
The Bencox Mirabo PE Liner Spec. Inclusion is essentially same as Bencox Mirabo PE Liner cleared under K150007 with respect to material, design, locking system, manufacturing and sterilization. This submission is only for the inclusion of specification of Standard and Elevated Liners with larger head size, 40 mm.

3. Bencox Hip Replacement System Instrumentation (Non Sterile)
   Bencox Hip Replacement System Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons. The parts of the instruments are made of stainless steel and/or polymers and/or silicon and cleared for use in previous premarket notifications of Corentec. Bencox Hip System Instrumentation to be used Bencox M Stem Lateralized & Bencox Mirabo Cup System is same with Instrumentation cleared under K152084 , K120924 & K150007 along with the inclusion of instruments specific to Bencox M Stem Lateralized and Bencox Mirabo Cup System.

The provided text is a 510(k) summary for the "Bencox M Stem Lateralized & Bencox Mirabo Cup System," a total hip arthroplasty device. It describes the device, its indications for use, and how it demonstrates substantial equivalence to existing predicate devices.

However, the request asks for details about acceptance criteria and a study proving a device meets acceptance criteria, specifically related to performance metrics typical of AI or diagnostic devices (e.g., accuracy, sensitivity, specificity, MRMC studies, ground truth establishment, sample sizes for training/test sets).

The presented document does not contain any information about AI device performance studies, clinical trials with human readers, or statistical metrics like sensitivity/specificity. It focuses on the substantial equivalence of a physical orthopedic implant (hip replacement) to previously cleared predicate devices.

The "Performance Data" section of the document primarily refers to non-clinical mechanical testing of the hip implant components (e.g., FEA, Risk Analysis, Fatigue Testing, Range of Motion Testing, Endotoxin testing) conforming to ISO and ASTM standards. This is a very different type of "performance data" than what would be presented for an AI/diagnostic device.

Therefore, I cannot fulfill your request using the provided text because it does not contain the information you are looking for regarding:

1. A table of acceptance criteria and reported device performance (for an AI/diagnostic device).
2. Sample sizes used for a test set and data provenance (for an AI/diagnostic device).
3. Number of experts and qualifications for ground truth establishment (for an AI/diagnostic device).
4. Adjudication method for the test set (for an AI/diagnostic device).
5. MRMC comparative effectiveness study results (for human readers with/without AI assistance).
6. Standalone AI algorithm performance.
7. Type of ground truth (expert consensus, pathology, outcomes data) for an AI/diagnostic device.
8. Training set sample size (for an AI/diagnostic device).
9. How ground truth for the training set was established (for an AI/diagnostic device).

The document is solely about a traditional medical device (hip prosthesis) and its mechanical and material equivalence.

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