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510(k) Data Aggregation
(133 days)
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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(449 days)
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 BENCOX Mirabo Z Cup Cortinium is a porous coated non hemispherical outer shell made of Ti-6Al-4V alloy (ASTM F136) via machining processes and coated by pure titanium powder (ASTM F1580) through an additive manufacturing process. The device design allows for the cementless use of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation.
The provided text is a 510(k) premarket notification for the BENCOX Mirabo Z Cup Cortinium. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices. However, it does not contain information about acceptance criteria, detailed study results proving a device meets acceptance criteria, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.
This document focuses on regulatory compliance through substantial equivalence, primarily based on design and material similarities, and a set of non-clinical bench tests comparing the device to existing standards and predicate devices.
Therefore, I cannot fulfill your request for this specific information based on the provided text. The document states "Device Comparisons and performance testing indicate that the BENCOX Mirabo Z Cup Cortinium is substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles," and lists the nonclinical testing performed (e.g., Cup Fatigue Testing per ASTM F3090-20, Porous Structure Characterization per various ASTM and DIN EN ISO standards). These tests are typically performed to demonstrate that the device meets existing standards and is comparable to previously cleared devices, rather than establishing specific acceptance criteria and proving performance against them in a clinical study format.
In summary, the provided document does not contain the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a clinical performance study.
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