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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 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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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

The Bencox Mirabo Cup System is a Cementless hip acetabular system (Poly Liner) intended to be used with femoral components including either metal or ceramic heads and femoral stems to form a total hip system for hip arthroplasty. This submission consists of the following line extension components:

• Acetabular Cup Bencox Mirabo Cup
• . Acetabular Liner - Bencox Mirabo PE Liner

Acetabular Cup: Bencox Mirabo Cup

The Bencox Mirabo Cup Spec. Inclusion is similar to Bencox Mirabo Cup cleared under K162127 & K120924 with respect to material - Titanium alloy (ASTM F136), coating with pure Titanium powder (ASTM F1580), design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameter 50 mm.

Acetabular Liner: Bencox Mirabo PE Liner

The Bencox Mirabo PE Liner specification inclusion is similar to Bencox Mirabo PE Liner cleared under K162127 & K150007, with respect to material, conforming to ASTM F648, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation, design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of Liner with head size, 28/42, 32/42, 36/42 mm.

This FDA 510(k) submission for the BENCOX Mirabo Cup System is for a medical device (hip joint prosthesis components), not an AI/ML software. Therefore, the information typically requested regarding acceptance criteria and studies for AI/ML performance (such as test set sample sizes, data provenance, expert ground truth, MRMC studies, or training set details) is not applicable to this document.

The document discusses mechanical testing and biocompatibility studies, which are relevant to the safety and effectiveness of a physical medical implant. Here's a summary of the non-clinical testing referenced for this device, which serves as the "study that proves the device meets the acceptance criteria" for a physical implant:

Acceptance Criteria and Reported Device Performance (Non-Clinical Testing for Physical Device)

Information Not Applicable or Available in the Provided Document (as it pertains to AI/ML devices):

The following points are not applicable to this 510(k) submission because it concerns a physical orthopaedic implant, not an AI/ML software device. Information relevant to AI/ML performance would not be found in this type of submission.

• Sample sizes used for the test set and data provenance
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Stand-alone (algorithm only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How the ground truth for the training set was established

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