Search Results

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.

Ask a specific question about this device

The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Congenital hip dysplasia.
• Acute traumatic fracture of the femoral head or neck.
• Certain cases of Ankylosis.
• Dislocation of the hip.
• Correction of functional deformity.
• Revision of failed joint reconstruction or treatment.
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

NOTE:

• The Modular Shell and Uncemented Stem are intended for press-fit, uncemented use only.
• The Cemented stem is intended for cemented use only.

The Libertas™ Hip Replacement System consists of the following components:

• Acetabular Cup System
  • Modular Shell
  • Modular Liner HXLPE
  • Cobalt Chromium alloy Modular Femoral Head
  • Biolox® delta Modular Femoral Head
• Femoral Stem
  • Uncemented Femoral Stem
  • Cemented Femoral Stem
• Accessories (Sub components)
  • Bone Screw
  • Apical Hole Occluder
  • Centralizer
  • Cement Restrictor
  • Screw Hole Occluder

This document describes the Libertas™ Hip Replacement System, a medical device for total hip arthroplasty, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria or detailed performance data in the format requested.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, nor the details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document primarily focuses on establishing substantial equivalence through non-clinical performance testing and similarity to predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics.

Ask a specific question about this device

Bencox Mirabo Cup System of Benox 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 (Metal on Poly Liner or Ceramic on Poly Liner) for hip arthroplasty. This submission consists of the following 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 44 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 Liners with head size, 28/35 & 32/39 mm.

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 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 with Bencox Mirabo Cup System is same with Instrumentation cleared under K162127 and K150007 & K120924 along with the inclusion of instruments specific to Bencox Mirabo Cup System components included in this submission.

This document is a 510(k) summary for the Bencox Mirabo Cup System, a hip acetabular system. The information provided outlines the system's specifications, indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not describe any acceptance criteria for "device performance" in terms of clinical outcomes or human-in-the-loop performance. Instead, it focuses on laboratory testing to ensure the device materials and design meet established engineering standards for orthopedic implants.

Therefore, many of the requested sections (acceptance criteria related to clinical performance, clinical study details, expert input, MRMC studies, standalone algorithm performance, and training set details) cannot be extracted from this document as it is focused on a medical device clearance based on substantial equivalence through material and mechanical testing, not a digital health or AI-based device's diagnostic performance.

Based on the provided text, here is what can be extracted:

1. A table of acceptance criteria and the reported device performance

Note: The document explicitly states "The results of this testing/analysis showed that the subject devices are expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices." This implies that the device met the acceptance criteria defined by these standards, even if specific numerical thresholds aren't provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "testing protocols" and "series of testing," which are typically laboratory-based mechanical and material tests for medical implants. These do not usually involve "test sets" in the same way clinical or AI performance studies do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable to the type of testing described (mechanical and material performance of an orthopedic implant).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable to the type of testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device described is a hip arthroplasty system, not an AI-based diagnostic tool or system that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device described is a hip arthroplasty system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance data, the "ground truth" is established by adherence to recognized international and ASTM standards (e.g., ISO 14242-1, ASTM F1820, ISO 11137-1). For a medical implant, this means that the materials behave as expected under specified mechanical loads, wear conditions, and sterilization processes, demonstrating substantial equivalence to previously cleared devices.

8. The sample size for the training set

This information is not provided and is not applicable to the type of testing described (mechanical and material performance of an orthopedic implant), which does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not provided and is not applicable.

Ask a specific question about this device