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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)

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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.

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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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