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BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:

· non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;

· Inflammatory degenerative joint disease, such as rheumatoid arthritis;

· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques;

· patients with failed previous surgery where pain, deformity, or dysfunction persists;

· revision of previously failed total hip arthroplasty.

The Additional components being added to the BENCOX THR System are:

• Instrumentation (Head trial, Bencox Hybrid PE Liner Trial - STD/ELV, Bencox Mirabo PE Liner Trial - STD/ELV, Shell Trial, Bipolar Cup Trial, Bipolar Cup Trial Ring, Head Impacting Part, Liner Impacting Part)

The Bencox Hip 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 Propylux and/or SUS along with colorants which are biocompatible and used in medical industry for decades and cleared for use in previous premarket notifications of Corentec.

The Trials are used to match the different anatomical structures of the hip joint and the Impacting Parts are used to combine the components together. These instruments are reusable devices that must be sterilized prior to use.

The trials and impacting parts of this submission are made of Propylux and/or SUS conforming to ASTM D4101: Standard Classification System and Basis for Specification for Polypropylene Injection and Extrusion Materials, and ASTM F899:

Standard Specification for Wrought Stainless Steels for Surgical Instruments, respectively.

The provided document is a 510(k) premarket notification for a medical device, the BENCOX THR System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or its data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
• Sample size for a training set.
• How ground truth for a training set was established.

Explanation from the document:

The document states under "Non-Clinical Testing":
"The designs, dimensions and function of additional instruments are similar with predicate devices under K162127. Additional performance testing is unnecessary since the trial is not implanted."

And under "Clinical Testing":
"Clinical testing for BENCOX THR System Instrumentation were not required as a basis for substantial equivalence."

This explicitly indicates that no clinical performance studies, which would typically involve testing against acceptance criteria, were conducted or required for this 510(k) submission. The basis for clearance is the demonstrated substantial equivalence to predicate devices through technical characteristics and non-clinical engineering analysis (e.g., dimensions).

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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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