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Bencox M Stem (Bencox 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 ID Cemented Stem (with Centralizer) & Bencox Bone Plug is intended for cemented use in total or partial hip arthroplasty and 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 trochanteric 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 Centralizer is intended to be used with Bencox ID Cemented Stem to centralize the femoral stem within the intramedullary canal.

The Bencox Bone Plug is intended to be used with cemented hip replacement procedures to control and restrict the flow of cement within the intramedullary canal.

Bencox M Stem (Bencox Hip System) - Sterile
The Bencox M Stem 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 and used with Bencox Acetabular Cups cleared under K103431, K112019, K120924. K121665 & K150007. When used in partial hip arthroplasty Bencox M Stem is coupled to a Femoral Head and used with Bencox Bipolar Cup cleared under K112019.

Bencox M Stem 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 used in subject device, Bencox M Stem, have been cleared for use in K112019 & K150007 for Bencox ID Stem & Bencox ID Stem (offset). The stem has a tapered rectangular section. The stem has a neck with a standard 12/14 conical taper to couple to Bencox Femoral Heads which have been cleared earlier. The Bencox M Stem is available 13 sizes with CCD angle of 132°. The stem is available in 13 sizes.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

BENCOX ID Cemented Stem (with Centralizer) & Bone Plug - Sterile
Bencox ID Cemented Stem has bone plug and centralizer as accessories. The Collarless Bencox ID Cemented Stem consists of a polished double tapered distal geometry which generates the radial compressive load in distal body. The neck shape is similar to cleared Corentec's hip femoral stems in K103431, K122099 and K150007. The standard Morse taper (12/14) is used for femoral head assembly similar to cleared devices to couple to Bencox Femoral Heads and their compatible acetabular components which have been cleared in previous premarket notifications. The Bencox ID Cemented Stem is available 06 sizes with CCD angle of 132°. Bencox ID Cemented Stem is made of SS allov.

The deformable centralizer is made of PMMA with flexible wing like projections that extend outwards from the base of the centralizer and fits over the outside diameter of the stem tip. These projections contact the walls of the femoral canal, centralizing the hip stem within the canal. The hollow centralizer is designed to allow stem to engage distally within the cement mantle, subjecting the cement to compressive loading, and reducing end bearing of the stem directly onto the cement. The centralizer is a molded acrylic device manufactured from PMMA.

Bencox bone plug has a double flanged geometry very similar to the predicate devices. The plug blocks the propagation of the doughy bone cement downward in the medullary cavity. The proximal flange provides a proximal barrier, while the more flexible distal flange forms a secondary seal to prevent cement leakage. Bencox bone plug is manufactured from UHMWPE.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

Accessory BENCOX Hip Instrumentation: (Non Sterile)
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 stainless steel and/or polymers and/or silicon which are cleared for use in previous premarket notifications of Corentec.

Bencox Hip System Instrumentation to be used Bencox M Stem (Bencox Hip System) & Bencox ID Cemented Stem is same with Instrumentation cleared under K103431, K112019, K120924 & K122099 along with the inclusion of instruments specific to Bencox M Stem such as Rasp, Impactor etc.

The provided text is a 510(k) summary for the Bencox M Stem and Bencox ID Cemented Stem (with Centralizer) & Bone Plug. This document describes a medical device and its equivalence to previously approved predicate devices, primarily based on non-clinical performance data. It does not describe a study involving patient data, ground truth establishment, or clinical performance metrics in the way your request outlines for AI/software-based devices.

Therefore, for the specific questions related to acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, the information is not applicable or not available within this document because it pertains to a different type of device evaluation (hardware instead of software/AI).

However, I can extract the relevant performance data based on the non-clinical testing conducted for this orthopedic implant.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an orthopedic implant, the "acceptance criteria" and "reported device performance" are based on mechanical properties and material standards rather than diagnostic accuracy metrics. The document asserts that the device met these criteria through various tests, demonstrating substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not applicable in the context of diagnostic accuracy. For mechanical testing, "samples" would refer to the number of physical devices or components tested. This number is not specified in the 510(k) summary, but it would typically be a statistical minimum required by the testing standard.
• Data Provenance: Not applicable for clinical data. The performance data is derived from in vitro mechanical testing conducted by the manufacturer, Corentec Co., Ltd., in South Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a physical implant, not a diagnostic AI/software. There is no "ground truth" derived from expert interpretation in the clinical diagnostic sense. The ground truth for mechanical properties is established by adherence to recognized engineering and material standards.

4. Adjudication method for the test set:

• Not applicable. There is no expert adjudication for mechanical testing of this nature. Test results are compared against predefined acceptance criteria from international standards.

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:

• Not applicable. This is a physical orthopedic implant, not an AI/software.

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

• Not applicable. This is a physical orthopedic implant, not an AI/software.

7. The type of ground truth used:

• Ground Truth Type: For orthopedic implants, the "ground truth" is defined by adherence to established engineering and material standards (e.g., ISO and ASTM standards for mechanical properties, material composition, and sterilization validation). The device's performance is compared against the requirements and benchmarks set by these standards, and against the equivalent performance of legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is a physical orthopedic implant. There is no "training set" in the context of machine learning. Design and manufacturing processes would be informed by engineering principles and historical data on similar devices, but not a "training set" in the requested sense.

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

• Not applicable. As above, there is no training set. Design and manufacturing are based on established engineering principles and compliance with international standards.

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