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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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The Bencox Hip System is intended for cementless use in total or partial 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

Bencox II Stem cleared under K103431 is modified at the proximal neck region. The other aspects of design / material / specification / manufacturing & sterilization / packaging are not altered and remain the same as discussed in K103431. The component is manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.

Bencox Metal Head is cleared under K103431 & K112019 with the neck lengths of small, medium and large. This submission includes extra large (XL) neck length as an inclusion to the existing specification. The other aspects of design / material / specification / manufacturing & sterilization/packaging are not altered and remain the same as discussed in K103431 & K112019. The component is manufactured from Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.

Here's an analysis of the acceptance criteria and supporting study for the Bencox II Stem & Bencox Metal Head, based on the provided text:

Important Note: This document describes a modification to an existing medical device (hip prosthesis components). The acceptance criteria and performance data provided relate to demonstrating that the modified device performs similarly or better than the previously cleared predicate devices, particularly regarding fatigue strength and range of motion. This is a common approach for 510(k) submissions for device modifications, focusing on demonstrating equivalence rather than establishing de novo clinical performance benchmarks.

Acceptance Criteria and Study Details for Bencox II Stem & Bencox Metal Head (K122099)

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not specify explicit numerical acceptance criteria in the typical sense for a diagnostic device (e.g., accuracy thresholds). Instead, for this orthopedic implant modification, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices through performance testing. The reported performance is comparative.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify exact sample sizes for the mechanical and sterilization tests, but refers to "a series of testing protocols." For such device modifications, testing typically involves a sufficient number of samples to statistically demonstrate compliance with standards and equivalence, but specific numbers are not provided.
• Data Provenance: The data is generated from laboratory testing (mechanical, sterilization, packaging) of the modified Bencox II Stem & Bencox Metal Head and comparison with the predicate devices. This is not patient-derived data. The manufacturing country is South Korea (Corentec Co., Ltd.). The data is prospective, generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable: For this type of submission involving mechanical and sterilization testing of an orthopedic implant component, "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and established engineering principles, rather than expert clinical consensus on patient data. There is no mention of clinical experts being involved in establishing "ground truth" for these specific performance tests.

4. Adjudication Method for the Test Set:

• Not Applicable: As the "test set" consists of physical devices undergoing laboratory performance testing against engineering standards, there is no need for an adjudication method involving multiple human readers/experts. The tests produce quantifiable results compared to standard requirements and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, not done. This 510(k) submission pertains to physical modifications of an orthopedic implant system and its mechanical and sterilization performance, not a diagnostic device requiring human-in-the-loop performance evaluation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No, not done. This product is a physical hip prosthesis component, not an algorithm or AI software. Therefore, an "algorithm only" performance study is not applicable.

7. Type of Ground Truth Used:

• Engineering Standards and Predicate Device Performance: The "ground truth" for the performance evaluation is based on established international engineering standards for orthopedic implants (ISO 7206-4, ISO 7206-6, ISO 21535, ISO 11137-1 & 2) and the demonstrated performance of the previously cleared predicate devices (K103431 & K112019). The goal is to demonstrate that the modified device meets or exceeds these established benchmarks.

8. Sample Size for the Training Set:

• Not Applicable: As this is a physical medical device (hip prosthesis components) and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by established engineering principles and prior device designs, but not through data-driven 'training' in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable: As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The performance evaluation is based on direct physical testing and comparison to engineering standards and predicate device performance.

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The Bencox Forte and Bencox Delta ceramic heads is intended for use in total or partial 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 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 hip arthroplasty

The Bencox Biolox Ceramic Head is a component of a Hip Prosthesis System and intended for mechanical fixation to a mating hip stem, with a standard 12/14 taper. It is intended to articulate between both Highly Cross Linked UHMWPE as well as Conventional UHMWPE.

The Bencox Ceramic Head is available as standard type and is manufactured from bio-inert alumina ceramic, Al2O3 as per ASTM F603 / ISO 6474. The ceramic femoral balls heads range in diameter from 28 mm to 40 mm with small, medium & large versions.

Radiation (gamma) sterilization is used for Bencox Forte and Bencox Delta Biolox ceramic heads. Sterilization by Co-60 gamma irradiation has been validated to a sterility assurance level (SAL) of 10-6 by the bioburden method, according to ISO 11137-1 & ISO 11137-2. Following sterilization packaging was validated for a shelf life of 5 years for BENCOX Forte & Delta ceramic femoral heads.

The provided text describes the 510(k) summary for the BENCOX® Forte & BENCOX® Delta femoral heads, which are ceramic components for hip arthroplasty. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria in the context of AI/software device studies.

Therefore, many of the requested elements pertaining to AI/software device evaluation (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission, as it concerns a physical medical device (femoral heads).

However, I can extract the information on performance testing and acceptance criteria as presented for this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but standard test methods (e.g., ISO 7206-10, ISO 11137) would have defined sample sizes for physical product testing.
• Data Provenance: Not applicable in the sense of patient data. The tests are laboratory-based mechanical and sterilization validations of the physical device.

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

• Not applicable. Ground truth for a physical device like a ceramic femoral head is established through adherence to international standards and validated testing procedures by qualified technicians and engineers in accredited laboratories.

4. Adjudication method for the test set

• Not applicable. The "adjudication method" typically refers to expert consensus for ground truth establishment in clinical or imaging studies. For physical device performance, the acceptance is based on meeting the specifications and standards outlined in the test protocols.

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 medical device, not an AI/software device involving human readers.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• Mechanical Performance: Adherence to international standards (e.g., ISO 7206-10) and established biomechanical testing protocols. The "ground truth" is that the device passes or fails these pre-defined mechanical tests.
• Sterilization: Demonstrated Sterility Assurance Level (SAL) of 10^-6, verified by bioburden methods as per ISO 11137.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" for this type of physical device submission.

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

• Not applicable. There is no concept of a "training set" for this type of physical device submission.

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