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BENCOX Delta Option Heads of BENCOX Total 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 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 BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters.

The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.

This document is a 510(k) premarket notification for a medical device (BENCOX Delta Option Heads, a hip joint prosthesis component). It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device.

Crucially, this document is NOT a study describing the performance of an AI/ML medical device. It details the engineering and material properties of a physical orthopedic implant. Therefore, the questions related to AI/ML device performance, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical (bench) testing performed to demonstrate the device's safety and effectiveness compared to predicate devices, rather than clinical performance or AI/ML algorithm validation.

Here's a breakdown of the requested information based on the provided document:

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

The document does not provide a table with specific acceptance criteria values and the device's reported performance against those criteria. It lists the types of non-clinical tests performed to demonstrate substantial equivalence. These tests are implicitly conducted against established engineering and material standards for orthopedic implants.

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

• Sample Size: The document does not specify the sample sizes (number of units tested) for each non-clinical test (Burst, Fatigue, etc.). These are typically described in detailed test reports not included in this summary.
• Data Provenance: The tests were performed by Corentec Co., Ltd. (manufacturer) based in the Republic of Korea. The data is non-clinical/bench testing data, not human subject data, so "retrospective or prospective" doesn't apply in the same way.

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)

Not applicable. This is not an AI/ML device and the "ground truth" for mechanical testing is based on engineering specifications, material science, and well-established test methods (e.g., ISO standards, ASTM standards), not expert interpretation of medical images.

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

Not applicable. This is not an AI/ML device where image adjudication would be relevant. Mechanical testing results are objective measurements.

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/ML medical device.

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/ML medical device.

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

The "ground truth" for this device's performance relies on engineering specifications, material properties, and established international standards (e.g., ISO 6474-2 Type X for ceramic material, USP<161>, ANSI/AAMI ST72 for pyrogenicity) for mechanical and biocompatibility testing of hip prostheses. Equivalence is demonstrated to legally marketed predicate devices which conform to these standards.

8. The sample size for the training set

Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.

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

Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.

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