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Bencox Mirabo Cup Multi Hole 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

This submission consists of inclusion of additional variant to the existing devices Bencox Mirabo Cup System which is a cementless hip acetabular system (Metal on Poly Liner or Ceramic on Poly Liner) for hip arthroplasty. The subject device Bencox Mirabo Cup Multi Hole is similar to Bencox Mirabo Cup System cleared under K172806 and K162127 & K120924, with respect to material – Titanium alloy (ASTM F136), coating with pure Titanium powder (ASTM F1580), design, locking system, manufacturing, packaging and sterilization.

The provided text is a 510(k) summary for a medical device called "Bencox Mirabo Cup Multi Hole." This document describes the device, its intended use, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or the detailed aspects of a clinical or analytical study as requested in your prompt.

The document primarily focuses on demonstrating that the new device is "substantially equivalent" to existing predicate devices based on material, design, manufacturing, and performance testing data from the predicate devices. The only performance testing specifically mentioned for the subject device is "deformation testing as per ISO 7206-12," and it states that this testing showed the device is "expected to be safe and effective."

Therefore, I cannot fulfill your request for the tables and detailed study information as this data is not present in the provided text.

Based on the information available, I can only provide the following:

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

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

• Sample Size for Test Set: Not specified. The document refers to "engineering risk analysis & deformation testing as per ISO 7206-12" but does not detail the sample size for this testing.
• Data Provenance: Not specified, other than the manufacturer being Corentec Co., Ltd. based in the Republic of Korea.

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 document refers to mechanical and sterilization testing, not expert-adjudicated clinical data or ground truth.

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

• Not applicable. This document does not describe results from a study requiring expert adjudication.

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 medical device (hip cup) submission, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a medical device (hip cup) submission, not related to an algorithm's performance.

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

• For mechanical properties: Ground truth would be established by physical testing against recognized standards (e.g., ISO 7206-12) to ensure the device performs within acceptable mechanical limits.
• For sterilization: Ground truth is established by validation methods following international standards (ISO 11137-1 & 2) to demonstrate a specific Sterility Assurance Level.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning submission.

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

• Not applicable.

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