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Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM® Liners
Treatment of nonumion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner
The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Acetabular Shells are indicated for cementless use only.

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and dome hole plugs are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident® Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments. The purpose of this Special 510(k) is to add an additional dome hole plug option for use with the Trident® II Acetabular System.

This document is a 510(k) summary for the Stryker Orthopaedics Trident® II Acetabular System. It primarily focuses on demonstrating substantial equivalence to a predicate device for the addition of an acetabular dome hole plug option.

Based on the provided text, the device is a medical implant, not an AI/ML powered device, and therefore the request to describe acceptance criteria and associated studies for an AI/ML device is not applicable.

Here's the breakdown of why the requested information cannot be provided from this document:

• No AI/ML Component: The device described, the Trident® II Acetabular System, is a hip joint prosthesis. The document discusses its components (shells, screws, liners, dome hole plugs), intended use, indications for use, and a comparison to predicate devices, all of which are characteristic of traditional medical devices. There is no mention of artificial intelligence, machine learning, software algorithms for image analysis, or any computational diagnostic or prognostic functionality.
• Focus on Substantial Equivalence for a Physical Component: The primary purpose of this 510(k) filing is to add an "additional dome hole plug option." The entire "Non-Clinical Testing" section explicitly states "No new non-clinical testing was performed." Instead, it references analyses for "equivalence in dimensions and MR evaluation" and prior bacterial endotoxin testing. This is typical for a minor modification to an already cleared physical device, not for a new AI/ML product.

Therefore, the following information points from your request are not present because they relate to the evaluation of an AI-powered medical device:

1. A table of acceptance criteria and the reported device performance: Not applicable.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Stand-alone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this document describes a physical medical device (hip implant components) and its regulatory clearance process, which does not involve the type of AI/ML performance evaluation criteria and studies you are inquiring about.

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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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