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For Locking Cage

1. Revision of previous unsuccessful acetabular replacement.
2. Class III segmental and/or cavitary acetabular defects which make it difficult to achieve satisfactory results while using standard total hip replacement acetabular components and procedures.

For Full XPE Cup

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
3. Correction of function deformity;
4. Revision procedures where other treatments or devices have failed;
5. Treatment of nonunion and femoral neck fractures of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cemented use only.

"United" Locking Cage
The "United" Locking Cage is designed to achieve stable and lasting fixation of the severely deficient acetabulum. The "United" Locking Cage includes locking cage and several accessory components including: ischial flange, hook, cancellous locking screw and auto break-off locking nut. They are all manufactured from Ti6A14V which confirms to ASTM F136-13.

"United" Full XPE Cup
The "United" Full XPE Cup is designed for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The Full XPE Cup is manufactured from highly cross-linked UHMWPE which conforms to ASTM F2565-06. The UHMWPE raw material is in accordance with ASTM F648-14 and ISO 5834-1:2005. The PMMA Spacer and X-ray marking wire are made of PMMA (Medical Grade) and Co-20Cr-15W-10Ni alloy (ASTM F90-14), respectively. The X-ray marking wire is designed for X-ray image identification purpose. The "United" Full XPE Cup is available in a range of sizes to fit varying anatomical requirements.

The "United" Locking Cage can be used with correspondent sizes of "United" Full XPE Cup with bone cement. The "United" Full XPE Cup is also compatible with "United" Metal Femoral Head (K994078, K022520, K111546 and K122504) and "United" Ceramic Femoral Head (K103497) in correspondent sizes. The "United" Femoral Heads can be used with various types of "United" hip stems (K003237, K062978, K111546, K123550, K132207, K151316 and K152530).

The provided text is a 510(k) premarket notification for a medical device (Locking Cage, Full XPE Cup). It details the device description, indications for use, and a comparison to predicate devices, along with performance data. However, this document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested by your prompt.

The performance data section (page 6) states:

● Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:

• a. Structural compression stiffness of locking cage
• b. ROM for Full XPE Cup
• c. Bending fatigue testing of flanges
• d. Locking strength of locking cage and cemented cup
• e. Endurance testing
• f. Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP .
  Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.

● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.

This indicates that the manufacturer performed non-clinical (benchtop) tests to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for a novel AI/software performance as implied by your prompt's questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance).

The "acceptance criteria" here implicitly refer to the device performing as safely and effectively as the predicate devices based on these engineering tests, but no specific numerical criteria (e.g., sensitivity, specificity, or specific threshold values for fatigue testing) are provided or explicitly referred to as "acceptance criteria" in this document.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: No explicit numerical acceptance criteria or detailed performance metrics are listed in this document in the format appropriate to an AI/software device. The document only lists the types of non-clinical tests performed.
2. Sample sized used for the test set and the data provenance: Not applicable, as this is a mechanical device, not an AI/software device with test sets of data. The "tests" are engineering evaluations (e.g., fatigue, compression).
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 mechanical properties is established by physical measurement and engineering standards, not expert adjudication of images or data.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human reading, not a mechanical implant.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For mechanical tests, the "ground truth" is the physical property being measured (e.g., stiffness, strength), and the measurement itself is the truth, often against an industry standard.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to a mechanical orthopedic implant, not an AI or software as a medical device (SaMD). The regulatory approval is based on "substantial equivalence" to existing predicate devices through non-clinical (benchtop) engineering tests, not clinical studies or AI performance evaluations against expert-adjudicated ground truth.

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The Modified Bencox Hip System 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 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 Modified Bencox Mirabo Hip System consists of the following components,

• Acetabular Insert Bencox Mirabo PE Liner (Std. & Elevated), .
• Femoral Stem Bencox ID Stem (Offset), .
• Femoral Head Bencox Delta Head (XL), ●
• Instrumentation Bencox Total Hip System Instrumentation. .

The components are modification of Acetabular Insert cleared in K120924 (& K103431), Femoral Stem cleared in K112019 & specification inclusion of Femoral Heads cleared in K121665. The modified components are cementless, metal-onpolyethylene hip system for hip arthroplasty similar to devices cleared in respective mentioned 510(k)'s.

Modified Bencox Mirabo PE Liner is manufactured from similar material cleared under K120924 & K103431, conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation similar to predicate device Bencox Mirabo PE Liner and other predicates such as Stryker Crossfire.

Modified Bencox ID Stem (Offset) is similar to the predicate device Bencox ID Stem cleared in K112019, except for the slightly thicker neck geometry and horizontal offset.

Bencox Delta Head XL specification inclusion consists of diameters 32, 36 & 40 mm design is similar to the 510k cleared devices, Bencox Delta Head (K121665). The specification is also similar with other predicate devices and has the same supplier, CeramTec, AG.

This document describes the Modified Bencox Hip System, a hip implant. The information provided outlines the performance data rather than the acceptance criteria for an AI/ML device. Therefore, it is important to note that the following analysis is based on the provided text, which details the performance testing conducted for a medical device (hip implant components), not an AI/ML algorithm.

Given the context of a hip implant system, the "acceptance criteria" are typically related to the physical and mechanical properties of the device, ensuring it meets established international standards for safety and performance in the human body. The "study" refers to the mechanical and material testing performed on the device to demonstrate its substantial equivalence to previously cleared predicate devices.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (Applied to a Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the specific questions intended for AI/ML device evaluation, the provided document does not contain information for most of these points, as it describes a physical medical device. However, I will address them to the best of my ability based on the information not present or by inferring the closest equivalent for a physical device.

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

• Sample Size: Not explicitly stated in terms of "test set" samples as one would for an AI/ML model. For physical devices, "sample size" typically refers to the number of units tested. The document mentions "worst case combination" for the Bencox ID Stem, implying specific device configurations were selected for testing. The number of individual components or assemblies tested to meet standard requirements is not detailed.
• Data Provenance: Not applicable in the context of an AI/ML model's data. The testing was physical and performed to international standards. The manufacturer is Corentec Co., Ltd. from South 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. "Ground truth" in this context would be the objective criteria defined by the ISO and ASTM standards and the measurements taken during mechanical and material testing. No human experts are used to "establish ground truth" in the way they would for labeling in an AI/ML diagnostic task.

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

• Not applicable. This concept pertains to resolving discrepancies in expert labels for AI/ML training/testing data. For medical device testing, adjudication is typically not performed in this manner; results are objectively measured against established standard thresholds.

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 framework for evaluating diagnostic AI/ML systems. No human readers or AI assistance are involved in the performance testing of a hip implant.

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

• Not applicable. This refers to the performance of an AI algorithm alone. The "performance" described here is for a physical device.

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

• For a physical medical device, the "ground truth" is defined by the objective, measurable criteria within the referenced ISO and ASTM international standards. These standards specify test methods (e.g., how to measure wear, fatigue strength, material properties) and acceptable performance limits. The device's performance is then compared directly to these limits.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of developing and testing this type of physical medical device. The device itself is manufactured, and specific samples are then tested for performance.

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

• Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for one. The "ground truth" for the device's performance is the adherence to the published standards as mentioned in point 7.

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