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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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The subject devices are single use components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows:

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
• . rheumatoid arthritis,
• . correction of functional deformity,
• revision procedures where other treatments or devices have failed, and .
• treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

The subject Crossfire™System 12® Acetabular Inserts are the same as the predicate non-Crossfire™System 12® Acetabular Inserts, except that the subject devices are fabricated from polyethylene that has been crosslinked via the procedure described in, and found Substantially Equivalent in, 510(k) #K974685.

This document describes a 510(k) submission for "Additional Crossfire™ Acetabular Components," specifically Crossfire™ System 12® Acetabular Inserts. It focuses on demonstrating substantial equivalence to previously marketed devices and does not present a typical "study" in the sense of a clinical trial or algorithm performance evaluation. Instead, it relies on materials comparison, design equivalence, and mechanical testing to show the new components are safe and effective.

Here's a breakdown based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implied by the performance of the predicate devices and the focus of the additional testing. The primary "performance" assessed here is the structural integrity and locking strength of the acetabular inserts, particularly after the Crossfire™ crosslinking process.

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

• Sample Size for Structural/Locking Test: "After 107 cycles, three inserts were axially distracted (pushed-out) and two were carefully removed by sectioning their metal shells." For the wear claims, specific insert models (e.g., 2041C-2850) were used, but the exact number of samples for each wear test condition isn't explicitly stated beyond implying "inserts."
• Data Provenance: The tests are described as in vitro mechanical and wear simulator tests. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities (Howmedica Osteonics Corp.). These are prospective tests performed for regulatory submission.

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

This type of information is not applicable to this submission. The "ground truth" here is objective mechanical performance data, not expert subjective interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical tests follow defined protocols and yield objective measurements, not subjective evaluations requiring 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

This is not applicable. This submission is for a medical device (acetabular components), not an AI algorithm or an imaging study.

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

This is not applicable. This is not an algorithm, and there is no human-in-the-loop component relevant to its mechanical function.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the acetabular components is based on:

• Objective Mechanical Measurements: Axial distraction force measurements for locking strength, and gravimetric wear measurements from hip wear simulation.
• Visual Inspection: Gross inspection for signs of structural compromise.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as point 8.

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