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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 BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion: patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40 mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BIOLOX delta Ceramic Femoral Heads:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device, its intended use, and a comparison to a predicate device. It does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., specific fatigue limits, wear rates, a certain number of cycles successfully passed). Instead, the performance is assessed against the substantial equivalence to a predicate device.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not specified. The document refers to "non-clinical testing" which implies mechanical and engineering tests, not patient data in the traditional sense of a "test set" for an AI or diagnostic device.
• Data Provenance: The "non-clinical testing" was likely conducted by Zimmer GmbH, which is located in Winterthur, Switzerland. However, the exact location of the testing facilities is not explicitly stated. The data is non-clinical/engineering (not patient data), so the concept of retrospective or prospective doesn't directly apply in the same way as clinical trials.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable. For this type of device (femoral head prosthesis), "ground truth" is established through engineering principles, material science, and mechanical testing standards, rather than expert consensus on medical images or clinical diagnoses.
• Qualifications of Experts: Not specified, but implied to be engineers, material scientists, and regulatory specialists involved in medical device design, testing, and regulatory submissions.

4. Adjudication Method:

• Adjudication Method: Not applicable. This document describes a 510(k) submission for a medical device (a ceramic femoral head), not a study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1. The assessment is based on objective engineering test results and regulatory review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This is a physical orthopedic implant, not a diagnostic or AI-assisted device that would involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. There is no algorithm involved in this device. The performance is assessed through non-clinical (mechanical) testing of the physical implant.

7. Type of Ground Truth Used:

• Ground Truth: The "ground truth" in this context is established through engineering principles, material standards, mechanical testing results, and comparison to established performance characteristics of predicate devices. This includes:
  • Results from pull-off testing.
  • Results from range of motion analyses.
  • Results from fatigue strength analysis.
  • Adherence to material specifications (alumina matrix composite).
  • Compliance with relevant ASTM or ISO standards for orthopedic implants (though not explicitly listed, this is inherent in regulatory submissions).

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device that uses a "training set." The development of the device relies on established engineering design principles, material science, and manufacturing processes, which are refined through iterative design and testing rather than a statistical training set.

9. How Ground Truth for Training Set was Established:

• Ground Truth for Training Set: Not applicable, as there is no training set in the context of an AI/ML model for this device. The "truth" for the device's design and manufacturing is derived from decades of knowledge in biomedical engineering, orthopedics, materials science, and testing standards for implantable medical devices.

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The EXp Acetabular Shell Liner is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip Arthroplasty.
   Cemented and Uncemented Applications

The EXp Acetabular Shell Liner is made of polyethylene to which Vitamin E has been added. It is available in both hooded and non-hooded options. The liner is part of a complete total hip system and will be used in conjunction with an acetabular shell, femoral head and femoral stem in total hip arthroplasty. The femoral heads which are to be mated with the EXp Liner are made of Biolox forte, Biolox Delta, or CoCr alloy.

The provided text describes a 510(k) summary for the EXp Acetabular Shell Liner. This documentation focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than conducting a controlled clinical study with acceptance criteria often seen in AI/ML device submissions. Therefore, many of the requested elements for AI/ML device evaluation (like sample sizes for test sets, expert ground truth, MRMC studies, training set details) are not applicable or present in this specific type of submission.

However, I can extract and structure the information related to the performance claims and the studies that support them.

Acceptance Criteria and Study for EXp Acetabular Shell Liner

The submission details several claims regarding the oxidative stability and mechanical performance of the EXp material and the EXp liners, which can be interpreted as the performance goals or "acceptance criteria" for the device to be deemed substantially equivalent. The "reported device performance" are the results of the non-clinical tests conducted to support these claims.

1. Table of Acceptance Criteria and Reported Device Performance

• Maximum ASTM F2102 oxidation index for EXp: increased from 0.1 ± 0.02 to 0.2.
• Maximum ASTM F2102 oxidation index for conventional GUR1050: increased from 0.1 ± 0.04 to 3.8 ± 0.2.
• Ultimate load for EXp (ASTM F2183): remained constant (63.3 ± 8.9 N non-aged, 73.1 ± 5.2 N 4-week-aged).
• Ultimate load for conventional GUR1050: decreased from 71.5 ± 3.0 N (non-aged) to an embrittled condition (no sample could be machined after 4 weeks; 45.7 ± 5.9 N after 2 weeks). |
  | Morphology of EXp UHMWPE is consistent with conventional UHMWPE.
  Criteria: No consolidation defects or voids when imaged at high magnification under scanning electron microscopy. | Freeze fracture analysis and scanning electron microscopy showed both EXp UHMWPE and 25kGy GUR 1050 material demonstrated no consolidation defects or voids at high magnification. |
  | Vitamin E blended into EXp UHMWPE does not elute from the material.
  Criteria: No Vitamin E detected in hexane or isopropanol (IPA) extracts using GC-MS and LC-MS. | GC-MS and LC-MS analysis confirmed no Vitamin E was extracted from EXp material when refluxed in hexane at 74°C for 24 hours (detection limits: 50-250 ppb) or soaked in IPA at room temperature for 18 hours (detection limits: 1000 ppm). |
  | EXp liners remain resistant to oxidation after 5 million cycles of wear testing and artificial aging.
  Criteria: Resistance to oxidation (per ASTM F2102) after wear testing (ISO 14242-1) followed by accelerated aging (ASTM F2003). | After 5 million cycles of wear testing (ISO 14242-1) and subsequent 4 weeks of oxidative aging (ASTM F2003):
• Maximum oxidation index (ASTM F2102) for EXp liners: increased from 0.1 ± 0.02 (non-aged EXp material) to 0.2 ± 0.02 (4-week-aged EXp material). |
  | EXp liners experience no failures from dynamic impingement testing.
  Criteria: Resistance to rim fracture under fatigue loading conditions to 1.0 MC (million cycles) per ASTM F2582, with no failure of the locking mechanism. | Dynamic impingement testing per ASTM F2582:
• Three (3) artificially aged EXp liners were loaded to engage the rim with the femoral neck at 4.6 Nm (70% of static peak dislocation moments).
• All three samples reached run-out (1.0 MC) with no fractures observed and no failure of the locking mechanism. |

Regarding the other requested information, which is more relevant to AI/ML device studies:

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

• Not applicable. This submission is for a physical medical device (acetabular liner) and relies on non-clinical, in vitro, and mechanical bench testing, not data analysis from patient studies. The "samples" refer to physical specimens of the material or device.

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 is established by standardized physical, chemical, and mechanical testing protocols (e.g., ASTM, ISO standards), not human expert consensus on images or clinical data.

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

• Not applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical or image-based studies. This submission relies on objective physical 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 device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is a physical device, not an algorithm.

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

• The "ground truth" for the performance claims is derived from standardized physical and chemical measurements according to established industry standards (e.g., ASTM F2183, ASTM F2003, ASTM F2102, ISO 14242-1, ASTM F2582).

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling. The material properties are inherent to its manufacturing process and composition.

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

• Not applicable. As above, no training set is described for this physical device.

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The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion Patients with acute femoral neck fractures The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and re numeratured from Ti with Plasmapore with or without u-CaP®. The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement . patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of provious fractures of the femur. patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis . patients suffering from disability due to previous fusion ◆ ◆ patients with acute femoral neck fractures

The Aesculap Implant Systems BIOLOX® OPTION Ceramic Femoral Head System consist of a ceramic head manufactured from an alumina matrix composite available in diameters of 28, 32, and 36 mm and a titanium adapter for the femoral stem cone with a range of neck lengths. The BIOLOX® OPTION Ceramic head provides the surgeon another option to both the metal and alumina ceramic femoral heads for use in total hip arthroplasty. Two Metha® XL Heads are available. The CoCrMo head is offered in two diameters (28mm and 32mm). The BIOLOX® delta ceramic head is composed of an alumina matrix composite and is available in two diameters (32mm and 36mm).

The provided text describes a medical device submission (K090299) for the BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads. It outlines the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain information regarding acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or other statistical measures typically found in clinical studies or performance evaluations for AI/ML devices.

Instead, the "Performance Data" section lists various guidance documents from the FDA that were followed for testing. This suggests that the "acceptance criteria" for this device are related to compliance with these established standards and guidelines for orthopedic implants, rather than statistical performance thresholds from a specific study.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for a clinical or AI/ML study cannot be extracted from this document.

Here's an attempt to answer based on the available information:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Not applicable/Not provided. The document refers to engineering and material testing standards, not a clinical "test set" with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. Ground truth in this context would refer to material science and mechanical engineering standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

• Not applicable/Not provided. This concept is for clinical studies with human review of data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The document focuses on regulatory compliance for mechanical and material properties of an implant, not clinical effectiveness studies comparing human readers with and without AI assistance.

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

• Not applicable/Not provided. This device is a physical orthopedic implant, not an algorithm or software.

7. The type of ground truth used:

• The "ground truth" for this device's performance would be established through material property testing, mechanical performance testing, and biocompatibility assessments based on the referenced FDA guidance documents and recognized international standards (e.g., ISO standards for implants, not specified in detail here but implied by "where applicable"). This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI/ML evaluation.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" in the context of an AI/ML algorithm for this physical device.

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

• Not applicable/Not provided. There is no "training set" or corresponding ground truth for an AI/ML algorithm for this physical device.

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