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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 ICONACY I-Hip system is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthrius, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip system consists of femoral stem and acetabular cup (i.e., shell) porous coated components intended for cementless, press-fit fixation

The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem, mated to a cobalt chrome modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispheric titanium alloy cup (i.e., shell) coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion and two screw holes to permit the use of screws for adjunct fixation. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press fit fixation. A titanium locking ring is fixed into a groove on the cup to engage the groove in the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.

The provided text describes a 510(k) submission for the ICONACY I-Hip System, a total hip replacement device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information about device performance, study details, and ground truth establishment is not available in the provided text.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No clinical test set or human subject data was used. The evaluation was based on nonclinical (bench) testing.

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

Not applicable. No expert-established ground truth for a test set was used, as no clinical testing was performed.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A multi-reader multi-case comparative effectiveness study was not performed. The submission explicitly states "Clinical Testing: Clinical testing was not required for determining substantial equivalency with the predicate devices."

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

Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was derived from nonclinical (bench) testing results (e.g., measurements of material properties, mechanical performance under various loads, wear rates) compared against established performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an AI/ML algorithm. The device's design and manufacturing processes are informed by engineering principles and existing knowledge of predicate devices.

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

Not applicable. As noted above, there was no "training set" for an algorithm. The design and manufacturing relied on established engineering standards and performance data from predicate devices.

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The Bencox Bipolar Cup 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 hip arthroplasty.

The BENCOX Bipolar Cup System is a cementless, metal-on-polyethylene bearing hip system for hip arthroplasty. It consists of components, Femoral stem -BENCOX ID Stem; Femoral head - BENCOX Metal Head; Acetabular system -BENCOX Bipolar Cup (Shell; Insert; Lock Ring & PE ring) and BENCOX Hip Instrumentation.

The Bencox ID Stem is manufactured from titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and has a proven titanium plasma spray coating with pure titanium conforming to ASTM F1580-07, Standard Specification for Titanium and Ti-6 Al-4 V Alloy Powders for Coatings of Surgical Implants with about two decades of clinical experience

Bencox Metal Head components are manufactured from cobalt-chromiummolybdenum alloy conforming to ASTM F1537, Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539).

The BENCOX Bipolar Cups are provided as the preassembled cup (CoCr shell + PE Liner) and PE ring is assembled by the user (surgeon). The shell is made of Cobaltchromium-molybdenum alloy conforming to ASTM F75-07, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants. The PE liner and locking ring is made of Ultra-high molecular weight polyethylene conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants.

Bencox Bipolar Cup System components are sterilized by gamma irradiation.

The provided document is a 510(k) Premarket Notification for a medical device, the BENCOX Bipolar Cup System. This type of document is centered on demonstrating substantial equivalence to legally marketed predicate devices, not on proving performance against specific acceptance criteria for a new AI/software-driven medical device.

Therefore, the document does not contain any information related to:

• A table of acceptance criteria and reported device performance (in the context of AI/software).
• Sample sizes for test sets or data provenance for AI/software.
• Number of experts and their qualifications for establishing ground truth for AI/software test sets.
• Adjudication methods for AI/software test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for AI/software.
• Sample size or ground truth establishment for a training set of an AI/software device.

Explanation:

The 510(k) Premarket Notification process for devices like the BENCOX Bipolar Cup System focuses on bench testing (performance testing) and material characterization to demonstrate that the new device is as safe and effective as a legally marketed predicate device. The performance tests mentioned (ISO standards like 7206-4, 7206-9, etc., and ASTM standards like F1147, F1044, etc.) are mechanical and material tests specific to orthopedic implants, assessing aspects like fatigue strength, wear, and corrosion resistance.

The document explicitly states the basis for substantial equivalence:

• Same intended use
• Same operating principles
• Same basic designs
• Same materials
• Similar packaging and sterilization

This is a traditional medical device submission, not one for an AI or software as a medical device (SaMD), which would require clinical performance data against specific metrics and ground truth.

In summary, the requested information regarding AI/software device acceptance criteria, study design, and ground truth establishment is not present in this document because it describes a mechanical orthopedic implant, not an AI/software medical device.

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The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are indicated for use in patients requiring total hip replacement due to the following:

1. Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
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 by other techniques.
5. Revision of previously failed total hip arthroplasty.

The M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads are designed for use with the Taper oc 12/14 taper femoral components and the articulating heads and shells of the M2a Maqnum™ Sytem (K043537) for uncemented applications.

There are two sets of taper inserts, each providing neck offsets from to +9mm. The first set has a smaller diameter and mates with modular head sizes 42mm. The second set of taper inserts has a larger outer diameter and mates with modular head sizes 52mm through 60mm. The one-piece 12/14 modular head sizes will include 38mm and 40mm outer diameters. Available neck offsets will range from -6mm to +9mm.

The provided document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a 510(k) summary for a hip joint prosthesis (M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads) and an FDA clearance letter.

Instead, the document states:

• Non-Clinical Testing: "Non-clinical laboratory testing had been previously performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." However, specific acceptance criteria or details of these tests are not provided.
• Clinical Testing: "None provided as a basis for substantial equivalence." This indicates that no clinical studies were performed to prove the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily based on similar technological characteristics (materials, design, sizing, articulating surface, and indications).

Therefore, I cannot provide the requested information for the following points:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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