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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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1. Noninflammatory 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.
6. Dislocation risks.
   The ArComXL™ Active Articulation Head is a single-use implant, intended for uncemented applications.

The ArComXL™ Active Articulation belongs to the family of dual mobility acetabular implants: the presence of two articulating surfaces in the same joint device. The ArComXL™ Active Articulation Head fits over a femoral modular head, which articulates within the ArComXL™ Head. The resultant assembly then articulates within the acetabular metal shell. The ArComXL™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: M²a Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and M²a 38™ Flared Cups and Non-Flared Cups (K011110).
The ArComXL™ Active Articulation Heads are available in sizes 44-66mm (Note: Size 44-66mm references O.D. of mating shell; the actual head sizes are 38-60mm.) and are manufactured from highly cross-linked polyethylene, conforming to ASTM F648. ArComXL™ is not a new material; the material and manufacturing process were cleared in K042051, ArComXL™ Polyethylene Liners, as well as subsequent submissions. The ArComXL™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.

This document describes the Biomet ArComXL™ Active Articulation Head, a hip replacement component. This submission is for a material change from the predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Push-In and Lever-Out: Six samples.
  • Wear Testing: Not explicitly stated, but typically multiple samples are used in ISO 14242 testing. The document states "the ArComXL™ Active Articulation heads were tested".
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Biomet Manufacturing Corp. (the submitter). These are non-clinical tests.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable. The reported studies are non-clinical mechanical tests (Push-In and Lever-Out, Wear Testing), not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for Test Set

Not applicable. This section relates to clinical studies and expert review, which were not performed for the determination of substantial equivalence for this device.

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

Not applicable. No clinical studies were conducted, and therefore, no MRMC studies comparing human readers with and without AI assistance were performed. The device is a medical implant, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical implant, not an algorithm or software. The performance studies are non-clinical hardware tests.

7. Type of Ground Truth Used

• Push-In and Lever-Out: Comparison to the performance of a legally marketed predicate device (K991990), establishing functional equivalence.
• Wear Testing: Comparison to the wear rates of a legally marketed predicate device, ArCom™ 36mm liners (K032396), as per ISO 14242 standards.

8. Sample Size for Training Set

Not applicable. This device is a physical implant; there is no "training set" in the context of an algorithm or AI model development.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this device.

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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

Biomet Manufacturing Corp. is adding additional sizes and designs to the predicate ArComXL™ Acetabular Liners (K042051). The same manufacturing process used in the predicate results in a higher cross-linked polyethylene that Biomet will herein refer to as ArComXL™ . The femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from -6mm to +9mm made from CoCrMo.

The provided document is a 510(k) Summary for a medical device (ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads). It describes the device, its intended use, and claims substantial equivalence to predicate devices. Crucially, it states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, a study proving the device meets acceptance criteria as typically understood for AI/diagnostic devices (e.g., performance metrics, ground truth, expert adjudication, MRMC studies) was not conducted for this submission, as it is a medical device, not a diagnostic or AI product.

However, given the request's structure which assumes such a study, I can only extract information related to "Non-Clinical Testing" which serves a similar purpose of validating the device.

Here's a breakdown based on the provided text, primarily addressing the "Non-Clinical Testing" section since clinical trials were not performed.

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document does not specify the exact "standards or guidelines" or quantitative performance metrics, only that they were met or exceeded.)

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

The document does not detail specific sample sizes for non-clinical testing. It simply states "Verification activities were performed on ArComXL™ liners." There is no mention of a "test set" in the context of clinical or diagnostic data, as this is a physical medical implant. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the way it would be for a diagnostic study.

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

This section is not applicable. Since no clinical or diagnostic study was performed, there was no "ground truth" to establish in the context of expert review of data/images. The "ground truth" for non-clinical testing of a physical implant would typically involve engineering specifications, material properties, and mechanical test results against established benchmarks or regulatory standards, which are not detailed here.

4. Adjudication method for the test set

This section is not applicable. No test set requiring adjudication by experts was utilized as no clinical or diagnostic study was conducted.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

This section is not applicable. The device is a physical medical implant (hip replacement components), not an algorithm or AI product.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be related to engineering specifications, material science properties, and established regulatory/industry standards for medical implants (e.g., ASTM F-648 for UHMWPE). The document confirms that the device characteristics were "identical to the predicate (K042051)" and met "current standards or guidelines."

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of an AI/algorithm for this device.

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

This section is not applicable. There is no "training set" or corresponding ground truth establishment in the context of an AI/algorithm for this device. The "ground truth" for the manufacturing materials and processes would be based on validated scientific and engineering principles and quality control measures.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) Revision of previously failed total hip arthroplasty. Intended for cemented and uncemented applications

The ArComXLTM polyethylene liners are manufactured from highly cross-linked polyethylene conforming to ASTM F648 that was previously cleared in K042051. ArComXLTM is available in three designs: MaxRom, Hi-Wall, and 10o. Biolox® delta Ceramic Heads (K042091) are composed of Transition-Toughened-Platelet-Alumina (TTPA). The highly polished spherical surface articulates with the ArComXLTM polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper.

This document describes the 510(k) premarket notification for the ArComXL™ Acetabular Liners and Biolox® delta Ceramic Heads. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Instead, this document is a regulatory submission for a traditional medical device (hip joint prostheses) that relies on demonstrating substantial equivalence to previously cleared predicate devices. The "study" mentioned, "Volumetric wear testing," is a non-clinical test performed to support this substantial equivalence.

Therefore, many of the requested fields related to AI/ML device studies, ground truth, and expert evaluation cannot be filled from the provided text.

Here is an attempt to answer the questions based only on the provided text, with many fields noted as "Not applicable" or "Not provided" due to the nature of the document:

1. Table of acceptance criteria and the reported device performance

Explanation: For traditional medical devices like this, acceptance criteria typically involve demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through non-clinical testing and comparison of design and materials rather than explicit quantitative clinical performance metrics against pre-defined acceptance thresholds in the way an AI/ML study would. The key acceptance is the FDA's finding of "substantial equivalence."

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 for Test Set: Not applicable in the context of an AI/ML study. For the volumetric wear testing, the sample size of liners/heads tested is not specified.
• Data Provenance: Not applicable for an AI/ML study. The wear testing is a laboratory-based non-clinical study. Country of origin of the data is not specified (though Biomet is based in the US). Retrospective or prospective does not apply to a pre-clinical bench test.

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 device is a physical implant, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth from patient data. The "ground truth" for wear testing is the measured volumetric wear.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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

• No. An MRMC study was not done as this is not an AI/ML device impacting human reader performance.
• Effect size: Not applicable.

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

• Not applicable, as this is not an AI/ML algorithm.

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

• For the non-clinical volumetric wear testing, the "ground truth" is derived from physical measurements of material loss post-wear simulation. This is a physical measurement-based ground truth.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it's not an AI/ML algorithm.

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

• Not applicable. This device does not involve a training set.

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