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BI-MENTUM™ ALTRX® Dual Mobility System is indicated for total hip replacement in the following conditions: - Osteoarthritis - Femoral neck fracture - Dislocation risk - Osteonecrosis of the femoral head - Revision procedures where other treatments or devices have failed and if bone reconstruction so permits

BI-MENTUM™ ALTRX® Dual Mobility Liners are designed to provide additional stability where there is an unstable joint and are for use in total hip arthroplasty that is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation or a previously implanted prosthetic hip joint in patients where there is evidence of sufficient sound bone to seat and support the components.

The BI-MENTUM™ ALTRX® Dual Mobility Liners are intended for single use only.

BI-MENTUM™ ALTRX® Dual Mobility Liner is indicated for total hip replacement, which includes: - Osteoarthritis - Femoral neck fracture - Dislocation risk - Osteonecrosis of the femoral head - Revision procedures where other treatments or devices have failed are if bone reconstruction so permits

The BI-MENTUM™ ALTRX® Dual Mobility Liner is highly cross-linked ultra- high molecular weight polyethylene. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. The BI-MENTUM™ ALTRX® Dual Mobility Liner is compatible with all the stems listed on K181744 as well as all the BI-MENTUM™ cups cleared in K181744. The BI-MENTUM™ ALTRX® Dual Mobility Liner is also compatible with the PINNACLE® Dual Mobility Liner, cleared in K200854.

The provided text describes a 510(k) premarket notification for a medical device called the BI-MENTUM™ ALTRX® Dual Mobility Liner. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo performance criteria or conducting a clinical study with human patients and associated AI performance metrics.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth establishment, and training set details) are not applicable to this type of regulatory submission because the device is a mechanical implant, not an AI/software device.

The "acceptance criteria" in this context are the demonstration of mechanical and material properties that are substantially equivalent to predicate devices, ensuring safety and efficacy.

Here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (which in this context are the non-clinical performance standards to demonstrate substantial equivalence) consisted of a series of non-clinical tests as listed above.

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

• Sample Size: Not explicitly stated as "sample size" in the context of patients or independent data points for an AI model. The tests were likely performed on a sufficient number of device units/specimens required by the respective ISO/ASTM standards.
• Data Provenance: Not applicable as this is a mechanical device, not an AI/software device using medical image data from specific countries or patients. The data is generated from laboratory testing of the physical device.

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

• Not applicable. Ground truth in this context refers to established engineering specifications and successful performance against industry standards (ISO, ASTM). The "experts" would be the engineers and scientists conducting and analyzing the mechanical tests, ensuring adherence to the standard methodologies.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are used for human review of data, typically in diagnostic or clinical settings. Mechanical tests have objective pass/fail criteria based on measured values against specified 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 hip implant, not an AI-powered diagnostic device that would assist human readers in interpreting medical data.

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

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

7. The type of ground truth used:

• Expert Consensus / Industry Standards: The "ground truth" for the device's performance is defined by established international and American standards for orthopedic implants, specifically ISO 14242-2 (for wear testing) and ASTM F1820-13, ASTM F2582-20, ASTM F2003-02 (for mechanical properties like head assembly, retention force, impingement, and accelerated aging). These standards represent accumulated expert consensus on what constitutes safe and effective performance for such devices.

8. The sample size for the training set:

• Not applicable. This is a physical medical device. There is no "training set" in the machine learning sense. The device itself is manufactured following standardized designs and processes, and then tested.

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

• Not applicable. As there's no training set, there's no ground truth to establish for it in the context of an AI model. The "ground truth" for the design and manufacturing of such a device is derived from extensive biomechanical research, clinical experience with previous generations of implants, and compliance with material and engineering standards.

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Total hip replacement is indicated in the following conditions:

• 1. A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease).
• 2. Failed previous hip surgery.
• 3. Dislocation risks.
     PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.

The DePuy PINNACLE Dual Mobility Liner is manufactured from cobalt-chrome-molybdenum alloy. The Liner is assembled with a taper locking mechanism to PINNACLE Acetabular Shells. The inner surface of the Dual Mobility Metal Liner articulates with a BI-MENTUM polyethylene mobile bearing head. The Dual Mobility construct is compatible with DePuy metal or ceramic modular femoral heads, for use in total hip arthroplasty.

This document describes the DePuy PINNACLE Dual Mobility Liner, a medical device for total hip replacement. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials for efficacy.

Therefore, the requested information regarding acceptance criteria, study outcomes proving device merits, expert number and qualifications, sample sizes for test and training sets, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided directly from this document. This document focuses on demonstrating substantial equivalence through non-clinical testing.

Here's an analysis based on the provided text, addressing the points where information is available or inferable:

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

The document describes non-clinical tests performed to demonstrate substantial equivalence, implying that the device performance met the standards set by these tests, which serve as "acceptance criteria" in this context.

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

• Sample Size for Test Set: Not explicitly stated. The "tests" mentioned are non-clinical, likely involving a specific number of device units or components, but this number is not provided.
• Data Provenance: Not explicitly stated but inferred to be internal laboratory testing results conducted by DePuy Ireland UC or its affiliates. The tests are "non-clinical" and do not involve human subjects or retrospective/prospective patient data.

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

This information is not applicable/provided as the study is a non-clinical, in-vitro (e.g., mechanical, wear) testing study comparing device characteristics to established standards and predicate devices. There is no "ground truth" established by human experts in the way clinical studies would for diagnostic performance.

4. Adjudication method for the test set:

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies with human assessors to resolve discrepancies in diagnoses or assessments. For non-clinical, objective performance tests, the results are typically quantitative and directly measured against predefined criteria.

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 information is not applicable. This device is a hip implant, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant.

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

This information is not applicable. This device is a hip implant, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" would be the established scientific and engineering standards (e.g., ISO 21535:2007, ASTM F1820, ANSVAAMI ST72:2011) and the performance characteristics of the legally marketed predicate devices (Stryker Modular Dual Mobility Liner (K103233) and BI-MENTUM Dual Mobility System (K181744)). The tests aim to show that the subject device performs similarly or meets the same safety and performance requirements as these benchmarks.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As per point 8, there is no training set for this type of device submission.

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