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The DePuy Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid 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.

The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.

The DePuy Pinnacle ALTRX Acetabular Liners are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6Al-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter. The subject devices represent additional sizes and style combinations of the predicate acetabular liners.

The DePuy Pinnacle ALTRX Acetabular Liners are a medical device used in total hip replacement procedures. The 510(k) summary provides information on the device's acceptance criteria and the study that proves it meets these criteria.

Acceptance Criteria and Device Performance

The acceptance criteria for the DePuy Pinnacle ALTRX Acetabular Liners are implicitly demonstrated by showing substantial equivalence to legally marketed predicate devices. The study conducted was a non-clinical test that focused on specific performance requirements.

Here's a table summarizing the characteristics of the subject device in comparison to its predicate and reference devices, which effectively serve as the acceptance criteria based on equivalence:

The device performance, as reported, indicates that the subject devices "met the applicable performance requirements and are as safe and effective as a legally marketed device."

Study Details

Given that this is a 510(k) submission for a line extension, the primary "study" is a demonstration of substantial equivalence through non-clinical testing.

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

   • No specific sample sizes for test sets are provided in the document. The testing mentioned (Impingement, High Angle Fatigue, Push-out, and Torque-out) would involve specific numbers of physical samples of the liners and associated components, but these numbers are not detailed here.
   • Data Provenance: The data is from non-clinical tests conducted by the manufacturer, DePuy Orthopaedics. The country of origin of the data is not explicitly stated but is implied to be within the company's testing facilities, likely in the US (Warsaw, IN). The tests are prospective in the sense that they were conducted for the purpose of this submission to demonstrate performance.

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

   • For non-clinical performance testing of medical devices like acetabular liners, the "ground truth" is typically established by engineering standards and validated test methodologies. There isn't a concept of medical "experts" establishing ground truth in the same way as, for example, reviewing medical images. The acceptance criteria for these tests (e.g., maximum force, cycles to failure) are derived from industry standards, regulatory requirements, and historical data from similar, cleared devices. The engineers and technicians who conduct and interpret these tests are qualified in biomechanical testing and materials science, but their specific number or qualifications are not provided here.

3. Adjudication method for the test set:

   • Not applicable in the traditional sense. Non-clinical mechanical tests are generally quantitative, and their outcomes are determined by meeting predefined engineering specifications and statistical analysis, rather than through expert human adjudication.

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

   • No, a MRMC comparative effectiveness study was explicitly stated as not conducted. The document states, "No clinical tests were conducted to demonstrate substantial equivalence." This type of study is typically used for diagnostic or screening devices involving human interpretation of data (e.g., radiology images).

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

   • Not applicable. This device is a physical implant (acetabular liner) for hip replacement, not a software algorithm.

6. The type of ground truth used:

   • The ground truth for the non-clinical tests (Impingement, High Angle Fatigue, Push-out, and Torque-out) is based on established engineering performance requirements and industry standards for such orthopedic implants. The reported performance of the subject device was compared against these predefined acceptable limits (derived from the predicate devices and general orthopedic device standards) to ensure it performs "as safe and effective as a legally marketed device."

7. The sample size for the training set:

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

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

   • Not applicable.

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The DePuy Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid 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. The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications. The subject liners are intended to be used with the DePuy Pinnacle metal acetabular shells and DePuy metal or ceramic femoral heads to resurface the acetabular socket in cementless total hip arthroplasty. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to support the components.

The DePuy Pinnacle AltrX Acetabular Liners are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6Al-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter. The subject devices represent four additional sizes of the predicate acetabular liners.

The provided document is a 510(k) summary for the DePuy Pinnacle AltrX Acetabular Liners. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a novel device's performance against acceptance criteria.

Therefore, the document states clearly that "No clinical testing was required to demonstrate substantial equivalence."

Based on the information provided in the document, here's what can be inferred or stated about acceptance criteria and studies:

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

Since no clinical testing was required, there are no reported device performance metrics from clinical trials to populate such a table. The acceptance criteria for the nonclinical testing are implied to be meeting "applicable performance requirements" and being "as safe and effective as the predicate."

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, as no clinical testing was performed. For nonclinical (bench) testing, sample sizes are not specified, nor is data provenance in terms of country of origin or retrospective/prospective nature.

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, as no clinical testing was performed that would require expert ground truthing.

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

Not applicable, as no clinical testing was performed for which adjudication would be relevant.

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 device is a medical implant (acetabular liners), not an AI-assisted diagnostic or intervention system involving human readers.

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

Not applicable. This device is a medical implant, not a standalone algorithm.

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

Not applicable, as no clinical testing that would require such ground truth was performed. For the nonclinical testing, the "ground truth" would be the engineering specifications and performance standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

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The Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures.

Total hip replacement is indicated in the following conditions:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Certain cases of ankylosis

The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.

The subject liner is intended to be used with the DePuy Pinnacle metal acetabular shells, and DePuy metal or ceramic femoral heads to resurface the acetabular socket in cementless total hip arthroplasty. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

The DePuy Pinnacle AltrX Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6A1-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter.

The subject Pinnacle AltrX liners are cross-linked UHMWPE acetabular cup liners that are available in a neutral, lateralized neutral, lipped or lateralized face-changing orientation. The subject liners are intended for use with modular, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range.

The provided text describes a 510(k) premarket notification for the DePuy Pinnacle® AltrX™ Acetabular Liners. The submission aims to support a marketing claim regarding reduced wear when these liners are articulated against ceramic femoral heads.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific wear rate thresholds for the new claim. Instead, the claim is comparative: "Pinnacle AltrX UHMWPE liners (articulated against ceramic heads) reduce wear by 33% compared to articulation against cobalt-chromium heads."

Therefore, the success criteria for the study would be demonstrating this 33% reduction (or greater statistical significance) with the ceramic head articulation compared to cobalt-chromium heads.

Calculation of reduction: ((4.99 - 3.32) / 4.99) * 100% = 33.47% reduction. | Yes |

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

• Sample Size: The study involved multiple groups of liners and femoral heads. While the exact number of individual devices per group isn't explicitly stated, the text mentions a "12-station orbital bearing hip simulator," which implies a certain capacity for simultaneous testing. The report provides mean and standard deviation for wear rates, indicating multiple samples were tested for each configuration.
• Data Provenance: The study was an in-vitro hip simulator wear study. As such, there is no country of origin for patient data (as it's not patient data) and it is not retrospective or prospective in the clinical sense. It's a laboratory-based study.

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

Not applicable. This is an in-vitro mechanical wear study, not a study requiring expert clinical interpretation or ground truth establishment based on human observational data. The "ground truth" here is the measured wear rate in a standardized laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. As this is an in-vitro mechanical wear study, there is no human adjudication of findings. The wear rates are determined by quantitative laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This is an in-vitro mechanical wear study, not a clinical study involving human readers or cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a conceptual sense, this was a "standalone" performance evaluation of the device's physical properties. The device's wear performance was measured directly in a simulated environment without human intervention influencing the wear measurement itself. It's not an AI algorithm, but rather a physical device being tested.

7. The Type of Ground Truth Used

The ground truth used was quantitative laboratory measurement of wear rates (mg/million cycles) from a standardized in-vitro hip simulator study.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" for an algorithm. The "training" for the device's design and manufacturing would involve engineering principles and previous material science studies, not a data-driven training set.

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

Not applicable, as there is no training set in the context of an algorithm. For material development and design, "ground truth" would be established through material testing, mechanical properties analysis, and prior scientific understanding of UHMWPE behavior under simulated joint loading.

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