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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 hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

• Severely painful and/or disabled joint: as a result of osteoarthritis, posttraumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Mpact Extension components are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Extension acetabular components that are the subject of this 510(k) consist of a multi-hole or rim-hole shell (Ti-6Al-4V, ASTM F136 and Ti, ASTM F1580 porous coating), a fixed liner in sizes "J" and "K" that is made of ultra-high molecular weight polyethylene (UHMWPE ISO 5834-2 Type1) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE), and a cortical bone screw, flat head (Ti-6AJ-4V, ISO 5832-3).

The provided document describes the 510(k) submission for the Mpact Extension, a hip prosthesis system. It outlines the performance testing conducted to demonstrate substantial equivalence to predicate devices, but it does not include the detailed information requested regarding sample sizes, data provenance, expert qualifications, or comparative effectiveness studies in the context of an AI/algorithm-based device.

This document is for a traditional medical device (hip prosthesis), not an AI/ML-based medical device. Therefore, many of the requested categories (like "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," etc.) are not applicable to this type of submission.

However, I can extract the available information related to acceptance criteria and device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria Met:

The study was described as "Performance testing of the Mpact Extension," conducted "in accordance with various international standards and FDA guidance documents." The testing was part of "design verification to written protocols with pre-defined acceptance criteria."

Details on the Study (as much as available in the text):

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: The document states that testing was "conducted on the worst case component size and option/design." However, it does not specify the exact number of samples or units tested for each type of test (e.g., number of shells, liners, or screws).
   • Data Provenance: Not specified. This type of physical device testing typically wouldn't have "country of origin of the data" in the same sense as patient data.
   • Retrospective or Prospective: Not applicable in the context of physical product testing. It's prospective testing.

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 this is performance testing of a physical medical device, not an AI/ML algorithm requiring expert interpretation for ground truth.

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

   • Not applicable.

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 not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

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

   • The "ground truth" or reference standard for this type of testing is established by the relevant "international standards and FDA guidance documents" specific to orthopedic implants. These standards define the benchmark performance requirements for pull-out strength, wear, deformation, etc.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

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DePuy Modular M Heads are indicated for use in total hip replacement procedures. 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. 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 DePuy Modular M Heads are indicated for use with the Pinnacle® Acetabular Cup in cementless application.

The subject DePuy Modular M Heads are manufactured from wrought Co-Cr-Mo alloy and are available in:

• 40, 44, and 48 mm diameters with a 12/14 Articul/eze taper and -- 2, +1.5, +5, . +8.5. +12 and +15.5 mm neck lengths. All of the Articul/eze taper femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).
• 40 and 44 mm diameters with an 11/13 S-ROM taper and -3, +0, +3, +6, +9 . and +12 mm neck lengths. The 48 mm heads with the 11/13 S-ROM taper are available in +0, +3, +6, +9 and +12 mm neck lengths. All of the S-ROM taper femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).

The subject device is designed to articulate with the Pinnacle™ Marahon®" ES3 Liners (K033273) inside a Pinnacle™ Acetabular System shell (K033338) in cementless applications.

I am sorry, but the provided text is a 510(k) summary for a medical device (DePuy Modular M Heads), and it does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

The document focuses on:

• Device Description and Intended Use: What the device is made of, its sizes, and what medical conditions it's used for.
• Classification and Product Codes: Regulatory categories.
• Substantial Equivalence: Comparing the new device to previously cleared devices.
• FDA Correspondence: The official letter from the FDA regarding the 510(k) clearance.

Therefore, I cannot extract the specific information you requested regarding acceptance criteria and study details (like sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies) because that information is not present in the provided text. This type of detailed study data is typically found in the full 510(k) submission, not in the public summary.

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