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The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The system is intended for use either with or without bone cement in total hip arthroplasty.

The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty.

The Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, optional dome and screw hole plugs

The subject devices are line extensions to the previously cleared predicate systems to add 42mm OD shells and additional 22mm, 32mm, and 36mm ID elevated liners. The subject 32mm and 36mm liners are identical to the previously cleared devices; no changes have been made except for the additional sizes. The subject 22mm liner has been modified to include a poly-relief ring above the scallops. The subject 42mm shells have been modified so that they will not accept the option screw hole plugs.

The provided document describes a 510(k) premarket notification for a medical device (hip prosthesis components) and as such, it does not detail acceptance criteria and a study in the same way one would for a diagnostic AI device. Instead, it outlines non-clinical performance testing to demonstrate substantial equivalence to predicate devices.

Here's an interpretation based on the document, addressing the requested points where applicable, and noting when the information is not present for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside performance metrics in the format typically seen for AI device validation. Instead, it states that "the observed test results exceeded all acceptance criteria." The acceptance criteria would likely be defined by relevant ISO standards or internal Zimmer specifications for mechanical and wear performance of orthopedic implants.

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

• Test Set Sample Size: The document does not specify the exact sample sizes (number of devices, test repetitions) for each non-clinical test. This information would typically be detailed in the full test reports, not in this summary document.
• Data Provenance: The data is from non-clinical (laboratory) testing conducted by Zimmer, Inc. or its contracted labs. It is not human subject data from a specific country or retrospective/prospective in the medical sense.

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

This requirement is not applicable to this type of non-clinical device submission. Ground truth for mechanical and wear testing is typically established through engineering and metrology standards, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data (e.g., image interpretation), not for non-clinical mechanical testing.

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

Not applicable. This is a non-clinical evaluation of medical device components (hip prosthesis). MRMC studies are relevant for diagnostic AI devices assessing human reader performance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is not an AI algorithm. The performance described is "standalone" in the sense that the device components were tested in a controlled laboratory environment without human interaction during the test itself, but it's not an "algorithm-only" evaluation.

7. Type of Ground Truth Used

The ground truth for this device's performance relies on:

• Engineering specifications and design requirements.
• Industry standards (e.g., ISO standards for orthopedic implants).
• Performance data of legally marketed predicate devices, which serve as the benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of medical device submission.

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The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The system is intended for use either with or without bone cement in total hip arthroplasty.

The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The liners are available in 22, 28, 32 and 36mm articulation diameters.

Here's a breakdown of the acceptance criteria and the study information for the Longevity® IT Highly Crosslinked Polyethylene Elevated Liners based on the provided text:

Lack of Specific Acceptance Criteria and Detailed Study Information:

It's important to note that the provided document is a "Summary of Safety and Effectiveness" (510(k) Premarket Notification) for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report with statistical performance metrics like sensitivity, specificity, or AUC. The document states that "Non-Clinical testing demonstrated that the Longevity IT Highly Crosslinked Polyethylene Elevated Liners met performance requirements and are as safe and effective as their predicate." This general statement is the core finding presented without delving into specific numerical acceptance criteria or granular study results.

Therefore, many of the requested details, especially those related to AI algorithm performance (like sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, adjudication methods, or MRMC studies), are not applicable to this type of device and document. This is a traditional medical device (hip prosthesis liner), not an AI-powered diagnostic or predictive algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "Non-Clinical testing" which would typically involve mechanical testing, material characterization, and wear studies, not clinical patient data in the typical sense of a "test set" for an AI algorithm.
• Data Provenance: Not explicitly stated, as it pertains to non-clinical laboratory testing rather than patient data from a specific country. The device sponsor is Zimmer, Inc. from Warsaw, IN, USA.
• Retrospective or Prospective: Not applicable for non-clinical bench testing.

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

• Not applicable. This device is a physical implant. "Ground truth" would be established through engineering specifications, material science standards, and performance benchmarks in non-clinical testing settings, not via expert interpretation of patient data.

4. Adjudication Method for the Test Set

• Not applicable. This is a physical device, not an AI model requiring adjudication of interpretations.

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

• No, an MRMC study was not done. This is not an AI-assisted diagnostic or imaging device.

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

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

7. The Type of Ground Truth Used

• The implicit "ground truth" for this device's performance would be established through engineering specifications, material testing standards (e.g., ISO standards for orthopaedic implants), and performance benchmarks set by the predicate device. These would typically involve measures like wear rate, mechanical strength, fatigue resistance, and biocompatibility.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI model that undergoes a "training set" process.

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

• Not applicable.

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