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The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)

Indications:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
• Revision of previous failed femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The existing Trident® Acetabular System features acetabular liners in neutral, hooded and eccentric versions. The subject Trident® Elevated Rim Liners are an addition to the existing liners. They feature an elevated superior rim. The elevated rim is intended to provide added resistance to dislocation during high flexion/adduction angles. The subject liners will also be offered in five new sizes. The subject liners, like the predicate liners, are manufactured using Crossfire® polyethylene.

Here's an analysis of the provided text regarding acceptance criteria and the study performed, structured according to your requested information.

It appears the provided document is a 510(k) Premarket Notification for a line extension of an artificial hip component (Trident® Elevated Rim Liners). This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance in the same way a novel device might. The "study" mentioned is primarily engineering analysis and hip wear simulator testing, not a clinical trial or AI algorithm validation.

Based on the provided text, the device is a mechanical medical device, not an AI/ML-driven diagnostic or therapeutic tool. Therefore, many of your requested items, particularly those related to AI algorithm performance (e.g., test set, ground truth, experts, MRMC studies, standalone performance), are not applicable to this submission.

Acceptance Criteria and Device Performance Study for Trident® Elevated Rim Liners

1. Table of Acceptance Criteria and the Reported Device Performance

Explanation: The acceptance criteria are implicit based on the comparison to predicate devices, which is fundamental to a 510(k) submission. The goal is to show the new device is "substantially equivalent" in terms of safety and effectiveness.

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: Not explicitly stated. The studies mentioned are:
  • Engineering analysis: This would involve calculations, simulations, and possibly mechanical testing of a limited number of physical prototypes or CAD models. No "sample size" in the conventional sense of patient data is applicable.
  • Hip wear simulator testing: This involves testing physical implants in a lab setting. The number of devices tested and the duration of testing (cycles) are not specified.
• Data Provenance: Not applicable in the context of patient data. This is a pre-market submission for a physical device, based on engineering principles and laboratory 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. This is a mechanical device, and no "ground truth" derived from expert consensus on medical images or diagnostic outcomes is relevant to the studies described. The "ground truth" for mechanical performance is based on engineering principles, material science, and established biomechanical testing standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable. As no expert review or clinical trial data is presented for adjudication, this concept does not apply.

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 mechanical implant device, not an AI-driven system.

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

• Not Applicable. This is a mechanical implant device, not an AI algorithm.

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

• The "ground truth" for the engineering analysis and hip wear simulator testing is based on:
  • Engineering Principles and Biomechanical Standards: For cam-out risk, this would tie into established mechanical properties, design specifications, and relevant biomechanical forces.
  • Laboratory Measurements and Material Science: For wear, this involves direct measurement of wear rates in controlled simulator environments, compared against industry standards and predicate device performance.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not an AI model, so there is no "training set."

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

• Not Applicable. There is no training set for a mechanical device.

Summary regarding the provided text:

The submission focuses on demonstrating "substantial equivalence" of the new Trident® Elevated Rim Liners to existing predicate devices. This is achieved through:

• Technological Comparison: Highlighting that the new liners are an addition to the existing system, using the same material (Crossfire® polyethylene), but with an elevated rim and new sizes.
• Engineering Analysis: To show that the risk of "cam-out" (a mechanical disengagement issue) is improved compared to predicate devices.
• Hip Wear Simulator Testing: To demonstrate that the wear characteristics of the thinner new liners are comparable to the predicate devices, thus ensuring similar safety and effectiveness in terms of durability.

The document does not detail patient-based studies or the validation of an AI/ML algorithm.

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