Search Results

The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident® Acetabular Shells. The Trident® Acetabular Shells are intended for cementless fixation. The Trident® Acetabular Hip System Polyethylene inserts are indicated for use in total hip arthroplasty in the following instances:

• Painful, disabling joint disease of the hip resulting from: non-inflammatory . 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The device includes the acetabular inserts of a total hip system. These components are used for the replacement of the bearing surface of the acetabulum to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.

The provided text describes the 510(k) premarket notification for the Trident® Hip System and its polyethylene inserts. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically expected for AI/software-as-a-medical-device (SaMD) clearances.

This document is for a physical medical device (a hip replacement system), not an AI/software device. Therefore, the questions related to AI performance metrics, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

The "Summary of Safety and Effectiveness" section (page 1) broadly outlines data presented to demonstrate equivalence to predicate devices, but this is about the physical properties and performance of the hip implant itself, not an AI's diagnostic or predictive capabilities.

Here's an attempt to answer the questions based on the available information, noting the differences between a physical device clearance and an AI/SaMD clearance:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds (e.g., sensitivity, specificity, AUC). Instead, it refers to demonstrating "equivalence of the proposed products to the predicate devices" through various tests for a physical medical device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in terms of patient numbers or specific clinical study sizes, as this is a materials/mechanical performance submission for a physical device. The "test set" would refer to batches of manufactured components or materials samples used in laboratory testing.
• Data Provenance: Not specified. The testing described (material properties, wear, sterilization effects, dimensions, disassembly force, contact stresses) sounds like laboratory-based engineering and bench testing, rather than human clinical trial data.

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)

This concept is not applicable to this 510(k) submission. "Ground truth" in the context of this device refers to the physical and mechanical properties of the hip implant itself, verified through laboratory measurements and engineering principles, not expert interpretation of outputs from an AI model.

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

Not applicable. This is not an AI/SaMD submission requiring expert adjudication of outputs.

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 physical medical device. MRMC studies are relevant to AI/SaMD for diagnostic or assistive purposes.

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

Not applicable. There is no algorithm or AI component mentioned in this submission.

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

For this physical device, the "ground truth" for the performance claims would be established through:

• Engineering specifications and design requirements.
• Laboratory measurements of material properties (e.g., tensile strength, fatigue life).
• Bench testing results for wear, dimensional accuracy, disassembly forces, and contact stresses.
• Comparison to the known properties and performance of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable. There is no AI model or "training set" for this physical device.

Ask a specific question about this device