(442 days)
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.
| Acceptance Criteria (Implied for a physical device) | Reported Device Performance (Summary) |
|---|---|
| Equivalence to predicate devices in material properties. | Material properties testing performed. |
| Equivalence to predicate devices in wear characteristics. | Wear testing performed. |
| Sterilization process effectiveness and material integrity post-sterilization. | Effect of STERRAD gas plasma sterilization on the sequentially crosslinked and annealed material assessed. |
| Dimensional accuracy and fit with mating components. | Dimensional assessment of the sequentially crosslinked and annealed material performed. |
| Mechanical stability and assembly integrity (e.g., resistance to disassembly). | Disassembly force evaluation performed. |
| Appropriate contact stresses during use. | Contact stresses evaluated. |
| Meeting established standards for hip implants (implied by predicate comparison). | A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. |
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.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.