(15 days)
The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® II X3® Polyethylene bearing inserts, which are also the subject of this submission. If additional fixation is desired, the dome screw holes, if present, have . been designed to accept Howmedica Osteonics 6.5mm or 5.5mm bone screws.
The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation with the mating Trident® II X36 Polyethylene Inserts.
Indications for Use:
- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- · Revision of previous unsuccessful 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.
This Special 510(k) submission is intended to add the Trident® II Acetabular System. This system is a minor modification to the locking mechanism of the predicate Trident Acetabular System.
Here's an analysis of the provided text regarding the Trident® II Acetabular System, focusing on the acceptance criteria and the study proving it:
Acceptance Criteria and Device Performance for Trident® II Acetabular System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Comparable mechanical properties to predicate device | Mechanical testing demonstrated comparable mechanical properties to the predicate components. |
| Material | Same as predicate device | Shares the same materials as the currently available acetabular components of the Trident® Acetabular System. |
| Design Concept | Basic design concepts same as predicate device | Shares the same basic design concepts as that of the currently available acetabular components of the Trident® Acetabular System. |
| Intended Use | Same as predicate device | Shares the same intended use as that of the currently available acetabular components of the Trident® Acetabular System. |
| Substantial Equivalence | Demonstrates substantial equivalence to predicate device based on mechanical properties and design. | Mechanical testing demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices. |
2. Sample Size and Data Provenance:
The document does not provide details on specific sample sizes for the mechanical testing. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, the study involved mechanical testing of the device, implying laboratory-based data rather than patient data.
3. Number of Experts and Qualifications for Ground Truth:
The document does not mention the use of experts to establish ground truth. The evaluation of the device was based on mechanical testing and comparison to a predicate device, not on expert interpretations of clinical data or images.
4. Adjudication Method:
Adjudication methods (e.g., 2+1, 3+1, none) are relevant for studies involving human interpretation or clinical outcomes. This submission focuses on engineering analysis and comparison to a predicate device, so an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of a device (often AI-assisted) on human reader performance, which doesn't apply to a mechanical implant like an acetabular system.
6. Standalone (Algorithm Only) Performance:
No standalone (algorithm only) performance study was done. This refers to the performance of an AI algorithm without human intervention, which is not relevant to a mechanical hip implant.
7. Type of Ground Truth Used:
The ground truth for this device's acceptance was:
- Mechanical Test Results: The measured mechanical properties of the Trident® II Acetabular System itself.
- Predicate Device Specifications/Performance: The established mechanical properties, materials, and design concepts of the legally marketed predicate Trident Acetabular System.
Essentially, the device's performance was compared directly to engineering standards and a pre-existing, approved device.
8. Sample Size for the Training Set:
There is no mention of a "training set" because this is a medical device, not an AI or machine learning model. The evaluation is based on mechanical testing and comparison.
9. How Ground Truth for the Training Set Was Established:
As there is no training set mentioned or relevant for this type of device submission, this question is not applicable.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.