(97 days)
The Trident® "I" Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® polyethylene acetabular bearing inserts. If additional fixation is desired, the dome screw holes, if present, have been designed to accept Stryker Orthopaedics 6.5mm or 5.5mm bone screws.
Indications
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-oraunatic arthrits or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative rechniques are less likely to ache ve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum
The subject devices are identical to their corresponding predicate devices, except that they feature thicker walls. Consequently, for each shell size (except the smallest, which remains unchanged) the subject Trident® "T" Shells will be compatible with a liner one size smaller than ihat used for the predicate Trident® designs. In addition, to accommodate the thicker walls, the screw holes were mimimally shifted (not more than 4 degrees measured off the center of the shell) so as not to run into each other on the inner radius of the shell.
The provided text describes a 510(k) premarket notification for the Trident® "T" Acetabular Shells. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials. Therefore, the information typically requested in your prompt (like specific acceptance criteria with numerical performance targets, sample sizes for test/training sets, expert qualifications, and detailed ground truthing methods for AI devices) is not present here, as it's not generally required for a 510(k) for this type of medical device.
The "study" mentioned is a bench test comparing physical properties to demonstrate a design modification (thicker walls) did not negatively impact performance but rather improved it or maintained equivalence.
Here's a breakdown of the available information in relation to your prompt:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Deflection should be no worse than predicate devices. | Thicker wall design of subject devices resulted in: |
- Less deflection (upon implantation into the acetabulum) than some predicate shells.
- About the same deflection as seen in other predicate shell designs. |
Note: The acceptance criteria are implied to be "non-inferiority" or "improvement" compared to the predicate devices regarding deflection upon implantation.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The study is described generally as "A study was performed to compare the deflection experienced by the subject and predicate devices." It does not provide the number of devices tested.
- Data Provenance: The study was a bench test performed by Stryker Orthopaedics. It does not involve patient data or human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of information is not applicable as the "test set" refers to physical devices in a bench test, not clinical data requiring expert human review for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This refers to clinical data review, not engineering bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
- No. This is a bench test for physical device properties, not a clinical study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a mechanical implant, not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this engineering study was the measured deflection of the subject and predicate acetabular shells under simulated implantation conditions. These measurements would be considered objective, quantitative data.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical implant and does not involve AI or machine learning with a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, no training set or AI is involved.
Summary of the "Study":
The "study" was an engineering bench test comparing the mechanical property of deflection between the new Trident® "T" Acetabular Shells and their predicate devices. The key finding was that the new design (featuring thicker walls) either reduced deflection or maintained similar deflection compared to the predicate shells, which demonstrated that the design modification did not introduce new safety or effectiveness concerns and, in some cases, improved performance. This type of testing is standard for demonstrating substantial equivalence for design modifications in 510(k) submissions for mechanical implants.
§ 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.