(89 days)
The DePuy Tri-Lock Hip Stem is indicated for cementless use in the treatment of:
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
- Avascular necrosis of the femoral head;
- Acute traumatic fracture of the femoral head or neck;
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement;
- Certain cases of ankylosis.
The DePuy Tri-Lock Hip Stem consists of variously sized femoral hip stems which will be available in two versions (standard and lateralized) with a modular head design. The DePuy Tri-Lock Hip Stem employs Porocoat porous coating for use with or without cement. When it is used cementless, it is intended for tissue ingrowth to obtain biological fixation.
This submission is a 510(k) summary for a hip stem device (DePuy Tri-Lock Hip Stem). It relies on substantial equivalence to predicate devices rather than clinical studies to demonstrate safety and effectiveness. Therefore, the questions related to studies, ground truth, and expert evaluation are not directly applicable.
Here's an analysis of the provided information, addressing what is present and noting what is not:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the typical sense for a performance study (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, the basis for approval is substantial equivalence to predicate devices. The "performance" is implicitly deemed equivalent to the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The DePuy Tri-Lock Hip Stem is found to be substantially equivalent in terms of materials, design, sizing, and intended use to the predicate devices: DePuy Prodigy Hip, AML Proximally-Coated Stem, and Porocoat Dual Lock Total Hip System. The performance is expected to be similar to these predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission is a 510(k) for a medical device (hip stem) seeking clearance based on substantial equivalence. It does not involve a "test set" of data from clinical studies in the way a diagnostic or AI device would. The approval is based on comparison to existing, legally marketed predicate devices.
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. There is no "test set" requiring ground truth establishment by experts for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As there is no test set or clinical study data requiring adjudication, this question is not relevant to this submission.
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 hip stem, not an AI-powered diagnostic device or a device involving human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant (hip stem), not an algorithm or software. Standalone performance is not relevant in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. As stated, there is no "ground truth" derived from clinical data in this submission. The "truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which the new device is compared.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device and does not involve a learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. Since there is no training set, there is no ground truth establishment for it.
§ 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.