(65 days)
The DePuy Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications. The subject liners are intended to be used with the DePuy Pinnacle metal acetabular shells and DePuy metal or ceramic femoral heads to resurface the acetabular socket in cementless total hip arthroplasty. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to support the components.
The DePuy Pinnacle AltrX Acetabular Liners are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6Al-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter. The subject devices represent four additional sizes of the predicate acetabular liners.
The provided document is a 510(k) summary for the DePuy Pinnacle AltrX Acetabular Liners. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a novel device's performance against acceptance criteria.
Therefore, the document states clearly that "No clinical testing was required to demonstrate substantial equivalence."
Based on the information provided in the document, here's what can be inferred or stated about acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
Since no clinical testing was required, there are no reported device performance metrics from clinical trials to populate such a table. The acceptance criteria for the nonclinical testing are implied to be meeting "applicable performance requirements" and being "as safe and effective as the predicate."
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Nonclinical Testing | Applicable performance requirements for: | Met applicable requirements (demonstrated by testing and design evaluation) |
| - Push-out | ||
| - Torque | ||
| - Impingement | ||
| - High angle fatigue | ||
| Clinical Testing | Substantial equivalence to predicate device | Not applicable; no clinical testing performed. Substantial equivalence was demonstrated through similarities in design, materials, and performance to the predicate device, with additional sizes posing no new safety/effectiveness issues. |
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, as no clinical testing was performed. For nonclinical (bench) testing, sample sizes are not specified, nor is data provenance in terms of country of origin or retrospective/prospective nature.
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, as no clinical testing was performed that would require expert ground truthing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing was performed for which adjudication would be relevant.
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 device is a medical implant (acetabular liners), not an AI-assisted diagnostic or intervention system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical testing that would require such ground truth was performed. For the nonclinical testing, the "ground truth" would be the engineering specifications and performance standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
§ 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.