(164 days)
Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease).
-
- Failed previous hip surgery.
-
- Dislocation risks.
PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.
- Dislocation risks.
The DePuy PINNACLE Dual Mobility Liner is manufactured from cobalt-chrome-molybdenum alloy. The Liner is assembled with a taper locking mechanism to PINNACLE Acetabular Shells. The inner surface of the Dual Mobility Metal Liner articulates with a BI-MENTUM polyethylene mobile bearing head. The Dual Mobility construct is compatible with DePuy metal or ceramic modular femoral heads, for use in total hip arthroplasty.
This document describes the DePuy PINNACLE Dual Mobility Liner, a medical device for total hip replacement. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials for efficacy.
Therefore, the requested information regarding acceptance criteria, study outcomes proving device merits, expert number and qualifications, sample sizes for test and training sets, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided directly from this document. This document focuses on demonstrating substantial equivalence through non-clinical testing.
Here's an analysis based on the provided text, addressing the points where information is available or inferable:
1. Table of acceptance criteria and the reported device performance:
The document describes non-clinical tests performed to demonstrate substantial equivalence, implying that the device performance met the standards set by these tests, which serve as "acceptance criteria" in this context.
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Range of motion (in accordance with ISO 21535:2007 / AMD 2016) | Demonstrated substantial equivalence through testing. (Implies performance within ISO standards) |
| Verification of product compatibility | Demonstrated substantial equivalence through testing. (Implies successful compatibility) |
| Standard walking wear testing | Demonstrated substantial equivalence through testing. (Implies wear characteristics comparable) |
| Jump distance assessment | Demonstrated substantial equivalence through testing. (Implies jump distance comparable) |
| Mechanical testing (in partial compliance with ASTM F1820) | Demonstrated substantial equivalence through testing. (Implies mechanical properties comparable) |
| Taper performance testing | Demonstrated substantial equivalence through testing. (Implies taper performance comparable) |
| Bacterial endotoxin testing (as specified in ANSVAAMI ST72:2011) | Meets the requirements of bacterial endotoxin testing. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The "tests" mentioned are non-clinical, likely involving a specific number of device units or components, but this number is not provided.
- Data Provenance: Not explicitly stated but inferred to be internal laboratory testing results conducted by DePuy Ireland UC or its affiliates. The tests are "non-clinical" and do not involve human subjects or retrospective/prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable/provided as the study is a non-clinical, in-vitro (e.g., mechanical, wear) testing study comparing device characteristics to established standards and predicate devices. There is no "ground truth" established by human experts in the way clinical studies would for diagnostic performance.
4. Adjudication method for the test set:
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies with human assessors to resolve discrepancies in diagnoses or assessments. For non-clinical, objective performance tests, the results are typically quantitative and directly measured against predefined criteria.
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:
This information is not applicable. This device is a hip implant, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a hip implant, not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" would be the established scientific and engineering standards (e.g., ISO 21535:2007, ASTM F1820, ANSVAAMI ST72:2011) and the performance characteristics of the legally marketed predicate devices (Stryker Modular Dual Mobility Liner (K103233) and BI-MENTUM Dual Mobility System (K181744)). The tests aim to show that the subject device performs similarly or meets the same safety and performance requirements as these benchmarks.
8. The sample size for the training set:
This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable. As per point 8, there is no training set for this type of device submission.
§ 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.