(28 days)
The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- · Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of a previously failed hip arthroplasty.
- Patients who require a total hip replacement.
The Total Joint Orthopedics Klassic HD® Hooded Acetabular Insert with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly are permanently implanted devices for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The subject inserts are fully compatible for use with the previously cleared Klassic HD® Hip System and are manufactured from UHMWPE crosslinked by gamma irradiation and infused with vitamin E. The subject inserts are sterilized by ethylene oxide gas and intended for single-use only.
This document is a 510(k) premarket notification for a medical device, a hip implant. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing details of a study on device performance that would typically include acceptance criteria and specific performance metrics like those for an AI/ML diagnostic tool. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this text.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document states that "The information summarized in the Design Control Activities Summary demonstrates that the Klassic HD® Hooded Acetabular Inserts with E-Link® Poly and Klassic HD® Low Profile Acetabular Insert with E-Link® Poly meet the pre-determined acceptance criteria for the verification activities." It also lists the types of tests performed.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Lever out strength | Pre-determined | Met acceptance criteria |
| Push Out Strength | Pre-determined | Met acceptance criteria |
| Torque Disassembly Strength | Pre-determined | Met acceptance criteria |
| Impingement | Pre-determined | Met acceptance criteria |
| Wear | Pre-determined | Met acceptance criteria |
| LAL testing | Requirements | In compliance |
Note: The specific numerical values for the acceptance criteria and the device's performance are not provided in this summary. The document only confirms that the "pre-determined acceptance criteria" were met.
The remaining questions (2-9) are largely not applicable or cannot be answered from the provided text, as this is a regulatory submission for a physical orthopedic implant, not a software or AI/ML-based diagnostic device. The document describes mechanical performance testing and equivalency to a predicate device, not a "study" in the sense of clinical trials or AI model validation.
Here's why and what limited information could be inferred:
- 2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical implants, not a "test set" of data. The document does not specify the number of implants tested in each category.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance tests is established by engineering standards and measurements, not expert radiologists or similar medical professionals.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is irrelevant for mechanical testing of an implant.
- 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 for AI/ML diagnostic tools, not an orthopedic implant.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML diagnostic tools, not an orthopedic implant.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical tests, the ground truth would be physical measurements and established engineering standards and methodologies. The document does not elaborate further.
- 8. The sample size for the training set: Not applicable. This is for AI/ML models. For a physical device, "training" would refer to design iterations and early testing.
- 9. How the ground truth for the training set was established: Not applicable for AI/ML sense. For device development, "ground truth" during design would involve engineering principles, materials science, and testing against industry standards.
§ 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.