(268 days)
The Klassic HD " Extended Offset Femoral Head, for use within the Klassic HD" Hip System, is intended for prosthetic replacement without bone cement 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 Klassic" HD Extended Offset Femoral Head is a modular component to be used within the Klassic HD™ Hip System (K100445). The Klassic HD™ Extended Offset Femoral Head is t used within the System as an optional prosthesis to the Klassic HD™ Femoral Head, a modular femoral head used within the Klassic HD™ Hip System. The Klassic HD™ Extended Offset Femoral Head features an offset bore and is composed of cobalt chromium and available in 32mm or 36mm diameters and available in -3.5mm, neutral, +3.5mm and +7mm head lengths. The Klassic HD " Extended Offset Femoral Head is to be used within the hip joint replacement system as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing leg length and offset.
This 510(k) premarket notification describes a medical device, specifically a femoral head for hip replacement surgery, and focuses on demonstrating its substantial equivalence to previously approved devices rather than proving its performance against specific acceptance criteria through a traditional clinical study.
Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable in this context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a device demonstrating substantial equivalence, there are no specific "acceptance criteria" for clinical performance in the way a new drug or novel AI algorithm would have. Instead, the "acceptance criteria" are implied by the performance of the legally marketed predicate devices, and the "reported device performance" refers to bench testing that shows the new device performs similarly or meets established engineering standards.
| Acceptance Criteria (Implied by Predicate Devices & Engineering Standards) | Reported Device Performance (Klassic HD™ Extended Offset Femoral Head) |
|---|---|
| Mechanical Strength & Durability: Maintain structural integrity under physiological loads (e.g., fatigue resistance). | Successfully passed Fatigue Testing to demonstrate consistent performance during intended use. |
| Modular Connection Integrity: Secure and stable connection between components (e.g., ability to resist unintended disassembly). | Successfully passed Disassembly Testing to demonstrate consistent performance during intended use. |
| Biomechanical Functionality: Allow for appropriate range of motion. | Performance data for Range of Motion was provided to support substantial equivalence. |
| Material Compatibility: Biologically safe materials. | Passed Biocompatibility testing. |
| Sterility: Achieve and maintain sterility. | Passed Sterilization and cleaning validations. |
| Packaging & Stability: Maintain device integrity and sterility over time. | Passed Packaging and shelf life testing. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of clinical cases or patient data. The "test set" here refers to physical devices or component assemblies used in bench testing. The document does not provide the number of units tested for each non-clinical test (e.g., how many femoral heads were subjected to fatigue testing).
- Data Provenance: Not applicable in the context of clinical data. The data provenance is from laboratory bench testing conducted by the manufacturer, Total Joint Orthopedics, Inc.
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 a physical device's mechanical properties is established through engineering specifications and industry standards, not by expert consensus on clinical cases. The tests are designed to measure physical properties.
4. Adjudication method for the test set
- Not applicable. The "adjudication method" is not relevant for bench testing of physical device properties. The tests have predefined pass/fail criteria based on engineering standards.
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 physical hip implant component, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical implant; there is no algorithm involved.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on engineering specifications, international standards (e.g., ISO, ASTM for medical devices), and the proven performance characteristics of legally marketed predicate devices. The non-clinical tests (fatigue, disassembly, range of motion, biocompatibility, sterilization, packaging) are designed to ensure the device meets these established physical and biological performance benchmarks.
8. The sample size for the training set
- Not applicable. There is no AI algorithm or "training set" of data for this physical medical device. Device design and manufacturing processes are informed by engineering principles and safety standards, not machine learning training.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set."
Summary of the Study:
The study conducted for the Klassic HD™ Extended Offset Femoral Head was a series of non-clinical, bench-top tests. These tests were designed to demonstrate that the device's technological characteristics (material, design, function) are substantially equivalent to existing, legally marketed predicate devices. The objective was to show that the new device performs as intended and does not raise new questions of safety or effectiveness.
The specific tests performed included:
- Fatigue Testing
- Disassembly Testing
- Range of Motion
- Biocompatibility
- Sterilization and cleaning validations
- Packaging and shelf life
The study demonstrated that "the materials chosen, the manufacturing processes, and design of the Klassic HD™ Extended Offset Femoral Head meet the established specifications necessary for consistent performance during its intended use." This conclusion, supported by the collective results of the non-clinical testing, was sufficient for the FDA to determine substantial equivalence and clear the device for marketing.
§ 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.