(97 days)
The Klassic HD™ Hip System is intended for prosthetic replacement in treatment of the following:
· Patient conditions of non-inflammatory degenerative joint disease (NID)D): 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® Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum. leg length. offset and version. The purpose of this 510(k) is to add Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems to the Klassic HD® Hip System. The modified stems can be mated with the previously cleared metal (CoCrMo) or ceramic femoral heads and UHMWPE acetabular components of the Klassic HD® Hip System.
The provided document is a 510(k) premarket notification for a medical device called the "Klassic HD™ Hip System." It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, the document does not contain information regarding detailed acceptance criteria, specific study designs, sample sizes for test or training sets, expert qualifications, or adjudication methods that would typically be found in a clinical study report or a more comprehensive technical document.
Therefore, I cannot provide the requested information for acceptance criteria and the study proving device performance in the format you specified.
The closest information available is related to engineering analyses and testing to establish substantial equivalence to predicate devices. This is not a study proving clinical acceptance criteria in the way you've described for AI models with ground truth and human reader comparisons.
Here's what can be extracted from the document regarding the engineering testing used to show substantial equivalence:
Acceptance Criteria and Device Performance (Based on Engineering Testing for Substantial Equivalence):
The document states that "The test results and analyses demonstrated that the modified stems are substantially equivalent to the predicate components." While specific numerical acceptance criteria are not explicitly detailed, the implied acceptance criterion for these engineering tests is successful completion without failure, indicating performance comparable to or better than the predicate devices.
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Range of Motion: Comparable to predicate hip systems. | Tested and demonstrated substantial equivalence to predicate components. |
| Worst Case Fatigue: Withstand worst-case fatigue loading. | Tested and demonstrated substantial equivalence to predicate components. |
| Disassembly Properties: Properties comparable to predicate hip systems. | Engineering analyses conducted and demonstrated substantial equivalence to predicate components. |
| Porous Coating Properties: Properties comparable to predicate hip systems. | Engineering analyses conducted and demonstrated substantial equivalence to predicate components. |
Missing Information (Not available in the provided document):
- Sample size used for the test set and data provenance: Not applicable in the context of the mentioned engineering tests. These are likely cadaveric or mechanical testing, not a dataset of patient cases.
- Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. The "ground truth" for engineering tests is typically based on material science, biomechanical principles, and established testing standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: No, this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the engineering tests, the "ground truth" would be the successful completion of the tests according to established biomechanical and material standards for hip implants, demonstrating equivalence to already approved predicate devices. It's not a clinical "ground truth" as you'd find for a diagnostic AI.
- The sample size for the training set: Not applicable (this is not an AI device).
- How the ground truth for the training set was established: Not applicable (this is not an AI device).
Summary of available information:
The document describes an engineering evaluation for a hip implant system to demonstrate substantial equivalence to previously cleared predicate devices. The evaluation included Range of Motion testing, worst-case fatigue testing, and engineering analyses of disassembly properties and porous coating properties. The results of these tests and analyses were deemed sufficient to show substantial equivalence. This is a common approach for 510(k) clearances of mechanical devices, where the focus is often on material properties, design specifications, and biomechanical performance rather than clinical trials with patient outcomes or AI performance metrics.
§ 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.