(66 days)
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
The Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating is a modular, titanium alloy femoral stem designed to replace the proximal human femur in total hip arthroplasty. It is flat, collarless, and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge-shaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region. Calcicoat® Ceramic Coating (hydroxyapatite tricalcium phosphate [HA/TCP]) has been added to the porous coating to aid bony ingrowth.
This document describes a 510(k) premarket notification for a medical device, the Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with detailed acceptance criteria and performance metrics against human readers or pathology.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, expert adjudication, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets as would be found in AI/ML device submissions are not applicable here.
The crucial information provided relates to the non-clinical performance and comparison to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Device materials and processes: Same as predicate device. | The M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating is manufactured, packaged, and sterilized using the same materials and processes as the predicate devices. |
| Intended use and fixation methods: Same as predicate device. | The subject device also has the same intended use and fixation methods as the predicate devices. |
| Performance requirements: Meet performance requirements and be as safe and effective as the predicate device. | Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating met performance requirements and is as safe and effective as the predicate device. |
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 for this type of submission. This submission relies on non-clinical testing and comparison to a predicate device, not a human reader performance study or a clinical test set with a specific sample size of cases in the way an AI/ML device would. The "test set" here refers to the physical samples of the device undergoing non-clinical tests. The document does not specify the number of hip prostheses tested. The provenance would be the manufacturing site (Warsaw, IN, USA).
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. "Ground truth" in the context of this device does not pertain to expert review of images or data, but rather to the physical, chemical, and mechanical properties of the device as assessed through non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for clinical trials or expert consensus in data labeling, which is not part of this 510(k) submission.
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
- No. This is a medical device (hip prosthesis), not an AI/ML diagnostic or assistive tool. Therefore, MRMC comparative effectiveness studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established through non-clinical testing (e.g., mechanical strength, wear resistance, biocompatibility, coating adhesion, etc.) according to recognized standards and engineering principles, demonstrating that it meets performance requirements and is equivalent to the predicate device.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set" in the context of machine learning.
§ 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.