(247 days)
Total hip replacement for patients with: severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for patients with: 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 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 femoral stem is for cementless use only.
The purpose of this submission is to update the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology Instructions for Use to include MR Conditional labeling within the precaution section. The device package label will also be updated to include the MR Conditional symbol. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization. The subject devices are intended for use in hip arthroplasty.
The provided text describes a 510(k) premarket notification for the "Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling." This submission is to update the Instructions for Use to include MR Conditional labeling, and therefore, does not involve studies proving clinical performance of the hip prosthesis itself. Instead, the studies focus on the MR safety of the device.
Here's an analysis of the provided information concerning the acceptance criteria and study proving MR safety:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (MR Safety) | Reported Device Performance |
|---|---|
| RF-induced heating: Device should not heat excessively during MRI. (Referenced standard: ASTM F2182-11a) | The submission indicates that Zimmer performed non-clinical MRI studies for RF-induced heating, aligning with ASTM F2182-11a, to determine the implants are "MR Conditional." While specific quantitative results are not provided in this summary, the statement "Non-clinical tests... establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment" implies that the heating criteria were met under specified MR conditions for MR Conditional labeling. |
| Image Artifact: Device should not cause significant image distortion or artifacts in MRI. (Referenced standard: ASTM F2119-07) | Zimmer performed non-clinical MRI studies for image artifact, aligning with ASTM F2119-07, to determine the implants are "MR Conditional." The summary states the tests establish "conditional safety and compatibility," suggesting the image artifact criteria were met under specified MR conditions. |
| Magnetic Displacement: Device should not experience undue displacement due to magnetic forces in MRI. (Referenced standard: ASTM F2052-14) | Zimmer performed non-clinical MRI studies for magnetic displacement, aligning with ASTM F2052-14, to determine the implants are "MR Conditional." The summary indicates these tests contribute to establishing "conditional safety and compatibility," implying the magnetic displacement criteria were met. |
| Overall MR Safety Status: Device must be designated as "MR Conditional" in accordance with ASTM F2503-13. | The submission's explicit purpose is "to update the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology Instructions for Use to include MR Conditional labeling within the precaution section." The summary concludes that "Non-clinical tests... establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment." This confirms the device met the criteria for MR Conditional labeling. |
2. Sample Size Used for the Test Set and Data Provenance
The text does not specify the sample size used for the non-clinical MR safety tests. The data provenance is not explicitly stated in terms of country of origin, but it is clear these were non-clinical (in-vitro/benchtop) tests, not studies on human subjects, so concepts like "retrospective or prospective" do not apply.
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. The "ground truth" for MR safety in this context is established by adherence to recognized ASTM standards (ASTM F2503-13, ASTM F2182-11a, ASTM F2119-07, ASTM F2052-14) for evaluating physical interactions of the device with an MR environment. This is a technical assessment rather than an expert clinical consensus.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for interpreting clinical data or images by multiple experts. For non-clinical bench testing, the results are objectively measured and evaluated against the established standard's criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission is for MR labeling, not for demonstrating the clinical effectiveness of the hip prosthesis itself or comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This submission is about the MR safety of a physical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these tests is defined by the acceptance criteria specified in the referenced ASTM standards for evaluating MR safety parameters (RF-induced heating, image artifact, magnetic displacement). These standards provide objective methodologies and pass/fail criteria.
8. The Sample Size for the Training Set
This information is not applicable. There is no AI algorithm being trained in this submission. The tests are physical evaluations of a medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for an AI algorithm. The ground truth for the non-clinical tests is established by the methods and criteria outlined in the relevant ASTM standards for MR safety testing.
§ 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.