(28 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 femoral stem is for cementless use only.
The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is a modular, wedge-shaped stem that is coated with Ti-6A1-4V titanium alloy plasma spray.
The provided text describes a 510(k) premarket notification for a hip prosthesis, not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable or mentioned in this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance as these are not relevant to this type of device submission based on the provided information.
However, I can extract the information that is relevant to the "acceptance criteria" and "study" for this particular device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meeting performance requirements for hip prostheses | "Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements..." |
| Safety and effectiveness comparable to predicate device | "...and is as safe and effective as its predicate." |
| Same intended use as predicate device | "The subject device also has the same intended use... as the predicate device." |
| Same fixation methods as predicate device | "The subject device also has... the same... fixation methods as the predicate device." |
| Packaged, manufactured, and sterilized using same materials/processes as predicate | "The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is packaged, manufactured, and sterilized using the same materials and processes as its predicate." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission relies on non-clinical testing of the device itself, not patient data in the context of an AI/ML test set.
- Data Provenance: Not applicable. The "data" refers to the results of non-clinical device testing, not patient data.
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 as typically defined for AI/ML algorithms is not relevant here. Device performance is assessed through engineering and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established by recognized engineering standards and biocompatibility requirements for hip prostheses.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.