(25 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.
This 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 commercially pure titanium alloy plasma spray.
The modular neck options allow for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of patient anatomies.
The provided document describes a 510(k) premarket notification for the "Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System." This is a medical device submission for a hip prosthesis, and as such, the acceptance criteria and study data provided are related to the physical and mechanical performance of the device, not diagnostic or AI performance.
Therefore, many of the typical questions for AI/diagnostic devices regarding sample size, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of submission.
Here's the breakdown of the information that is applicable and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Requirements for Hip Prosthesis (Implied from substantial equivalence to predicate device) | Met performance requirements |
| Safety and Effectiveness (Implied from substantial equivalence to predicate device) | As safe and effective as its predicate |
Explanation: The document states that "Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements and is as safe and effective as its predicate." The specific numerical or qualitative acceptance criteria for "performance requirements" are not detailed in this summary document. These would typically be established through recognized standards (e.g., ISO for implant materials and mechanical testing) and internal company specifications for the similar predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. For non-clinical testing of a hip prosthesis, "samples" would refer to the physical devices or components subjected to laboratory tests (e.g., fatigue testing, wear testing).
- Data Provenance: Not specified, but inherently "non-clinical" (i.e., laboratory testing). The country of origin for the data is Zimmer, Inc. (Warsaw, IN, USA). The studies are prospective in the sense that they are conducted specifically for this submission, but they are not clinical studies on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. For mechanical testing of medical devices like a hip prosthesis, "ground truth" is established by physical measurements, engineering principles, and adherence to recognized standards, rather than expert human interpretation.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review contexts, typically in diagnostic studies. This is a non-clinical device performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is for evaluating the impact of a diagnostic tool (often AI) on human reader performance, which is not relevant for a hip prosthesis itself. The comparison here is between the new device and its predicate device based on manufacturing, materials, and intended use, and non-clinical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This question pertains to AI algorithms. The Zimmer M/L Taper Hip Prosthesis with Kinectiv™ Technology System is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
- Engineering and Materials Standards / Predicate Device Performance: The "ground truth" for non-clinical testing of this device would be established by conforming to relevant industry standards (e.g., ISO standards for orthopedic implants), internal Zimmer specifications, and demonstrating equivalence to the performance of the legally marketed predicate device (Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology).
8. The Sample Size for the Training Set
- Not applicable. This question refers to machine learning models. This document describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This question refers to machine learning models.
§ 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.