(49 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 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.
This document, K032726, is a 510(k) premarket notification for a medical device called the "Zimmer® M/L Taper Hip Prosthesis." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving safety and effectiveness through extensive clinical trials with acceptance criteria for device performance as would be seen for novel devices or those undergoing a PMA.
Therefore, the requested information about acceptance criteria, detailed study designs, sample sizes, expert involvement, and ground truth establishment, does not directly apply in the same way as it would for a study proving the efficacy and safety of a novel device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
There are no explicit quantifiable acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) reported for this device in this 510(k) summary, as it is a hip prosthesis, not a diagnostic AI device.
Instead, the "performance" demonstrated is substantial equivalence to predicate devices based on non-clinical testing.
- Acceptance Criteria (Implied for 510(k) substantial equivalence): The device must demonstrate similar material properties, mechanical performance (e.g., fatigue strength, fixation), and intended use as the predicate devices. It must not raise new questions of safety or effectiveness.
- Reported Device Performance:
- "Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis met performance requirements and is as safe and effective as the predicate devices."
2. Sample Size for Test Set and Data Provenance:
- Test Set Description: The document refers to "Non-clinical testing." This typically involves laboratory testing of physical device samples (e.g., in vitro mechanical tests, material characterization). It's not a "test set" in the context of clinical data for AI algorithms.
- Sample Size: The document does not specify the number of hip prostheses samples tested.
- Data Provenance: Not applicable in the context of clinical data. It would be lab-generated data.
- Retrospective/Prospective: Not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. This pertains to establishing ground truth for diagnostic or prognostic algorithms, not for the mechanical testing of a hip implant. The "ground truth" here would be established by validated engineering testing standards and protocols.
4. Adjudication Method:
- Not applicable. Adjudication relates to expert consensus on clinical data for algorithms.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, this was not done. MRMC studies are specific to evaluating diagnostic imaging systems or AI algorithms with human readers. This device is a hip prosthesis.
6. Standalone (Algorithm Only) Performance:
- No, this was not done. This device is a physical hip prosthesis, not an algorithm.
7. Type of Ground Truth Used:
- Engineering Standards and Benchmarking against Predicate Devices: The "ground truth" for this device's performance would be established through adherence to recognized international and national standards for orthopedic implants (e.g., ISO, ASTM standards for fatigue, material properties) and comparison to the known performance characteristics of the predicate devices. This is implied by "Non-clinical testing."
8. Sample Size for Training Set:
- Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device.
9. How Ground Truth for Training Set Was Established:
- Not applicable. As above, there is no "training set" in this context.
In summary, for K032726, the "study" demonstrating the device meets "acceptance criteria" is a set of non-clinical (laboratory/mechanical) tests to show substantial equivalence to already cleared predicate devices. The 510(k) pathway does not typically require or present the kind of detailed clinical efficacy and safety data, expert reviews, and ground truth establishment that would be seen for novel diagnostic algorithms or drugs.
§ 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.