(311 days)
The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.
The ZMR Hip System is a modular hip system for cementless revision hip arthroplasty. The stem assembly is manufactured from Tivanium® Ti-6Al-4V Alloy and utilizes modular junctions between the head and neck, and the metaphyseal body and diaphyseal stem segments. A variety of body and stem components are provided to achieve fixation and restore joint kinematics. The femoral stem assembly contains a 12/14 taper designed to mate with the corresponding femoral head component.
The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semiconstrained acetabular systems and acetabular augments, restrictors, and cages. Both the indications for use provided below and the indications for use provided with those devices combined with the ZMR Hip System must be followed.
The provided document describes a 510(k) premarket notification for the ZMR® Hip System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than strictly meeting acceptance criteria through a study with performance metrics in the way a new, novel AI device might.
Therefore, the requested information components related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable in their typical sense to this device and its submission. The document explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that the regulatory pathway chosen did not require a study demonstrating quantitative performance against predefined acceptance criteria from clinical data.
However, I can extract and interpret the available information regarding the "study" (non-clinical performance testing) and substantial equivalence.
Summary of Acceptance Criteria and Device Performance (Interpreted for a Predicate-Based Submission)
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Non-Clinical) |
|---|---|
| Intended Use Equivalence: The device has the same intended clinical purpose. | The ZMR Hip System is indicated for cementless revision hip arthroplasty, similar to predicate devices. |
| Materials Equivalence: The device uses similar or identical materials. | Manufactured from Tivanium® Ti-6Al-4V Alloy, comparable to predicate devices. |
| Sterility Equivalence: The device maintains similar sterility characteristics. | Similar sterility characteristics to predicate devices. |
| Performance Characteristics Equivalence (Non-Clinical): The device demonstrates comparable mechanical and functional performance to predicate devices. | Fretting Fatigue Testing: Results showed the device is safe and effective and substantially equivalent. |
| Range of Motion Analyses: Results showed the device is safe and effective and substantially equivalent. | |
| Substantial Equivalence to Predicate(s): The totality of evidence demonstrates the device is as safe and effective as a legally marketed predicate device. | The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. FDA concurred with this determination. |
Explanation of Applicability for Other Requested Information:
-
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No human-based test set in the traditional sense was used. The "performance data" was non-clinical lab testing.
-
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. No human-based clinical test set requiring expert ground truth was performed for this 510(k) submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human-based clinical test set requiring adjudication was performed.
-
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 a hip implant, not an AI diagnostic device. No MRMC study was performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hip implant, not an AI algorithm. Its performance is evaluated through material properties and mechanical testing, not algorithm-only performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For non-clinical testing: The "ground truth" (or reference standard) would be established by engineering standards, material specifications, and validated mechanical testing protocols, comparing the ZMR Hip System's performance to those of the predicate devices under controlled lab conditions.
-
The sample size for the training set:
- Not Applicable. No training set in the context of machine learning or AI was used.
-
How the ground truth for the training set was established:
- Not Applicable. No training set for AI was used.
Conclusion based on the document:
The ZMR® Hip System received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices. This was primarily achieved through non-clinical (lab) performance testing, specifically Fretting Fatigue Testing and Range of Motion Analyses. These tests demonstrated that the device is "safe and effective and substantially equivalent" to the predicate devices in terms of intended use, materials, sterility, and performance characteristics. The document explicitly states that "Clinical data and conclusions were not needed for this device," meaning no human clinical study was required to establish performance against specific acceptance criteria in a clinical setting.
§ 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.