(151 days)
Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.
The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with:
- . Rheumatoid arthritis.
- Post-traumatic arthritis. .
- Degenerative arthritis. .
This device is intended for cemented use only.
The Zimmer Trabecular Metal Total Ankle is an implant and instrument system designed to preserve motion in arthritic ankle patients. It is a semiconstrained device intended for the replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury.
The Zimmer Trabecular Metal Total Ankle is a bicondylar system. The articular surfaces of the implants are designed to mimic the truncated cone shape of the natural ankle joint, thereby reproducing normal ankle joint kinematics.
The talar component is machined from a wrought Cobalt Chrome Molybdenum (CoCrMo) Alloy (Zimaloy®) diffusion bonded to a Trabecular Metal™ surface via an interlayer of commercially pure Titanium.
The tibial component consists of a Tivanium® (Ti-6Al-4V) tibial baseplate diffusion bonded to a Trabecular Metal™ surface and a modular insert of Prolong® Highly Crosslinked Polyethylene (HXLPE).
The provided document describes the 510(k) premarket notification for the Zimmer® Trabecular Metal™ Total Ankle. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing rather than presenting a study where a device's performance is measured against acceptance criteria in a clinical setting.
Therefore, the following information cannot be extracted or is not applicable based on the provided text:
- A table of acceptance criteria and the reported device performance: The document lists types of non-clinical tests performed but does not provide specific acceptance criteria values or the quantitative results of these tests. It only states that the device "met performance requirements."
- Sample size used for the test set and the data provenance: No clinical test set data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set data is provided.
- Adjudication method: No clinical test set data is provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document explicitly states, "Clinical data and conclusions were not needed for this device."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
- The type of ground truth used: No clinical test set data is provided.
- The sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable as there is no mention of a training set for an algorithm.
Summary of Device Acceptance Criteria and Study (Based on Non-Clinical Performance):
The Zimmer® Trabecular Metal™ Total Ankle device achieved acceptance through demonstration of substantial equivalence to predicate devices (Alvine Total Ankle Prosthesis (Agility) and Salto Talaris Total Ankle Prosthesis) based on non-clinical performance testing. The study performed was a series of engineering and material tests, not a clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance:
As mentioned, specific quantitative acceptance criteria and detailed performance results are not provided in this summary. The document generally states that the device "met performance requirements."
| Acceptance Criteria Category (General) | Reported Device Performance |
|---|---|
| Material & Design Safety/Efficacy | Met performance requirements |
| Per FDA Guidance Document (Orthopedic Implants with Modified Metallic Surfaces) | Met performance requirements |
| Per ASTM F2665 (Total Ankle Replacement Prosthesis Standard) | Met performance requirements |
| MRI Compatibility | Met performance requirements |
| Range of Motion | Met performance requirements |
| Fatigue Analysis | Met performance requirements |
| Wear Evaluation | Met performance requirements |
| Contact Area / Contact Stress Evaluation | Met performance requirements |
| Constraint Evaluation | Met performance requirements |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the non-clinical tests. These tests typically involve a relevant number of components or systems as per the specific ASTM or internal test protocols.
- Data Provenance: The tests were conducted internally or by contracted labs by Zimmer, Inc., a US-based company, as part of their 510(k) submission. The data is non-clinical/engineering.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome. For non-clinical engineering tests, the "ground truth" is defined by the test standards and methodologies themselves, executed by qualified engineers and technicians. No mention of external experts establishing a ground truth for these engineering tests is provided.
4. Adjudication method for the test set:
Not applicable for non-clinical engineering tests. Results are typically analyzed and deemed to meet or not meet specifications by the testing personnel and verified by quality/regulatory teams.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
No. The document explicitly states: "Clinical data and conclusions were not needed for this device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical prosthetic device.
7. The type of ground truth used:
Not applicable in the clinical sense. For the non-clinical tests, the "ground truth" was established by recognized industry standards (e.g., ASTM F2665) and FDA guidance documents for orthopedic implant testing. Meeting these standards confirms the device's physical and mechanical properties.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/algorithm device that requires a training set.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.