(197 days)
The NexGen Trabecular Metal Tibial Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Tibial Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.
The NexGen Trabecular Metal Tibial Cone Augments are designed to be used in conjunction with Zimmer Inc.'s Legacy@ Stemmed Tibial Bases (LCCK) and Rotating Hinge Knee (RHK) tibial components. The subject devices are used to address proximal tibial cavitary defects encountered when implanting either of these two systems. The augments are manufactured from Trabecular Metal and have tapered posterior, medial and lateral walls. The periphery of the inferior surface is smaller than that of the superior surface. The augments are hollow such that they are to be filled with bone cement, and allow for placement of the stem and/or keel of the associated tibial base plate. Fixation of the augment to the tibial baseplate is accomplished by using bone cement. The inferior surface of the LCCK and RHK tibial baseplates must be cemented to bone. The Trabecular Metal Tibial Cone Augments are for cemented use along the bone in the USA, and for cementless or cemented use along the bone outside the USA.
This submission describes a medical device, the NexGen Trabecular Metal Tibial Cone Augments, and seeks to demonstrate its substantial equivalence to previously marketed predicate devices. This is a premarket notification for a medical device (510(k)), not a study to prove performance against specific acceptance criteria. Therefore, most of the requested information about a clinical study is not applicable to this document.
Here's a breakdown of the relevant information provided and how it addresses your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of acceptance criteria and reported device performance for the NexGen Trabecular Metal Tibial Cone Augments. The submission aims to establish substantial equivalence to predicate devices rather than proving performance against specific, pre-defined acceptance criteria through a new study.
The closest statement to "reported performance" is:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The submission is for substantial equivalence, not performance against pre-defined criteria. | "Testing of the subject devices were not performed. Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence. An engineering analysis was provided to support this." |
| Conclusion: "The NexGen Trabecular Metal Tibial Cone Augments are substantially equivalent to the predicate devices identified in this premarket notification." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No new test set or clinical study was performed for this 510(k) submission on the subject device. The determination of substantial equivalence was based on an engineering analysis and previous testing of the material (Trabecular Metal) and other Trabecular Metal devices, not a specific clinical test set for these augments.
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. No clinical test set with ground truth established by experts was used for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set was used.
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 device is a passive implant (tibial cone augment), not an AI-powered diagnostic tool. Therefore, an MRMC study or assessment of AI assistance for human readers is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new ground truth was established for the subject device. The basis for the submission is demonstrating substantial equivalence through an engineering analysis and previously conducted testing on the material itself.
8. The sample size for the training set:
Not applicable. There was no "training set" in the context of an algorithm or AI model development. The basis of the submission is the material properties of Trabecular Metal and its prior use in other devices.
9. How the ground truth for the training set was established:
Not applicable. As there was no training set, there was no ground truth for a training set to be established.
In summary: This 510(k) submission for the NexGen Trabecular Metal Tibial Cone Augments relies on demonstrating substantial equivalence to existing predicate devices. This typically involves comparing device design, materials, manufacturing processes, and intended use. The submission states that "Testing of the subject devices were not performed" and instead, "Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence. An engineering analysis was provided to support this." This means the regulatory decision was made based on a comparison to known, safe, and effective devices already on the market, rather than a new clinical study with acceptance criteria and measured performance of this specific augment.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.