(90 days)
Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty.
Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty. These devices are of monoblock construct and are manufactured from Trabecular Metal (Hedrocel Porous Tantalum) and direct compression molded ultrahigh molecular weight polyethylene. The Trabecular Metal Tibial and Patellar Components for the NexGen Knee System articulate with the appropriate Zimmer CR and LPS Femoral Components.
The provided text describes a 510(k) summary for medical devices, specifically prosthetic knee components. This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through a study with acceptance criteria in the way envisioned by the prompt.
Therefore, many of the requested categories (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, training set size) are not applicable to this document as it does not detail a study conducted to establish performance metrics against predefined acceptance criteria for a new, unique device.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance Study (Not Applicable in the traditional sense for this 510(k))
This 510(k) relies on demonstrating substantial equivalence to existing predicate devices. It does not present a new clinical or performance study with acceptance criteria and measured performance in the typical sense of a novel device. The core argument is that the subject device is essentially the same as the predicate and will therefore perform similarly.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Stated | Not Stated |
| (No explicit numerical or qualitative acceptance criteria for clinical performance are presented as this is a substantial equivalence submission, not a de novo device performance study.) | (No specific performance metrics are reported against acceptance criteria. The document states "the device will perform as intended" based on testing per applicable standards, but doesn't quantify this performance against specific thresholds.) |
2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a clinical "test set" for performance evaluation in the context of a new device study. The testing refers to engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment by experts is not described, as this is not a study assessing diagnostic accuracy or similar performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is mentioned, as no clinical test set requiring expert review is described.
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 knee implant, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not a software algorithm; it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Ground truth is not a concept pertinent to this type of substantial equivalence submission for a physical implant. The "truth" in this context is that the device adheres to established material and design standards and is functionally equivalent to already marketed devices.
8. The sample size for the training set:
Not applicable. There is no machine learning or AI component requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no machine learning or AI component, and thus no training set or its associated ground truth establishment.
Summary of Relevant Information from the Document:
- Device Name: Trabecular Metal Tibial and Patellar Components for the NexGen Knee System
- Intended Use: For severe degeneration, trauma, or other pathology of the knee joint indicating cemented or cementless total knee arthroplasty.
- Basis for Equivalence:
- The subject device is described as "identical" to the predicate device in materials, size options, technological design, and geometry features.
- The primary difference is the addition of an "uncemented use" option to the indications for use.
- Performance Data: "The NexGen TMT Tibia, LPS Tibia and Primary Porous Patella were all tested per applicable standards and the results demonstrated that the device will perform as intended." This refers to engineering/bench testing according to standards, not a clinical trial with specific performance criteria.
- Regulatory Conclusion: FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.