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The NexGen Trabecular Metal femoral and tibial 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 femoral and tibial augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.

The NexGen Trabecular Metal Augments are designed for attachment to selected commercially available NexGen tibial base plates and femoral components using either bolts, cement or a combination of both (depending on the augment). In the USA, the augment must be cemented to the bone surface; outside the USA the use of cement along the bone surface is optional. The augments are manufactured to interface with selected femoral and tibial NexGen components. The femoral augments come in four different sizes (sizes C, D, E and F) that correspond with the sizes of the femoral components. Each NexGen LCCK or RHK femoral component has two corresponding augments, one for the distal segment and one for the posterior segment of the femoral component. The thickness options of the augments vary from 5mm to 20mm. The tibial augments are sized to match the tibial base plates. There are 6 sizes (sizes 2 through 7) of tibial augments to match the six sizes of the augmentable NexGen tibial base plates. Within each size, there are different thickness options (from 5mm - 20mm for sizes 2 and 7; from 5mm - 20mm for sizes 3, 4, 5, 6, and 10mm thick for full blocks for sizes 1-7), right-left configurations and the thicker sizes are tapered to mimic proximal tibial anatomy. The NexGen RHK full block tibial augments are 10mm thick and are offered in sizes 1 through 6.

The provided 510(k) summary does not contain the kind of information typically associated with establishing acceptance criteria and proving device performance for a diagnostic device via a study with a test set, ground truth, or expert review.

Instead, this document is for a medical implant (knee augments) and focuses on substantial equivalence to previously approved predicate devices, rather than a performance study.

Here's an breakdown of why the requested information is absent and what the document does state:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria for Performance Study: Not applicable to this type of submission. The document states: "Testing of the subject devices were not performed."
• Reported Device Performance: Instead of performance metrics from a study, the document relies on prior testing of the material (Trabecular Metal) and the geometric similarity to already cleared NexGen Knee System augments. The "performance" here is an assertion of equivalence based on material and design.

2. Sample Size for Test Set and Data Provenance

• Not Applicable: No clinical or laboratory test set was used for this 510(k) submission as "Testing of the subject devices were not performed."

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: There was no ground truth establishment in the context of a performance study, as no such study was conducted for this submission.

4. Adjudication Method for the Test Set

• Not Applicable: No test set, no adjudication method.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• Not Applicable: This is an implant, not a diagnostic device involving human readers. No MRMC study was performed or is relevant.

6. Standalone (Algorithm Only) Performance

• Not Applicable: This is an implant, not an algorithm or AI device.

7. Type of Ground Truth Used

• Not Applicable: No ground truth in the context of a performance study. The "truth" for this submission is that the device is substantially equivalent to existing, cleared devices based on its material and design.

8. Sample Size for the Training Set

• Not Applicable: No training set was used, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

• Not Applicable: No training set or ground truth in that context.

Summary of Device Acceptance (as per this 510(k) document):

The device (NexGen® Complete Knee Solution - Trabecular Metal Augments) was "accepted" and cleared by the FDA based on substantial equivalence to predicate devices. This means the FDA determined that the new device is as safe and effective as a legally marketed device (predicate device) that is not subject to premarket approval (PMA).

Specifically, the document states:

• "Testing of the subject devices were not performed."
• "Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence."
• "Additionally, these augments have the same geometry as cleared NexGen Knee System augments."

The FDA's letter explicitly confirms: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "acceptance criteria" here implicitly revolve around demonstrating that the device shares the same fundamental scientific technology, indications for use, and performance characteristics (as defined by material and design similarity) with the following predicate devices:

The "study that proves the device meets the acceptance criteria" in this case is the comparison to predicate devices detailing the material (Trabecular Metal, previously tested/cleared) and the geometry (same as cleared NexGen Knee System augments).

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