Search Results

The Interax® Total Knee System is intended to be used in cemented primary and/or revision total knee arthroplasty procedures in patients who require total knee replacement as a result of non-inflammatory joint disease and all of its variants, inflammatory joint disease, trauma, or failed previous prosthesis. The Interax® system is intended to accommodate the posterior cruciate ligament if it is intact. The collateral ligaments should be intact, or reparable, or there must be adequate capsular support to provide medio-lateral stability. The Interax® Total Knee System is intended to be implanted using bone cement.

The Interax® femoral component and tibial baseplate previously cleared in K973121 are made available with a PMMA plug inserted onto their central stems. The purpose of this plug is to occlude the internal threaded portion of the central stem of the femoral component, and the internal taper surface of the tibial component. The PMMA plug can also be removed to allow the optional use of stem extensions. The current femoral and tibial plugs are fabricated from pellitized PMMA (Simplex P). The new femoral and tibial plugs will be made from a acrylic resin which is supplied by Rohm & Haas.

This 510(k) summary (K980713) is a submission for an alternate material for already cleared devices (Interax® Femoral and Tibial Plugs). The acceptance criteria and supporting study in this document focus on demonstrating that the new material is substantially equivalent to the previously approved material, not a groundbreaking new device or AI algorithm. Therefore, many of the typical questions for AI/algorithm-based devices (like MRMC studies, training set details, or number of experts) are not applicable here.

Here's the relevant information based on the provided text, reinterpreting some questions to fit the context of a material change for an existing device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in this summary. For a material change, "samples" would refer to physical specimens of the new material and/or the plugs fabricated from it, subjected to various tests (e.g., mechanical, biocompatibility). The summary does not detail the number of test specimens.
• Data Provenance: Not specified. It's likely that the testing (e.g., mechanical, chemical, biocompatibility) was performed in a laboratory setting, typically by the manufacturer or a contracted lab. This would be prospective testing of the new material.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable in the context of this 510(k) for a material change. "Ground truth" in this scenario would refer to the validated properties of the new material compared to the predicate material, established through laboratory testing and engineering analysis, not expert medical opinion on pathology or images.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study involving human interpretation or a need for adjudication among experts regarding a test set.

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

• No. This submission is for an alternate material in a medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used

• Engineering/Material Comparison: The "ground truth" implicitly used for this type of submission is the established physical, chemical, and biological properties (e.g., biocompatibility) of the predicate material (pellitized PMMA Simplex P). The study would have aimed to demonstrate that the new acrylic resin from Rohm & Haas possesses equivalent characteristics, typically through:
  • Material Characterization: Chemical composition, molecular weight, purity.
  • Mechanical Testing: Strength, fatigue, wear resistance (if applicable to the plug's function).
  • Biocompatibility Testing: According to ISO 10993 standards.
  • Performance data on the finished product (the plugs) to ensure they function as intended (e.g., fit, retention).

8. The Sample Size for the Training Set

• Not applicable. There is no AI algorithm involved, and thus no training set.

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

• Not applicable. There is no training set for an AI algorithm.

Ask a specific question about this device

The Interax® Total Knee System is intended to be used in cemented primary and/or revision total knee arthroplasty procedures in patients who require total knee replacement as a result of non-inflammatory joint disease and all of its variants, inflammatory joint disease, trauma, or failed previous prosthesis. The Interax® system is intended to accommodate the posterior cruciate ligament if it is intact. The collateral ligaments should be intact, or reparable, or there must be adequate capsular support to provide medio-lateral stability. The Interax® Total Knee System is intended to be implanted using bone cement.

The Interax® Total Knee System consists of a variety of components: Femoral Component, Tibial Baseplate, Tibial Inserts (standard condylar and high conformity condylar, available in two halves), All Polyethylene Patellar Components (resurfacing and inset designs), Femoral Extension Stems, Tibial Extension Stems (cylindrical and cruciform styles), and Tibial Wedges.

The provided text is related to a 510(k) submission for the Interax® Total Knee System, a medical device. This document is a premarket notification for a Class II medical device, indicating that its approval is based on demonstrating substantial equivalence to a predicate device already on the market, rather than new clinical trials demonstrating safety and effectiveness.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way described in the prompt (i.e., with specific performance metrics, sample sizes, expert ground truth, etc.). This type of detailed performance criteria and study results are typically generated for novel devices or those undergoing PMA (Premarket Approval), not for 510(k) submissions that rely on substantial equivalence.

Instead, the document states:

• "Testing was presented in accordance with the FDA Total Knee Guidance Document." This implies that the device met generally accepted testing standards relevant to knee implants (e.g., mechanical, wear, fatigue testing), but the specific acceptance criteria and results are not detailed.
• The FDA's letter confirms substantial equivalence to predicate devices: Duracon® Total Knee System (Howmedica) and Kinemax® Plus Total Knee System (Howmedica).

Therefore, I cannot provide the requested table and detailed study information based on the input text. The prompt's requirements (acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance) are not typically found in a 510(k) summary focused on substantial equivalence.

Ask a specific question about this device