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The RT-PLUS™ Knee System is a tri-compartmental rotating hinged prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It is indicated for use as a replacement of the knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision or connective tissue disorders. The RT-PLUS™ Modular Cemented Knee provides joint stability when any or all of the following structures are non-functional: MCL, LCL, PCL, ACL and the iliotibial band.

The RT-PLUS™ Knee System is a tri-compartmental rotating hinged prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. The snapping mechanism of the PE tibial inserts for the RT-PLUS™ Device Knee System (S/E May 11, 2001 - K003504) has been modified by adding a clamp to secure the PE insert to the tibial component. All PE tibial inserts of the predicate device have been modified, and they are available in sizes 2, 4, 6, 8 and 10, and each size in 8 mm, 11 mm, 14 mm and 17 mm height.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document describes a 510(k) submission for a modified medical device, the "RT-PLUS™ Knee System" (specifically, a modification to the PE tibial inserts). The core of the submission is to demonstrate substantial equivalence to a predicate device (K003504).

Here's what the document does state regarding performance:

Performance Data:

• Type of Study: Biomechanical tests were performed.
• Results: "The test results of the modified components were superior to the predicate device and are sufficient for in vivo loading."

However, the document lacks the following information that you requested:

• A table of acceptance criteria and the reported device performance: While it states the modified device was "superior" and "sufficient," it doesn't provide specific numerical criteria or performance metrics.
• Sample size used for the test set and the data provenance: No details on the number of samples tested or where the biomechanical test data originated.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was a biomechanical test, not an expert-driven diagnostic study.
• Adjudication method: Not applicable for biomechanical testing.
• Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned. No information on human readers or AI assistance.
• Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, as this is a physical prosthetic device, not an algorithm.
• The type of ground truth used: Not explicitly stated beyond "biomechanical tests."
• The sample size for the training set: Not applicable, as there is no mention of a training set or an AI algorithm.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a 510(k) summary for a physical medical device modification and focuses on demonstrating substantial equivalence through biomechanical testing, rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.

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