(28 days)
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.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.