(80 days)
The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:
• Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
• Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
• Ligamentous instability requiring implant bearing surfaces with increased constraint;
• Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement, with the exception of porous coated femoral components which can be used cemented or uncemented (biological fixation).
The Arthrex iBalance® TKA System consists of femoral components, tibial tray, tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components are available in left and right versions as well as cemented and uncemented (biological fixation) versions and are designed to work with the Arthrex dome patella components. Tibial bearing components are offered in PS, CR and CR Plus configurations.
The proposed Arthrex iBalance® TKA System line extension of this submission adds an additional smaller tibial bearing component size (i.e. Size 1) to the product offering.
This document is a 510(k) premarket notification for a medical device called the "Arthrex iBalance® TKA System", a knee prosthesis. It details a submission to obtain clearance for a line extension that adds a new smaller-sized component to the existing system.
Based on the provided text, there is no information present regarding acceptance criteria, reported device performance in those terms, or a specific study designed to "prove" the device meets acceptance criteria in the format of a clinical or comparative effectiveness study.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various means, primarily through the assertion that the new component size does not alter the fundamental safety and effectiveness of the system.
Here's a breakdown of the specific points requested, based on the available information:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document as a formal table with acceptance criteria linked to specific performance metrics. The document broadly states: "The fatigue, wear and interlock testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards." This implies that the device did meet compliance standards, but the specific, quantified criteria and results are not detailed.
2. Sample size used for the test set and the data provenance:
- Sample Size: This information is not provided. The text mentions "fatigue, wear and interlock testing" but does not specify the number of components or iterations tested.
- Data Provenance: This information is not provided. It's implied the testing was conducted by Arthrex, Inc., but details like country of origin, retrospective or prospective nature are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing mentioned (fatigue, wear, interlock) are mechanical engineering tests, not clinical studies requiring expert ground truth establishment in the traditional sense of diagnostic accuracy or clinical outcomes.
4. Adjudication method for the test set:
This information is not applicable and not provided for the same reasons as point 3. Mechanical tests typically rely on predefined engineering specifications for pass/fail, not expert adjudication.
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:
This information is not applicable and not provided. The device is an orthopedic implant (knee prosthesis), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to "human readers improving with AI" would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. As mentioned, this is a physical medical device (a knee prosthesis), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the mechanical testing would be the established engineering specifications and industry standards for fatigue, wear, and interlock performance of knee prostheses. The document states compliance with "FDA Guidance and industry standards." There's no mention of expert consensus, pathology, or outcomes data being used as ground truth for this specific submission for a line extension.
8. The sample size for the training set:
This information is not applicable and not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided for the same reasons as point 8.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.