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The iBalance UKA System is indicated for use in unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

These components are single use only and are intended for implantation with bone cement.

The iBalance PFJ System is indicated for use in patellofemoral joint, (PFJ) knee arthroplasty as a result of:

• Degenerative arthritis in the distal femur and patella;
• A history of patellar dislocation or fracture;
• Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful partial knee replacement or other procedure.

The iBalance BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.

These components are single use only and are intended for implantation with bone cement.

The Arthrex iBalance Partial Knee System encompass the following FDA cleared devices:

• Arthrex iBalance UKA System
• Arthrex iBalance PFJ System
• Arthrex iBalance BiCompartmental Arthroplasty System

These systems are comprised of femoral, tibia and patellar components for use in knee prosthesis.

The provided FDA 510(k) clearance letter for the Arthrex iBalance Partial Knee System does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-based medical device.

This document is a clearance letter for a physical medical device (a knee replacement system), not an AI-powered diagnostic or treatment algorithm. The "performance data" mentioned refers to non-clinical and in-vivo electromagnetic simulation related to the device's "MR Conditional" status, which is about its safety in an MRI environment, not its diagnostic or therapeutic accuracy as an AI would have.

Therefore, I cannot extract the requested information (such as sample sizes for test/training sets, expert consensus, MRMC studies, etc.) from this document because it is not relevant to an AI/algorithm-based device study.

To provide the information you're looking for, I would need a 510(k) clearance letter or a clinical study report specifically detailing the performance evaluation of an AI/algorithm-based medical device.

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The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of:
• 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.

The Accin™ total knee system consists of a series of cobalt chrome femoral components, a series of cobalt chrome tibial tray components and a series of UHMWPE modular tibial bearing components.

The provided text describes a 510(k) premarket notification for the "Accin™ total knee system," a medical device, and its comparison to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as AI improvement effect size, standalone algorithm performance, training set details, ground truth establishment for training set, and AI/ML acceptance criteria) are not applicable.

However, I can provide information based on the available text regarding the testing and comparison of the Accin™ total knee system to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative targets and the device's reported performance against those targets. Instead, it states that the device "meets the requirements of the current FDA Guidance documents on total knee arthroplasty product" and passed a series of tests. The "acceptance criteria" here implicitly refer to the requirements outlined in the FDA guidance documents and ASTM standards.

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

The document mentions "numerous tests were performed on the Accin™ total knee system" but does not specify the sample size (number of devices or components tested) for these tests.
The data provenance is not explicitly stated in terms of country of origin or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, the "tests" likely refer to mechanical and material property testing in a laboratory setting.

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

This question is not applicable as the submission pertains to a physical medical device (a knee implant) and its mechanical/material performance, not an AI/ML algorithm that requires expert-established ground truth from data for diagnostic or prognostic purposes.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. Testing for medical device equivalence typically involves engineering and materials science analyses, not expert adjudication of clinical cases.

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 question is not applicable as the submission is for a physical medical device, not an AI/ML powered device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the submission is for a physical medical device, not an AI/ML powered device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device comes from established engineering and material science principles, FDA guidance documents, and ASTM standards for testing the mechanical properties, wear resistance, and biocompatibility of total knee arthroplasty devices. The equivalence is established by demonstrating that the new device meets these recognized standards and performs comparably to the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable as the submission is for a physical medical device, not an AI/ML powered device. There is no "training set" in the context of an AI/ML algorithm.

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

This question is not applicable for the same reasons as point 8.

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