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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 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 PFJ components are intended for use in patellofemoral knee arthroplasty in patients with:

• 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.

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, rheumatic 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 the exception of porous coated femoral components which can be used cemented (biological fixation).

Arthrex iBalance UKA System is intended 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 Arthrex Knee Systems encompass the following FDA cleared devices:

• Arthrex iBalance TKA System
• Arthrex iBalance UKA System
• Arthrex iBalance PFJ
• Arthrex iBalance BiCompartmental Arthroplasty System
  These systems are comprised of femoral, tibia, and patellar components for use in knee prosthesis.

The provided document is a 510(k) premarket notification for Arthrex Knee Systems. It states that this particular submission (K171365) is a special 510(k) for a labeling modification to include an "MR Conditional" statement. It references general intended uses and provides some non-clinical testing for "MR Conditional" status and bacterial endotoxin but does not describe a study that proves the device meets specific performance acceptance criteria related to its clinical function, such as efficacy or longevity in patients.

Therefore, I cannot provide the requested information in full. However, I can extract the information that is present regarding the non-clinical tests mentioned.

Here's what I can provide based on the given document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a labeling change to include "MR Conditional" status and mentions bacterial endotoxin testing, it does not describe a clinical study for proving patient-related performance or effectiveness. Consequently, the following requested information cannot be found in the provided text:

• Sample size used for the test set and the data provenance: Not applicable for the described tests (MR Conditional and bacterial endotoxin). These are non-clinical or laboratory tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the described tests.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the described tests.
• 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: Not applicable. This document is not about AI or diagnostic imaging.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an algorithm or AI.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "MR Conditional" status, the ground truth is established by meeting criteria specified in the FDA Guidance for MR environments. For bacterial endotoxin, the ground truth is meeting pyrogen limit specifications. This doesn't involve clinical outcomes or expert consensus in the typical sense of evaluating device effectiveness for its primary medical purpose.
• The sample size for the training set: Not applicable. There is no mention of a training set for an algorithm.
• How the ground truth for the training set was established: Not applicable.

This 510(k) notification focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety aspects relevant to an MRI environment and pyrogenicity for sterile devices, rather than a de novo clinical study proving the effectiveness of the knee system itself. The phrase "Performance Data" section specifically highlights "Non-clinical testing and in-vivo electromagnetic simulation" and "Bacterial endotoxin" tests.

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