Search Results

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 and are designed to work with the Arthrex dome patella components. Femoral and tibial tray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibial bearing and patellar components are manufactured from UHMWPE conforming to ASTM F-648.
The Arthrex iBalance® BioSync™ Femoral Components line offers the option of affixing the system's femoral components without cement through the use of a titanium scaffold porous coating (biological fixation).

The provided document is a 510(k) premarket notification for a medical device, the Arthrex iBalance® TKA System. It does not describe an AI/ML powered device, therefore, the requested information about acceptance criteria and the study proving the device meets those criteria, particularly as it relates to AI/ML performance metrics, is not present.

The document discusses the substantial equivalence of the Arthrex iBalance® TKA System to legally marketed predicate devices, focusing on design features, intended uses, materials, and mechanical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving performance for an AI-powered device, as this document pertains to a traditional orthopedic implant.

The document details the following for the Arthrex iBalance® TKA System:

• Device Description: A total knee arthroplasty system consisting of femoral components, tibial tray, tibial bearing components, and patellar components. The BioSync™ Femoral Components line extension offers the option of uncemented fixation through a titanium scaffold porous coating.
• Intended Use/Indications for Use: For individuals undergoing surgery for painful, disabling joint disease of the knee (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of knee joint configuration and function, moderate varus, valgus, or flexion deformity, and revisions of previous unsuccessful knee replacement. Additional indications for posteriorly stabilized components include ligamentous instability and absent or non-functioning posterior cruciate ligament.
• Substantial Equivalence Summary: The device is considered substantially equivalent to the predicate device (K081127: Accin™ Total Knee System and K121771: Zimmer® Persona™ Personalized Knee System). Differences are considered minor and don't raise questions concerning safety and effectiveness.
• Testing Information: Fatigue, biocompatibility, metallurgical, corrosion, microstructure, strength, bonding, abrasion, and ingrowth testing information was submitted to demonstrate consistency with FDA Guidance for porous-coated orthopedic implants.

Ask a specific question about this device

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 stabilization 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 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 (CR) configurations. Femoral components are available in left and right versions and are designed to work with the Arthrex dome patella components. Femoral and tibial tray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibial bearing and patellar components are manufactured from UHMWPE conforming to ASTM F-648.

The provided text describes a 510(k) premarket notification for the Arthrex iBalance® TKA System, specifically addressing a change in the sterilization method for the UHMWPE tibial bearing components from EtO to Gamma Irradiation. The submission focuses on demonstrating substantial equivalence to a predicate device (K081127: Accin™ Total Knee System) despite this change.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the mechanical testing of the UHMWPE components. It generally refers to "mechanical testing data submitted."

The data provenance is not explicitly stated. However, given that it's a 510(k) submission to the FDA, the testing would typically be conducted according to recognized ASTM standards, implying a controlled laboratory setting. It is a retrospective analysis comparing the properties of gamma-sterilized and EtO-sterilized UHMWPE.

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

This information is not provided in the document. The study described is a laboratory-based mechanical testing study, not one requiring expert human interpretation of medical images or clinical outcomes for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the type of study described (mechanical testing). Adjudication methods are typically used in studies involving human interpretation or clinical outcomes.

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?

No, an MRMC comparative effectiveness study was not done. This submission is for a knee prosthesis and focuses on material properties after a sterilization change, not on AI assistance for human readers or interpretation of data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This submission is about the physical properties of a medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this study is based on established material science standards and physical measurements. Specifically, the "ground truth" for the material properties of UHMWPE is defined by ASTM standard F648 for Type 2 PE, and the characterization of material properties after gamma sterilization was conducted per ASTM F2565. The comparison of mechanical strength between EtO and Gamma specimens relies on direct physical measurement of these properties.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this mechanical testing study. The device is a physical implant, not an AI system that requires training data.

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

This information is not applicable as there is no "training set."

Ask a specific question about this device

The Cardo Medical Total Knee 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 procedures.

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 Cardo Medical Femoral Cement Restrictor is only intended for use with Cardo Medical PS femoral components (previously cleared in K081127). The device is an optional accessory and is manufactured from UHMWPE.

The provided document, K101032 for the Cardo Medical Femoral Cement Restrictor, is a 510(k) premarket notification submission. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive new studies.

Therefore, many of the typical elements of a study proving acceptance criteria (like specific performance metrics, sample sizes, expert adjudication, or MRMC studies) are not present in this document.

Here's a breakdown of the information that can be extracted based on your request, and where details are not available or not applicable for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than establishing and testing against novel acceptance criteria.

2. Sample size used for the test set and the data provenance

No specific test set or data provenance in terms of patient data is mentioned. The submission states: "The Cardo Medical Femoral Cement Restrictor is a non-load-bearing plug that does not change the worst-case products for testing purposes, therefore the previous testing applies to these components." This indicates that no new primary clinical or performance testing was conducted for this specific device beyond what was covered by the predicate or the overall knee system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set requiring expert ground truth establishment for performance evaluation is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No new test set requiring adjudication is described.

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

Not applicable. This device is a cement restrictor, not an imaging or diagnostic device that would typically involve human readers or AI assistance.

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

Not applicable. This device is a physical medical component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For a physical device like a cement restrictor, "ground truth" typically refers to engineering specifications, material properties, and functional performance (e.g., ability to occlude, biocompatibility). These are implicitly addressed by similarity to the predicate and overall system testing, rather than through complex "ground truth" like in diagnostic AI.

8. The sample size for the training set

Not applicable. This device is a physical medical component, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not a machine learning algorithm.

Summary of the Study (as described in the 510(k) submission):

The "study" described in this 510(k) is primarily a comparative analysis for substantial equivalence rather than an independent performance study against novel acceptance criteria.

The submission states:

• Synopsis of Test Methods and Results: "The Cardo Medical Femoral Cement Restrictor is a non-load-bearing plug that does not change the worst-case products for testing purposes, therefore the previous testing applies to these components."
• Comparison to Predicates: The device "is substantially equivalent to the Howmedica Osteonics Tibial Tray Screw Hole Plugs (K032479), having the same technological characteristics. The device and its predicate are made of the same material, are used in total knee arthroplasty, and serve the same purpose: to occlude an opening to help prevent bone cement from migrating."
• Conclusion: "Cardo Medical, Inc. has determined that any differences in the proposed device will not impact the safety or effectiveness of the total knee system for its intended use."

Essentially, the "study" for this 510(k) is a declaration and justification that because the new device is technologically equivalent to a legally marketed predicate device (made of the same material, serving the same function, and being non-load-bearing), the safety and effectiveness are also considered equivalent, and no new, specific performance studies beyond what's already established for the predicate or the overall knee system are deemed necessary by the submitter. The FDA's clearance of the 510(k) confirms agreement with this claim of substantial equivalence.

Ask a specific question about this device