Search Results

The INBONE™ Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion movement in the ankle ioint.

The INBONE™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INBONE™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The ankle prosthesis is intended for cement use only.

The INBONE™ II Total Ankle System consists of tibial trays, talar domes and tibial inserts. The tibial trays and talar domes have modular stem connections. The tibial trays are manufactured from titanium alloy; the talar domes are manufactured from cobaltchrome; and the tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The INBONE™ II Total Ankle System is compatible with the predicate INBONE™ Total Ankle System components.

The INBONE™ II Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

The provided text describes a 510(k) summary for the INBONE™ II Total Ankle System, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific performance criteria through a clinical study in the way an AI/ML device would. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable to this document.

The document focuses on non-clinical evidence (stability and contact area testing) to demonstrate substantial equivalence.

Here's the information that can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in the context of an AI/ML device (e.g., sensitivity, specificity, AUC) is not applicable here. Instead, the device aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed through non-clinical testing.

Acceptance Criteria (Implied by Substantial Equivalence):
The INBONE™ II Total Ankle System should perform "at least as well as" the legally marketed predicate INBONE™ Total Ankle System regarding stability and contact area. New types of safety and effectiveness questions should not be introduced.

Reported Device Performance:
"Substantial equivalence was shown through stability and contact area testing. The results of the test show that the subject INBONE™ II Total Ankle System can be expected to perform at least as well as the legally marketed predicate INBONE™ Total Ankle."

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

Not applicable. This is a medical device, not an AI/ML algorithm that uses a test set of data. The testing mentioned (stability and contact area) would involve a sample of the manufactured device. The document does not specify the sample size for these non-clinical tests.

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

Not applicable. This is a medical device, and the concept of "ground truth" established by experts for a test set is not relevant in this context.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This type of study is not relevant for a total ankle system and is typically used for diagnostic imaging devices or AI/ML algorithms.

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

No. This is not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the AI/ML sense. For general device safety and effectiveness, the "ground truth" would be established through engineering principles, mechanical testing standards, and a comparison to the known performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no training set for a rigid implantable device like a total ankle system.

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

Not applicable.

Ask a specific question about this device