(149 days)
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.
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.