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The Vantage Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage Total Ankle System is indicated for cemented use only.

Vantage Total Ankle Flat Cut Talar Components are for use in resurfacing talar bone as one of the four components of the Exactech Vantage Total Ankle System (including tibial plate, tibial insert, locking component and talar component) intended for use in total ankle arthroplasty.

The proposed Vantage Flat Cut Talar Components represent modifications to the Vantage Total Ankle Talar Components cleared per 510(k) K152217. The proposed Vantage Total Ankle Flat Cut Talar Components are equivalent to the previously cleared talar components, but utilize one additional fixation structure and flat cut geometry on devices' bone-contacting surface rather than a curved underlying surface featured in the cleared, predicate talar components.

The proposed and predicate devices share the same fundamental scientific technology, have the same intended use, indications for use, and similar design features, employ the same materials of construction and manufacturing processes, are offered in the same product size scope, are implanted using similar surgical techniques and instrumentation, work with the same compatible Vantage Total ankle tibial plates and locking components, and, size for size, are compatible with the same tibial inserts from the previously cleared Exactech Vantage Total Ankle System.

The provided text is a 510(k) summary for a medical device, the Exactech® Vantage® Total Ankle Flat Cut Talar Components. It describes the device, its intended use, and substantial equivalence to a predicate device, focusing on non-clinical testing.

However, the document does not provide information about the acceptance criteria or a study that uses those criteria to evaluate a device's performance in the context of an AI/ML algorithm. The product described is a physical implant for ankle replacement, not a software or AI/ML-driven diagnostic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML or algorithm performance.

The non-clinical testing mentioned (Sizing Studies, Cadaveric Study, Bone Stability Testing, Range of Motion Study, Comparative Analysis, Finite Element Analysis, Pyrogen testing) are typical for physical orthopedic implants, demonstrating biological safety, mechanical integrity, and surgical fit, rather than diagnostic accuracy or algorithmic performance against a ground truth.

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The Salto Talaris ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Components are intended for cemented use only.

The Salto XT ankle prosthesis is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Components are intended for cemented use only.

The cleared Salto Talaris and the new Salto XT are intended for total ankle replacement. Both are a semiconstrained anatomical design, which reproduces the kinematics of the ankle joint. And both consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar component.

The submission seeks clearance for:

• the addition of new components to the Salto XT (tibial and talar components).
• the addition of a new size and new thicknesses to the cleared range of Salto Talaris tibial inserts.

The tibial inserts are compatible with both Salto Talaris (K060544, K090076, K130533) and the new Salto XT. The new device Salto XT has been designed to be compatible with the cleared and the new Salto Talaris tibial inserts. All Salto XT components are compatible with cleared Salto Talaris components.

The provided document is a 510(k) premarket notification for two medical devices, Salto XT and Salto Talaris ankle prostheses. This document details the FDA's decision of substantial equivalence to predicate devices, but does not describe acceptance criteria for software performance or a study proving that a device meets such criteria.

The document describes non-clinical testing for mechanical performance, such as tibial fatigue, insert locking mechanism strength, talar stability, contact pressure, and wear. These are physical tests of the prosthesis components, not software performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies related to software performance from this document.

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Intended Use: The INFINITY™ 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.

Indications For Use: The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

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

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

The INFINITY™ Total Ankle System is a fixed-bearing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial insert, and talar dome) that are assembled to create a two-piece prosthesis. The device is composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium and each component is available in multiple sizes to accommodate variable patient anatomy.

The provided text is a 510(k) summary for the INFINITY™ Total Ankle System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the medical device is at least as safe and effective as a legally marketed device (predicate device).

However, the information provided does not contain details about acceptance criteria, a study proving device performance against those criteria, or any of the specific reader study methodologies requested.

The document primarily focuses on:

• Device Description: What the INFINITY™ Total Ankle System is made of and how it functions.
• Intended Use and Indications for Use: For whom and under what conditions the device is designed to be used.
• Technological Characteristics Comparison: A high-level statement that its features are similar to predicate devices.
• Non-Clinical Evidence: A list of types of non-clinical analyses performed (Bone interface stability, Component stability, Fatigue testing, Contact area/stress testing) and a conclusion that these results show the device performs "at least as well as" predicate devices. No specific performance metrics, acceptance criteria, or detailed study results are given.
• Clinical Evidence: Explicitly states "N/A", meaning no clinical evidence was presented for this 510(k) submission.
• Substantial Equivalence Conclusion: A general statement of safety and effectiveness based on non-clinical evidence and comparison to predicate devices.

Therefore, I cannot populate the requested table and answer the specific questions because the necessary data is not present in the provided text. The document aims to demonstrate substantial equivalence to existing devices through non-clinical testing and design comparison, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for an AI/software device.

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