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The Elevo® Snoring Intervention Set is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals.

The Elevo® Snoring Intervention Set is comprised of three (3) sterile, absorbable, barbed, poly(L-lactide-co-D L-lactide) sutures and three (3) corresponding disposable, sterile, single use suturing needles. A silk disposable tension suture (DTS) is attached to the proximal end of each of the poly(L-lactide-co-D L-lactide) barbed suture implants. The proximal end of the DTS is secured to the suturing needle handle during device assembly. One (1) Pilot Hole Initiation Tool (PHIT) completes the contents of the set.

The provided text describes a medical device, the "Elevo Snoring Intervention Set," and its FDA 510(k) submission for substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-driven diagnostic or assistive device.

The document focuses on:

• The FDA's 510(k) clearance letter.
• The Indications for Use for the device.
• A 510(k) summary detailing the device description, intended use, and its comparison to a predicate device.

The "Equivalence Testing" section mentions that "The material characteristics of the poly(L-lactide-co-D L-lactide) suture implant have been evaluated for equivalence to the material characteristics of the polydioxanone (PDO) suture implant of the predicate device (Elevo® Kit Snoring Intervention Device K181107), including tensile strength and absorption profile." It also states, "In vitro bench test data demonstrate that the Elevo® Snoring Intervention Set with poly(L-lactide-co-D Llactide) sutures performs as anticipated, and the device raises no new questions of safety and effectiveness when compared to the predicate device."

This indicates that the study performed was a bench test comparing physical characteristics of the new device's material to the predicate device's material to establish substantial equivalence, rather than a clinical study or a study with specific performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML diagnostic.

Therefore, I cannot provide the requested information for an AI/ML-driven device's acceptance criteria and study in the format specified because such details are not present in the provided text. The device described is a physical implant for stiffening soft palate tissue, not an AI/ML system.

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