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The Atrion Medical Autogenous Tissue Collector is useful in the collection of bone or other tissue for reconstruction, implants and repair procedures, for collection of tissue for pathological analysis and for retrieving root tips and precious metals.

The Atrion Medical Autogenous Tissue Collector consists of a screen, a gasket, screen support, plastic cover and elastomer tube. The device is a single-use product, sterilized by gamma or E-Beam irradiation.

This document is a 510(k) premarket notification for the Atrion Medical Autogenous Tissue Collector, and it does not contain a study that proves the device meets acceptance criteria in the way a clinical trial or performance study would for an AI/ML device.

Instead, this submission focuses on establishing "substantial equivalence" to a predicate device (SciTech Clearline® Filter, K930144). The "Summary of Safety Testing" section explicitly states: "Based on the 510(k) "Substantial Equivalence" decision-making process and the information provided herein, we conclude that the new device is substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving performance, as this type of data is not present in the provided text. The device's suitability is based on its similarity to an already approved device, not on specific performance metrics established through a novel study.

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