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The Tuttnauer Horizontal Models: 4472, 5596, 6690, 6990, 66120, 69120 and 69180 autoclaves that are intended for use by a health care r no rathant nealized products by means of pressurized steam. The devices are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products.

Tuttnauer Horizontal Models: 4472, 5596, 6690, 66120, 69120 and 69180 autoclaves

This document is a 510(k) premarket notification for Tuttnauer Horizontal Autoclaves and details their intended use and preprogrammed sterilization cycles. It is not a study proving a device meets acceptance criteria, nor does it contain information about AI/ML device performance. Therefore, I cannot extract the requested information from this document.

The document discusses:

• Device Name: Tuttnauer Horizontal Models: 4472, 5596, 6690, 6990, 66120, 69120 and 69180 autoclaves
• Regulation Name: Steam Sterilizer (21 CFR 880.6880)
• Intended Use: Sterilization of heat-stable medical devices (wrapped solids, hollow, and porous products) by means of pressurized steam in a healthcare setting.
• Preprogrammed Cycles: Details sterilization temperature, sterilization time, dry time, and maximum load for various cycles (IUSS, Wrapped, IUSS delicate, Wrapped delicate, Bowie and Dick, Vacuum test) across different models.

To answer your request, I would need a document specifically detailing an acceptance study for a device, including performance metrics, sample sizes, ground truth establishment, and if applicable, AI/ML study details. This document is a regulatory approval notification.

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