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Guided DAS Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Guided DAS Surgical Kit is intended to allow sterilization of the enclosed medical devices.

Guided DAS Surgical Kit requires the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kit is to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: dynamic air removal steam sterilization- Exposure at 132 °C for 4 minutes and 30 minutes dry time.

Guided DAS Surgical Kit is intended for sterilization of non-porous loads.

Guided DAS Surgical Kit is recommended not to be stacked during sterilization.

The combined weight of the Guided DAS Surgical Kit and the associated instruments is 760 grams.

The weight of the empty Guided DAS Surgical Kit is 600 grams.

This tray is designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the trays by the healthcare provider.

The provided text is a 510(k) clearance letter and summary for the "Guided DAS Surgical Kit," which is a sterilization wrap/container. It outlines the device's indications for use, classification, and a comparison to a predicate device.

However, the provided document does not contain information relevant to AI/ML device performance, such as:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for AI/ML test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes of AI assistance on human readers.
• Standalone (algorithm-only) performance metrics.
• Type of ground truth used (expert consensus, pathology, outcome data).

The "Summary of Nonclinical Testing Table" on page 8 focuses on validation tests typical for medical devices related to cleaning, sterilization, dry time, life cycle, and biocompatibility, which are hardware-related and not AI/ML performance metrics. The conclusion explicitly states, "No clinical data were included in this submission."

Therefore, based solely on the provided text, it's impossible to describe the acceptance criteria and the study that proves an AI/ML device meets them, as the document is about a physical medical device (sterilization kit) and not an AI/ML algorithm.

If the request assumes this document should or would contain information about an AI/ML component, then the answer is that the document explicitly does not provide such information.

To answer your request within the confines of the provided text, I must state that the document does not contain the information needed to describe the acceptance criteria and study for an AI/ML device.

The document describes the testing performed for a physical medical device (sterilization kit). The listed tests are for material and functional validation, not for an AI/ML algorithm's analytical or clinical performance.

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