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The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158, are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device up until 30 days. The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158. are provided non-sterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum, 270oF, 4 minutes with 20 minutes drying time).

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This is a letter from the FDA regarding the 510(k) premarket notification for "Hinson and Hale Medical Technologies, Inc. Infused® Polyester Wrappers". This document is a regulatory approval letter and an indications for use statement. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot generate the requested information based on the provided text.

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The Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towels, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR17X27WB), are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The OR towels are further used as a fluid absorbing towel during surgery or as a device to dry the hands of OR personnel. These towels are provided non-sterile and must be processed before use. These towels may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum sterilizer, 270°F, 4 minutes with 20 minutes drying time).

Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towel, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR17X27WB).

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details for a medical device.

The document is a 510(k) premarket notification letter from the FDA to Hinson and Hale Medical Technologies, Incorporated, concerning their "Next Generation 'Infused' OR Towel." It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. The letter also includes the "Indications for Use" for the OR towel.

Therefore, I cannot fulfill your request based on the given input.

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