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Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in pouch plus mode and chamber mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.

The maximum load weight that can be placed in the Tyvek® roll is 1 lb (450g) for pouch plus mode and 3.97 bs (1.8kg) for chamber mode.

The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2015) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the following one type:

· Sterilization roll, Flat

Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.

The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer.

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).

This prompt describes a medical device, specifically a "Tyvek® Roll with CI for STERLINK™ Sterilizer," and provides information about its regulatory submission (K223025) and comparison to a predicate device (K212198). The document focuses on regulatory approval based on demonstrating substantial equivalence, primarily through non-clinical testing.

However, the provided text does not describe an AI/ML powered medical device and therefore does not contain information typically associated with acceptance criteria or studies used to prove performance for such devices. The questions in the prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types) are all relevant to the validation of AI/ML algorithms, not to the physical properties and sterilization efficacy of a sterilization wrap.

Therefore, I cannot directly answer your detailed questions about acceptance criteria and study design as if this were an AI/ML device. The information provided is for a traditional medical device (sterilization wrap with a chemical indicator).

Here's how I can address the request based on the actual content of the document:

The document provides a summary of non-clinical testing performed to demonstrate that the subject device (Tyvek® Roll with CI for STERLINK™ Sterilizer) is substantially equivalent to a predicate device, focusing on its ability to maintain sterility and the performance of its chemical indicator.

Acceptance Criteria and Study for a Traditional Medical Device (Sterilization Wrap):

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for each test but states "Pass" for all performed tests, indicating that the device met the requirements of the standards cited. The acceptance criteria are implicitly defined by the successful completion of the referenced standards.

2. Sample size used for the test set and the data provenance:

• The document does not specify the exact sample sizes for each of the non-clinical tests listed.
• Data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. The tests were performed as part of the regulatory submission by Plasmapp Co., Ltd. (South Korea) and its manufacturer Sigma Medical Supplies Corp.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable to the non-clinical performance testing of a sterilization wrap. "Ground truth" in the context of material science and sterilization efficacy is established by validated laboratory testing against specified standards, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This is not applicable as the evaluation involves meeting established engineering and biological standards, not human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This is not applicable as the device is a physical sterilization wrap, not an AI-assisted diagnostic or decision-support tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This is not applicable as the device is a physical sterilization wrap.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by validated laboratory testing against recognized international and national standards (e.g., ISO 14937, ANSI/AAMI/ISO 11140-1, ASTM series, DIN 58953-6). For biocompatibility, it's ISO 10993-5. For chemical indicator performance, it involves observable color changes under controlled sterilization conditions as per ISO 11140-1.

8. The sample size for the training set:

• This is not applicable as there is no AI/ML algorithm involved that would require a training set.

9. How the ground truth for the training set was established:

• This is not applicable for the same reason as above.

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