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The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The recommended Gas Plasma sterilization cycle parameter is 6 minutes (Injection volume: 2880µ L) at 50°C. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain 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 until used up to 3 years post sterilization.

The Pouch/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 STERRAD® Sterilization System.

The proposed pouches are constructed from Tyvek® plastic films, with H2O2 Chemical Indicator printed onto the Tyvek" film. The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.

The H2O2 Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.

The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:

• Self-sealing sterilization pouches .
• . Sterilization pouches, Flat
• . Sterilization pouches, Gusseted
• Sterilization rolls, Flat
• Sterilization rolls, Gusseted

This document is a 510(k) premarket notification for a medical device called "Sterilization Pouch/Roll Made with Tyvek®". It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence, which is the basis for its FDA clearance.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document presents performance data primarily in a comparative table (Table 5-2, continued on subsequent pages in the original document) comparing the new device against its predicate. It also lists the standards used for testing throughout the "Effectiveness and Safety" section.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each test (e.g., number of pouches/rolls tested for peel strength, burst strength, etc.). It mentions that "the test items were performed on materials of the products" for some physical property tests, implying samples of the materials were used.

The data provenance is from Taiwan (R.O.C.), as the manufacturer is Sigma Medical Supplies Corporation located in New Taipei City, Taiwan. The studies appear to be prospective as they involve testing the newly developed device against established standards and a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this type of device and study. The "ground truth" for this medical device (sterilization pouches/rolls) is established through adherence to recognized international and national consensus standards for physical properties, sterilization efficacy, biocompatibility, and product performance, rather than through expert clinical assessment or interpretation of medical images. The studies are laboratory-based and measure objective physical and biological parameters. Therefore, there are no "experts" in the traditional sense of medical image interpretation (like radiologists) establishing ground truth.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need to be resolved. For laboratory-based testing of physical and chemical properties of a medical device like a sterilization pouch, direct measurements are taken against predefined acceptance criteria from standards. There isn't a process of expert adjudication for these types of objective measurements.

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 section is not applicable. MRMC studies are related to the evaluation of AI-powered diagnostic devices that involve human readers (e.g., radiologists, pathologists). This document is for a physical medical device (sterilization pouches/rolls) and does not involve AI or human "readers" in the context of diagnostic interpretation.

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

This section is not applicable. This device is a physical product, not an algorithm related to AI or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of the Sterilization Pouch/Roll Made with Tyvek® is based on established international and national consensus standards for medical device packaging, sterilization processes, and biocompatibility. These include:

• Sterilant Penetration: Adherence to SAL 10-6 as per ANSI/AAMI/ISO 14937:2009.
• Package Integrity and Material Properties: Defined by standards like AAMI/ANSI/ISO 11607-1:2006/(R) 2010, ASTM D882, ISO 1924-2, ASTM D 5035, ASTM F 2251-03, ASTM D 1922, ASTM D 1004, ASTM F 1140-07, ASTM F 1929-98 (04), ASTM F88/F88M-09, ASTM F 1980-2007.
• Microbial Barrier: DIN 58953-6:2010-05.
• Biocompatibility: ISO 10993-10 Third Edition 2010-08-01.
• Chemical Indicator Efficacy: AAMI / ANSI / ISO 11140-1:2005.

These standards provide objective, measurable criteria for the device's performance, thereby defining the "ground truth" for its acceptability.

8. The sample size for the training set

This section is not applicable. This submission is for a physical medical device and does not involve machine learning algorithms that require a "training set." The materials and manufacturing processes are validated, not "trained."

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

This section is not applicable as there is no training set involved for this device submission.

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