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The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 30 minutes.
• · Gravity steam at 132°C (270°F) for 15 minutes; Drying time of 30 minutes.
• · Gravity steam at 135°C (275°F) for 10 minutes; Drying time of 30 minutes.
• · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• · Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes.
  · EO sterilization cycle is 4 hours at 55°C (131°F) with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L.
  Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouches and rolls are inserted into the Pouch/Roll, sealed, and then sterilized in the 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 EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.
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 steam/or EO Sterilization cycles.
The chemical indicators ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. And the color changes from red to yellow, when exposed to EO gas.
The 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. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

The provided document is a 510(k) premarket notification for the SIGMA Sterilization Pouch and Roll. It does not describe an AI/ML medical device, but rather a sterilization packaging product. Therefore, the questions related to AI/ML device performance metrics such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K180661) through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study as presented for this non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are extensively detailed across multiple tables, primarily Table 2 ("Summary of the Proposed and Predicate Devices Technological Characteristics") and Table 3 ("Summary of Non-Clinical Testing"). I will extract the key information from these tables.

Regarding the sections that are not applicable to non-AI/ML devices (points 2-9):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device. The testing involves laboratory evaluations of material properties and sterilization efficacy, not interpretation of data. The document does not specify general "sample sizes" in terms of number of patients/cases, but rather the number of units tested for specific physical and chemical properties. The provenance is likely from the manufacturer's testing facilities in Taiwan.

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): Not applicable. "Ground truth" in the context of AI/ML refers to expert-labeled data. For this device, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO, AAMI) and their specified pass/fail criteria for physical and chemical properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling of AI/ML data. The "acceptance criteria" here are objective measurements against defined standards.

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: Not applicable. This is a standalone physical product, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm. The device's performance is inherently standalone in its function as a sterilization pouch.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical device, the "ground truth" for its performance is determined by adherence to established international and national standards for sterilization packaging, material science, and chemical indicators (e.g., microbial barrier, tensile strength, peel strength, chemical indicator color change).

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model for which a training set would be required.

9. How the ground truth for the training set was established: Not applicable. Same reason as point 8.

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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® 100S Sterilizer.

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

Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® 100S Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® 100S Sterilization System (The recommended cycle parameter is 6 minutes (Injection volume: 2880µL) at 50°C.). After completion of the sterilization process, the Pouch/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 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® 100S Sterilization System.

The 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 additional way to verify 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

The provided text describes the regulatory submission for a medical device (Sterilization Pouch/Roll Made with Tyvek®) seeking 510(k) clearance from the FDA. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel AI/software-as-a-medical-device (SaMD).

Therefore, the information typically requested regarding acceptance criteria and study design for AI/SaMD devices (like sample size for test/training sets, data provenance, expert
qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this submission. This device is a physical product, and its performance is evaluated through material science, sterility, and packaging tests.

However, I can extract the acceptance criteria and reported performance for the physical device based on the non-clinical testing summaries.

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

For the following points, as explained, they are not applicable because this is a 510(k) submission for a physical medical device (sterilization pouches) based on substantial equivalence, not an AI/SaMD (Software as a Medical Device). The evaluation focuses on material properties and performance under sterilization conditions rather than algorithmic performance on complex data (like images or medical records).

2. Sample sizes used for the test set and the data provenance: Not applicable. The tests performed are engineering and material-science based, using samples of the device and specific test setups, not patient-derived data. The document does not specify a "test set" in the context of an AI algorithm, nor "data provenance" (e.g., country of origin) relevant to patient data. The non-clinical tests were likely conducted in a controlled laboratory environment.

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): Not applicable. Ground truth as typically defined for AI/SaMD (e.g., disease diagnosis from medical images) is not relevant here. The "ground truth" for these tests are objective measurements against established engineering and biological standards (e.g., quantitative measures of tensile strength, observable microbial growth, or chemical indicator color change).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among human annotators/experts for ground truth establishment in AI/SaMD; this is not relevant for materials testing.

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: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance evaluations are based on established industry standards and scientific principles for material properties (e.g., ASTM standards for mechanical properties), biological efficacy (e.g., 6-log reduction for sterilization), and chemical reactivity (e.g., color change of indicators). No human expert consensus or outcomes data in a clinical context is used as "ground truth" for this device's acceptance.

8. The sample size for the training set: Not applicable. There is no AI training set involved.

9. How the ground truth for the training set was established: Not applicable. There is no AI training set involved.

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