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The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
• · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).
  The SterileRight provides the sterilization pouch and roll made with Paper/Film or Tyvek®/Film.
  The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
  The SterileRight sterilization pouch and roll which are made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The medical devices are inserted into the Sterilization Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains the 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 6 months post Steam or EO gas sterilization.
The Self-seal pouch permits the sealing of the pouch without the need of heat-sealing equipment, while the heat-sealed pouches and rolls are heat-sealed prior to processing in the steam/or EO Sterilization.
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 the Chemical Indicator changes from Pink to Brown/Black when exposed to Steam. And the color changes from Blue to Yellow/Brown, when exposed to EO gas.
The 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. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.
The SterileRight sterilization pouch and roll made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization.

This document is a 510(k) premarket notification for the SterileRight Sterilization Pouch and Roll. It details the device's characteristics, intended use, and comparative performance against a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary table summarizing acceptance criteria and results is Table 3. Summary of Non-Clinical Testing (pages 14-15).

2. Maintain the endpoint stability of the color change after being in the presence of the sterilant.
   All performance attributes should maintain the original color: 3 years shelf life | Real-time test shows the test group exposed to Steam maintained Black color, EO maintained Yellow color, and Control group maintained original color from March 15, 2018 to April 15, 2021 (3 years). | Pass |

2. Sample Sizes Used for the Test Set and Data Provenance:

The document describes non-clinical performance testing. It does not explicitly state the exact sample sizes for each test within the "Summary of Non-Clinical Testing" section. However, it indicates these are validation studies and the results are presented as having "Passed." No specific number of units/pouches per test is given.

• Data Provenance: The studies were conducted by the manufacturer, SterileRight Packaging Mfg., Inc., based in Taiwan (address 1F, No.33-7, Dahua 2nd Rd., Qidu Dist., Keelung City 206, Taiwan, on page 4). The data is prospective as it's part of the premarket submission for a new device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This document is for a sterilization pouch and roll, which is a physical device, and the testing is primarily non-clinical performance testing (physical, chemical, and biological barrier tests).

• No human expert interpretation of images or other medical data (like radiology reads) is involved. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation of medical data is not applicable here.
• The ground truth is established by objective laboratory measurements against defined engineering and biological standards (e.g., SAL 10-6 for sterility, specific ranges for physical properties, specific color changes for chemical indicators).

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the testing involves objective measurements against established standards, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where multiple human readers interpret medical cases, and the AI's impact on their performance is evaluated. This device is a sterilization wrap, subjected to engineering and biological performance testing, not interpretation by human readers.

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

This question implies an AI/algorithm. This device is a physical product (sterilization pouch and roll), not an AI algorithm. Its "standalone" performance is assessed by the non-clinical tests summarized in Table 3, demonstrating its ability to meet acceptance criteria for sterility, barrier integrity, and indicator function independently.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is established by:

• Objective laboratory measurements and validated test methods according to recognized consensus standards (e.g., ISO, ASTM, AAMI).
• Biological indicators (BIs): For sterility, the "ground truth" is the absence of bacterial growth after sterilization, indicating a sterility assurance level (SAL) of $10^{-6}$.
• Physical property measurements: For package integrity, measurements like tensile strength, burst strength, seal peel strength, and thickness variations are compared against defined numerical acceptance criteria.
• Chemical indicator color changes: The "ground truth" for the chemical indicators is a specific, visually identifiable color change after exposure to the sterilant under defined conditions, and the absence of a change under non-sterilant or harsh conditions.
• Biocompatibility testing: Ground truth for biocompatibility is the absence of irritation or sensitization (index of 0).

8. The Sample Size for the Training Set:

This question is typically relevant for machine learning models that require a training set. As this is a physical medical device (sterilization pouch and roll) undergoing non-clinical performance testing, there is no concept of a "training set" in the context of AI/ML. The device's design and manufacturing processes are developed through traditional engineering methods, not trained on data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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