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PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator, is a device 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 until used.

The recommended (and validated) sterilization cycle parameters for all models (Sterilization Pouches (FP) and Rolls(FL) with Chemical Indicator) are:

• For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes. Validated minimum dry time is 20 minutes.
• For EO sterilization; 100%ethylene oxide(EO) with a concentration of 725mg/l at 55 degrees C and 50o 80%relative humidity for 60 minutes. Aeration time is 8 hours.

Chemical process indicators on the exterior of the pouch and roll indicate by color change that the pouch has undergone either a steam or ethylene oxide sterilization process.

Type1 steam indicator will change color from pink to brown after exposure to pre-vacuum steam sterilization process.

Type 1 ethylene oxide indicator will change from turquoise to ethylene oxide sterilization process.

As Worst Case Validated Load; general medical devices with stainless steel lumens with the following internal diameter (ID) and Maximum Lumen Lumen length can be processed in the validated steam and ETO sterilization cvcles as follows:

Table 1.Worst Case Validated Load and Lumen Claims.

| Pouch Size | Product
Code | Max.Load
Weight (Ibs.) | Max. lumen length
(mm) | Min. internal
diameter (mm) | Max # Lumens |
|--------------|-----------------|---------------------------|---------------------------|--------------------------------|--------------|
| 50 x 200 mm | FP 0520 | 0.062 | 50.8 mm | 1.5 mm | 1 |
| 200 x 300 mm | FP 2030 | 0.516 | 200 mm | 3.0 mm | 1 |
| 250 x 300 mm | FP 2530 | 0.520 | 200 mm | 3.0 mm | 1 |
| 500 x 600 mm | FP 5060 | 3.344 | 400 mm | 3.0 mm | 1 |

PMSSteripack Flat Sterilization pouches (FP) and rolls (FL) with Chemical Indicator; are manufactured from medical grade paper/ laminated PET/PP film, by heat sealing on sides. Triple band seal provides three independent barriers to contamination, while reducing the risk of fiber tear.

PMSSteripack Flat Sterilization Pouches (FP) and Rolls (FL) with Chemical Indicator; are divided into 2 main groups as below;

• Sterilization Pouches, Flat: These pouches are manufactured from medical grade paper/plastic film that are heat sealed on 3 sides, the remaining open side is heat sealed by the end user.

• Sterilization Rolls, Flat: These rolls are manufactured from medical grade paper/plastic film that is heat sealed on opposite two sides. The required size is cut from the roll and the remaining open sides are heat sealed by the end user.

The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas.

After the sterilization process is completed, the sterility of the enclosed medical device is rnaintained for 30 days.

This document describes the PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual test. However, it mentions a "Worst Case Validated Load" tested for different pouch sizes and lumen claims:

• Pouch Size 50 x 200 mm (FP 0520): Max. Load Weight 0.062 lbs., Max. lumen length 50.8 mm, Min. internal diameter 1.5 mm, Max # Lumens 1
• Pouch Size 200 x 300 mm (FP 2030): Max. Load Weight 0.516 lbs., Max. lumen length 200 mm, Min. internal diameter 3.0 mm, Max # Lumens 1
• Pouch Size 250 x 300 mm (FP 2530): Max. Load Weight 0.520 lbs., Max. lumen length 200 mm, Min. internal diameter 3.0 mm, Max # Lumens 1
• Pouch Size 500 x 600 mm (FP 5060): Max. Load Weight 3.344 lbs., Max. lumen length 400 mm, Min. internal diameter 3.0 mm, Max # Lumens 1

The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The studies listed are performance tests against recognized standards rather than studies involving expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable as the studies described are performance tests against standards, not studies requiring adjudication of output from a device or algorithm.

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

An MRMC comparative effectiveness study was not done. The device in question is a sterilization pouch with a chemical indicator, not an AI-assisted diagnostic or interpretative device that would involve human readers.

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

This is not applicable for this device type. The chemical indicator operates standalone as a chemical reaction, but it is not an algorithm, nor does it require human-in-the-loop performance in the sense of an AI system. Its function is to change color, indicating exposure to a sterilization process.

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

The "ground truth" for the tests performed is based on meeting the requirements of internationally recognized standards for sterilization packaging, such as ISO, AAMI, and ASTM. For example:

• Sterilant Penetration: Ground truth is effective penetration as defined by the aforementioned standards.
• Biocompatibility: Ground truth is the absence of cytotoxic effects as per ANSI/AAMI/ISO 10993-5.
• Chemical Indicator Efficacy: Ground truth is the reproducible color change according to ANSI/AAMI/ISO 11140-1 Class 1 indicator requirements.

8. The sample size for the training set

This is not applicable as the device is a physical product (sterilization pouch with a chemical indicator) and not an AI or machine learning model that requires a training set.

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

This is not applicable as the device is not an AI or machine learning model that requires a training set.

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