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The Kimberly-Clark Th Self-Seal Pouch for Low Temperature Sterilization is intended to be used to enclose another medical device that is to be sterilized by a health care provider and to maintain sterility of the enclosed device until needed. The sterilization pouch is intended for use with low temperature sterilization processes (hydrogen peroxide gas plasma/STERRAD Sterilization System, peracetic acid

The Kimberly-Clark Self-Seal Pouch is available in sizes to suit the health care provider (3.5 " x 8.5", 5.25" x 10.25", 5" x 15", 7.5" x 13.5", 12" x 15", 12" x 18" & 15.75" x 18"). The pouch has a Tyvek backing with a clear, polyolefin/polyester film laminate material as a front.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document directly states the "Result" for each test but doesn't explicitly state the numerical or qualitative "Acceptance Criteria" that were pre-defined. However, the reported results ("No growth of indicator organism" and "Superior to 140 count cloth packages") implicitly serve as the acceptance criteria being met. "No growth" signifies successful performance for the first two and "Superior to" indicates acceptable performance for the third.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not explicitly state the sample sizes used for the sterilant penetration, microbial barrier efficiency, or event-related sterility maintenance tests.

The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned in the provided document. As this is a 510(k) submission to the US FDA, it can be inferred that the studies were conducted to meet US regulatory requirements, but the specific location of the study (e.g., laboratory, institution) or its design (retrospective/prospective) is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. These tests are laboratory-based and generally rely on standard microbiological and physical testing protocols, not expert interpretation of results in the way, for example, a medical imaging study would. The "ground truth" would be established by the objective outcome of the microbiological cultures (growth/no growth) and the physical integrity tests.

4. Adjudication Method for the Test Set

This section is not applicable as the tests described are objective laboratory tests with clear endpoints (e.g., "no growth") rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device (sterilization pouch). MRMC studies are typically used for diagnostic devices, particularly in medical imaging, to assess human reader performance with and without AI assistance. This device is a passive sterilization packaging material.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical product (a sterilization pouch), not an algorithm or AI system. The tests performed are standalone in the sense that they assess the intrinsic performance of the pouch itself.

7. The Type of Ground Truth Used

The ground truth for the tests appears to be:

• Sterilant Penetration: Objective microbiological culture results (absence of indicator organism growth after sterilization).
• Microbial Barrier Efficiency: Objective microbiological culture results (absence of indicator organism growth after exposure to microbes).
• Event Related Sterility Maintenance: Objective microbiological culture results comparing the pouch's ability to maintain sterility against a reference standard (140 count cloth packages).

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical product, not a machine learning algorithm requiring a training set.

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

This question is not applicable as the device is a physical product, not a machine learning algorithm requiring a training set.

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