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KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider in the Amsco V-PRO 1 Low Temperature Sterilization System's Cycle or the Amsco V-PRO 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PRO 1 Cycle) and Non Lumen Cycles. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated to be effectively aerated during the pre-programmed V-PRO 1 and V-PRO 1 Plus Sterilization Cycles.

The KIMGUARD ONE-STEP* Sterilization Wrap is identical to the predicate in intended use, design, materials, and performance. The KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectangular fabric produced using a polypropylene three-layer SMS (spunbondmeltblown-spunbond) process.

The provided text describes the acceptance criteria and the summary of testing for the KIMGUARD ONE-STEP* Sterilization Wrap.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a "Summary of Testing" that was conducted to demonstrate the performance of the KIMGUARD ONE-STEP* Sterilization Wrap.

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

• Test Set (General): The document states that testing included "biocompatibility in compliance with the methods of ISO 10993, sterilant penetration, and physical integrity." It indicates that "All results of testing met acceptance criteria." However, specific sample sizes for these tests are not provided.
• Test Set (Sterility Maintenance): The table detailing "Wrap Model Recommendations" describes specific test loads used in the "Sterility Maintenance Validation Study". These loads represent a sample set for evaluating the ability of each wrap model to maintain sterility. For instance:
  • KC100: 3 lbs metal mass, 6 forceps
  • KC200: 2.5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • All other models had similar specified loads (e.g., 5 lbs metal mass, 6 forceps, specific V-PRO tray sizes).
• Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the FDA for a device manufactured by Kimberly-Clark Corporation, which suggests the testing was likely conducted in accordance with US regulatory requirements or international standards recognized by the US. The testing appears to be prospective as it was conducted to support the 510(k) submission for the additional indication for use.

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 tests described (biocompatibility, sterilant penetration, physical integrity, sterility maintenance) are laboratory-based performance tests, not clinical studies requiring expert interpretation of results in the same way, for example, a diagnostic imaging AI would. The "ground truth" for these tests would typically be established by validated scientific methods and measurements rather than expert consensus on subjective evaluations.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided in the document. The described tests are objective laboratory measurements, not subjective evaluations requiring adjudication by multiple experts.

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 is not applicable. The device is a sterilization wrap, not an AI-assisted diagnostic tool or an imaging device involving human readers or AI. Therefore, no MRMC comparative effectiveness study was performed.

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

This is not applicable. The device is a physical product (sterilization wrap), not an algorithm or AI system.

7. The type of ground truth used:

The ground truth for the tests described is based on:

• Objective Laboratory Measurements: For biocompatibility (ISO 10993), sterilant penetration, and physical integrity, the ground truth is established through standardized laboratory procedures and measurement techniques as defined by relevant industry standards and guidance documents.
• Performance Validation based on Controlled Conditions: For sterility maintenance, the ground truth is established by demonstrating the wrap's ability to maintain sterility of specific, validated test loads for a defined period (up to 30 days) under standard conditions. This involves microbiology testing to confirm the absence of viable microorganisms.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not a machine learning model or AI, and therefore does not have a "training set" in the context of AI development. The document refers to "testing" and "validation studies" for product performance.

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

This is not applicable as there is no training set for this type of device.

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