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Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modality:

• Standard and Advanced cycles of the STERRAD® NX Sterilization System .
  The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time testing for the following durations:
• 30 days following sterilization by STERRAD® NX (Standard and Advanced cycles) .
  All models of DuraBlue™ Sterilization Wrap have been validated for use with the following STERRAD® NX Sterilization Cycles.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider by Standard and Advanced cycles of the STERRAD® NX hydrogen peroxide gas plasma sterilization system. This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically.
This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

The provided document describes the Cardinal Health DuraBlue™ Sterilization Wrap, its intended use, and the studies conducted to demonstrate its performance and substantial equivalence to predicate devices. However, it does not contain the level of detail typically found in a clinical study report for an AI/ML medical device, which would include specific acceptance criteria with numerical targets and the reported device performance against those targets.

Instead, the document focuses on regulatory approval for the sterilization wrap itself, demonstrating its ability to facilitate sterilization and maintain sterility. The "acceptance criteria" here are implied by the successful completion of various performance tests in accordance with FDA guidance for sterilization packaging systems.

Here's an attempt to structure the information based on your request, with noted limitations due to the nature of the source document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a sterilization wrap, the "acceptance criteria" are not reported as numerical metrics like sensitivity or specificity (as would be for an AI diagnostic device). Instead, they are functional requirements for a sterilization packaging system. The performance is reported as successful completion of these requirements.

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

• Sample Size: The document mentions "Extensive performance testing" and "Sterility Maintenance Validation Study" and "performance tests." However, it does not specify a numerical sample size (e.g., number of wraps, number of test cycles, or number of individual tests) for these studies. It lists various load configurations for the six different wrap models (CH100-CH600) used in the Sterility Maintenance Validation Study, each with a 23 in. x 11 in. x 4 in. tray containing metal instruments.
• Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer (Cardinal Health, located in McGraw Park, IL, USA) and the FDA 510(k) submission, it is highly likely that the studies were conducted in the USA. The studies appear to be prospective in nature, as they involve testing the device under specific conditions set up to validate its performance for sterilization and sterility maintenance.

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

This information is not applicable and therefore not provided in the document. The DuraBlue™ Sterilization Wrap is a sterile barrier system, not a diagnostic or AI device that requires expert ground truth for image interpretation or disease diagnosis. The "ground truth" for its performance is established through microbiological testing (sterilization efficacy and sterility maintenance) and physical material testing, rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, typically for AI/ML devices where differences in expert opinions need to be reconciled to establish a robust ground truth. For this device, the outcomes are objective (e.g., presence/absence of microbial growth, material tear strength, seal integrity).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and therefore not provided in the document. MRMC studies are designed to evaluate the performance of diagnostic tools when used by multiple readers across multiple cases, often comparing AI-assisted performance to unassisted human performance. The DuraBlue™ Sterilization Wrap is a medical device used for packaging, not for diagnostic interpretation, so such a study would not be relevant.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable and therefore not provided in the document. The DuraBlue™ Sterilization Wrap is a physical product, not an algorithm or software. Its performance is inherent to its physical and material properties and how it interacts with the sterilization process, not an independent algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance of the DuraBlue™ Sterilization Wrap is established through objective laboratory testing:

• Microbiological assays: To confirm sterilization efficacy (e.g., kill rate of biological indicators) and maintenance of sterility (e.g., absence of microbial ingress after a specified period).
• Physical and chemical property testing: To assess material integrity, strength, porosity, and compatibility with the sterilization process (e.g., tensile strength, burst strength, visual inspection for damage, chemical compatibility with hydrogen peroxide plasma).

8. Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. The DuraBlue™ Sterilization Wrap is a physical product and does not use machine learning algorithms that require a "training set" of data.

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

This information is not applicable and therefore not provided in the document, as there is no "training set" for this type of medical device.

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