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The Halyard ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed devices by the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Flexible Cycles). Additionally, the Halyard ONESTEP Sterilization Wrap was validated to allow effective aeration under the pre-programmed HC 80TT Sterilization Cycles. All models of the Halyard ONE-STEP Sterilization Wrap have been validated for use with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer cycles as described below:

Lumen Cycle:

Reusable metal and nonmetal devices including devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors and up to fifteen (15) stainless steel lumens per load with the following dimensions:

Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are: ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm long, or ≥ 1.33 mm ID and ≤ 430 mm long;

and, Triple channeled rigid and semi-rigid endoscopes, with stainless steel lumens that are ≥ 1.00 mm ID and ≤ 310 mm long. (Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 20.1 lb. per load).

Flexible Cycle:

Reusable rigid or semi-rigid non-lumen medical devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors;

Single channel flexible endoscopes with flexible lumens that are ≥ 1.00 mm ID and ≤ 1280 mm long; and Dual channel flexible endoscopes with flexible lumens that are ≥ 0.80 mm ID and ≤ 1000 mm long.

(Refer to the HC 80TT User Manual for complete instructions on load(s) and cycle(s), including chamber loading instructions (i.e. 25 lb. per load).

Halyard ONE-STEP* Sterilization Wrap is comprised of two sheets of Halyard Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a three layer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with phthalocyanine blue pigment, titanium dioxide pigment, and antistatic treatment. The wrap allows a sterilized package to be opened aseptically.

The acceptance criteria and device performance for the Halyard ONE-STEP* Sterilization Wrap are presented below based on the provided text.

Acceptance Criteria and Reported Device Performance

Analysis of the Study to Prove Device Meets Acceptance Criteria:

1. Sample Size and Data Provenance:
   The document does not explicitly state the specific sample sizes used for each test. The studies were bench tests, meaning they were conducted in a laboratory setting. There is no information regarding country of origin or whether the data was retrospective or prospective in the sense of human subject studies, as these tests are for a sterilization wrap's performance.

2. Number of Experts and Qualifications for Ground Truth:
   Not applicable. These are performance tests for a medical device (sterilization wrap), not diagnostic AI tools requiring expert interpretation. The "ground truth" is based on objective microbiological and physical test results, not expert consensus.

3. Adjudication Method:
   Not applicable, as this is related to expert review of diagnostic results, which is not relevant for this type of device performance testing.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   Not applicable. This is not an AI-powered diagnostic device, and therefore, no MRMC study comparing human readers with and without AI assistance was conducted.

5. Standalone Performance Study:
   Yes, the studies reported are standalone performance tests of the Halyard ONE-STEP* Sterilization Wrap. The document states, "Performance of Halyard ONE-STEP* Sterilization Wrap... has been evaluated to show that all results of testing met acceptance criteria..." These tests assess the device's ability to allow sterilization and maintain sterility.

6. Type of Ground Truth Used:
   The ground truth used for these tests is based on objective microbiological assays (demonstration of no growth of challenge microorganisms) and physical integrity assessments (maintenance of package integrity).

7. Sample Size for Training Set:
   Not applicable. This device is a physical product (sterilization wrap), not an AI algorithm that requires a training set.

8. How Ground Truth for Training Set was Established:
   Not applicable, as no training set was used.

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