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HALYARD® SMART-FOLD Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

• Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 30 minutes.
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 110° F/43.3ºC.

STERIS V-PRO® Low Temperature Sterilization Systems.

• · STERIS® V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS® V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS® V-PRO® 1 (Lumen Cycle)

• · STERIS® V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)

• · STERIS® V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)

• · STERIS® V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle)

• Advanced Sterilization Products STERRAD® Sterilization System

• STERRAD® 100S

• · STERRAD® NX®, (Standard Cycle, Advanced Cycle)

• · STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)

• · STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GL Cycle)

• STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, EXPRESS Cycle, DUO Cycle, ULTRA GI Cycle)

HALYARD* ONE-STEP, QUICK CHECK and SEQUENTIAL Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600.

• · 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 43.3℃.
  · STERIS V-PRO® Low Temperature Sterilization Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles.

• · STERIS V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS V-PRO® s2 (Lumen, Non-Lumen and Flexible Cycles)

• · STERIS V-PRO® 1 (Lumen Cycle)

• · STERIS V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)

• · STERIS V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)

• · STERIS V-PRO® maX 2 (Lumen, Non-Lumen and Flexible Cycle)

· Gravity steam at 250°F/121°C for 30 minutes (25 minute dry time for Models 100, 200 and 30 minute dry time for Models 400, 500 and 600)

• · Advanced Sterilization Products STERRAD® Sterilization System
• · STERRAD® 50, 100S, and 200
• · STERRAD® NX®, (Standard Cycle, Advanced Cycle)
• · STERRAD® NX® with ALLClear® Technology, (Standard Cycle, Advanced Cycle)
• · STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle)
• · STERRAD® 100NX® with ALLClear® Technology, (Standard Cycle, EXPRESS Cycle, DUO Cycle)
• · STERILUCENT® HC80TT Sterilization Cycles (Lumen and Flexible Cycles)
• · Stryker Sterizone® VP4 Sterilizer Cycle 1

HALYARD SEQUENTIAL Sterilization Wrap is supplied to the customer as bulk packages of single sheets, where in accordance with standard hospital practices, two sheets are then used to wrap a medical device or a collection of medical devices for sterilization. HALYARD ONE-STEP, HALYARD QUICK CHECK and HALYARD SMART-FOLD Sterilization Wraps are comprised of two sheets of HALYARD* SEQUENTIAL Sterilization Wrap. This allows for convenient wrapping with two sheets simultaneously.

The HALYARD ONE-STEP, QUICK CHECK and HALYARD SMART-FOLD Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider.

The document describes the regulatory submission for HALYARD sterilization wraps. It focuses on demonstrating substantial equivalence to a predicate device through performance testing. No AI/ML algorithm is involved in the device. Therefore, a complete response is not possible for all aspects of your request.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the test sets of each specific test. It refers to validation loads and specific lumen configurations used in testing, but not the total number of items tested for each criterion. The data provenance is not specified, but the testing would typically be conducted in a laboratory setting under controlled conditions. It's prospective testing as it's for a new or modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the device is a sterilization wrap, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. The "ground truth" for this type of device is established through scientific and engineering standards for sterility and material properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable since there is no human interpretation or subjective assessment involved that would require an adjudication method. The tests are objective and based on measurable physical and chemical properties.

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/ML software or a device that impacts human reader performance.

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.

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

The ground truth for this device is based on established scientific and regulatory standards for sterilization assurance, material performance, biocompatibility, and residual levels. This includes:

• Sterility Assurance Level (SAL): A 10^-6 SAL is a universally accepted standard for sterilization, meaning there is a 1 in 1,000,000 chance of a non-sterile item.
• Physical Properties: Standards like ISO 11607-1, ISO 13938-2, ASTM D4966-12, and CPSC 1610 define acceptable limits for the physical integrity and strength of packaging materials.
• Biocompatibility: ISO 10993 series standards define acceptable levels for cytotoxicity, irritation, and sensitization to ensure the materials are safe for patient contact.
• Residuals: Specific thresholds for residual sterilants (e.g., H2O2, EtO, ECH) are defined by ISO standards and validated for safety.

8. The sample size for the training set

This is not applicable as the device is a physical product and does not involve AI/ML requiring a training set.

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

This is not applicable as the device is a physical product and does not involve AI/ML requiring a training set with established ground truth.

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