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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

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HALYARD SMART-FOLD Sterilization Wrap (H450 and H650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products STERRAD 100NX Sterilizer ULTRA GI Cycle.

The H450 and H650 models of the HALYARD SMART-FOLD Sterilization Wrap have been validated for use with the STERRAD 100NX ULTRA GI Cycle as follows:
• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions of ≥1mm inner diameter x ≤1500mm in length, or ≥2mm inner diameter x ≤1630mm in length.
• One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle

Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.
Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes

The HALYARD SMART-FOLD Sterilization Wrap (H450, H650) is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.

Halyard 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 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 SMART-FOLD Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using the Advanced Sterilization Products, Inc. (ASP) STERRAD 100NX Sterilizer ULTRA™ GI Cycle.

The provided text describes the performance testing for the HALYARD* SMART-FOLD* Sterilization Wrap (H450 and H650).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for each test. The data provenance is not explicitly mentioned as a country of origin, nor is it stated whether the data is retrospective or prospective. These are non-clinical (laboratory) tests by their nature.

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

This section is not applicable as the tests performed are non-clinical, performance-based, and biocompatibility assessments, which rely on defined technical standards and measurements rather than expert human interpretation of complex data (like image analysis).

4. Adjudication Method

This section is not applicable for the same reasons as point 3.

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 section is not applicable. This submission is for a medical device (sterilization wrap), not an AI/software as a medical device (SaMD). Therefore, no MRMC study or AI-related effectiveness assessment was conducted.

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

This section is not applicable for the same reasons as point 5.

7. The Type of Ground Truth Used

For the tests conducted, the "ground truth" is defined by the technical standards and specifications outlined in the referenced ISO, AAMI, ASTM, and CPSC documents. For instance:

• Sterilant Penetration/Efficacy: The ground truth is a sterility assurance level (SAL) of 10$^{-6}$. This is an objective measurement based on microbiological testing.
• Performance Testing: The ground truth is compliance with specified physical properties (e.g., tensile strength, tear resistance as defined by the standards).
• Maintenance of Package Integrity: The ground truth is the ability to maintain sterility for up to 90 days, which is determined through microbial barrier testing and accelerated aging studies.
• Biocompatibility: The ground truth is material properties meeting non-cytotoxic, non-irritating, and specific residual level criteria, evaluated through chemical extractions and biological assays.

8. The Sample Size for the Training Set

This section is not applicable as the device is a physical sterilization wrap and does not involve machine learning or AI models with training sets.

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

This section is not applicable for the same reasons as point 8.

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HALYARD SMART-FOLD* Sterlization Wap (H450, H650) is intended to enclose and is to be sterlized by a healthare provider using Steris V-PRO Low Temperature Sterilization system. The wrap was validated in the following pre-programmed cycles:

• STERIS V-PRO 1 low temperature sterilization system (lumen cycle),
• STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle),
• STERIS V-PRO maX low temperature sterilization system (Lumen cycle, flexible cycle), .
• STERIS V-PRO 60 sterilizer (Lumen, Non-Lumen cycle, flexible cycle)
• STERIS V-PRO maX 2 low temperature sterilization system (Lumen cycle, flexible cycle)
  HALYARD SMART-FOLD* Sterlization Wrap (H450, H650) is intended to allow terminal sterlization of medical devices using vaporized hydrogen peroxide (VHP) and to maintain sterilly of the enclosed within the period of time for which performance data demonstrating maintenance of sterility has been provided.

HALYARD SMART-FOLD* Sterlization Wrap is supplied in bulk to the customer as pre-shaped sterilization wap which is then used to wrap a medical device or a collection of medical devices for sterilization Wrap is compised of two preshaped sheets of HAL YARD* Sequential Sterilization Wrap. Each sheet is composed of a three-laver SMS (spunbond-meltblownspunbond) polypropylene fabric treated with an antistatic treatment.
The SMART-FOLD* Sterilization Wrap features reinforcement reference line, a white inner layer, sidetabs with closure strips and pull-tabs which allow for aseptic presentation of the sterilized medical device. The white same material composition but contains no blue pigment.

The provided text is a 510(k) Summary for a medical device (HALYARD SMART-FOLD* Sterilization Wrap), and it describes the device's acceptance criteria and the studies conducted to prove it meets those criteria. However, it is not an AI/ML device, so many of the requested fields related to AI/ML model validation (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable and therefore not present in the document.

Here's a breakdown of the information that is available, formatted to address your specific questions where possible.

Device Name: HALYARD SMART-FOLD* Sterilization Wrap (Models: H450, H650)
Device Type: Sterilization Wrap (not an AI/ML device)
Intended Use: To enclose medical devices for sterilization using Steris V-PRO Low Temperature Sterilization systems and maintain sterility until used.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests and their results, which essentially serve as the acceptance criteria and proof of performance for this non-AI medical device. The "acceptance criteria" are implied by the "passing results" of these tests.

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

The document does not explicitly state the sample sizes (e.g., number of sterilization wraps or test packages) used for each test. For example, for "Maintenance of 365-Day Package Integrity," it mentions "simulated test pack for the best and worst-case weight wraps" but not the quantity of these packs.

Data Provenance: The studies were conducted by the manufacturer, Owens & Minor Halyard, Inc., based in Alpharetta, GA (USA). The document does not specify if the testing was performed retrospectively or prospectively, but standard medical device validation studies are typically prospective.

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

Not Applicable. This is not an AI/ML device that requires human expert annotation for ground truth. The acceptance criteria are based on physical and biological laboratory tests.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML device, there are no "interpretations" that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

Not Applicable. This is not an AI/ML device, and no human reader effectiveness is being evaluated.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Laboratory Testing Standards: Adherence to established scientific and regulatory standards (e.g., ISO 10993 for biocompatibility, various ASTM and ISO standards for physical properties, and internal validation protocols for sterilization efficacy).
• Biological Indicators: For sterilization efficacy tests, the "ground truth" of sterility is typically determined by the absence of microbial growth in biological indicators after processing.
• Physical Measurements: For physical properties, the ground truth is direct measurement against pre-defined specifications.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device and does not have a "training set."

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

Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant to the provided document.

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