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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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied by Test Objective)	Reported Device Performance (Results)
Sterilant Penetration/Efficacy: Demonstrate effective sterilant penetration into instrument trays wrapped with the device, under half-cycle and worst-case lumen conditions, achieving a 10⁻⁶ SAL.	The Halyard SMART-FOLD* (H450, H650) Sterilization wrap demonstrated effective sterilant penetration into instrument trays wrapped with Halyard Health SMART-FOLD* (H450, H650) Sterilization Wrap after processing in the V-PRO maX low temperature sterilizer under half cycle condition in the V-PRO maX low temperature sterilizer, worst-case lumen cycle. (And achieved a 10⁻⁶ SAL following processing in a worst-case half-cycle, as noted in the Technological Characteristics Comparison section for both proposed and predicate devices).
Maintenance of 365-Day Package Integrity: Demonstrate that the device is an effective barrier for maintaining sterility of various sterilization loads for 30, 180, and 365 days after processing in the worst-case V-PRO 60 Low Temperature Sterilizer Lumen cycle, followed by an event-related shelf life study.	The Halyard SMART-FOLD* (H450, H650) Sterilization wrap demonstrated effective barrier using the simulated test pack for the best and worst-case weight wraps for maintaining the sterility of their contents for 30, 180, 365 days after processing in the worst-case V-PRO 60 Low Temperature Sterilizer Lumen cycle and followed by an event-related shelf life study. (Also explicitly stated 365 days passing results for all V-PRO models in Technological Characteristics Comparison section).
Material Biocompatibility: Demonstrate non-irritating and non-cytotoxic properties in accordance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).	The Halyard SMART-FOLD* (H450, H650) Sterilization wrap was found to be non-cytotoxic and non-irritant based on the conditions of these tests.
Physical Properties: Demonstrate passing results for various physical properties (bursting, air permeability, abrasion resistance, mass per unit area, flame resistance, water resistance, linting/cleanliness, tearing strength, breaking strength, seam failure, bacterial filtration efficiency).	The physical properties testing met the acceptance criteria and demonstrated passing results for the Halyard SMART-FOLD* (H450, H650) Sterilization wrap.

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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