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Reliance® Fusion Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:

• . Pre-vacuum Steam 270°F/132°C for 4 minutes
  • Dry time of 12 minutes for Fusion Light O
  • Dry time of 20 minutes for Fusion Heavy O
  • Pre-vacuum steam sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.
• 100% Ethylene Oxide (EO) with a concentration of 725-759 mg/L @ 131°F/55°C and 40% 70% relative ● humidity for 60 minutes
  • Aeration time of 8 hours at 55oC O
  • Ethylene oxide sterilization of two stainless steel lumens 3 mm in diameter or larger and 400 mm in O length or less.

The Reliance® Fusion Sterilization Wraps are square or rectangular nonwoven sheets consisting of two layers of nonwoven ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices. The Fusion wraps consist of two distinct nonwovens for each layer.

Outer Layer: SMS nonwoven layer produced using a spunbond-meltblown-spunbond process and composed of polypropylene with blue pigment and an anti-static treatment.

Inner Layer: Wetlaid nonwoven, produced using a wood pulp process, composed of natural wood pulp and synthetic fibers bonded with a synthetic binder, containing green pigment and treated to impart hydrophilic properties.

The Reliance® Fusion Sterilization Wraps allow a sterilized package of medical devices to be opened aseptically and are supplied in a variety of sheet sizes ranging from 12 in. x 12 in. The Sterilization Wraps have no intended patient contact and are supplied non-sterile. They are for Single Use Only.

The provided text describes the regulatory clearance for the Ahlstrom-Munksjo Nonwovens LLC's Reliance® Fusion Sterilization Wraps (K230137), not an AI/medical imaging device. Therefore, the details requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test sets in AI studies, expert qualifications for ground truth in AI, MRMC studies, and training set details, are not applicable to this document.

This document focuses on the substantial equivalence of a physical medical device (sterilization wraps) to a predicate device, which is demonstrated through non-clinical performance data related to material science, sterilization efficacy, and biocompatibility.

Here's a breakdown of the information that is available in the document, framed in the context of the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria," but adapted for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comprehensive table in Section VII "PERFORMANCE DATA" detailing the tests performed, the standards followed, the acceptance criteria, and the results for both the predicate and proposed devices.

2. Sample size used for the test set and the data provenance:

The document does not specify exact sample sizes for each test. For a physical device like sterilization wraps, individual tests (e.g., sterilization efficacy, dry time, physical properties) would involve a certain number of units or replicates to demonstrate statistical validity. The provenance is not explicitly stated beyond being part of the manufacturer's non-clinical testing performed for regulatory submission. It is inherently "prospective" in the sense that these are specific tests conducted by the manufacturer for this submission, rather than retrospective analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as this is not an AI/medical imaging device. Ground truth in this context would be established by validated laboratory testing procedures and adherence to the specified standards (e.g., ISO, ASTM, AAMI).

4. Adjudication method for the test set:

This is not applicable as there are no human interpretations or judgments to adjudicate in the performance testing of a physical sterilization wrap. The results are quantitative measurements against defined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

This is not applicable as this is not an AI/medical imaging device that would involve human readers.

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

This is not applicable as there is no algorithm or AI involved. The "performance" is the physical functional performance of the wrap itself.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by validated laboratory testing methods against recognized industry standards (e.g., ANSI/AAMI, ISO, ASTM). For example:

• Sterilization Efficacy: Determined by the absence of microbial growth from biological indicators and test samples.
• Dry Time: Quantified by weight difference and visual assessment of moisture.
• Physical Properties: Measured using standardized mechanical and material testing methods (e.g., tensile strength, burst strength, air permeability).
• Biocompatibility & Residuals: Determined by laboratory assays per ISO standards.

8. The sample size for the training set:

This is not applicable as there is no training set for a physical medical device like this.

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

This is not applicable as there is no training set.

In conclusion: The provided document details the non-clinical performance testing of a physical medical device (sterilization wraps) to demonstrate substantial equivalence to a predicate device for FDA clearance. The acceptance criteria and "studies" are laboratory and physical tests, not AI model evaluations.

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