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Used to enclose another medical device that is to be sterilized. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the device until used. ArjoRad Sterilization Wraps will maintain sterility for a maximum period of thirty (30) days. Intended for use with STERRAD 100S, NX, and 100NX Systems.

ArjoRad Sterilization Wrap is a sterilization packaging system consisting of one SMS sheet to be double wrapped during use. ArjoRad Sterilization Wrap will be sold in a non-sterile condition in packaged form of various sizes depending on the needs of the end user.

The ArjoRad Sterilization Wrap is a sterilization packaging system. The performance testing detailed in the provided 510(k) summary demonstrates its substantial equivalence to the predicate device (K092167 - Kimguard one step sterilization wrap - Kimberly - Clark Corporation) and its ability to meet acceptance criteria for maintaining sterility and allowing sterilant penetration.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size" in terms of number of wraps tested for each physical property or sterility test. However, it implicitly refers to "performance testing" and "studies" being carried out.

• Data Provenance: The studies were conducted by Arjo Wiggins Medical to demonstrate substantial equivalence to a legally marketed predicate device (Kimguard one step sterilization wrap). The testing would typically be performed in a controlled laboratory setting. No country of origin for data is specified, but it originates from the manufacturer for submission to the US FDA. The studies are prospective in nature, designed specifically to evaluate the performance of the ArjoRad Sterilization Wrap against established standards and a predicate device.

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

This information is not provided in the summary. For a physical device like sterilization wrap, "ground truth" is typically established through adherence to recognized international standards (e.g., EN, ASTM) and validated test methodologies rather than expert consensus on a test set in the way a diagnostic algorithm might require. The "experts" would be the scientists and engineers conducting the tests in accordance with these standards.

4. Adjudication Method for the Test Set

This concept is not applicable in the context of testing a physical device like sterilization wrap. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers when establishing ground truth for diagnostic studies, particularly in medical imaging. For device performance testing, results are determined by objective measurements against predefined acceptance criteria from standards.

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 as the device is a sterilization wrap, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This is not applicable as the device is a physical sterilization wrap, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance of the ArjoRad Sterilization Wrap is based on:

• Objective Measurements against Industry Standards: Physical properties (tensile strength, burst, tear, air permeability) are measured against criteria defined in standards like EN 868-2:2009 and ASTM D737.
• Validated Test Methodologies: Microbial aerosol challenge tests and sterilization efficacy studies follow validated protocols to demonstrate germ resistance and sterility assurance levels (SAL).
• Comparability to Predicate Device: The performance data is explicitly compared to a legally marketed predicate device (K092167) to establish substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical product and does not involve a "training set" in the context of machine learning or AI algorithms.

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

This is not applicable for the same reason as above (not an AI/ML device). The "ground truth" for the development and validation of the sterilization wrap would involve materials science, engineering principles, and adherence to regulatory and industry standards for medical device manufacturing and sterilization.

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ArjoWrap 47/100 and ArjoWrap 47/88 models are single use, non-sterilization wraps intended to be used by healthcare facilities to wrap other medical devices for terminal sterilization by steam or ethylene oxide. ArjoWrap 47/100 and ArjoWrap 47/88 maintain the sterility of the enclosed devices until they are used.

ArjoWrap 47/100 and ArjoWrap 47/88 are not recommended for any type of irradiation sterilization.

ArjoWrap is a sterilization wrap to be used by healthcare facilities to wrap other medical devices for terminal sterilization by steam or ethylene oxide. The ArjoWrap product is composed of two materials and will be offered two different weights. Each weight will be markcted in twelve sizes.

This 510(k) summary does not contain the information required to populate the acceptance criteria and study details. This document is a premarket notification for a sterilization wrap (ArjoWrap) and focuses on demonstrating substantial equivalence to a predicate device (Sterisheet Sterilization Wrap).

The provided text details:

• Device Description: ArjoWrap is a sterilization wrap made of two materials, available in two weights and twelve sizes.
• Intended Use: For wrapping other medical devices for terminal sterilization by steam or ethylene oxide, maintaining sterility until use. Not for irradiation sterilization.
• Substantial Equivalence: Claimed based on equivalent intended use, manufacturing materials, operating principles, and physical, operational, and biological specifications compared to the predicate device K931202.

Crucially, there is no mention of:

• Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or performance metrics for a diagnostic device).
• Any performance study with a test set, ground truth, or expert review. This type of submission (for a sterilization wrap) typically relies on material properties testing and comparative analysis to a predicate device rather than clinical performance studies involving interpretation by experts.
• Algorithms, AI assistance, or human-in-the-loop performance. This is a medical device (sterilization wrap), not an AI/ML diagnostic or assistive tool.

Therefore, I cannot fill out the requested table and study details from the provided text. The submission type and device being described do not generate the kind of information asked for in your prompt (which is typically related to AI/ML diagnostic or image interpretation devices).

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