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The Rexam Self-Seal Tyvek® Pouch is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider using a sterilization process where a non-cellulose pouch is indicated. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

The chemical process indicator on the Rexam Self-Seal Tyvek® Pouch is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

The Rexam Self-Seal Tyvek® Pouch is constructed of medical grade Tyvek® sealed to polyethylene/polyester film. A chemical sterilization process indicator may be incorporated to monitor one or more of the sterilization process parameters. The final seal of the pouch is applied by the health care provider using the pressure sensitive self-seal tape closure. The self-seal tape closure facilitates manual sealing as an alternate method to heat sealing.

This document describes a sterilization pouch (Rexam Self-Seal Tyvek Pouch) and its comparison to a predicate device, focusing on its ability to maintain sterility and the effectiveness of its self-seal tape closure. It does not describe an AI medical device, but rather a physical sterilization product. Therefore, many of the requested categories related to AI device studies (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, data provenance) are not applicable.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the "study" that proves the device meets them, while acknowledging the non-AI nature of the device.

Acceptance Criteria and Device Performance for Rexam Self-Seal Tyvek Pouch

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The text mentions "the seal strength test results were statistically analyzed" and "performed as well as the Medi-Oxide™ Pouch on the seal integrity tests," implying a test set was used, but the specific number of pouches tested is not provided.
• Data Provenance: Not explicitly stated. Given the context of a 510(k) submission, it is assumed to be internal testing conducted by Rexam Medical Packaging. It is retrospective in the sense that the testing was performed and then the results were submitted.

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

• Not Applicable: This is a physical device where performance (seal strength, seal integrity) is measured through objective, quantifiable tests, not subjective interpretation requiring human experts for ground truth establishment.

4. Adjudication Method for the Test Set

• Not Applicable: As no human interpretation requiring adjudication was involved, this is not relevant.

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

• Not Applicable: This is not an AI device.

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

• Not Applicable: This is not an AI device. The tests performed ("seal strength" and "seal integrity") are inherently standalone in the sense that they assess the physical properties of the pouch without human intervention during the measurement, but this is a different context than AI standalone performance.

7. The Type of Ground Truth Used

• Objective Measurement (Physical Device Performance): The ground truth was established by direct physical measurements against predefined limits or comparative performance against a predicate device for properties like seal strength and seal integrity.

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI device, so there is no concept of a "training set" for an algorithm.

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

• Not Applicable: This is not an AI device, so there is no concept of a "training set" or ground truth establishment for it in this context.

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