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The REXAM Fracture Resistant Pouch is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. 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 Fracture Resistant 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 predicate device and the REXAM Fracture Resistant Pouch are constructed of sterilizable kraft paper sealed to the polypropylene surface of a polyester-polypropylene plastic film lamination. Three sides of the pouch are sealed during manufacture. There are two versions of the REXAM Fracture Resistant Pouch: (1) a final heat seal closure of the paper and plastic film laminate components, and (2) a final self-seal closure employing a pressure sensitive self-seal tape assembled on the paper component and sealed to the polyester layer of the plastic film laminate. Both types of final closures are applied by the health care provider.

A chemical sterilization process indicator for steam or ethylene oxide sterilization, or both, may be incorporated to monitor exposure to the sterilant.

Here's an analysis of the REXAM Fracture Resistant Pouch based on the provided text, outlining the acceptance criteria and study details:

This document is a 510(k) summary for a medical device, the REXAM Fracture Resistant Pouch. It's important to note that the type of "acceptance criteria" and "study" discussed here relate to the performance characteristics of the physical medical device (a sterilization pouch), not to the performance of an AI/ML algorithm. Therefore, many of the questions related to AI/ML studies (like MRMC studies, standalone AI performance, ground truth establishment for AI, and expert qualifications for AI ground truth) are not applicable to this document.

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 a numerical "sample size" for the specific film property, seal strength, or fracture rate tests. It mentions "All analyses were performed at a 95% confidence level," which implies statistical testing, but the raw number of units tested is not provided.

• Sample Size: Not explicitly stated numerically.
• Data Provenance: The tests were conducted internally by REXAM Medical Packaging. The data is thus prospective in the sense that the tests were performed on the newly developed device. The country of origin for the data is implicitly USA as the manufacturer is based in Illinois, USA.

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

This question is not applicable. The "ground truth" for this physical device is based on objective, quantifiable physical and chemical tests (e.g., measuring tensile strength, seal strength, fracture rates, and biocompatibility through standardized methods like U.S. Pharmacopeia Agar Diffusion and Elution Testing) rather than expert interpretation of medical images or other subjective data. No human experts were required to "establish ground truth" in the way they would for an AI diagnostic algorithm.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for resolving discrepancies in human expert interpretation, often in diagnostic studies. The performance of this device was assessed through objective physical and chemical measurements; thus, no subjective adjudication was necessary.

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 question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document describes a physical medical device (a sterilization pouch) and its performance through material science and functional tests, not an AI system.

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

This question is not applicable. "Standalone performance" refers to the performance of an AI algorithm without human input. This document does not describe an AI algorithm or system.

7. The Type of Ground Truth Used

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

• Objective physical measurements: Tensile strength, puncture resistance, seal strength, fracture rates.
• Standardized chemical/biological tests: U.S. Pharmacopeia Agar Diffusion and Elution Testing for safety/biocompatibility.
  In essence, the ground truth is derived from established scientific and engineering testing standards and protocols for medical device materials and function.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this device is a physical product, not an AI/ML model that requires training data.

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

This question is not applicable for the same reason as above; there is no training set.

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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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