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The Allegiance BioShield® Express™ Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This wrap is intended for use in Ethylene Oxide and Gravity Steam Sterilization processes.

The Allegiance BioShield® Express™ Sterilization Wrap is composed of a wet formed non-woven cellulose fiber with acrylic binders.

This submission describes the Allegiance BioShield® Express™ Heavy & Super Duty Sterilization Wrap. The document provided is a 510(k) Premarket Notification, which is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than comprehensive clinical studies with acceptance criteria as one would find for a novel device.

The provided text does not contain the specific information required to complete all sections of your request, particularly regarding detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training data. This type of information is typically part of a comprehensive clinical study report, which is not fully described in this 510(k) summary.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria or performance metrics in a table. Instead, it relies on demonstrating equivalence to predicate devices and adherence to an ISO standard.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document states "Physical and performance testing was completed," but no details on the number of units or tests are provided.
• Data Provenance: Not specified. Given it's a 510(k) in the US, the testing would typically be conducted to meet US regulatory requirements, but the origin of the data (e.g., country where tests were run) is not detailed. It is retrospective in the sense that the testing was completed prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable and not provided. The ground truth for this device is established through laboratory testing against established physical, chemical, and biological standards (e.g., ISO 10993, sterilization efficacy). There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation by multiple human readers (e.g., radiologists for medical images). This device is a sterilization wrap, and its performance is assessed through laboratory tests.

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 device is a medical product (sterilization wrap), not an AI or imaging diagnostic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.

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

Not applicable. This is not an algorithm or an AI device. The "standalone performance" would refer to the physical and biological performance of the wrap itself, which was tested.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance is based on:

• Established standards: Compliance with ISO Standard 10993 Part 1 for biocompatibility.
• Laboratory test results: Objective measurements from physical (e.g., strength, porosity), chemical, and biological tests (e.g., cytotoxicity, sterilization efficacy validations).
• Predicate device performance: The performance of the predicate device serves as a benchmark for equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning device that requires a "training set."

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

Not applicable. This device is not an AI/machine learning device that requires a "training set."

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