(9 days)
The SupraShield® Express™ Sterilization Wrap is a device 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 steam or ethylene oxide (EO) sterilization processes.
The Allegiance SupraShield Express™ Sterilization Wrap is composed of a "SMS Sandwich type" - Spun Bonded) fabric.
The Allegiance Healthcare Corporation's SupraShield Express™ Sterilization Wrap undergone testing to ensure its safety and effectiveness. The summary of safety and effectiveness outlines the following:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (skin sensitization, intracutaneous reactivity, cytotoxicity) | Material was subjected to and passed skin sensitization, intracutaneous reactivity, and cytotoxicity testing. |
| Physical and Performance Testing (including sterilization performance) | All physical and performance testing was completed. The product is in compliance with established standards and deemed acceptable for its intended use. |
| Substantial Equivalence to Predicate Device (Convertors® Sterilization Wrap) | The Allegiance SupraShield™ Express™ Sterilization Wrap is substantially equivalent in: intended use, material composition, and performance attributes. |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for the test set or the specific data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the "material used in the composition of this sterilization wrap was evaluated and tested."
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.
4. Adjudication Method
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information about a multi-reader multi-case (MRMC) comparative effectiveness study is provided in the document. Therefore, no effect size of human reader improvement with AI assistance can be reported.
6. Standalone (Algorithm Only) Performance Study
This device is a physical product (sterilization wrap), not an algorithm or AI-based system. Therefore, a standalone (algorithm only) performance study is not applicable.
7. Type of Ground Truth Used
The ground truth for the performance of the sterilization wrap was established through compliance with established standards and physical and performance testing, including sterilization performance tooling. It also relied on demonstrating substantial equivalence to an existing predicate device (Convertors® Sterilization Wrap), implying that the predicate device's established safety and effectiveness served as a benchmark.
8. Sample Size for Training Set
As this is a physical medical device and not an AI/ML product, the concept of a "training set" in the context of machine learning is not applicable here.
9. How Ground Truth for Training Set Was Established
Similarly, as this is not an AI/ML product, there is no "training set" and therefore no ground truth established for it in that context. The "training" for this device would refer to its manufacturing process and quality control to meet the performance specifications.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, 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.(b)
Classification. Class II (performance standards).