(683 days)
A sterilization container system, 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 container system is intended to be used in prevacuum steam and ethylene oxide sterilization processes.
The Allegiance Genesis™ Container System is a reusable device which features an assortment of container designs and sizes, and Inner basket and platform types.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization performance | "all acceptance criteria were met." |
| Thirty-Day Event Related Shelf Life Sterility | "demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use." |
| Ninety-Day Event Related Shelf Life Sterility | "demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set. It also doesn't provide information about the data provenance (e.g., country of origin, retrospective or prospective nature).
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 information is not provided in the document. The studies conducted are described as "Sterilization performance studies" and "Thirty-Day and Ninety-Day Event Related Shelf Life Sterility tests," which typically involve laboratory testing against established standards rather than expert consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. The studies appear to be performance tests against objective standards rather than studies requiring human adjudication of results.
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
There is no indication of an MRMC comparative effectiveness study being done. The device is a sterilization container system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a physical sterilization container, not an algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The "sterilization performance studies" and "shelf life sterility tests" can be considered as standalone tests of the device's physical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "sterilization performance studies" and "shelf life sterility tests" would be based on established standards and scientific methods for sterility validation and shelf-life testing. These would likely involve microbiological assays (e.g., spore-kill assays for sterilization, microbial challenge tests for sterility maintenance) and physical testing to confirm integrity and barrier function over time. The document states that the product is "in compliance with established standards."
8. The sample size for the training set
This information is not applicable and not provided. The device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/machine learning product.
§ 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).