(354 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 STERRAD® 50, STERRAD® 100 and STERRAD® 100S, ethylene oxide and pre-vacuum sterilization processes.
The Allegiance Genesis™ STERRAD® Compatible Reusable Sterilization Container System is a reusable device which features an assortment of container designs and sizes, and inner basket and platform types.
The provided text describes the "Genesis™ STERRAD® Compatible Reusable Sterilization Container System" and its substantial equivalence to a predicate device, focusing on its intended use and performance in sterilization. However, the document does not contain specific acceptance criteria values in a table, detailed device performance metrics with numerical values, or descriptions of a study structured to prove a device meets those criteria with a specified sample size.
Therefore, I cannot fully complete the requested table or answer all questions as the specific data is not present in the provided text.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Criteria (Not explicitly stated with values) | Reported Device Performance (Summary) |
|---|---|---|
| Sterilization Performance (STERRAD®) | Ensure sterilization of enclosed medical devices | "All acceptance criteria were met." |
| Sterilization Performance (Ethylene Oxide) | Ensure sterilization of enclosed medical devices | "All acceptance criteria were met." |
| Sterilization Performance (Pre-vacuum) | Ensure sterilization of enclosed medical devices | "All acceptance criteria were met." |
| Shelf Life Sterility (30-day) | Maintain sterility of enclosed devices | "Results demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use." |
| Shelf Life Sterility (180-day) | Maintain sterility of enclosed devices | "Results demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "Sterilization Performance studies were conducted" and "Thirty-Day and One Hundred Eighty-Day Event Related Shelf Life Sterility tests were conducted," but does not provide the number of units or tests performed.
- Data provenance: Not explicitly stated (e.g., country of origin). The testing was conducted for the manufacturer, Allegiance Healthcare Corporation, a US-based company. The studies were likely performed domestically or at a contracted US-based laboratory. The document implies these were prospective studies conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The document only states that "all acceptance criteria were met" and "results demonstrate that this product is in compliance." It does not describe any expert adjudication process.
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:
- No MRMC comparative effectiveness study was done or mentioned. This device is a sterilization container, 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:
- This question is not applicable. The device is a physical sterilization container, not an algorithm or AI. The performance discussed is the physical ability of the container to facilitate sterilization and maintain sterility.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for sterilization performance and sterility maintenance would typically be established through laboratory testing using biological indicators, chemical indicators, and sterility testing according to established standards (e.g., AAMI, ISO). This would not necessarily involve expert consensus in the same way a diagnostic imaging study would, but rather adherence to validated scientific methods.
8. The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI or machine learning model.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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).