(245 days)
The SteriTite® containers with FlashIlite® valve plate(s) are intended to be used in conjunction with MediTray basic tray for the flash sterilization of one instrument or instrument set.
The SteriTite container system with MediTray product are intended to be used to contain medical devices for steam sterilization. The full line of MediTray product is intended for complex customization in prevacuum steam sterilization. MediTray basic trays are intended to be used in the sealed container for sterilization in steam pre-vacuum and gravity sterilization. MediTray products may be used scoarately for sterilization when wrapped in FDA cleared medical grade wrappers.
The MediTray products include case/trays with lid and base, insert boxes, cassettes, trays, baskets, instrument racks, silicone mats, brackets, posts, partitions.
The SteriTite® container system consists of the SteriTite line of rigid reusable containers with an additional option of a FlashTite valve plate(s). The line features an assortment of container designs and sizes.
The MediTray product line includes instrument baskets, trays, and case/trays (incorporating a lid and base), organizing insert boxes, cassettes, trays, baskets, instrument racks, silicone mats, brackets, posts, and partitions designed to contain medical devices within sealed containers or to be wrapped.
SteriTite Containers with FlashTite valve plate(s) and MediTray products may be stacked.
The provided text describes a 510(k) summary for the "SteriTite® Rigid Sterilization Container System with FlashTite® valve plate(s) & MediTray Products." However, it does not contain specific acceptance criteria or a detailed study description with performance metrics in the format requested. The document states that "All acceptance criteria were met" and that "Results demonstrate that the product is in compliance with established standards and is validated for its intended use," but it does not elaborate on what those criteria were or present the specific results.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an attempt to answer the questions based only on the provided information, noting where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | All acceptance criteria were met. Results demonstrate the product is in compliance with established standards and is validated for its intended use. |
2. Sample size 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.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted at "independent laboratories," but no further details are given.
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)
- Not applicable. This device is for sterilization, not a diagnostic device requiring expert interpretation of ground truth in the same way as, for example, medical imaging. The "ground truth" would likely be based on objective sterility indicators or microbial assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study that would involve adjudication by experts in the typical sense.
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 a diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. However, performance studies were conducted on the device itself without human intervention being part of the primary performance metric.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for sterilization devices generally involves objective measures of sterility (e.g., biological indicators, chemical indicators, microbial assays) after sterilization cycles. The document states "Sterilization Performance studies were conducted," implying these types of objective measurements were used, but it does not specify the exact methods.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 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).