(234 days)
The ULTRA SYSTEM is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in ethylene oxide sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to facilitate placement of the enclosed surgical instruments.
The ULTRA SYSTEM is a reusable sterilization container system.
I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance results, or any study details.
The document is a 510(k) clearance letter from the FDA for a device called "ULTRA SYSTEM," which is a sterilization container system. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities. It also includes the "Indications for Use" for the device, listing its purpose and various container sizes.
However, it does not contain any of the following requested information:
- A table of acceptance criteria and the reported device performance: This document explicitly states that the FDA's issuance of a substantial equivalence determination "does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It simply allows the device to be marketed based on its equivalence to a predicate, not necessarily on performance against specific acceptance criteria presented in this letter.
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Therefore, I cannot fulfill your request for this information based on the provided text.
§ 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).