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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:

1. 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.
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Therefore, I cannot fulfill your request for this information based on the provided text.

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The ULTRA SYSTEM SP™ is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in the STERRAD™ 50 and 100S Sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to feciliate placement of the enclosed surgical instruments. The maximum load is 8.35 pounds in the STERRAD™ 50 or 16.70 pounds in the STERRAD™ 100S. A maximum of Junens may be sterilized in each load.

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This letter is a 510(k) clearance for a sterilization wrap (specifically, a reusable sterilization container system), not an AI/ML device. Therefore, the detailed questions about acceptance criteria, study design, and performance metrics related to AI/ML devices are not applicable.

The document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used (pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

This is a regulatory clearance for a physical medical device, not a software or AI/ML product.

Ask a specific question about this device