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The Silicone Vacuum Cup is to assist a clinician in delivery of an infant during childbirth.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (All Silicone Vacuum Suction) and does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The letter simply states that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The letter confirms substantial equivalence, not performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
6. If a standalone study was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document is a regulatory approval, not a clinical study report.

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