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The plate is a sterile non-pyrogenic, Embryotoxicity tested singleuse plasticware intended for preparing, manipulating or transferring gametes and embryos in group of the many of the in vitro fertilization techniques, and cell culture

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Based on the provided text, this document is a 510(k) clearance letter for the Nunc IVF Multidish 4 wells Nunclon. It's a regulatory approval document and does not contain the acceptance criteria or a study description of the type requested for an AI/CADe device.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. The FDA's review for such devices generally focuses on manufacturing, labeling, and other general controls, not on a detailed performance study as would be required for a novel AI/CADe system.

Therefore, I cannot provide the requested information from this document. It does not include:

1. A table of acceptance criteria and reported device performance: This document doesn't define performance criteria or report on device performance based on a study.
2. Sample size, data provenance: Not applicable to this type of regulatory submission.
3. Number/qualifications of experts, adjudication method: Not applicable.
4. MRMC comparative effectiveness study: Not conducted for this type of device.
5. Standalone performance study: Not conducted.
6. Type of ground truth used: Not applicable.
7. Sample size for training set, how training ground truth was established: Not applicable, as this is not an AI/ML device.

The "Indications for use" states that the device is "a sterile non-pyrogenic, Embryotoxicity tested single-use plasticware interface for preparing, handling, manipulating or transferring gametes or embryos in vitro in conjunction with many of the in vitro fertilization techniques, and cell culture." This describes the intended function of the laboratory dish itself, not the performance of an analytical or AI algorithm.

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