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The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes: hysteroscope, laparoscope, cystoscope, and colonoscope.

The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes: hysteroscope, laparascope, cystoscope, and colonoscope. The seal comes with 4 different size channels to accommodate different size instruments. They are: 0.6mm, 1.2mm, 1.6mm, and 2.0mm. The 4 different seals are marked with different colored bands: yellow (0.6mm seal), light pink (1.2mm seal), green (1.6mm seal), and blue (2.0mm seal).

The provided text is a 510(k) premarket notification letter from the FDA regarding the OBP Self-Sealing Endoscopic Seal. It determines the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the format requested. It describes the device, its intended use, classification, and regulatory information, but lacks detailed performance data, study methodologies, or expert validation information.

Therefore, I cannot fulfill the request for information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study 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

This type of detailed performance data and study information would typically be found in the full 510(k) submission, which is more extensive than this summary letter. The letter confirms substantial equivalence but does not present the underlying data from performance tests.

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