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ENDOCERVICAL CYTOLOGICAL CELL COLLECTOR BRUSH FOR PAP SMEAR.

ORIBRUSH - WITH PROTECTIVE TIP - B001

This document is a 510(k) clearance letter from the FDA for a medical device called "ORIBRUSH Cervical Brush Model B001 with protective tip." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The document is purely an administrative letter granting market clearance based on substantial equivalence, not a detailed report of device performance testing.

Therefore, I cannot extract the requested information from the provided text.

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ENDOCERVICAL CYTOLOGICAL CELL COLLECTOR BRUSH FOR PAP SMEAR.

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The provided text {0} and {1} is a 510(k) clearance letter from the FDA for a medical device called "ORIBRUSH™ Cervical Brush Model B002". Unfortunately, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The letter primarily focuses on:

• Confirmation of Substantial Equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices. This means it has similar intended use, technological characteristics, and performs as safely and effectively as a legally marketed device.
• Regulatory Classification: The device is classified as Class II, under 21 CFR §884.4530/Procode: 85 HHT.
• Marketing Authorization: The letter grants authorization to market the device, subject to general controls and, potentially, additional special controls if applicable.
• Indications for Use: The device is indicated as an "ENDOCERVICAL CYTOLOGICAL CELL COLLECTOR BRUSH FOR PAP SMEAR."

Therefore, I cannot provide the requested information in the structured format because the input text does not contain the necessary data points related to:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in the 510(k) submission itself (which is not provided) and summarized in a "Summary of Safety and Effectiveness" document. The FDA clearance letter is a summary of their decision regarding the submission, not a detailed report of the studies performed.

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