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The RectoSight® RS300-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.

The ProctoSight® PS310-04 device is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.

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I apologize, but the provided text from the FDA 510(k) summary for Re: K011825 RectoSight® RS300-04 and ProctoSight® PS310-04 does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a letter from the FDA confirming substantial equivalence for the device, based on the applicant's submission. It lists the indications for use but does not delve into the specifics of the performance studies or the acceptance criteria used in those studies.

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

1. A table of acceptance criteria and the reported device performance
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, and its effect size
6. If a standalone (algorithm only) 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

To answer these questions, I would need access to the actual 510(k) submission (Section 13 - Performance Data) from SightLine Technologies Ltd., which would detail the clinical and non-clinical studies performed to demonstrate substantial equivalence.

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