Search Results

The ClearView™ Endoscope Cover System is indicated as a one time use sterile jacket, placed over a medical Otolaryngology or Rhinological endoscope, during examination procedures, conducted by trained medical professional. It is designed and sized to fit on to specific manufactures' endoscope models.

Flexible Endoscope Barrier Sheath.

The provided text is a 510(k) premarket notification approval letter for the "Clearview Endoscope Cover" and does not contain detailed information about acceptance criteria or specific study results that prove the device meets such criteria. A 510(k) summary (which is a separate document typically submitted with the 510(k) application) would generally contain this type of performance data if it were required for substantial equivalence.

Based on the provided text, the device is a Flexible Endoscope Barrier Sheath (ClearView™ Endoscope Cover System). The FDA's letter indicates that they have reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, meaning it does not require a full Premarket Approval (PMA). This type of approval often relies on demonstrating that the new device meets the same performance characteristics as an already approved predicate device, or that any differences do not raise new questions of safety and effectiveness.

Therefore, I cannot provide the requested information from the given text alone. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
6. Information about a standalone (algorithm only) 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.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the application likely contained information (e.g., in a 510(k) summary) that demonstrated the device's performance, but those details are not present in this approval letter itself.

Ask a specific question about this device