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The SCC-100 is indicated for the re-auachment of the bone flap after a craniotomy.

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I apologize, but the provided text only contains an FDA 510(k) clearance letter for the "SCC-100" device without any details about acceptance criteria or a study proving its performance. The letter simply states that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information, including:

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 results.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.

Sevrain Cranial Clamp 200 Series (Polyethylene)

I am sorry, but this document is an FDA 510(k) clearance letter for a medical device called the "Sevrain Cranial Clamp 200 Series." This type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not elaborate on the specific performance studies or data used to reach this determination.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device