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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.

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Ventilation tubes are indicated where cases of enstachian tube dysfunction fails to respond conventional therapy. This includes : Chronic otitis Media with effusion (serous , mucoid, or pur ulent). Recurrent acute ofitis Media . persistent high negative A record of with associated middle ear pressure, hearing conductive Symptomatic otalgia, vertige and for timmitas brangia, version of the tympanic membraine.

Tympanostomy Ventilation Tube-TVT 800

The provided text is a 510(k) premarket notification letter from the FDA regarding a Tympanostomy Ventilation Tube (TVT 800). It is a regulatory document addressing the substantial equivalence of this medical device.

This document does NOT contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies. It is a regulatory approval letter, not a device performance study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document confirms that the device is "substantially equivalent" to legally marketed devices, but it does not detail the specific performance metrics or studies used to determine this equivalence.

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