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The Polar Wand Cryotherapy System is indicated for the endoscopic ablation of tissue in the gastrointestinal tract.

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The provided text is a 510(k) clearance letter from the FDA for the Polar Wand Cryotherapy System. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. These details are typically found in the 510(k) submission itself, not in the clearance letter issued by the FDA. The clearance letter only confirms that the FDA has reviewed the submission and found the device to be substantially equivalent.

Therefore, I cannot provide the requested table or answer the specific questions based solely on the provided text.

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The Polar Wand Cryotherapy System is used for ablation of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and gastroenterology. The system may be used with a variety of cryogens, e.g. carbon dioxide, nitrous oxide, argon, krypton.

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I am sorry, but the provided text is a 510(k) clearance letter for the Polar Wand Cryotherapy System. It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies related to its effectiveness. The document is solely a regulatory approval for marketing the device.

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IS INDICATED FOR ENDOSCOPICALLY MARKING LESIONS IN THE GE TRACT MARKING LESTONS IN CONSTITUTIONATES WHEN THE REQUIRE SURGICAL REMOVAL WITHIN (30) THEFTY DAYS .

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves a device meets such criteria.

The document is a letter from the FDA to "Chek-Med Systems, Inc." regarding their "Spot Endoscopic Marker" device. It is a 510(k) premarket notification letter, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Information about sample sizes, data provenance, or the number/qualifications of experts.
3. Adjudication methods.
4. A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
5. A standalone performance study.
6. The type of ground truth used.
7. Information about training set size or how its ground truth was established.

The letter primarily concerns the regulatory approval status of the device based on substantial equivalence and general controls provisions of the Act.

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