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Bari-Kad™ is a device intended to protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening.

Bari-Kad™ Packing Device

The provided document is an FDA 510(k) clearance letter for the BioEnvelop Agro, Incorporated's "Bari-Kad™ Packing Device". This device is a dental product (rubber dam and accessories) intended to "protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening."

Based on the content of this regulatory letter, it is not a study report or clinical trial documentation. It primarily states:

• The FDA has reviewed the 510(k) premarket notification.
• The device is found substantially equivalent to legally marketed predicate devices.
• It outlines regulatory compliance requirements.
• It includes an "Indications for Use Statement."

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not provide any of the following information:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results (human readers improvement with/without AI).
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is a regulatory clearance notice, not a scientific study report. To find the information you're looking for, you would typically need to consult the original 510(k) submission summary or any clinical studies referenced within it (if any were required, which is less common for Class I devices like this one).

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