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510(k) Data Aggregation
(50 days)
The Ultrasonic Scaler is intended to be used by a dental hygienist for use during dental cleaning to remove calculus deposits from the teeth.
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The provided document is a 510(k) clearance letter from the FDA for an "Ultrasonic Scaler." This letter grants clearance for the device to be marketed based on its substantial equivalence to a predicate device. However, it does not contain a description of the acceptance criteria nor a study that proves the device meets specific acceptance criteria.
The information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance, training set details) is typically found in the summary or detailed reports of the studies submitted to the FDA as part of the 510(k) application, not in the clearance letter itself. The clearance letter only states that the FDA has reviewed the submission and found the device substantially equivalent.
Therefore, I cannot provide the requested information because it is not present in the given text. The relevant sections of the document are:
- {0} and {1}: These sections are the FDA clearance letter, which approves the device for marketing. They mention the device name, regulation number, product code, and the basis for clearance (substantial equivalence to a predicate device).
- {2}: This section provides the "Indication for Use" for the Ultrasonic Scaler, stating it's intended for dental hygienists to remove calculus deposits from teeth during dental cleaning.
To answer your questions, one would need to review the actual 510(k) submission document or a summary thereof, which would detail the performance studies conducted.
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