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The Dream Cleans "S" Scaler and Dream Compact "S" scalers are hand held ultrasonic instruments used for removal of supragingival and subgingival calculus and stains from teeth. They are also used for periodontal scaling and root planing.

hand held ultrasonic instruments

The provided document is an FDA 510(k) clearance letter for the "Dream Cleans 'S' Scaler and Compact 'S' Scaler." This type of document does not contain information about acceptance criteria or detailed study results for device performance.

The 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness from scratch. It relies on a comparison of technological characteristics and indications for use.

Therefore, I cannot extract the requested information from this document. To answer your questions, one would typically need access to the 510(k) submission itself or a separate study report.

Here's why the document doesn't contain the requested information:

• Acceptance Criteria & Device Performance: The letter states that the device is "substantially equivalent" to a predicate device. It doesn't detail performance metrics or acceptance criteria for those metrics.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all elements of a detailed study design and results, which are not typically included in the final FDA clearance letter. The letter confirms a regulatory decision, not the scientific details of the submission's evidence.

In summary, based solely on the provided text, I cannot provide the requested details regarding acceptance criteria and the study that proves the device meets them because this information is not present in the FDA 510(k) clearance letter.

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