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Ultrasonic Applications for:

• All sub-gingival and supra-gingival scaling and routine prophylaxis procedures.
• Periodontal therapy

The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used.

The provided document is a 510(k) Premarket Notification for a medical device called the BioSonic US200 Ultrasonic Scaler, which is an ultrasonic scaling unit for dental procedures. It is a Class II device (Regulation Number 872.4850, Product Code ELC).

This document does not contain the specific acceptance criteria and detailed study results for a device that uses a test set for performance evaluation in the way typically expected for AI/ML-driven devices. This is because the BioSonic US200 Ultrasonic Scaler is a hardware device, not an AI/ML software device.

The "studies" referenced are non-clinical performance tests conducted to ensure safety and effectiveness in comparison to a predicate device, focusing on electrical and mechanical aspects, and material compatibility. There are no mentions of "test sets", "ground truth", "experts", "adjudication methods", "MRMC studies", or "standalone performance" in the context of assessing an algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill your request for items 1-9 based on the provided text, as those categories are not applicable to the type of device and submission described.

However, I can extract information about the type of tests performed and the general conclusion regarding acceptance criteria (though not specific numerical criteria for performance metrics).

Here's what I can extract regarding the device's testing and intended performance from the document:

General Acceptance Criteria and Reported Device Performance (as inferred from the document):

• Frequency testing (e.g., verifying 25kHz or 30kHz operation).
• Power testing.
• Tip displacement testing.
• Insert extraction testing. |
  | Material Compatibility | Materials compatibility testing with cleaning and disinfecting agents was performed. |
  | Substantial Equivalence to Predicate | The device's indications for use are identical to the predicate. Technological characteristics are substantially equivalent with minor differences (mechanism to change modes, automatic frequency detection, removable autoclavable sheath) that "do not constitute a new intended use or raise different questions of safety and effectiveness compared with the predicate." This is the overarching acceptance criterion for 510(k) clearance. |

Why the other requested information cannot be provided from this document:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a hardware device's non-clinical testing. "Test sets" in this context refer to electrical/mechanical measurements, not patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" usually refers to diagnostic accuracy in AI/ML, not the physical properties of an ultrasonic scaler.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable for this hardware device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm-only device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

This document solely concerns the FDA's 510(k) clearance of a traditional, non-AI medical device based on its physical and electrical performance and comparison to a predicate device.

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