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The Hu-Friedy® brand Satin Swivel™ ultrasonic insert is similar to the predicate device with the addition of a swivel mechanism allowing for ease of rotational movement during dental cleaning procedures. This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth. The Satin Swivel™ ultrasonic insert has essentially the same internal design as the predicate device except for the addition of several stainless steel and resin components. The steel components enable the insert tip to swivel. The two different resin components allow for a positive grip for the dental professional and a smooth cone to tip transition for ease of use.

AI/ML Overview

The provided 510(k) summary for the Hu-Friedy® brand Satin Swivel™ ultrasonic insert describes its equivalence to a predicate device and includes information about performance evaluation. However, it does not contain detailed statistical acceptance criteria or a comprehensive study report in the format typically required for medical device AI/ML performance evaluation. This document is for a mechanical device, not an AI/ML device, so many of the requested categories (like number of experts, adjudication, MRMC, training sets) are not applicable.

Based on the provided text, here's a summary of the acceptance criteria and study as described, with an acknowledgment of the limitations due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as inferred)	Reported Device Performance / Conclusion
Laboratory Tests	Safe and effective performance in:	The device performed similarly or better than the predicate device.
Cleaning	Sufficiently cleanable (implies meeting hygiene standards)	Met clinical requirements.
Sterilization	Capable of being sterilized (implies meeting sterilization efficacy standards)	Met clinical requirements.
Mechanical Life Testing	Durable and functional over its expected lifespan (implies meeting durability standards)	Met clinical requirements.
Field Evaluation	Clinician satisfaction and effective performance in:	The overall conclusion was that both the Satin Swivel™ and the predicate device met their clinical requirements. Clinicians had complete control of the Satin Swivel™ ultrasonic insert, and it did not turn on its own while in use.
Scaling Effectiveness	Effective removal of calculus from teeth	Met clinical requirements.
Vibration	Acceptable levels of vibration during use	Met clinical requirements.
Water Delivery	Adequate and consistent water delivery for cooling and lavage	Met clinical requirements.
Swivel Function	Smooth and controlled rotational movement for ease of use without unintended turning	Met clinical requirements. Clinicians had complete control, and it did not turn on its own.
Grip	Secure and comfortable grip for the dental professional	Met clinical requirements.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as a numerical sample size. For the "field study," it mentions "clinicians were asked to evaluate the inserts." The number of clinicians or the number of cases/patients observed is not provided.
Data Provenance: The study was a "field evaluation," implying prospective data collection during actual clinical use by dental professionals. The country of origin is not specified, but the applicant is based in Chicago, IL, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not explicitly stated. The study involved "clinicians" evaluating the device. It implies multiple clinicians, but the exact number is not given.
Qualifications of Experts: They are referred to as "dental professionals" and "clinicians," indicating they are qualified to use and evaluate dental instruments. No specific years of experience or board certifications are mentioned.

4. Adjudication method for the test set

Adjudication Method: Not described. The text states that "clinicians were asked to evaluate the inserts." It appears to be a direct assessment by the clinicians without a formal adjudication process described for conflicting opinions. The "overall conclusion of this evaluation" suggests a consensus or summary of their findings, but no specific method like 2+1 or 3+1 is mentioned.

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

MRMC Study: No, an MRMC study was not conducted. This is not an AI/ML device, but a mechanical dental instrument. The comparison was between the new mechanical device and a predicate mechanical device, evaluated by clinicians.
Effect Size of AI: This is not applicable as the device does not involve AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a mechanical device, not an algorithm. The "laboratory tests" can be considered a form of standalone testing for the mechanical properties of the device itself (cleaning, sterilization, mechanical life).

7. The type of ground truth used

Ground Truth Type: For the field evaluation, the "ground truth" was established through expert opinion/assessment by dental professionals on the device's performance in real-world clinical use. For the laboratory tests, the ground truth would be based on established engineering and regulatory testing standards for cleaning, sterilization, and mechanical durability.

8. The sample size for the training set

Training Set Sample Size: Not applicable. As a mechanical device, it does not use machine learning, and therefore does not have a "training set" in the context of an AI/ML device.

9. How the ground truth for the training set was established

Training Set Ground Truth: Not applicable. No training set as it's not an AI/ML device.

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