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To be used by dental professionals for dental cleaning and periodontal(gum) therapy to remove calculus from the teeth.

EVOCLEAN CLEANsert Ultrasonic Insert is used with EVOCLEAN Ultrasonic Scaler that was cleared under K201317. It is used by dental professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth. EVOCLEAN CLEANsert Ultrasonic Inserts are available in three models (ELITE IF-50 Universal Slim, PRO IF-50 Universal Slim and CLASSIC P-10 Universal). Each model has two oscillating frequencies (25KHz and 30KHz), three different grip sleeves and two water supply methods (internal/external). EVOCLEAN CLEANsert Ultrasonic Insert consists of a Tip, a Magnetostrictive stack, an Inner O-ring, a Grip sleeve and an Outer O-ring. CLASSIC P-10 Universal has an external water tube.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: EVOCLEAN CLEANsert Ultrasonic Insert

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

This submission (K210832) is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a legally marketed predicate device (Hu-Friedy Satin Swivel Ultrasonic Insert, K012060). The bulk of the proof that the device meets acceptance criteria comes from non-clinical testing and a comparison of technical characteristics to the predicate device, rather than a traditional clinical study with human patients.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of human subjects or cases for AI. The "test sets" here refer to samples of the device and its components used for engineering, material, and sterilization validation. Specific quantities of inserts or materials tested in these non-clinical studies are not provided in the summary.
   • Data Provenance: The tests were conducted by TTBIO CORP. or their contracted labs. The provenance is internal (Taiwan, where the company is located) and pertains to manufactured devices/materials, not patient data.

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

   • Not applicable in the context of establishing ground truth for a diagnostic AI model. The "ground truth" here is defined by the technical standards (ISO, AAMI, FDA guidance) and the performance of the predicate device. Expert involvement would be in the form of engineers, material scientists, and microbiologists conducting and interpreting the non-clinical tests. Their specific numbers and qualifications are not detailed in this summary.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as this is not a diagnostic imaging study or a clinical trial requiring human expert adjudication of cases. The "adjudication" is based on meeting predefined engineering specifications, material biocompatibility standards, and validation protocols outlined in recognized international standards.

4. 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:

   • No MRMC study was done, as this device (an ultrasonic insert for dental scaling) does not involve AI assistance or human "readers" in the context of diagnostic interpretation.

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

   • Not applicable, as this is a physical medical device, not an AI algorithm. Its performance is evaluated through its physical characteristics, material safety, and functional capabilities.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" is established by:
     • Industry Standards: ISO 18397:2016 (functions), ISO 10993-1, -5, -10 (biocompatibility), ISO 17665-1 (sterilization).
     • Regulatory Guidance: AAMI TIR30 and FDA Reprocessing Guidance (cleaning and sterilization validation).
     • Performance Equivalence: Demonstrating that the subject device's performance (e.g., flow of cooling liquid, extraction/insertion force, frequency, and amplitude) is comparable to or meets the requirements implied by the predicate device and safe clinical use.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI that would require a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this device.

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