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The AEI Dr. Terauchi Ultrasonic Tips are intended for use by dental professionals for endodontic root preparation procedures. The Ultrasonic Tips can remove soft and hard tissue from a narrow dentinal structure in order to make space for permanent filling material in the canal. They can also assist in the removal of separated instruments or other intra-canal blockages.

The AEI Ultrasonic Tips are an accessory to a Piezo ultrasonic hand piece and unit. These external power supplies are not part of the device submitted for application with the 510(k) submission. The Ultrasonic Tips with a concave spoon shape or straight tip are very small and will not cut significant amounts of dentin during use. The AEI Ultrasonic Tips will be available in M3x0.6 thread with 5 different types of tip design to facilitate reaching specific angles and directions in the root of the tooth.

Here's an analysis of the provided text regarding the AEI Ultrasonic Tips, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance

• Same technological characteristics
• Same operating principle
• Similar design features
• Same connection capabilities to piezoelectric ultrasonic generator
• Same material |

Study Information:

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

   • The document mentions "Clinical evaluations were conducted outside the US." It does not specify the sample size of these clinical evaluations (test set) nor specific countries of origin. It indicates these were clinical evaluations, implying prospective data collection.

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

   • This information is not provided in the document.

3. Adjudication method for the test set:

   • This information is not provided in the document.

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. This is a medical device (ultrasonic tips), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not applicable and was not conducted.

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

   • No. This is a medical device (ultrasonic tips), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not conducted.

6. The type of ground truth used:

   • For the safety and effectiveness aspect, the "clinical evaluations" performed likely used clinical outcomes and observations by dental professionals as the ground truth.
   • For substantial equivalence, the "ground truth" was established by direct comparison of the device's technical specifications and intended use against those of the predicate device.

7. The sample size for the training set:

   • This is not applicable as this isn't an AI/machine learning device. The "training" for such a device would be its design and manufacturing process to meet specifications.

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

   • This is not applicable as this isn't an AI/machine learning device. The design and manufacturing process would be guided by engineering principles and standards relevant to dental instruments.

Summary of the Study:

The document primarily relies on the concept of substantial equivalence to an already cleared predicate device (DENTSPLY ProUltra® Endo Tips, K200880). The "study" proving the device meets the acceptance criteria is detailed as:

• Non-Clinical Testing: This was not conducted as a separate mechanical test, as substantial equivalence was based on a direct comparison of indications, intended use, and materials. The report explicitly states: "Mechanical testing was, therefore, not conducted."
• Clinical Testing: "Clinical evaluations were conducted outside the US and showed that the devices were safe and effective for the proposed indications." No details are provided regarding the methodology, sample size, or specific outcomes of these evaluations.

Essentially, the bulk of the "proof" for regulatory approval hinges on the numerous similarities between the AEI Ultrasonic Tips and the predicate device, implying that since the predicate device is safe and effective, and the new device is substantially similar, it too should be considered safe and effective. The clinical evaluations served as a corroborating factor for safety and effectiveness.

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An ultrasonic scaling system is used by dental professionals as a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth. This device is contraindicated for children and adults with synthetic teeth. This device should not be used on patients or by users who have a pacemaker.

XP TECHNOLOGY Ultrasonic Scaler

This document is a 510(k) premarket notification letter from the FDA for an ultrasonic scaler, not a study report. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to existing, legally marketed devices to allow its sale, rather than requiring a new, independent study to prove specific performance criteria were met.

The document includes:

• Trade/Device Name: XP TECHNOLOGY Ultrasonic Scaler
• Indications For Use: "An ultrasonic scaling system is used by dental professionals as a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth." It also lists contraindications for children and adults with synthetic teeth, and for patients/users with pacemakers.

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
6. Information about a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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