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. Removing supra and subgingival calculus deposits and stains from the teeth
Periodontal pocket lavage with simultaneous ultrasonic tip movement .
Scaling and root planing .
. Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
. Plugging for amalgam condensation
Amalgam burnishing ●
. Preparing, cleaning, and irrigating root canals
. Preparing approximal cavities
Cementing inlays and onlays .
. Retrograde preparation of root canals

Device Description

The miniMaster is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls and displays, ultrasonic generator, and a bottle-fed irrigation system. A 2-step footswitch is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord, with irrigant flow control located on the cord itself. Instruments designed for specific dental procedures are attached to the distal end of the handpiece.
Two versions of the miniMaster will be commercially distributed in the US, one with and the other without the capability for dry work.

AI/ML Overview

This document, K050710, is a 510(k) premarket notification for a medical device called the "miniMaster Ultrasonic Scaler." It seeks to demonstrate substantial equivalence to a legally marketed predicate device, the EMS Kermit (K992504).

Based on the provided text, the acceptance criteria and study information are as follows:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria or a specific table with reported performance metrics in the format typically seen for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, EMS Kermit. The performance is assessed against the predicate's known and cleared capabilities.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence: The miniMaster must have the same intended uses as the predicate device.	"The intended uses of the proposed miniMaster and predicate EMS Kermit are identical."
"All of the procedures for which the miniMaster is indicated were cleared for use with the EMS Kermit."
Fundamental Scientific Technology Equivalence: The modifications should not alter the fundamental scientific technology.	"These modifications do not alter the intended use or fundamental scientific technology of the device."
Safety and Effectiveness: The modified device must be safe and effective for its indicated uses.	"The appropriate design verification and design validation activities were conducted to address the potential risks associated with the modified device that were identified in the Risk Analysis. The results confirm that the modified miniMaster is safe and effective for the dental and periodontal cleaning, preparatory, and restorative procedures listed in Section 8."
Functional Performance Equivalence: The modifications should lead to improved functional performance and ease of use without introducing new safety/effectiveness concerns.	"The modifications made to the parent EMS Kermit to produce the proposed miniMaster were implemented to improve the functional performance and ease of use of the ultrasonic scaler."
"The similarities in intended use, technical specifications, and functional performance between the miniMaster and the parent EMS Kermit lead to a conclusion of substantial equivalence between the proposed and parent devices."

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

The document does not describe a test set or data provenance in the context of an AI/ML algorithm evaluation. This is a traditional medical device submission, not an AI/ML device submission. The "study" here refers to Design Verification and Design Validation activities.

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

This information is not applicable/not provided as this submission is not for an AI/ML device requiring expert-established ground truth.

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

This information is not applicable/not provided as this submission is not for an AI/ML device requiring adjudication of a test set.

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:

This information is not applicable/not provided. This is not an AI-assisted device.

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

This information is not applicable/not provided. This is not an AI algorithm.

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

Given this is a physical medical device (ultrasonic scaler), the "ground truth" for its performance would implicitly be:

Clinical Efficacy: Whether the device effectively performs the stated dental procedures (removing calculus, scaling, root planing, etc.) as demonstrated through design validation. This is likely assessed by direct observation, measurement, and comparison to established best practices and the predicate device's performance.
Safety: Absence of adverse events or undue risks, assessed through risk analysis and testing.

The document refers to "design verification and design validation activities" as the basis for confirming safety and effectiveness, but it doesn't detail the specific methodology or "ground truth" sources in the way an AI/ML submission would.

8. The sample size for the training set:

This information is not applicable/not provided. This is not an AI/ML device and therefore does not have a "training set."

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

This information is not applicable/not provided. This is not an AI/ML device.

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