FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

As with its predicate device, SSS is an air scaler for use by dental professionals. The basic design of the predicate and modified devices are same: both are made in the shape of handpiece like dental turbines, used on a dental treatment unit and activated by compressed air delivered from the dental unit.

The common operation principle to the predicate is used in the modified device: When the compressed air runs into scaler's built-in vibratory cartridge, it generates elliptical movement of the scaling tip mounted.

The scaling tip movement removes dental calculus, plaque or stain from teeth.

AI/ML Overview

The provided text is a 510(k) summary for the Air Scaler SSS, a dental device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving performance against those criteria in the context of typical AI/ML medical device evaluations. The information provided is primarily about the device's design, intended use, and comparison to a predicate device, not performance metrics and studies as would be expected for an AI/ML device.

Therefore, I cannot extract the requested information in the format typically associated with AI/ML device evaluation. The document states that the device is an "Air Scaler SSS" for "Removal of dental calculus, plaque or stain" and is not an AI/ML powered device.

However, I can provide the available information relevant to regulatory submission for this non-AI dental device based on the provided text, while acknowledging that it doesn't align with the detailed performance study requests for an AI model.

Here's a breakdown of what can be extracted and what cannot be extracted given the nature of the device:

Cannot Be Extracted (as it's not an AI/ML device):

A table of acceptance criteria and the reported device performance (in terms of sensitivity, specificity, etc. typical for AI).
Sample sizes used for test sets and data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study or human reader improvement with AI.
Standalone algorithm performance.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

What is Available in the Document (Relevant to a traditional medical device submission):

The submission focuses on substantial equivalence to a predicate device, not on demonstrating performance against specific numerical acceptance criteria typical for AI. The "study" here is primarily a comparison to a predicate device and adherence to standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria for this device are focused on substantial equivalence to the predicate and compliance with standards, not performance metrics like accuracy or sensitivity.
The document implies that the device "meets" its purpose by being substantially equivalent to a legally marketed predicate device and by conforming to relevant standards.

Acceptance Criteria (Implicit from Submission)	Reported Device Performance
Substantial Equivalence to Predicate Device	The modified Air Scaler SSS has:

Equivalent indication of use
Same operating principle applied
Same basic product design
Conformity to the same and similar standards (These points demonstrate substantial equivalence to the predicate device, "Air scaler VIP 60," K991239, also manufactured by Micron Corporation). |
| Compliance with Relevant Standards | - ISO 15606: 1999 - Dental handpieces -- Air-powered scalers and scaler tips
EN 1639: 1996 - Dentistry - Medical devices for dentistry - Instruments
AAMI / ISO 14971-1: 1998 - Medical Devices - Risk Management - Part 1: Application of risk analysis (General) |
| Functional Improvements (without compromising safety/effectiveness) | - Running noise substantially reduced by applying vibration frequency of 16,000 to 17,000 Hz, increasing comfort for user and patient (predicate device had 5,000 to 6,000 Hz and emitted audible noise).
Vibration cartridge redesigned for easier replacement by the user in their dental office.
These are design modifications, with the implication that effectiveness for "Removal of dental calculus, plaque or stain" is maintained due to substantial equivalence. |
| Risk Management (Impact of modifications assessed) | - Risk analysis method: Failure Modes and Effects Analysis (FMEA), building upon the risk analysis of the predicate device. |
| Indications for Use (Must match predicate or be substantially equivalent) | - "Removal of dental calculus, plaque or stain" (Stated as equivalent to predicate). |

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

Not applicable / Not explicitly stated. This device is an air scaler, a mechanical device. Performance testing would likely involve engineering tests (e.g., vibration frequency measurements, noise levels, material compatibility, durability) rather than a "test set" of clinical data in the way an AI model would be evaluated. The documentation refers to design control activities and risk analysis based on FMEA, not a clinical "test set" with patients.

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 in the context of an AI device typically refers to expert labels on data. For this mechanical device, "ground truth" would relate to its physical specifications and performance against engineering standards, not expert interpretations of clinical images or data.

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

Not applicable. Adjudication methods are used to resolve disagreements among human experts labeling data, which is not relevant for the evaluation of this device.

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. This device is a dental tool, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is a hardware device, not an algorithm.

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

Not applicable / Implicit in standards compliance. For a mechanical device like this, "ground truth" generally refers to physical measurements and specifications aligning with engineering standards and the device's functional design (e.g., vibration frequency measured at 16,000-17,000 Hz). The FMEA process identifies potential failure modes.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this device.

Summary

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is 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.(b)
Classification. Class II.