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

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K032995

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6. 510 (k) Summary of Safety and Effectiveness (revised)

510 (k) number K032995

Air Scaler SSS

[As required by 21 CFR 807.87 (h) ]

6.1 Submitter Identification

Establishment:

Owner / Operator Number:
Establishment Registration Number:
Telephone Number:
Fax Number:
Official Correspondent:
E-mail Address:
Date of Summary Preparation:

6.2 Product Identification

Device Trade Name: Classification Panel: Classification Name: Common Name: Product Code: Regulatory Class:

Micron Corporation 1-34-14, Higashiyukigaya Ota-ku, Tokyo, 145-0065 Japan 9037104 9614726 +81-3-3726-0396 +81-3-3726-5396 Takashi Terui (Mr.) terui@micdent.com November 13th, 2003

ਫੜ੍ Dental Scaler Ultrasonic, per 21 CFR 872.4850 Air Scaler ELC Class II
Models:

SSS 4H (with standard 4-hole coupling), product number 1072001 SSS 2H (with standard 2-hole coupling), product number 1072002

6.3 Identification of Legally Marketed Predicate Device

A - E P P P - S - S - S - S - S - S - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
Device	Manufacturer	510 (k) Number
Air scaler VIP 60	Micron Corporation	K991239

6.4 Device Description

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

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6. 510 (k) Summary of Safety and Effectiveness (revised)

Page 2/2

510 (k) number K032995 [As required by 21 CFR 807.87 (h) ] Micron Corporation Submitter/Manufacturer: 1-34-14, Higashiyukigaya, Ota-ku, Tokyo, 145-0065 JAPAN Air scaler SSS Product name:

6.5 Indications for Use

SSS is intended for the applications below in the area of dental treatment by dental professionals.

· Removal of dental calculus, plaque or stain

6.6 Description of Modification

The running noise of SSS is substantially reduced by applying vibration frequency of 16.000 to 17.000 Hz for increased comfort of the user and patient, while the predicate device has frequency of 5,000 to 6,000 Hz and emits audible noise. The vibration cartridge is redesigned so that the user can easily replace in his / her dental office.

6.7 Standards Met

ISO 15606 : 1999 - Dental handpieces -- Air-powered scalers and scaler tips 2) EN 1639 : 1996 - Dentistry - Medical devices for dentistry - Instruments 3) AAMI / ISO 14971-1 : 1998 - Medical Devices - Risk Management - Part 1: Application of risk analysis (General)

6.8 Summary of Design Control Activities

The risk analysis method to assess the impact of the modifications was based on a Failure Modes and Effects Analysis (FMEA).

This analysis built upon the risk analysis of the predicate device.

6.9 Substantial Equivalence Conclusion

The modified air scaler SSS has the following commonalities to its predicate device:

· the equivalent indication of use,
· the same operating principle applied,
· the same basic product design,
· conformity to the same and similar standards

Thus we believe the Micron SSS described in this submission has the substantial equivalence to the predicate device, submitter's VIP 60 air scaler.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

Micron Corporation Mr. Takashi Terui Manager, Overseas Division 1-34-14, Higashiyukigaya Ota-Ku, Tokyo, 145-0065 Japan

Re: K032995

Trade/Device Name: Air Scaler SSS Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: November 14, 2003 Received: November 17, 2003

Dear Mr. Terui:

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 (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Terui

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Shih-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):__k032995

Device Name: Air scaler SSS

This air scaler is intended to remove dental plaque, Indications For Use: calculus and stain from tooth surface or root by dental professionals only.

Susan Rump

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: IC-32043

(Please Do NoT WRITE Below This LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

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.