The Air Solfy can be used to remove calculus deposits from teeth by application of an air-powered vibrating scaler tip from the teeth during dental cleaning and periodontal therapy.
The Air Solfy is a dental air-powered handpiece scaler and tips that can remove calculus deposits from the teeth by application of an air-powered vibrating scaler tip to the teeth during dental cleaning and periodontal therapy.

Device Description

This device receives energy resorces in handpiece such as air for high speed air turbine, cooling water for scaling and light source for illumination, through the tubes connected to a dental unit.
The cooling water is fed on the part of scaling treatment through pouring holes.
Air Solfy is classified into the model as is shown below Table-1 from the variations of connection, light or power adjuster.

AI/ML Overview

This is a 510(k) premarket notification for a dental scaler, a medical device. The document states that the device, "Air Solfy," is substantially equivalent to a legally marketed predicate device, the "Siroair L air" from Sirona Dental System, Inc. (K#033812).

It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel claims of efficacy or safety through new clinical studies. Therefore, the information you're asking for, such as acceptance criteria based on device performance, sample sizes for test and training sets, and details about ground truth establishment, is typically not required or provided in this type of submission for a Class I device like a dental handpiece. The acceptance criteria here are primarily about meeting existing standards and having comparable performance to the predicate device.

Let's break down what is available in the provided text:

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

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate device, Siroair L. The "reported device performance" is essentially that the Air Solfy performs in a "similar" manner to the predicate and complies with relevant international standards.

Acceptance Criteria (Implicit)	Reported Device Performance (Air Solfy)
Indication for use: Identical to predicate	Identical to predicate (remove calculus deposits from teeth)
Target population: Identical to predicate	Identical to predicate (patients requiring dental cleaning/periodontal therapy)
Design: Similar to predicate	Similar
Materials: Similar to predicate	Similar
Performance: Similar to predicate (as per ISO 15606:1999)	Similar (complies with ISO 15606:1999)
Sterility: Similar to predicate	Similar (Autoclavable models available)
Biocompatibility: Similar to predicate	Similar
Mechanical safety: Similar to predicate	Similar
Chemical safety: Similar to predicate	Similar
Anatomical sites: Similar to predicate	Similar
Human factors: Similar to predicate	Similar
Energy used and/or delivered: Similar to predicate	Similar (air-powered, cooling water, light source)
Compatibility with environment and other devices: Similar to predicate	Similar (connects to dental unit via tubes, specific couplings)
Where used: Identical to predicate	Identical (dental cleaning and periodontal therapy)
Standards met: Similar to predicate	Similar (complies with ISO 15606:1999)
Electrical safety: Similar to predicate	Similar
Thermal safety: Not applicable (for both)	Not applicable
Radiation safety: Not applicable (for both)	Not applicable

The critical "study" or evidence provided is the declaration that "Air Solfy is in compliance with ISO 15606:1999" (a standard for dental air-powered scalers) and the direct comparison to the predicate device, showing "similar" or "identical" characteristics with "minor differences" that "do not raise new questions of safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no mention of a "test set" or specific clinical study with human or animal subjects in the provided text for the Air Solfy itself. The submission relies on demonstrating compliance with standards and equivalence to a predicate device.

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. As noted above, there's no mention of a "test set" or ground truth established by experts for a new study of the Air Solfy's performance.

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

Not applicable. No test set mentioned.

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 mechanical dental scaler, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The ground for acceptance is primarily the device's compliance with established international standards (ISO 15606) and its proven substantial equivalence to an already legally cleared device. No specific "ground truth" derived from patient data is described for the Air Solfy itself.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, no training set is relevant to this device's submission.

Summary

{0}------------------------------------------------

K043497

510(k) SUMMARY

J. MORITA MFG. CORP.'s Air Solfy

Name of Device and Name/Address of Sponsor

Trade or Proprietary Name:	Air Solfy AS series(AS-4H/ AS-4H-O/ AS-4H-V/ AS-4H-OV andAS-1/ AS-1-O/ AS-1-V/ AS-1-OV)
Common Name:	Dental scaler
Classification Name:	Dental Handpiece and accessories (21CFR872.4200)
Product Code :	EFB ("Handpiece, Air-powered, Dental)
Registration No. 2081055	Registration No. 3002807636

Initial Distributor:	Manufacturer:
J. Morita USA, Inc.	J. MORITA MFG. CORP.
9 Mason	680 Higashihama Minami-cho
Irvine, CA 92618	Fushimi-ku, Kyoto
USA	Japan 612-8533
Telephone:	949-581-9600
	+81-75-611-2141
Facsimile:	949-581-9688
	+81-75-605-2354

Intended Use

The Air Solfy can be used to remove calculus deposits from teeth by application of an air-powered vibrating scaler tip from the teeth during dental cleaning and periodontal therapy.

Technological Characteristics and Substantial Equivalence

This device receives energy resorces in handpiece such as air for high speed air turbine, cooling water for scaling and light source for illumination, through the tubes connected to a dental unit.

The cooling water is fed on the part of scaling treatment through pouring holes.

Air Solfy is classified into the model as is shown below Table-1 from the variations of connection, light or power adjuster.

{1}------------------------------------------------

ml:11	€11

Table-1	Model of Air Solfy
---------	--------------------

			( - : not included )
Model	Connection	Light	PowerAdjuster	Autoclave
AS-1	They can be	-	-
AS-1-O	connected to the	Included	-	Autoclavable
AS-1 V	MORITA original	-	Included
AS-1-O V	a joint.	Included	Included
AS-4H	They can be	-	-
AS-4H-O	connected to the	Included	-	Autoclavable
AS-4H V	CP4 or CP4-O	-	Included
AS-4H-O V	coupling. NOTE-1	Included	Included

NOTE-1 CP4 or CP4-O is the ISO9168 type C coupling.

Air Solfy covered by this submission is substantially equivalent to other legally marketed device. Specifically, Air Solfy is substantially equivalent to the Siroair L air marketed do from Sirona dental syatem , Inc(K#033812). Air Solfy has similar general seater "from Birona contraciples of operation, and similar technological characteristics as the previously cleared predicate device, Siroair L air scaler.

Although we cannot compare specifications of them minutely as we have not obtained Andrough Tre Sailfor sons of Siroair L, but we are able to figure out the specifications und equivalence as there exists a common international standard on the dental airand equivaliere of ISO 15606. Air Solfy is in compliance with ISO 15606:1999.

The Air Solfy's substantial equivalence to Siroair L is demonstrated at Comparison Summary Table as below.

Although there are minor differences in the characteristics of Air Solfy and its predicate device, these differences do not raise new questions of safety or effectiveness.

{2}------------------------------------------------

FDA file reference number	510k numberK033812
Attachment inside notification submission file	510k FDA
TECHNOLOGICALCHARACTERISTICS	Comparison result
Indication for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Similar
Sterility	Similar
Biocompatibility	Similar
Mechanical safety	Similar
Chemical safety	Similar
Anatomical sites	Similar
Human factors	Similar
Energy used and/or delivered	Similar
Compatibility with environmentand other devices	Similar
Where used	Identical
Standards met	Similar
Electrical safety	Similar
Thermal safety	Not applicable
Radiation safety	Not applicable

Substantial Equivalent comparison table

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it, representing medicine and health. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2005

J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. 11th Floor Washington, DC 20005

Re: K043497

Ro43477
Trade/Device Name: Air Solfy Air Powered Dental Handpiece Scaler and Tips Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: March 3, 2005 Received: March 4, 2005

Dear Mr. Barritt:

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 included a or 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 approvisions 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 Eederal Register.

{4}------------------------------------------------

Page 2 - Mr. Barritt

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled of a basean and many of the with other requirements mean that I DA has made a determinations administered by other Federal agencies. of the Act of ally I edelar statues and registered.
You must comply with all the Act s requirements, including, but not limited to: registration 1 out must comply with an any labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Patt 607), labeling (21 CFR Part 820); and if requirents as set forth in the quality byocans (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) I mis letter will anow you to begin maliering of substantial equivalence of your device to a premiarket notification. THE I D. I mails 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), IT you desire specific advice for Jour at (240) 276-0115. Also, please note the regulation in prease contact the Other or Somphise or premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miernational and Consumer Assistance at its toll-free Driston 01 01 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runne
Chiu 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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K043497

AIR SOLFY AIR POWERED DENTAL HANDPIECE SCALER AND TIPS Device Name: Indications For Use:

The Air Solfy is a dental air-powered handpiece scaler and tips that can remove calculus deposits from the teeth by application of an air-powered vibrating scaler tip to the teeth during dental cleaning and periodontal therapy.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruane

11 0. 201

; (2010) Par

Page 1 of 1

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.