This 510(k) summary for the Axis System, a dental handpiece, does not contain the detailed information necessary to answer your request about acceptance criteria and study results.

Here's why:

Device Type: The Axis System is a dental handpiece, which is a mechanical device. The concept of "acceptance criteria" and "device performance" in the context of an AI/software device (which your questions are geared towards, e.g., sensitivity, specificity, ground truth, MRMC studies) is not directly applicable to this type of medical device.
Information Provided: The summary focuses on established safety and effectiveness through the prior use of its components and existing predicate devices (Rapidd Highspeed Dental Handpiece and eStylus Electric Motor System). It states, "All of the components found in the Axis System have been used in legally marketed devices and/or were found safe for dental use." It also mentions "performance data provided" and "biocompatibility information provided," but the specifics of what that performance data entails or what the acceptance criteria were for a mechanical device are not detailed within this summary.
Regulatory Pathway: This is a Class I device (Dental Handpiece and Accessories), which generally has a less stringent regulatory pathway compared to devices that diagnose or interpret medical images using AI. The 510(k) process for such a device primarily establishes substantial equivalence to a predicate device, focusing on similar indications for use and technological characteristics rather than requiring extensive clinical performance studies to meet AI-specific metrics.

Therefore, I cannot provide the requested table or elaborations on AI-specific study details because the provided document does not contain information relevant to an AI/software-as-a-medical-device (SaMD) product.

Summary

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K072989

510(k) SUMMARY

JAN 28 2008

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

CONTACT:

Helen Lewis

DATE PREPARED:

October 19, 2007

TRADE OR PROPRIETARY NAME: Axis System

CLASSIFICATION NAME:

Dental Handpieces and Accessories and 872.4200

PREDICATE DEVICES:

Rapidd Highspeed Dental Handpiece (K003518) eStylus Electric Motor System (K031145)

DEVICE DESCRIPTION: The Axis System consists of air-powered dental handpieces with an electronic accessory to limit the speed.

INTENDED USE: The Axis System is indicated for use in general dentistry.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in the Axis System have been used in legally marketed devices and/or were found safe for dental use.

We believe that the prior use of the components of Axis System in legally marketed devices, the performance data provided, and the biocompatibility information provided support the safety and effectiveness of Axis System for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Public Health Service

JAN 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K072989

Trade/Device Name: Axis System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: January 17, 2008 Received: January 22, 2008

Dear Ms. Lewis:

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 - Ms. Lewis

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

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

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INDICATIONS FOR USE

510(k) Number (if known):

1072989

Device Name: Axis System

Indications for Use:

The Axis System is an air-powered dental handpiece system indicated for use in general dentistry.

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

Over-The-Counter Use No (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)

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

510(k) Number:

Premarket Notification

Axis System

DENTSPLY International

000000

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.