X-Smart Easy is designed for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).

Device Description

The X-Smart Easy is an electric motor-driven handpiece intended for root canal preparation procedures in endodontic industry.

AI/ML Overview

The provided text describes the 510(k) submission for the X-Smart Easy dental handpiece. However, it does not include information about specific acceptance criteria related to a numerical performance target (e.g., sensitivity, specificity, accuracy) for an AI/CAD/imaging device, nor does it detail a study designed to prove such criteria.

The document discusses non-clinical performance tests for safety and substantial equivalence, but these are not equivalent to a performance study for an AI algorithm.

Therefore, I cannot fulfill all parts of your request.

Here's what can be extracted based on the provided text, and what cannot:

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

Cannot provide. The document does not specify numerical acceptance criteria for clinical performance (e.g., accuracy metrics) for the device. It focuses on safety and electrical standards.

Acceptance Criteria	Reported Device Performance
Not specified for clinical performance/accuracy	Not specified for clinical performance/accuracy
Biocompatibility: Conformance to ISO 10993	All patient contact components demonstrated biocompatibility.
Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2 and IEC 61000-3-2	Conforms to IEC 60601-1-2 and IEC 61000-3-2.
Electrical Safety: Conformance to UL60601-1	Conforms to UL60601-1.
Substantial Equivalence: To predicate device K990682	Demonstrated equivalence of intended use, similar features, and technical characteristics.

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

Cannot provide. The document does not describe a "test set" in the context of data for an AI/CAD/imaging device. The performance testing mentioned is for electrical safety, EMC, and hardware/software functions, not for diagnostic accuracy on a dataset.

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

Cannot provide. Ground truth and expert adjudication are not applicable to the non-clinical tests performed for this device.

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

Cannot provide. Adjudication is not applicable here.

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

Cannot provide. This type of study is not mentioned as the device is a dental handpiece, not an AI-assisted diagnostic tool.

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

Cannot provide. Not applicable as this is a physical device, not an algorithm.

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

Cannot provide. Ground truth is not applicable in the context of the safety and electrical performance tests. The "truth" for these tests would be whether the device meets the specified engineering standards.

8. The sample size for the training set

Cannot provide. "Training set" is not applicable, as this is a physical device submission, not an AI/ML algorithm submission.

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

Cannot provide. Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document describes non-clinical performance testing rather than a clinical or AI-specific performance study. These tests were conducted to demonstrate the safety and effectiveness of the X-Smart Easy and its substantial equivalence to the predicate device (Prophy-Mate and Endo Mate Motor Handpiece, K990682).

Key areas of testing included:

Biocompatibility Testing: Performed in accordance with ISO 10993. All patient contact components were evaluated and found to demonstrate biocompatibility.
Electromagnetic Compatibility (EMC) and Electrical Safety: The device was tested for conformance to:
- UL60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety.
- IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility.
- IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits - Section 3: Limitations of Voltage Fluctuations.
  The device was found to conform to these standards.
Validation Testing: Included both hardware and software functions (details not specified beyond "validation testing").

Conclusion on Substantial Equivalence:

Based on these performance tests, the submitter concluded that the X-Smart Easy is substantially equivalent to the predicate device due to equivalence of intended use, similar features, and technical characteristics. The testing indicated that the device does not raise any new issues of safety, effectiveness, or performance.

Summary

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

Image /page/0/Picture/0 description: The image shows a partial view of the Dell logo. The letters "DE" are visible in bold, black font. The logo is simple and recognizable, representing the Dell brand.

K092614

DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 (717) 845-7511 {voice} (717) 849-4343 (fax) www.dentsply.com

DEC - 2 2009

510(k) Summary for X-Smart Easy

1. Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Contact Person:	Helen Lewis
Telephone Number:	717-849-4229
Fax Number:	717-849-4343

Date Prepared:

18 August 2009

Device Name: 2.
Proprietary Name: X-Smart Easy Classification Name: Dental Handpiece and Accessories 872.4200 CFR Number: Device Class: I EKX Product Code:
1. Predicate Device: Prophy-Mate and Endo Mate Motor Handpiece (K990682)
Description of Device: 4. The X-Smart Easy is an electric motor-driven handpiece intended for root canal preparation procedures in endodontic industry.
న్. Indications for Use:

X-Smart Easy is designed for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).

Description of Safety and Substantial Equivalence 6.

Technological Characteristics

Patient contact elements of the components found in X-Smart Easy have been used in legally marketed devices and/or were found safe for dental use.

DENTSPLY International | X-Smart Easy 18 August 2009

ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ

Image /page/0/Picture/21 description: The image contains the number 000015 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally.

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

Non-Clinical Performance

Biocompatibility Testing

Cytotoxicity, sensitization and irritation testing were performed in accordance with ISO 10993. All patient contact components demonstrated biocompatibility.

Electromagnetic Compatibility and Electrical Safetv

The X-Smart East conforms to UL60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety; IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility; and IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits - Section 3: Limitations of Voltage Fluctuations.

Conclusion as to Substantial Equivalence

The X-Smart Easy is substantially equivalent to the Prophy Mate and Endo Mate Handpiece (K990682) based on equivalence of the intended use, similar features and technical characteristics. Performance testing was performed to validate the safety and effectiveness of the X-Smart Easy, which included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions. The X-Smart Easy does not raise any new issues of safety, effectiveness, or performance of the product.

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

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 resembling a stylized caduceus or a family of three figures, with the central figure slightly taller than the others.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Helen Lewis Director DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

DEC - 2 2009

Re: K092614 Trade/Device Name: X-Smart Easy Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: November 24, 2009 Received: November 25, 2009

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 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.

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

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Division Director . Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

1092614 510(k) Number (if known):

Device Name: X-Smart Easy

Indications for Use:

X-Smart Easy is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).

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)

Kain Hurley for NSR

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Andelhoental Devices

510(k) Number:

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.