The ATR Surgical Micromotors are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors consist of a microprocessor control unit, foot pedal, electric micromotor, support rods and sterile irrigation tubes. The microprocessor unit also houses the peristaltic pump. The ATR Surgical Micromotors provide electronic control of velocity and torque. The ATR Surgical Micromotors can be programmed and retains up to five programs in memory. The ATR Surgical Micromotors are also fully operational from the foot pedal. The foot pedal not only controls the functions of the ATR Surgical Micromotors, but it can also be used for programming.

AI/ML Overview

The provided text describes a medical device submission (510(k)) for the ATR Surgical Micromotors. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study proving the device meets those criteria.

Here's an analysis of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the text. The document states: "The ATR Surgical Micromotors were subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the ATR Surgical Micromotors conformed to applicable emission, immunity and electromagnetic compatibility standards in accordance with EN and IEC regulations. Results of the testing showed that the ATR Surgical Micromotors perform as intended."

This is a summary statement that mentions testing against standards but does not list specific acceptance criteria (e.g., "torque must be within X +/- Y Nm") nor does it provide quantitative results for each criterion. It only gives a general conclusion that the device "perform[s] as intended."

2. Sample Size Used for the Test Set and Data Provenance

Not provided in the text. The document mentions "performance bench testing" and "physical performance studies" but does not specify the sample size of devices tested or any data provenance (e.g., country of origin, retrospective/prospective). This is typical for bench testing where the 'sample' might refer to the number of units tested, but it's not detailed here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/provided in the text. Ground truth is usually established for studies involving human interpretation or clinical outcomes. This document describes bench testing of a mechanical device (surgical micromotor), not a diagnostic or AI-driven system that would require expert-established ground truth for its performance evaluation.

4. Adjudication Method for the Test Set

Not applicable/provided in the text. See #3. Adjudication methods (like 2+1, 3+1) are relevant when multiple experts provide opinions on data (e.g., images), and a consensus is needed to establish ground truth for evaluating an AI or diagnostic tool. This is not the type of study described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC study was NOT done. This type of study would compare human readers' performance with and without AI assistance. The ATR Surgical Micromotors are a mechanical device for surgery, not an AI-driven diagnostic or interpretative tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. The device is a surgical micromotor, not an algorithm. The performance described is of the physical device itself.

7. The Type of Ground Truth Used

Given the nature of the device (a surgical micromotor), the "ground truth" for its performance would be established by engineering specifications, physical measurements, and compliance with industry standards (e.g., EN and IEC regulations). The text states it "conformed to applicable emission, immunity and electromagnetic compatibility standards" and "perform[s] as intended" based on these bench tests.

8. The Sample Size for the Training Set

Not applicable/provided in the text. Training sets are used for machine learning algorithms. The ATR Surgical Micromotors are a microprocessor-driven mechanical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. See #8.

In summary, the provided document focuses on establishing substantial equivalence for a physical medical device (a surgical micromotor) through bench testing against industry standards, rather than evaluating an AI or diagnostic tool that would involve ground truth established by experts, MRMC studies, or training sets.

Summary

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

SECTION 14: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

14.1 SUBMITTER INFORMATION

a. Company Name:	Advanced Technology Research
b. Company Address:	Via Giovanni Verga, 751100 Pistoia ITALY
c. Company Phone:Company Facsimile:	39 (0) 573 364 25439 (0) 573 364 002
d. Contact Person:	Sandra GiustiPresident
e. Date Summary Prepared:	April 21, 1999

DEVICE IDENTIFICATION 14.2.

a. Trade/Proprietary Names:	ATR 3000, ATR 2000, Implant-Pro
b. Classification Name:	Dental Handpiece and Accessories21 CFR 872.4200

14.3 IDENTIFICATION OF PREDICATE DEVICE

Company	Device	510(k) No.	Date Cleared
MicroMotors	Dynasurg Electric Handpieceand Irrigation System	K911068	05/15/91

14.4 DEVICE DESCRIPTION

The ATR Surgical Micromotors are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors consist of a

・

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

microprocessor control unit, foot pedal, electric micromotor, support rods and sterile irrigation tubes. The microprocessor unit also houses the peristaltic pump. The ATR Surgical Micromotors provide electronic control of velocity and torque. The ATR Surgical Micromotors can be programmed and retains up to five programs in memory. The ATR Surgical Micromotors are also fully operational from the foot pedal. The foot pedal not only controls the functions of the ATR Surgical Micromotors, but it can also be used for programming.

14.5 SUBSTANTIAL EQUIVALENCE

The ATR Surgical Micromotors are substantially equivalent to the Dynasurg Electric Handpiece and Irrigation System in commercial distribution by Micro Motors.

The fundamental technical characteristics of the ATR Surgical Micromotors are similar to those of the predicate device and are listed on the comparison charts provided in this 510(k) submission. The ATR Surgical Micromotors and the predicate device consist of a control unit, electric micromotor, footswitch and irrigation system. The ATR Surgical Micromotors and the predicate device have adjustable speeds, torque and reduction rates, and are programmable. The micromotor of the ATR Surgical Micromotors and the predicate device is autoclavable.

14.6 INTENDED USE

The ATR Surgical Micromotors are intended for the preparation of intraoral bone for implantology procedures.

14.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the ATR Surgical Micromotors with the predicate device is provided within this submission. The ATR Surgical Micromotors are programmable and retain the programs in

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

memory. The ATR Surgical Micromotors have adjustable speeds and torque that are related to the reduction rate of the handpiece selected. The device has an automatic shut off safety feature in the event that the dynamic resistance of the bone exceeds the set torque value. The ATR Surgical Micromotors can be fully programmed and operated using the foot pedal.

14.8 PERFORMANCE DATA

The ATR Surgical Micromotors were subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the ATR Surgical Micromotors conformed to applicable emission, immunity and electromagnetic compatibility standards in accordance with EN and IEC regulations. Results of the testing showed that the ATR Surgical Micromotors perform as intended.

14.9 510(K) CHECKLIST

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized graphic of three abstract human figures in profile, arranged in a row. The figures are connected by flowing lines that suggest movement or connection. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1999

Advanced Technology Research, S.A.S. Ms. Carol Patterson, Consultant for Advanced Technology Research, S.A.S. Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, CA 92630

Re : K991401 Advanced Technology Research ATR Surgical Trade Name: Micromotors Regulatory Class: I Product Code: EFB Dated: October 28, 1999 Received: October 29, 1999

Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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

Page 2 - Ms. Patterson

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

If you desire specific advice for your device on our labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATION FOR USE

510(k) Number:	To Be Assigned By FDA K991401
Device Name:	ATR Surgical Micromotors
Indications for Use:	The ATR Surgical Micromotors are intended to prepareintraoral bone for implantology procedures.

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

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
------------------	-----------------------------------------------------------------------------------------

(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)	Susan Runser
Division of Dental, Infection Control, and General Hospital Devices	CONFIDENTIAL
510(k) Number	K991401

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.