The E-STATIS type 40 dental system is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.

The E-STATIS 40 System is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. The system provides control for motorized handpieces by converting pneumatic output from the dental treatment center to permit the operation of electrically driven dental handpieces.

Device Description

The E-STATIS type 40 Electric Motor System is designed for use in various dental procedures including dental restoration, prophylaxis and endodontics. The system is comprised of a power supply, control unit, hose and a brushless micro motor.

The control unit is equipped with five customizable endo settings including torque control, with the option of auto-stop, auto-forward and auto-reverse-forward. In addition, there are also three standard customizable operative modes. All E-STATIS components are modular and can be placed wherever the operator chooses.

The inputs to the control unit are supplied by a control panel with touch screen operation. The touch-sensitive screen has clear, user friendly symbols and provides individual selection and usage of the parameters to the individual needs of the dentist. The touch pad is removable and can be mounted either internally or externally on the dental unit.

AI/ML Overview

Here's an analysis of the provided text regarding the E-STATIS 40 System, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary for a medical device (E-STATIS 40 Electric Motor System). A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as might be found in a PMA (Premarket Approval) submission. Therefore, some of the information requested, particularly regarding clinical study details like sample sizes, expert qualifications, and specific efficacy metrics, is not typically included or required in a 510(k) submission of this nature.

However, I will extract and infer information relevant to your request based on the available text.

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format for a clinical study. Instead, the "performance" discussed relates to the engineering and functional specifications of the device, which are typically verified through validation testing.

Table of Acceptance Criteria and Reported Device Performance (Inferred/Summarized):

Acceptance Criteria (Implied)	Reported Device Performance
Rotational Speed Range	100 - 40000 rpm
Rotational Direction	Clockwise and counter-clockwise direction
Torque Measurement	Performance testing conducted to evaluate torque measurements
Electrical Safety	Testing conducted in accordance with recognized standards
Electromagnetic Compatibility (EMC)	Testing conducted in accordance with recognized standards
Software Validation/Verification	Validation verification testing of the software conducted
Intended Use	Suitable for dental restoration, prophylaxis, and endodontic procedures
Operating Principles	Same as predicate devices
Technology and Design	Similar to predicate devices

Study Details:

Given the nature of a 510(k) for a dental handpiece, the "study" referred to is primarily performance testing (bench testing) and validation testing rather than a large-scale clinical trial.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the performance testing. For devices like this, the "sample size" would refer to the number of units tested. This information is typically detailed in internal validation reports, not in the 510(k) summary.
- Data Provenance: The testing was conducted by or for the manufacturer, SciCan, based in Toronto, Canada. The data is internal testing data. It is retrospective/prospective bench testing, not clinical data from patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to this type of submission. The "ground truth" for the device's functional performance (speed, torque, safety) is established by engineering specifications, recognized industry standards (e.g., for electrical safety, EMC), and material science principles, not by expert consensus on clinical cases.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for clinical studies where human interpretation of data (e.g., radiology images) requires consensus. For device performance testing, results are quantitative and objective.
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:
- No, this was not done. This device is a mechanical dental motor system, not an AI-assisted diagnostic tool. MRMC studies are specific to evaluating diagnostic accuracy and reader performance, commonly in imaging.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this was not done. This is not an algorithmic or AI-based device. Its performance is purely mechanical and electrical, designed to be used by a human dental professional.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing of this device is based on engineering specifications, industry standards, and validated measurement techniques. For example, the accuracy of the RPM measurement would be verified against traceable calibration standards. Software functionality would be verified against design requirements.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device. The device's operation is deterministic based on its hardware and programmed software, not learned from a dataset.
How the ground truth for the training set was established:
- Not applicable. As there is no training set.

Summary regarding the 510(k) context:

A 510(k) submission aims to demonstrate "substantial equivalence" to a predicate device. For mechanical and electrical devices like the E-STATIS 40 System, this primarily involves:

Showing the same intended use.
Having similar technological characteristics (e.g., operating principles, design).
Providing performance testing (bench testing) to ensure the device meets its own specifications and is safe and effective when compared to the predicate, often by referencing recognized standards (e.g., electrical safety, EMC).
Software validation to ensure the software performs as intended.

The document states, "Performance testing was conducted to evaluate the rotational speed and torque measurements of the devices. Testing was also conducted to validate the safety and efficiency of the device, including electrical safety, electromagnetic compatibility and validation verification testing of the software. Testing was conducted in accordance with recognized standards." This sentence summarizes the scope and nature of the "study" that supports the device meeting its functional requirements and, by extension, being substantially equivalent to its predicates.

Summary

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

1072

K090937

510(K) Summary

E-STATIS 40 SYSTEM

JUL 2 4 2009

Submitted by:	SciCan1440 Don Mills RoadToronto, Ontario CanadaM3B 3P9
Contact Person:	Brenda Murphy - Director of Regulatory Affairs(416) 446-2797
Date of Preparation:	March 23, 2009
Name of Device:	E-STATIS 40 Electric Motor System
Common name:	Controller, Foot, Handpiece and Cord
Classification name:	Dental Handpiece and Accessories
Predicate Device:	OPTIMA MX510(k) K042759	NuTorque510(k) K083252

Description of Device:

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

282

K090937

Intended use:

The E-STATIS type 40 dental system is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.

Technological Characteristics:

The micro motor has a rotation speed of 100 - 40000 rpm and can be rotated in a clockwise or counter clockwise direction. Performance testing was conducted to evaluate the rotational speed and torque measurements of the devices. Testing was also conducted to validate the safety and efficiency of the device, including electrical safety, electromagnetic compatibility and validation verification testing of the software.

Testing was conducted in accordance with recognized standards.

Substantial Equivalence:

Substantial equivalence was determined on the basis that the proposed device and the predicate devices were substantially equivalent in that they have the same intended use; the same operating principles; and a similar technology and design.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes extending from its wing, symbolizing service and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Brenda Murphy Director of Regulatory Affairs SciCan, Limited 1440 Don Mills Road Toronto, Ontario Canada, M3B 3P9

JUL 2 4 2009

Re: K090937

Trade/Device Name: E-Statis 40 System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: July 22, 2009 Received: July 23, 2009

Dear Ms. Murphy:

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. Murphy

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Runares

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

Enclosure

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

K090937

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

E-STATIS 40 System

Indications for Use:

Typical users of this system are trained dental professionals.

Prescription Use (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)

Office of Device Evaluation (ODE)

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

510(k) Number: K090931

SCICAN E-STATIS 40 SYSTEM

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.