CST61 High Speed Turbine Handpiece is indicated for use intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth

Device Description

CST61 high speed turbine handpiece is an air-powered, hand-held device for use as an operative dental unit accessory at 250KPa with rotation speed of 250,000 RPM in order to perform cutting, shaping, grinding, and polishing functions.

AI/ML Overview

This document is a 510(k) summary for a dental handpiece, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not available in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are not novel.

Here's an analysis based on the information provided:

Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria or performance metrics. Instead, it claims substantial equivalence to a predicate device based on technological characteristics.

Acceptance Criteria	Reported Device Performance
Not specified (equivalence to predicate device)	"CST61 high speed turbine handpiece is an air-powered, hand-held device for use as an operative dental unit accessory at 250KPa with rotation speed of 250,000 RPM in order to perform cutting, shaping, grinding, and polishing functions." (Implied performance is equivalent to the predicate for these functions).

Sample size used for the test set and the data provenance:

Not applicable. This device is not analyzed using a "test set" in the context of an AI/ML study. Substantial equivalence is typically demonstrated through bench testing, performance testing, and comparison of specifications with a predicate device. The document does not mention any clinical trials or data sets for evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth establishment with experts is not part of the 510(k) pathway for a non-AI/ML device like a dental handpiece.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for interpretation tasks where expert consensus is needed to establish ground truth, which is not the case for this device.
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 is not an AI-assisted device, and therefore, no MRMC study or AI improvement effect size is relevant or reported.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical dental instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The concept of "ground truth" as used in AI/ML validation does not apply to this device. The safety and effectiveness are established by demonstrating it functions as intended and is substantially equivalent to a predicate device based on its design, materials, and performance specifications.
The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set.
How the ground truth for the training set was established:

Not applicable. Since there is no training set, there is no ground truth for it.

Summary of the Study (as described in the 510(k) for this non-AI device):

The "study" or evaluation performed for the CST61 high-speed turbine handpiece is not a traditional clinical trial or AI performance study. Instead, it's a demonstration of substantial equivalence to a previously legally marketed device (K022535). This involves:

Comparison of Technological Characteristics: The submission includes a tabulated comparison of the new device's features, specifications, and intended use against the predicate device.
Performance Claims: The device is stated to operate at 250KPa with a rotation speed of 250,000 RPM for cutting, shaping, grinding, and polishing functions. The implication is that these characteristics are comparable to the predicate device to ensure similar safety and effectiveness.
Intended Use: The intended use of the CST61 high-speed turbine handpiece is explicitly defined: "intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth." This is compared to the predicate device's intended use.

The FDA's review concludes that the device is "substantially equivalent" for the stated indications for use, allowing it to be marketed under the general controls provisions of the Act.

Summary

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510(k) Summary OCT 2 6 2006 As Required by 21 section 807.92 ( c )

SHANGHAI DENTAL INSTRUMENT FACTORY CO., LTD 1-Submitter Name: ("SDIF") 820 LINGSHI ROAD. SHANGHAI CHINA 200072 2-Address:

Tel +86 21 66255988. 3-Phone:

4-Fax: Fax +86 21 56956197

Ms Chen Yimei, Vice General Manager 5-Contact Person:

6- Consultant: Jay Mansour, Mansour Consulting LLC, 845 Aronson Lake Court,

Roswell, GA 30075 USA. Tel 678-908-8180. Fax 678-623-3765 7-Date summary prepared: October 24th, 2006

8-Device Trade or Proprietary Name: CST61 high speed turbine handpiece

9-Device Common or usual name: high speed turbine handpiece

10-Device Classification Name: handpiece, air-powered, dental

11-Substantial Equivalency is claimed against the following device: K022535

12-Description of the Device:

13-Intended use of the device: (refer to FDA forms attached)

CST61 high speed turbine handpiece is intended for use intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth.

14-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

15-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Refer to the explanations within the main submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Dental Instrument factory C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

OCT 2 6 2006

Re: K063110

Trade/Device Name: CST61 High Speed Turbine Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece Accessories Regulatory Class: I Product Code: EFB Dated: October 9, 2006 Received: October 11, 2006

Dear Mr. Job:

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 - Mr. Job

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.

Suenluase
fr/Chiu Lin, Ph.D.

VChiu 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): KO63110

Device Name: CST61 HIGH SPEED TURBINE HANDPIECE

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suzy Quann
(Resident Signature)

intony, General Hosp

PAGE 13

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.