This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

Device Description

This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

AI/ML Overview

This 510(k) submission is for a dental handpiece, a general-purpose tool. As such, the submission does not contain the kind of detailed performance study data you'd typically find for an AI/ML powered device, which would require specific acceptance criteria related to accuracy, sensitivity, specificity, etc.

The document focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria through a clinical study. The "acceptance criteria" here implicitly refer to meeting the general safety and effectiveness standards a dental handpiece is expected to meet, and demonstrating that its performance is comparable to the predicate.

Given this, I cannot fill out all sections of your request as they pertain to AI/ML device testing. However, I can extract the relevant information from the provided text as it relates to this type of device submission.

No Specific Acceptance Criteria or Performance Study for AI/ML Device

This 510(k) submission is for a dental handpiece, which is a mechanical device, not an AI/ML-powered device. Therefore, the submission does not contain acceptance criteria related to accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML systems.

The submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device (PENG LIM High Speed Air Turbine Handpiece, K062947) by showing that it has the same intended use and similar technological characteristics. The "study" here is essentially the comparison to the predicate device and verification that the device is safe and effective for its intended use, consistent with general controls for Class I devices.

However, based on the provided text, here's what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific, quantifiable acceptance criteria and performance metrics (e.g., accuracy, sensitivity) are not applicable for this type of mechanical device submission in the context of an AI/ML evaluation. The acceptance criteria are implicitly related to the safety and effectiveness of a dental handpiece and its substantial equivalence to a predicate.

Acceptance Criteria (Implied for a Dental Handpiece)	Reported Device Performance (Implied by Substantial Equivalence)
Intended Use: Prepare dental cavities for restorations, such as tooth body treatment, tooth drilling, and tooth grinding of stomatology.	Met: Device's stated "Indications for Use" are identical to the predicate device, indicating it performs these functions.
Technological Characteristics: Air-powered, hand-held device.	Met: Device is described as an "air-powered hand-held device," matching the predicate.
Safety: Meets general controls for Class I devices, including good manufacturing practices.	Met: The FDA's letter states the device falls under general controls and allows marketing, implying safety requirements are met for a Class I device.
Effectiveness: Capable of performing the stated dental operations.	Met: Substantial equivalence determination implies the device is as effective as the predicate for its intended use.

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

Not Applicable in the context of an AI/ML clinical test set.
For a traditional mechanical device like this, performance is typically confirmed through engineering tests, comparison to standards, and demonstration of equivalence to a predicate, rather than a clinical "test set" in the AI/ML sense. Data provenance for such a device would relate to manufacturing controls and material specifications.

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

Not Applicable. This is not an AI/ML device requiring expert-established ground truth. Expert review would be part of the FDA's regulatory process for evaluating the submission's claims and data, but not for establishing a "ground truth" for the device's performance in the AI/ML sense.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is for AI/ML devices to assess their impact on human reader performance. It is not relevant for a mechanical dental handpiece.

6. Standalone (Algorithm Only) Performance Study

No. This device is a mechanical tool and does not have an algorithm to be evaluated in a standalone performance study.

7. Type of Ground Truth Used

Not Applicable in the AI/ML sense. For this device, "ground truth" is established by adherence to engineering specifications, recognized standards, and the demonstrated functional utility of the device for its intended purpose, as evidenced by its substantial equivalence to a predicate.

8. Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. See point 8.

Summary

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007 1 2 2007

Premarket Notification 510(k) Submission - 510(k) Summary Report No .:

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

1041561 The Assigned 510(k) Number is:

1. Applicant Device Information:

Device Trade/Proprietary Name: Multiple Brand Names Device Common Name: Handpiece, Air Powered, Dental Device Classification Name: Handpiece, Air Powered, Dental Review Panel: Dental Product Code: EFB Regulation Number: 872.4200 Device Class: I Intended Use:

This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

2. Submitter Information:

Establishment Registration Name and Address:

Beijin North Pole Dental Handpiece Co., Ltd Standard Workshop, Area A Beijing Airport Industrial Zone Shunyi, Beijing, P.R.China

Contact Person of the Submission:

Diana Hong Shanghai Mid-link Consulting Co., Ltd. 1441, 6th Avenue San Francisco, California 94122 U.S.A Email: Diana.hong@mid-link.net Fax: 760 466 5084

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Premarket Notification 510(k) Submission - 510(k) Summary Report No .:

3. Predict Device

PENG LIM High Speed Air Turbine Handpiece

K Number: K062947

Product Code: EFB

Intended Use:

The PENG LIM High Speed Air Turbine Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Manufactured by

PENG LIM ENTERPRISE CO., LTD. 67 Hwa Rong Rd., 2nd F1., Ku Shan Dist. Kaohsiung, CHINA (TAIWAN) Tel: 07-552-2995

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Public Health Service

OCT 1 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Beijing North Pole Dental Handpiece Company, Limited C/O Ms. Diana Hong General Manger Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No. 19 Lane 999, Zhongshan No. 2 Road (s) Shanghai 200030 CHINA

Re: K071561

Trade/Device Name: Hi-Speed Turbine Handipieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 17, 2007 Received: September 24, 2007

Dear Ms. Hong:

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. Hong

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 (OS) 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,

Swer Runnes
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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Premarket Notification 510(k) Submission-Indications for Use Report No .: A20071028

Indications for Use

1071561 510(k) Number:

Pending

Device Name: Hi-Speed Turbine Handpieces

Indications for Use:

This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susi Russo

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

Page

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.