Used for: 1) Removal of extremely tenacious deposits of calculus in both non-surgical and surgically exposed cases; 2) Removal of overhangs and re-contouring of dental restorations (amalgam, gold, composite, acrylic and porcelain) in both non-surgical and surgically exposed cases; and 3) Soft tissue debridement-removal of tissue tags, particularly in an intrabony lesions.

Device Description

DIAMOND COATED INSERTS are coated with a fine grit diamond powder. The diamonds are bonded by an electroplated metallic nickel. The se DIAMOND COATED INSERTS are designed for use in applications where an instrument with aggressive cutting capability is necessary. The inserts are designed to be used with DENTSPLY's Handpieces.

AI/ML Overview

The provided text is a 510(k) premarket notification for "DIAMOND COATED INSERTS" and a letter from the FDA confirming substantial equivalence. This type of regulatory submission does not typically include detailed studies or acceptance criteria tables for device performance in the way a clinical trial or performance study for a novel AI/medical device would.

The core of this submission is a claim of substantial equivalence to a predicate device (K923639), meaning the new device is essentially the same as one already legally marketed. Therefore, the information requested in your prompt (acceptance criteria, specific performance studies, sample sizes, ground truth establishment, expert qualifications, etc.) is largely not applicable or present in this document.

Here's an explanation based on the provided text, indicating what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided. This document is a 510(k) summary for a diamond-coated dental insert, claiming substantial equivalence to a predicate device. It does not present specific quantitative performance metrics or acceptance criteria for a novel device that would typically be found in a clinical study report. The "performance" is implicitly deemed acceptable because it is substantially equivalent to a previously cleared device.

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

Not applicable/Not provided. No "test set" in the context of a performance study (like an AI model or diagnostic device) is mentioned. The submission relies on demonstrating similarity to a predicate device, not on new performance data from a specific test set of patients or cases.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not provided. There is no mention of establishing ground truth by expert consensus or any other method for a test set, as this is not a study assessing diagnostic accuracy or similar performance.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No test set or independent adjudication process is described.

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

Not applicable/Not provided. This is not a study assessing human reader performance or the impact of AI assistance. The device is a dental insert, not a diagnostic imaging or AI system.

6. Standalone Performance Study (Algorithm Only)

Not applicable/Not provided. This device is a physical dental instrument, not an algorithm, so a standalone performance study in that context is not relevant.

7. Type of Ground Truth Used

Not applicable/Not provided. As there are no performance studies described, there's no mention of ground truth (e.g., pathology, outcomes data).

8. Sample Size for the Training Set

Not applicable/Not provided. This device is not an AI model, so there is no concept of a "training set."

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

Not applicable/Not provided. (See point 8)

Summary of Device and Rationale for Clearance Based on Provided Text:

The device, "DIAMOND COATED INSERTS," is a dental accessory with a diamond coating. It is intended for:

Removal of tenacious calculus.
Removal of overhangs and re-contouring dental restorations.
Soft tissue debridement for tissue tags, especially in intrabony lesions.

The basis for market clearance (510(k)) is substantial equivalence to an existing predicate device (K923639). The manufacturer states:

"Design modifications made to the DIAMOND COATED INSERTS (K923639) include a change in the grip material and a change in the amount of diamond coating on the inserts."
"There are no changes in intended use, fundamental scientific technology, or principles of operation."
"Because of the nearly equivalent material composition... no biocompatibility testing was necessary."
The manufacturer believes "prior use of the components of DIAMOND COATED INSERTS in legally marketed devices and the data provided support the safety and effectiveness of DIAMOND COATED INSERTS for the intended uses."

The FDA's letter confirms this substantial equivalence determination, allowing the device to be marketed without the need for new, extensive performance studies, as its safety and effectiveness are inferred from the predicate device.

Summary

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FEB 0 7 2003

NAME & ADDRESS:

DENTSPLY International

570 West College Avenue PO Box 877 York, PA 17405-0872 7) 845-7511 -ax (717) 849-4762

P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn CONTACT:

4030111

DATE PREPARED: JAN 1 0 2003

TRADE OR PROPRIETARY NAME: DIAMOND COATED INSERTS

CLASSIFICATION NAME: Accessory to dental unit (872.4850)

K923639 PREDICATE DEVICES: Diamond Coated Inserts

DESCRIPTION OF DEVICE: DIAMOND COATED INSERTS are coated with a fine grit dia nond powder. The diamonds are bonded by an electroplated metallic nickel.

The se DIAMOND COATED INSERTS are designed for use in applications where an instrument with aggressive cutting capability is necessary. The inserts are designed to be used with DE NTSP_Y's Handpieces.

IN 'ENDED USE: Used for: 1) Removal of extremely tenacious deposits of calculus in both nor -surgical and surgically exposed cases; 2) Removal of overhangs and re-contouring of dental res orations (amalgam, gold, composite, acrylic and porcelain) in both non-surgical and sur zically exposed cases; and 3) Soft tissue debridement-removal of tissue tags, particularly in an ntrabony lesions.

TECHNOLOGICAL CHARACTERISTICS: Design modifications made to the DIAMOND CC ATED INSERTS (K923639) include a change in the grip material and a change in the amount of liamond coating on the inserts. There are no changes in intended use, fundamental scientific tec mology, or principles of operation.

Be :ause of the nearly equivalent material composition of DIAMOND COATED INSERTS to the predicate device, no biocompatibility testing was necessary.

We believe that these DIAMOND COATED INSERTS are substantially equivalent to those ins rts in K923639, and that prior use of the components of DIAMOND COATED INSERTS in legally marketed devices and the data provided support the safety and effectiveness of DI AMOND COATED INSERTS for the intended uses.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of a stylized human figure with three faces in profile, overlaid with three curved lines resembling wings. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 7 2003

Mr. P. Jeffery Lehn Director of Corporate Compliance & Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17404

Re: K030111

Trade/Device Name: Diamond Coated Inserts Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 10, 2003 Received: January 13, 2003

Dear Mr. Lehn:

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. Lehn

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours.

Susa Qunner
Susan Runner, DDS, MA

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): 4030111

Device Name: DIAMOND COATED INSERTS

Used for:

Removal of extremely tenacious deposits of calculus in both non-surgical and í 1) surgically exposed cases;
(2) Removal of overhangs and re-contouring of dental restorations (amalgam, gold, composite, acrylic and porcelain) in both non-surgical and surgically exposed cases; and
Soft tissue debridement-removal of tissue tags, particularly in an intrabony (3) lesions.

This is the same intended use as previously cleared for K923639.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Re. Ruby for MSR

of Anesthesiology, ( General Hospital n Control. Dental D

510(k) Number

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.