· Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
· Scaling applications, including:
- · Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
- · Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- · Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation;
- · Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Device Description

Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Piezosurgery Touch), not a study report. Therefore, much of the requested information about device performance and ground truth establishment from a study is not present in this document.

However, I can extract information related to the device name, classification, and intended use.

Here's a breakdown of what can be inferred or explicitly stated:

1. A table of acceptance criteria and the reported device performance

This document describes a premarket notification for a medical device, not a performance study result. Acceptance criteria and reported device performance from a clinical study are not provided. The FDA's letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the regulatory acceptance criteria for 510(k) clearance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. This document is a regulatory approval notice, not a study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This document is a regulatory approval notice, not a study report.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This document is a regulatory approval notice, not a study report.

5. 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 device is a bone cutting instrument and ultrasonic scaler, not an AI-powered diagnostic device that would involve human readers for comparative effectiveness.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. This document is a regulatory approval notice, not a study report. The "ground truth" for 510(k) clearance is substantial equivalence to a predicate device, which is based on similar technological characteristics and intended use, not necessarily comparison to a 'ground truth' in a clinical study sense.

8. The sample size for the training set

Not applicable. This document is a regulatory approval notice, not a study report involving a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. This document is a regulatory approval notice, not a study report involving a training set for an algorithm.

Summary

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

K122322

medical technology

DEC 0 6 2012

Mectron S. p.A. Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com

P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc .: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 1.400.000 i.v. mectron@mectron.com

510(k) Summary in accordance with 21 CFR 807.92

Device Name:

Piezosurgery Touch

Traditional

July 30, 2012

Mectron Spa

3003933619

Mectron Spa

Roger Gray

Italy

Via Loreto, 15, 16042 Carasco - (GE)

VP, Quality and Regulatory Donawa Lifescience Consulting Piazza Albania, 10, 00153 Rome, Italy

Manufacturer:

Date of Submission:

FDA Registration Number:

Type of 510(k) submission:

510(k) Owner:

510(k) Contact:

Trade name:

Piezosurgery Touch

Drill, Bone, Powered Ultrasonic scaler

21 CFR 872.4120

Dental

Class II

DZI ELC

Tel: +39 06 578 2665 Fax: +39 06 574 3786

Common Name/Regulation Description: Bone cutting instrument and accessories Ultrasonic scaler

Device Classification Name

Classification Regulation:

FDA Panel:

Product Codes:

Class:

510(k) for Piezosurgery Touch - K122322

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

Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered and takes up most of the image. The font is a serif typeface.

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 6, 2012

Mectron S.PA. C/O Mr. Roger Gray Vice President, Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, Italy 00153

Re: K122322

Trade/Device Name: Piezosurgery Touch Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI, ELC Dated: November 30, 2012 Received: December 3, 2012

Dear Mr. Gray:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling.must be truthful and not misleading.

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.

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

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

Indications for Use

510(k) Number (if known): K122322

Device Name: Piezosurgery Touch

Indications for Use: Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:

· Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
· Scaling applications, including:
- · Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
- · Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- · Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation;
- · Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Prescription Use	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

2012.12.06
Susan Runner DDS, MA
12:17:02 -05'00'

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

Page 1 of 1

510(k) Number:

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.