The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical microvibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue. The device is supplied with sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.

AI/ML Overview

The provided text is a 510(k) summary for the Piezosurgery® device. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than providing a detailed study report with specific acceptance criteria and performance data as one might find for a novel AI/ML medical device.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission, as it describes a traditional medical device (an ultrasonic scaler) and its performance evaluation for established indications.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
For Ultrasonic Scaling: Substantial equivalence to predicate device (EMS Piezon® Master 600) for indications including: - Removing supra and subgingival calculus deposits and stains - Periodontal pocket lavage with simultaneous ultrasonic tip movement - Scaling and root planing - Retrograde preparation of root canals	Technical, clinical, and histologic comparisons supported a finding of substantial equivalence to the predicate device.
For Bone Cutting: Substantial equivalence to a predicate device (K043408, though the specific predicate for bone cutting is only referenced by K-number, not name) for bone cutting in oral surgery.	Performance and safety evaluations demonstrated: - Precisely delineated tissue cutting - Reduced risk of adjacent tissue damage - Needed limited pressure on the handpiece to achieve desired cutting action - Improved surgical control - Reduced possibility of trauma to soft tissue

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

Sample Size for Test Set: Not specified in the provided text. The submission mentions "clinical data," but no numbers are given for patient or case count.
Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts/Qualifications: Not specified. The summary refers to "clinical data" and "histologic comparisons" but does not detail how these assessments were conducted or by whom.

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

Adjudication Method: Not specified.

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

MRMC Study: Not applicable. This is a traditional medical device, not an AI/ML diagnostic tool, so an MRMC study is not relevant.

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

Standalone Performance: Not applicable. This is a traditional medical device that requires human operation; it is not an algorithm.

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

Type of Ground Truth: The performance evaluations were based on "clinical data on the characteristics of the inserts in vibration, cutting precision, and on the risk of adjacent tissue damage." It also mentions "histologic comparisons." These suggest a combination of clinical observation, physical measurements of device performance (vibration, cutting), tissue damage assessment, and potentially histopathological analysis to confirm tissue effects.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a traditional medical device, not an AI/ML model, so there is no "training set."

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

Ground Truth for Training Set Establishment: Not applicable. (See #8)

Summary of Key Findings from the Document:

The Piezosurgery® device achieved 510(k) clearance by demonstrating "substantial equivalence" to existing predicate devices (EMS Piezon® Master 600 for ultrasonic scaling and K043408 for bone cutting). This equivalence was supported by "technical, clinical and histologic comparisons." The performance evaluations specifically highlighted precise cutting, reduced risk of adjacent tissue damage, and improved surgical control with limited pressure. The document, being a 510(k) summary, does not provide detailed study methodologies, sample sizes, or expert qualifications as typically found in comprehensive clinical trial reports.

Summary

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Piezosurgery 510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92 (c)

Appendix H

K number:
1. Submitter's information:	Tomaso Vercellotti, M.D., D.D.S.Piezosurgery s.r.l.Molo Ponte Morosini 41/716126 Genoa, ItalyPhone: +39 010 254 1934E-mail: perfler@piezosurgery.com
2. Contact person:	Maria E. Donawa, M.D.Donawa ConsultingP.zza Albania, 1000153 Rome, ItalyPhone: +39 06 578 2665E-mail: medonawa@donawa.com
3. Date summary prepared:	September 1, 2005
4. Device name and classification:
a. Trade/device name:	Piezosurgery ®
b. Classification name:	Ultrasonic scaler(per 21 CFR section 872.4850)
c. Classification panel:	Dental
d. Regulatory class:	Class II
e. Product code:	ELC

5. Device description:

Korzz18

6. Intended use:

The Piezosurgery® device is intended for use in the following dental applications:

Bone cutting for use in oral surgery (K043408) -
Removing supra and subgingival calculus deposits and stains from teeth -
Periodontal pocket lavage with simultaneous ultrasonic tip movement -
Scaling and root planing -
ﺖ Retrograde preparation of root canals

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7. Predicate device:

EMS Piezon® Master 600 (K022328) for ultrasonic scaling.

8. Substantial equivalence comparison:

Technical, clinical and histologic comparisons presented in this submission support a finding of Technical, billiour and historogio orient Piezosurgery and the predicate device.

9. Performance evaluations:

Performance and safety evaluations were based on clinical data on the characteristics of the F enomance and Salety Cranadiens wersurely risk of adjacent tissue damage, inselt in Vibration, Suking proclain and on J. The evaluations demonstrated precisely delineated tiosac noating, and the need for limited pressure on the handpiece to achieve the desired cutting inction, which improves surgical control and reduces the possibility of trauma to soft tissue.

10. Conclusion:

The performance and safety data presented in this premarket notification support a finding of substantial equivalence between the Piezosurgery device and the predicate device specified in this submission.

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features an emblem of an eagle with three stylized wings. The text "HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, and "DEPARTMENT" is arranged around the bottom half of the circle. The eagle emblem is positioned in the center of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2005

Piezosurgery S.R.L. C/O Ms. Maria E. Donawa Donawa Consulting S.R.L. Piazza Albania 10 00153 Rome, ITALY

Re: K052518

Trade/Device Name: Piezosurgerv® Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: September 12, 2005 Received: September 14, 2005

Dear Ms. Donawa:

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. Donawa

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,

Sujite Y. Michie Omd

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

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KUy218

Indications for Use Statement

510(k) Number:

Device Name:

Piezosurgery®

Indications for Use:

The Piezosurgery® device is intended for use in the following dental applications:

Removing supra and subgingival calculus deposits and stains from teeth
Periodontal pocket lavage with simultaneous ultrasonic tip " movement
Scaling and root planing -
Retrograde preparation of root canals -

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)

Susan Rumm

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

510(k) Number: K65

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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.