The OSSTEMPiezo 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 rer 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 does not contain specific acceptance criteria or a detailed study proving that the OSSTEMPiezo device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on performance evaluations.

Here's a breakdown of the information that is available and what is missing, structured according to your request:

A table of acceptance criteria and the reported device performance
- No explicit acceptance criteria (e.g., "The device must achieve a cutting depth of X mm with Y pressure") are provided in the document.
- The "performance evaluations" section describes qualitative outcomes rather than measurable performance statistics against defined criteria.

Acceptance Criteria	Reported Device Performance
Not specified in the document	- Precisely delineated incisions
	- Limited pressure on the handpiece required for desired cutting action
	- Improved surgical control
	- Reduced possibility of trauma to soft tissue
	- Preserving osteotomized surfaces
	- Reduction of risk of adjacent tissue damage
	- Reduction of tissue heating
	- Improved post-operative healing

Sample size used for the test set and the data provenance
- The document does not provide details on a specific "test set" sample size or its provenance (e.g., country of origin, retrospective/prospective). The performance evaluations are described in general terms, implying a summary of observations rather than a detailed study protocol.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- No information is provided regarding the number of experts, their qualifications, or their role in establishing "ground truth" for any test set. The 'evaluations' appear to be based on general observation of device functionality.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- No adjudication method is mentioned, as there is no described formal test set requiring such a process.
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
- No MRMC study was conducted or mentioned. This device is a surgical instrument, not an AI-assisted diagnostic tool for "human readers."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device is a human-operated surgical instrument, so the concept of an "algorithm only" or "standalone" performance without human-in-the-loop is not applicable in this context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- No formal "ground truth" in the sense of a definitive reference standard (like pathology or clinical outcomes) is described for the performance evaluations. The evaluations appear to be based on observations of physical effects (e.g., incision quality, tissue preservation).
The sample size for the training set
- The document does not describe a "training set" as this is not a machine learning or AI-based device.
How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.

Summary

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PIEZOSURGERY®

K091227

162

Piezosurgery s.r.l. Registered Office: Molo Ponte Morosini 41/7 - 16126 Genoa, Italy Headquarter: Via Portobello, 12 - 16039 Sestri Levante, Italy Tel:+39 0185 450863, Fax:+39 0185 42799 E-mail: piezosurgery@piezosurgery.com

DEC 2 9 2009

510(k) Summary

Mectron S.p.A. Submitter's information Via Loreto 15/A 16042 Carasco (GE), Italy Tel. +39 0185 35361 Fax +39 0185 351374 E-mail: mectron@mectron.com
510(k) Contact person 2.

Enrico Perfler Executive Manager, Regulatory & Quality Assurance Meditrial s.r.l. Via Aldo Moro, 20 - 25124 Brescia, Italy +39 0185 474 847 Tel: +39 0185 394 904 Fax: +39 347 074 7145 Cell: Email: e.perfler@meditrial.eu

Summary's date 3.

Device name and classification

a. Trade/device nameb. Classification name	OSSTEMPiezoBone cutting instrument and accessories(per 21 CFR section 872.4120)Ultrasonic scaler(per 21 CFR section 872.4850)
c. Classification paneld. Regulatory classe. Product code	DentalClass IIDZI, ELC

3 April 2009

Device description ട്.

Intendend use/Indications for use 6.

The OSSTEMPiezo is intended for use in the following dental applications:

Bone cutting for use in oral surgery •
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 -

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PIEZOSURGERY®

/K091227

६०१२

7. Predicate device

Piezosurgery® device (K052518).

8. Performance evaluations

The device uses piezoeledric ultrasonic technology to generate mechanical microvibrations of insert tips for cutting mineralized structures with minimal trauma to soft tissue and for ultrasonic scaling. The insert tip microvibration results in a safe and effective cut, preserving the osteotomized surfaces, surgical tactile control, reduction of risk of adjacent tissue damage, reduction of tissue heating, and improved post-operative healing. The evaluations demonstrated precisely delineated incisions and the need for limited pressure on the handpiece to achieve the desired cutting action, which improves surgical control and reduces the possibility of trauma to soft tissue.

Conclusion 9.

We believe the information provided in this premarket notification support a finding of substantial equivalence between the OSSTEMPiezo and the predicate device Piezosurgery currently marketed.

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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 eagle or bird-like symbol with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

FEB 2 2 2010

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Piezosurgery S.R.L. C/O Mr. Ing. Enrico Perfler Executive Manager. Regulatory and Quality Assurance Meditrial S.R.L. Via Aldo Moro 20 - 25124 Brescia ITALY

Re: K091227

Trade/Device Name: Piezosurgery 3, OSSTEMPiezo Regulation Number: 21CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI, ELC Dated: December 17, 2009 Received: December 22, 2009

Dear Mr. Perfler:

This letter corrects our substantially equivalent letter of December 29, 2009.

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 (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 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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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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Number (if known):

Device Name: Piezosurgery 3

Indications for Use: The Piezosurgery 3 is intended for use in the following dental applications:

6417

Indications for Use

Bone cutting for use in oral surgery
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

RS. Betz DNS for Dr. K.P. Mulky (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K09/227

Prescription Use X (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)

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.