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

AI/ML Overview

The Piezosurgery device, indicated as a bone cutting instrument for oral surgery, underwent performance evaluations primarily based on clinical and histologic data.

Here's an analysis of the provided information in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Performance Evaluations)	Reported Device Performance
Incision Characteristics: Desired cutting action achieved with limited pressure.	The evaluations "demonstrated the desired cutting action and the need for limited pressure on the handpiece to achieve the desired cutting action."
Cutting Precision: Precise osteotomies.	The technology "has been shown to allow precise osteotomies."
Surgical Tactile Control: Adequate control.	Evaluated. (Specific performance metric not detailed, but implied to be acceptable)
Risk of Adjacent Tissue Damage: Minimal trauma to soft tissue.	"Minimal trauma to soft tissue." The technology "has been shown to allow precise osteotomies with minimal risk of tissue heating and osteonecrosis damage." Implied minimal risk to soft tissue due to the inherent nature of piezoelectric cutting.
Mineralized Tissue Heating: Minimal heating.	"Minimal risk of tissue heating."
Integrity of Osteotomized Surfaces: Good integrity.	"Integrity of the osteotomized surfaces." (Evaluated. Specific performance metric not detailed, but implied to be acceptable)
Post-operative Healing: Effective healing.	"The operative healing." (Evaluated. Specific performance metric not detailed, but implied to be acceptable)
Safety: Overall safety profile acceptable.	"Performance and safety evaluations were based on clinical and histologic data." "The performance and safety data presented in this premarket notification support a finding of substantial equivalence."

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

Sample Size: Not explicitly stated. The document refers to "clinical and histologic data," implying a study involving patients or tissue samples, but no specific numbers are provided for either human subjects or tissue samples.
Data Provenance: Not explicitly stated. The clinical and histologic data are likely retrospective, as no prospective study design is mentioned. The country of origin is not specified, but the submitter and contact person are associated with Italy, suggesting the data could be from Italy or Europe, though this is not confirmed.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. There is no mention of a formal adjudication process (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned. The evaluation focuses on the device's intrinsic performance characteristics rather than comparing human reader performance with and without AI assistance. This device is a surgical tool, not an AI diagnostic system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This device is a manual surgical instrument, not an algorithm or AI system. Its performance inherently involves a human operator.

7. The Type of Ground Truth Used

Ground Truth Type: Clinical observations and histologic findings. These are considered direct evidence of the device's effects on tissue and surgical outcomes.

8. The Sample Size for the Training Set

Sample Size: Not applicable. As this is a medical device and not an AI or machine learning model, there is no "training set" in the conventional sense. The "training" for such devices typically involves design, engineering, and iterative testing, sometimes using preclinical or basic science data, and ultimately clinical data serves as validation.

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

Ground Truth Establishment: Not applicable, as there is no training set mentioned for an algorithm. The development of the device would have relied on engineering principles, material science, and possibly cadaveric or animal studies to refine its design and operational parameters.

Summary

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

K number:	K043408
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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
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Contact person:

	Maria E. Donawa, M.D.Donawa ConsultingP.zza Albania, 1000153 Rome, ItalyPhone: +39 06 578 2665E-mail: medonawa@donawa.com
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Date summary prepared:

	June 6, 2005
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Device name and classification:

a. Trade/device name:	Piezosurgery®
b. Classification name:	Bone Cutting Instrument and Accessories (per 21 CFR section 872.4120)
c. Classification panel:	Dental
d. Regulatory class:	Class II
e. Product code:	DZI

5. Device description:

Device dessmithom:
The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical The riezdsurgery done cutting, with minimal trauma to soft tissue. The device is supplied mith sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery and surgical orthodontics.

6. Intended use:

o. The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.

7. Predicate device:

Micro-motor system MD20 Nouvag (K042434)

8. Substantial equivalence comparison:

o. Technical oquivals.comparisons presented in this submission support a Technical, clinical and niotologic compansent prosurgery and other bone cutting devices muling of oubotantial of the US. In addition, this technology has been shown to allow precise osteotomies with minimal risk of tissue heating and osteonecrosis damage.

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9. Performance evaluations:

Performance evaluations.
Performance and safety evaluations were based on clinical and histologic data on the Performance and salely evaluations were bacal on and surgical tactile control, risk of adjacent tissue
incision characteristics, cutting precision and surgical tactile contro Incision characteristics, cutting probision and ourgious technized surfaces, and postdamage, mineralized tissue heating, integrity of the osted insinces, and postdamage, mineralized tissue neating, megnity of the octosty delineated incisions and the operative nealling. The evaluations domenation pve the desired cutting action,
need for limited pressure on the handpiece to achieve the desired to ask tigen heed for limited pressure on the nanspioo to dellier sibility of trauma to soft tissue.

10. Conclusion:

Conclusion:
The performance and safety data presented in this premarket notification support a finding and The performance and salety uata proomed in this promation of the predicate device specified in this submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "U.S. Department of Health and Human Services, Inc." is written around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 8 - 2005

Piezosurgery Srl C/O Ms. Maria E. Donawa President Donawa Consulating Srl Piazza Albania, 10 00153 Rome, Italy

Re: K043408

Trade/Device Name: Piezosurgery® Regulation Number: 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: April 28, 2005 Received: May 2, 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 Iegally 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,

Jnette G. Michael m.D

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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Indications for Use Statement

510(k) Number:	K043408
Device Name:	Piezosurgery®
Indications for Use:	The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.

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 Runne

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

Kaus408 510(k) Number __

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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.