The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

Device Description

The Piezosurgery® Medical device is an ultrasonic surgical system consisting of a central console with two integral peristaltic irrigation pumps, and two detachable handpieces. Each handpiece is connected to the console electrically, and each is also connected to one of the irrigation pumps via an irrigation tubing kit. The handpieces contain the ultrasonic transducers. A separate electricallyoperated footswitch is provided with the device, which also attaches to the central console. The irrigation tubing kits and insert tips are supplied sterile and are intended for single-use. A range of optionally available handpiece tips provides the surgeon with a wide variety of options for drilling, cutting and sawing.

The console has a touch-screen display and contains general control system circuits and two ultrasonic generators which drive the handpiece functions. The irrigation tubing kit is fed with physiological saline solution during the surgical procedure from saline bags (not supplied) which hang from drip stands that attach to the rear of the central console.

The user may activate either of the two handpieces by the selection from the LCD touch-screen and by pressing the footswitch.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called Piezosurgery Medical. It's a submission to show substantial equivalence to already marketed devices, not a study demonstrating performance based on acceptance criteria in the way you've described for an AI/ML device.

Therefore, many of the specific questions about acceptance criteria, study design, sample sizes, ground truth, experts, and AI performance cannot be directly answered from the provided text. This document is focused on regulatory clearance based on equivalence, not a clinical performance study with specific metrics and acceptance criteria for a new algorithmic device.

However, I can extract what is provided related to "performance data" which, in this context, refers to the device's operational characteristics rather than clinical outcomes measured against statistical targets.

Here's an attempt to address your request based only on the provided text, highlighting where information is not applicable or missing for this type of submission:

1. Table of acceptance criteria and the reported device performance

This document does not present "acceptance criteria" in the context of specific quantitative efficacy or diagnostic performance targets, nor does it provide a direct "reported device performance" against such criteria. The "Performance Data" section describes the device's operational capabilities.

Acceptance Criteria (Not explicitly stated as such for clinical performance)	Reported Device Performance (Operational Characteristics)
Ability to cut bone, perform osteotomy, osteoplasty, and drilling.	The desired surgical effect is obtained by using an ultrasonic frequency of resonance modulated in amplitude with low frequency bursts.
User-selectable cutting modalities.	Four cutting modalities can be selected depending on the object bone type.
Adjustable physiological saline irrigation flow rate.	Flow rate of physiological saline irrigation solution is user-adjustable on five levels.
Adjustable power output.	Power output can be set from a choice of seven levels.
Automatic tuning of working frequency.	The integral Piezosurgery® electronic generator performs automatic tuning of the working frequency, optimizing the efficiency of the piezoelectric transducer.
"Hammering effect" of the insert tip for cutting action.	This feature makes it possible to produce a "hammering effect" of the insert tip, resulting in a cutting action.

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 applicable. This submission is for regulatory clearance based on substantial equivalence to predicate devices, not a clinical trial with a test set of patient data.
Data Provenance: Not applicable for a clinical test set. The manufacturer is Mectron Spa, Italy, and the 510(k) owner is Piezosurgery SRL, Italy.

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

Not applicable. There is no mention of a test set requiring expert-established ground truth for performance evaluation in this 510(k) submission.

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

Not applicable. No test set requiring adjudication is mentioned.

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 surgical instrument (Piezosurgery Medical), not an AI/ML diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

Not applicable. The Piezosurgery Medical is an ultrasonic surgical system, a physical instrument operated by a surgeon ("human-in-the-loop" by design), not a standalone algorithm.

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

Not applicable. The submission focuses on the device's functional and technological characteristics and its intended use, demonstrating equivalence to predicate devices. It does not present a clinical performance study that would require a defined "ground truth" in the context of diagnostic accuracy or treatment success.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a "training set" would be used.

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

Not applicable. As above, there is no training set for this type of device.

Summary of what is provided regarding performance and regulatory rationale:

The "Performance Data" section describes the device's operational flexibility (four cutting modalities, five irrigation levels, seven power levels) and its inherent technological features like ultrasonic frequency modulation and automatic tuning to achieve the desired surgical effect (a "hammering effect" for cutting action).

The conclusion of the 510(k) submission states that: "Based on the information contained within this submission, it is concluded that the Piezosurgery Medical device is substantially equivalent to the predicate devices already in interstate commerce within the USA." This statement, along with the FDA's clearance letter, indicates that the device met the regulatory standard of substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission – meaning it is as safe and effective as a legally marketed predicate device. The information supporting this includes the device description, intended use, and technological characteristics, as well as the operational "performance data" detailed above.

Summary

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PIEZOSURGERY®

Piezosurgery s.r.1. 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

APR - 8 2009

14083284 510(k) Summary in accordance with 21 CFR 807.92(c)

Device Name:	Piezosurgery Medical
Type of 510(k) submission:	Traditional
Date of Submission:	31 October 2008
Manufacturer:	Mectron SpaVia Loreto, 15, Carasco, GE 16042, Italy
FDA Registration Number:	3003933619
510(k) Owner:	Piezosurgery SRLRegistered Office:Molo Ponte Morosini 41/7 -16126 GE ItalyHeadquarters:Via Portobello, 12 - 16039 Sestri Levante GE Italy
510(k) Contact:	Roger GrayDirector, Global Regulatory AffairsDonawa ConsultingPiazza Albania, 10, 00153 Rome, ItalyTel: +39 06 578 2665Fax: +39 06 574 3786
Trade Name:	Piezosurgery Medical
Common Name:	Bone cutting instrument and accessories
Classification Regulation:	888.4580: Sonic surgical instrument andaccessories/attachments
Identification:	A sonic surgical instrument is a hand-held device withvarious accessories or attachments, such as a cutting tip thatvibrates at high frequencies, and is intended for medicalpurposes to cut bone or other materials, such as acrylic.
Class:	Class II
Product Codes:	HWE, DZI, ERL, HBE and JDX

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PIEZOSURGERY®

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

Predicate Devices:

Predicate device 1	Predicate device 2	Predicate device 3
Synthes Electric Pen Drive(EPD) System	Linvatec E9000 System	Piezosurgery (oral use)
Synthes (USA)	Linvatec Corporation	Mectron SPA
1690 Russell RoadPaoli, PA 19301 USA	11311 Concept BoulevardLargo, FL 33773-4908 USA	Via Loreto, 15/A16042 Carasco (GE) ITALY
K043310	K990524	K043408

Device Description:

The user may activate either of the two handpieces by the selection from the LCD touch-screen and by pressing the footswitch.

Intended Use:

Technological Characteristics:

The desired surgical effect is obtained by using an ultrasonic frequency of resonance modulated in amplitude with low frequency bursts according to the bone quality program selected by the operator. The integral Piezosurgery® electronic generator performs automatic tuning of the working frequency. optimizing the efficiency of the piezoelectric transducer in the handpiece.

This feature makes it possible to produce a "hammering effect" of the insert tip, resulting in a cutting action.

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PIEZOSURGERY®

Performance Data:

Depending on the object bone type, the user can select four cutting modalities. The flow rate of physiological saline irrigation solution is user-adjustable on five levels, and the user may also set the power output from a choice of seven levels.

Conclusion:

.......

Based on the information contained within this submission, it is concluded that the Piezosurgery Medical device is substantially equivalent to the predicate devices already in interstate commerce within the USA.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 8 2009

Piezosurgery SRL % Donawa Consulting Mr. Roger Gray Piazza Albania, 10 · 00153 Rome Italy

Re: K083284

Trade/Device Name: Piezosurgery Medical device Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: II Product Code: JDX, HWE, DZI, ERL, HBE - Dated: Mach 24, 2009 Received: March 31, 2009

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.

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.

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

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Page 2 - Mr. Roger Gray

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M. Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Indications for Use

14083284-510(k) Number (if known): Not known

Device Name: Piezosurgery Medical device

Indications for Use: The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

区

AND/OR

Over-The-Counter Use (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)

Niel R. Pylke for mxn

(Division Sign-O Division of General, Restorative, and Neurological Devices

510(k) Number K093284

Page 1 of 1

Regulation Number and Section

§ 888.4580 Sonic surgical instrument and accessories/attachments.

(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.