The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument designed for use in surgical dentistry. The device generates piezo-electric vibrations (ultrasonic energy) for cutting and non-cutting instruments used in surgical dentistry, including oral surgery, implantology, periodontal surgery, and maxillary surgery.

The EMS Piezon Master Surgery device consists of a main chassis containing an irrigation delivery system, an internal electric power supply, a control panel with lightemitting diode (LED) displays, and ultrasonic generator. A one-step footswitch is connected to the main chassis by a footswitch cord and a handpiece containing cutting and non-cutting instruments is connected directly to the main chassis.

AI/ML Overview

The provided document is a 510(k) summary for the EMS Piezon Master Surgery device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or the details of a study with reported performance metrics, ground truth establishment, or human reader effectiveness with AI.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices based on shared intended use, technical specifications, and functional performance. It states that "Performance testing has been conducted that confirms that the Piezon Master Surgery is able to perform ultrasonic bone-cutting for use in surgical dentistry," but it does not elaborate on the specific tests, their results, or the acceptance criteria used.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance because this information is not present in the provided text.

Based on the document, here's what can be inferred or explicitly stated:

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

Cannot be provided. The document states: "Performance testing has been conducted that confirms that the Piezon Master Surgery is able to perform ultrasonic bone-cutting for use in surgical dentistry." However, it does not provide details on specific acceptance criteria (e.g., bone cutting depth, precision, cutting time, temperature rise, etc.) or the measured performance results against such criteria.

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

Cannot be provided. The document states that performance testing was conducted but gives no details about the sample size (e.g., number of bone samples, number of procedures), country of origin, or whether the study was retrospective or prospective.

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 / Cannot be provided. The document does not describe a study involving expert assessment or ground truth establishment for a test set. The performance testing mentioned likely involved engineering or bench-top tests related to the device's functional capabilities (e.g., ability to cut bone) rather than diagnostic accuracy or clinical outcomes assessed by experts in a structured manner.

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

Not applicable / Cannot be provided. As there's no mention of a test set requiring expert adjudication for ground truth, this information is not relevant to the document's content.

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

No. This information is entirely irrelevant to the device described. The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a surgical instrument operated by a human, not an algorithm. Its "performance" refers to its physical capability to cut bone, not an algorithmic output.

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

Not applicable / Cannot be provided. No "ground truth" in the clinical or diagnostic sense is described or required for the type of performance testing alluded to. The performance testing would likely have focused on the device's functional characteristics (e.g., ability to perform ultrasonic bone-cutting).

8. The sample size for the training set

Not applicable. The device is a physical instrument, not an algorithm that requires a training set.

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

Not applicable. As above, this device does not involve a training set or ground truth in this context.

Summary

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510(k) Summary for the E.M.S. ELECTRO MEDICAL SYSTEMS SA EMS Piezon Master Surgery

SPONSOR

E.M.S. ELECTRO MEDICAL SYSTEMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Contact Person:	Suzanne Fassio-Hardy
Telephone:	022 994 47 00
DEC 1 8 2007

Date Prepared: August 2, 2007

DEVICE NAME 2.

Proprietary Name:	EMS Piezon Master Surgery
Common/Usual Name:	Bone-cutting instrument and accessories
Classification Name:	Drill, Bone, Powered

3. PREDICATE DEVICES

Piezosurgery s.r.l. Piezosurgery® (K043408) .
SATELEC Piezotome™ (K060274) .

4. INTENDED USE

The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry.

న. DEVICE DESCRIPTION

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The EMS Piezon Master Surgery and the predicate devices Piezosurgery s.r.l. Piezosurgery and SATELEC Piezotome™ generate piezo-electric vibrations (ultrasonic energy) for cutting and non-cutting instruments and are indicated for use in surgical dentistry. Differences between the proposed EMS Piezon Master Surgery and the predicate ultrasonic bone-cutting instruments are limited to design differences in the control panel, irrigation delivery system, and accessories available with each device. Performance testing has been conducted that confirms that the Piezon Master Surgery is able to perform ultrasonic bone-cutting for use in surgical dentistry.

The similarities in intended use, technical specifications, and functional performance between the EMS Piezon Master Surgery, Piezosurgery® and Piezotome™ leads to a conclusion of substantial equivalence between the proposed and predicate devices.

TRO MEDICAL SYSTEMS SA 510(k) S Piezon Master Surgery

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's role in public health and welfare.

DEC 1 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

E.M.S. Electro Medical Systems S.A. C/O Ms. Susan M. Bonapace Regulatory Associate Medical Device Consultant, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K072146

Trade/Device Name: EMS Piezon Master Surgerv Regulation Number: 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: December 13, 2007 Received: December 14, 2007

Dear Ms. Bonapace:

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. Bonapace

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.

Chiu Lin, Ph.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

510(k) Number (if known):

Device Name:

EMS Piezon Master Surgefy

Indications for Use:

The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry.

escription Use Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C) CTON

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne
(Division use only)

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510(k) Number K072146

Page 1 of 1

DICAL SYSTEMS SA 510(k) Master Surgery

August 2, 2007

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.