EMS KERMIT by (EMS SA) ELECTRO MEDICAL SYSTEMS

This document is a 510(k) Summary for a medical device called the EMS KERMIT®, an ultrasonic scaler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics as one might find in a Premarket Approval (PMA) application or a clinical trial report.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present within this 510(k) Summary for the EMS KERMIT®.

Here's why and what can be inferred:

510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This often relies on comparing technical specifications, materials, performance claims, and intended use rather than requiring new, extensive clinical trials to establish safety and effectiveness from scratch.
"Acceptance Criteria" in 510(k): For a 510(k), "acceptance criteria" generally refer to the criteria used to determine if the new device performs as safely and effectively as the predicate device for its intended use. This might involve bench testing, engineering comparisons, or limited performance testing, but not typically the kind of detailed clinical study data often associated with AI/software devices.
"Study that proves the device meets the acceptance criteria": In a 510(k), this is typically a "substantial equivalence" comparison, where the new device's features and performance are shown to be comparable to the predicate. The document lists predicate devices (EMS miniPiezon, Piezon Master 400, etc.) which means the applicant likely presented data or arguments showing the EMS KERMIT® performs similarly to these devices.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details because the information is not provided in this 510(k) Summary.

However, I can extract the relevant information about the device and its intended use, and explain the absence of the other requested data.

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

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (Inferred from 510(k) process)
Safety and Effectiveness: Demonstrate that the EMS KERMIT® is as safe and effective as its predicate devices for its stated intended uses.	The FDA determined the device is "substantially equivalent" to predicate devices, implying it meets comparable safety and effectiveness standards.
Performance for Intended Use: Perform consistently for tasks such as removing calculus, scaling, root planing, etc., without introducing new risks compared to predicates.	The device's intended uses are listed (removing calculus, scaling, root planing, etc.). The FDA's clearance indicates that the applicant successfully demonstrated it performs these functions comparably to predicates.
Technical Characteristics: Physical and operational characteristics (e.g., ultrasonic vibration, power output, tip design) should be comparable to predicate devices or have justified differences.	Not explicitly detailed in this summary, but a 510(k) submission would include such comparisons. The FDA's clearance implies these characteristics were found acceptable.

2. Sample sized used for the test set and the data provenance

Not provided in the 510(k) Summary. 510(k)s for mechanical devices like ultrasonic scalers often rely on bench testing, materials testing, and comparisons to predicate devices rather than clinical studies with large "test sets" in the context of AI. If any testing was done, the details are not in this summary.

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

Not applicable/Not provided. This level of detail is typically associated with clinical studies for AI/software devices where ground truth needs to be established by multiple expert reviewers. For an ultrasonic scaler, performance verification would likely rely on engineering/bench testing and comparison to predicate device specifications.

4. Adjudication method for the test set

Not applicable/Not provided. See the explanation for point 3.

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. The EMS KERMIT® is a physical medical device (ultrasonic scaler), not an AI or software-as-a-medical-device (SaMD) that assists human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

Not applicable. The EMS KERMIT® is a physical medical device, not an algorithm.

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

Not applicable/Not provided in this summary. For a physical device, "ground truth" often relates to measured physical properties, successful removal of calculus in in-vitro models, or comparison against established predicate device performance. Specific "ground truth" in the clinical AI sense is not relevant here.

8. The sample size for the training set

Not applicable. The EMS KERMIT® is a physical device, not an AI model that requires a training set.

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

Not applicable. See the explanation for point 8.

Summary

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JAN 27 2000

K992504

510(k) SUMMARY for EMS KERMIT®

1. SPONSOR
  EMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Suzanne Fassio Contact Person: 022 994 47 00 Telephone:

Date Prepared: December 17, 1999

DEVICE NAME 2.

Proprietary Name:	EMS KERMIT®
Common/Usual Name:	Ultrasonic Scaler
Classification Name:	Ultrasonic Scaler

3. PREDICATE DEVICES

EMS miniPiezon	K953026
Piezon Master 400	K896749
KiS Microsurgical Instruments
Sonicsys
Amdent® US30	K920328

4. INTENDED USE

removing supra and subgingival calculus and stains .
periodontal pocket lavage with simultaneous ultrasonic tip movement .
scaling and root planing .
releasing crowns, bridges, inlays and posts as wells as condensing gutta percha .
plugging for amalgam condensation .
. amalgam burnishing
. preparing and rinsing root canals

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures connected at the shoulders, forming a symbol that resembles a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 2000

Cynthia J. M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

K992504 Re :

EMS KERMIT® Trade Name: Requlatory Class: II Product Code: ELC December 17, 1999 Dated: December 20, 1999 Received:

Dear Dr. Nolte:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able Blaced in the enousband, or 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Dr. Nolte

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K992504

510(k) Number (if known):

Device Name: EMS KERMIT®

Indications for Use:

The EMS KERMIT® is an ultrasonic scaler which is intended for the following:

Removing supra and subgingival calculus deposits and stains from the teeth ●
Periodontal pocket lavage with simultaneous ultrasonic tip movement
Scaling and root planing .
Releasing crowns, bridges, inlays and posts as well as condensing gutta percha ●
Plugging for amalgam condensation ●
Amalgam burnishing
Preparing, cleaning, and irrigating root canals
Preparing approximal cavities
Cementing inlays and onlays
Retrograde preparation of root canals

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .

Prescription Use . (Per 21 CFR 801.109

Over-The-Counter Use

EMS KERMIT® Additional Information - K992504 12/17/99

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.