The C8+Dental Operative Unit with accessories is intended to supply power to and serve as a basc for dental devices and accessories. This product includes a dental The unit is intended for use in the dental clinic environment and used by chair. trained dentists and/or dental technicians and assistants.

The CB+ Dental Operative Unit is offered with the optional Sivision 3, an intraoral camera system intended to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity.

Device Description

The C8+ is a modification of the C8 Dental Operative Unit and includes some features previously available on the Spirit S1 Dental Operative Unit. The C8+ consists of the following major components:

Patient Treatment Chair ●
. Dentist's Element
Assistant's Element
Water Unit with Cuspidor
Overhead Dental Light

The C8+ can supply power to five (5) dental instruments, which may include an air water syringe, high and low speed turbines and electric motors, ultrasonic scalers, intraoral X -ray film viewer, fiber optic light instruments, dental curing light, water warmers, airscaler, and an air polisher. These accessories are not part of the C8+ dental operating unit 510(k). The C8+ also offers an optional built-in disinfection apparatus and an optional video system, SIVISION 3, which consists of an intraoral camera and a flat-screen LCD monitor.

AI/ML Overview

This document is a 510(k) summary for the Sirona Dental Systems C8+ Dental Operative Unit with Accessories. It describes a medical device that combines features of existing predicate devices.

Based on the provided text, the device is a dental operative unit and accessories (dental chair, dental light, etc.) which also includes an optional intraoral camera system (Sivision 3). The K032543 submission is a claim of substantial equivalence to previously cleared devices (C8 Dental Operative Unit K983242 and Spirit S1 Dental Operative Unit K962071).

Crucially, this type of 510(k) submission for a non-diagnostic, non-AI-powered device generally does NOT include formal acceptance criteria, clinical studies demonstrating specific performance metrics, or sophisticated ground truth establishment methods as would be seen for diagnostic AI/ML devices.

The submission focuses on demonstrating that the new device has "the same intended use" and "similar components, and are similar in design, characteristics, and mode of operation" to already cleared predicate devices, without raising new questions of safety or effectiveness. The optional SIVISION 3 intraoral camera system is described as providing "intraoral video images to view the condition of the teeth and oral cavity," which is a descriptive function rather than a performance claim requiring specific accuracy metrics.

Therefore, many of the requested elements for acceptance criteria and study details are not applicable to this type of device and submission.

Here's how to address each point given the nature of the document:

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

Acceptance Criteria	Reported Device Performance
Intended Use Equivalence: Device must have the same intended use as predicate devices.	The C8+ Dental Operative Unit has the same intended use as the predicates, to "supply power to and serve as a base for dental devices and accessories." The Sivision 3 intraoral camera is intended "to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity."
Technological Characteristics Equivalence: Device must have similar components, design, characteristics, and mode of operation as predicate devices, without raising new questions of safety or effectiveness.	The C8+ includes "similar components, and are similar in design, characteristics, and mode of operation" to the C8 and Spirit S1. It includes a chair, dentist's instrument board, cuspidor, assistant's board, dental light, and footswitches. Additional features do not change fundamental technology or raise new safety/effectiveness questions.
Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices.	The FDA response states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that no new questions of safety or effectiveness were raised.

Explanation: For a Class I device (manual dental operative unit) seeking 510(k) clearance based on substantial equivalence, "acceptance criteria" are typically met by demonstrating that the device is as safe and effective as a legally marketed predicate device. This is primarily established through comparison of intended use and technological characteristics rather than specific performance metrics from a formal clinical study. The optional intraoral camera is descriptive of its functionality rather than a quantified performance.

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

Not applicable. This submission is for a medical device that does not involve diagnostic algorithms or require "test sets" of data in the typical sense. The "testing" involved would be engineering verification and validation against design specifications and relevant standards, not a clinical data-driven performance test.

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. As above, there is no "test set" and corresponding ground truth in this context for a device of this nature. The "ground truth" for the device's function is its ability to perform its mechanical and electrical functions as designed and intended (e.g., supply power, provide intraoral images), which are verified through engineering tests and comparison to predicate devices, not expert consensus on diagnostic data.

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

Not applicable. No test set requiring expert adjudication for ground truth was used.

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 manual dental operative unit and an intraoral camera; it does not incorporate AI or machine learning algorithms, nor is it a diagnostic tool that would typically involve human readers or comparative effectiveness studies of this nature.

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

Not applicable. As stated, this device does not contain an algorithm in the sense of AI/ML or diagnostic image analysis.

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

Not applicable in the typical sense of diagnostic devices. The "ground truth" for the device's substantial equivalence is established by comparing its design specifications, intended use, and technological characteristics to those of the predicate devices, and demonstrating that it adheres to relevant safety standards. This is a regulatory "ground truth" rather than a clinical one derived from patient data.

8. The sample size for the training set

Not applicable. This device does not use machine learning, therefore, there is no training set.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.

Summary

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K032543

NOV 1 4 2003

510(k) Summary

for

Sirona Dental Systems C8+ Dental Operative Unit with Accessories

SPONSOR 1.

Sirona Dental Systems GmbH Farbrikstrasse 31 64625 Bensheim Germany

2. DEVICE NAME

Proprietary Name:	C8+ Dental Operative Unit
Common/Usual Name:	Dental Operative Unit
Classification Name:	Dental Operative Unit with Accessories

3. PREDICATE DEVICES

C8 Dental Operative Unit with Accessories, K983242

Spirit S1 Dental Operative Unit with Accessories, K962071

INTENDED USE 4.

The C8+Dental Operative Unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.

The C8+ Dental Operative Unit is offered with the optional Sivision 3 intraoral camera system, which is intended to provide the dentist and patient with intraoral video images to view the condition of the teeth and oral cavity.

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ડ. DEVICE DESCRIPTION

The C8+ is a modification of the C8 Dental Operative Unit and includes some features previously available on the Spirit S1 Dental Operative Unit. The C8+ consists of the following major components:

Patient Treatment Chair ●
. Dentist's Element
Assistant's Element
Water Unit with Cuspidor
Overhead Dental Light

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Sirona Dental Systems C8+ Dental Operative Unit with Accessories is substantially equivalent to the Sirona Dental Systems Sirona C8, K983242, and the Spirit S1 Dental Operative Unit, K962071. The C8+ has the same intended use as the predicates in that they are all used to supply power to, and serve as a base for dental devices and accessories.

The technological characteristics of the proposed and predicate devices are the same in that they include similar components, and are similar in design, characteristics, and mode of operation. Both the proposed and predicate devices include a chair, dentist's instrument board, cuspidor, assistant's board, dental light and footswitches for control of the various components. The C8+ includes various options also offered on either the C8 or the Spirit S1. The C8+ also includes additional features that do not change the fundamental technology of the device or raise new questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2003

Ms. Mary McNamara-Cullinane Regulatory Affairs Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K032543

Trade/Device Name: Sirona Dental Systems C8+ Dental Operative Unit with Accessories Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 15, 2003 Received: August 18, 2003

Dear Ms. Cullinane:

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. Cullinane

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 (OS) 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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours.

Ques

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

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510(k) Number (if known): K032543

Device Name: Sirona Dental Systems C8+ Denlal Operative Unit with Accessories

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

nesthesiology, General Hospital,

510(k) Number. K032543

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use -

Sirona Dental Systems 510(k) C8+ Dental Operative Unit with Accessories

November 10, 2003

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.