This product is a Dental Operative Unit with accessories that 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.

Device Description

The Sirona C8 Dental Operative Unit and Accessories consist of the following components:

Treatment Chair
Dentist's Element which controls the pressure for the air and water, spray and drive adjustments for the instruments which can also be controlled by a foot pedal, and control of the optional Cuspidor feature
Assistant's Element with Cuspidor, controls automatic and manual air vacuum and suction
Dental Lamp

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and device performance:

**Crucially, the provided document (a 510(k) summary for the Sirona C8 Dental Operative Unit) does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

This 510(k) submission is focused on demonstrating substantial equivalence to a predicate device (Pelton & Crane's Spirit S1 - K962071), rather than proving the device meets specific performance criteria through a study.

The document's purpose is to show that:

The Sirona C8 has the same intended use as the predicate device: "supply power to, and serve as a base for dental devices and accessories."
The Sirona C8 has similar technological characteristics (components, design, and mode of operation) to the predicate device.

Because the device is a "Dental Operative Unit," it is generally subject to general controls and does not typically require performance studies to demonstrate safety and effectiveness for a 510(k) clearance if substantial equivalence can be demonstrated through comparison to a predicate device. Performance data would typically be required for devices with new technologies, different intended uses, or higher risk classifications.

Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text.

Here's how I would answer your questions based solely on the provided information, highlighting the absence of the requested data:

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

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document
The device is substantially equivalent to a predicate device (Pelton & Crane's Spirit S1 - K962071) in terms of intended use, general components, design, characteristics, and mode of operation.	The Sirona C8 Dental Operative Unit and Accessories are described as having components (Treatment Chair, Dentist's Element, Assistant's Element, Dental Lamp) and functions (controls for air, water, spray, drive, chair movements, water unit) that are similar to the predicate device.

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; no performance study was conducted or reported in this 510(k) summary.
Data provenance: Not applicable; no data from a test set is reported.

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; no test set or ground truth establishment by experts is reported.

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

Not applicable; no test set or adjudication is reported.

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; no MRMC comparative effectiveness study was conducted or reported. This device is a physical dental unit, not an AI or diagnostic imaging device that would typically involve human readers.

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

Not applicable; this device is a physical dental unit, not an algorithm.

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

Not applicable; no ground truth was established for this submission. The demonstration is of substantial equivalence to an already legally marketed device.

8. The sample size for the training set

Not applicable; no training set was used or reported.

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

Not applicable; no training set or ground truth establishment is reported.

Summary of what is present in the document:

The document is a 510(k) premarket notification for a dental operative unit, seeking clearance based on substantial equivalence to an existing predicate device. It defines the device, its intended use, and compares its technological characteristics to the predicate. There is no information regarding performance testing, clinical studies, or data analysis against specific acceptance criteria.

Summary

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DEC 1 1 1998

510(k) Summary for Sirona C8

K983242

SPONSOR 1.

Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim, Germany

Contact Person: Walter Schneider Telephone: 49 625 1162 778

Date Prepared: September 14, 1998

2. DEVICE NAME

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

PREDICATE DEVICES 3.

Pelton & Crane's Spirit S1 - K962071

4. DEVICE DESCRIPTION

The Sirona C8 Dental Operative Unit and Accessories consist of the following components:

Treatment Chair
Dentist's Element which controls the pressure for the air and water, spray and drive adjustments for the instruments which can also be controlled by a foot pedal, and control of the optional Cuspidor feature

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Assistant's Element with Cuspidor, controls automatic and manual air vacuum and suction
Dental Lamp -

INTENDED USE 5.

The Sirona C8 is an electronically controlled dental operative unit with accessories that are intended to supply power to, and serve as a base for dental devices and accessories.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The general components, design, characteristics, and mode of operation of the Sirona C8 Dental Operative Unit and Accessories are substantially equivalent to Pelton & Crane's Spirit S1 Dental Systems. Both are AC powered dental operative units with accessories that are intended to supply power to, and serve as a base for dental devices and accessories. Both Dental Systems include a treatment chair, the Dentist's Element, the Assistant's Element and a Dental Light, offer several additional options and electronically control chair movements and water unit functions.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Sirona Dental Systems GmbH & Company KG C/O Ms. Sheila Hemeon-Heyer Senior Consultant Medical Device Consultant, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K983242 Sirona C8 Dental Operative Unit with Trade Name: Accessories Requlatory Class: I Product Code: EIA Dated: September 14, 1998 Received: September 16, 1998

Dear Ms. Hemeon-Heyer:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Hemeon-Heyer

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 requlation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Patricio Cuevitt/kbr

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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510(k) Number (if known): _

Device Name: _________________________________________________________________________________________________________________________________________________________________ Sirona C8

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hesalol Shepp

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 98374 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

9/14/98

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Sirona Dental Systems GmbH 510(k) Sirona C8

Page v

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.