The SciCan Classic and accessories is to provide video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology. It is used to perform various diagnostic procedures, to provide educational information to patients as well as to other clinical personnel and to provide documentation for patient records and for insurance companies.

SciCan Classic also is used for inspection of reliable diagonsis of border gaps when dealing with inlays. Additionally it acts as an effective caries detector during the examination of areas of the mouth which are normally difficult to approach. Further indications for use are extra-oral imaging of the whole face and of the mouth, outline imaging of the quadrants and macroscopic images of the dental enamel.

The SciCan Classic and accessories are indicated for use when video images are desired to provide visual information during dental examinations and procedures.

Device Description

The SciCan Classic is a video camera system with a modular design due to a handpiece system with interchangeable optics. It uses a CCD ½" camera chip and provides fiber optic illumination by an integrated light source with automatic exposure control. It has removable and interchangeable probe options (90° probes, 0° probe). It supports NTSC / PAL video systems and has a power consumption of 150 Watt.

AI/ML Overview

The provided 510(k) summary for the Ka84556 SciCan Classic device does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would be analyzed.

Instead, this submission is for a video camera system, and its "effectiveness" is established based on its intended use for providing video images and adherence to general safety and quality standards, and comparison to a predicate device.

Here's an breakdown of the information as requested, highlighting what is present and what is absent given the nature of this submission:

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

Based on the provided document, specific quantitative "acceptance criteria" related to a performance study for image quality or diagnostic accuracy are not defined. The effectiveness is broadly stated:

Acceptance Criteria (Implied)	Reported Device Performance
Providing video images for dental examinations and procedures.	"The SciCan Classic is effective for its intended use of providing video images for the above described purposes and procedures."
Compliance with relevant safety standards.	"The device complies with IEC 601-1-2, and IEC 601-1-2, and IEC 601-2-18."
Substantial equivalence to predicate device.	The FDA's letter (K984556) affirms substantial equivalence to the Welch Allyn Reveal Intraoral Camera System (K981937).

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 does not describe a clinical performance study with a test set of data (e.g., images for diagnostic evaluation). Its effectiveness is based on technological characteristics and comparison to a predicate device, rather than a statistical analysis of a sample of cases.

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 such test set or ground truth establishment by experts is described for this device.

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

Not applicable. No test set requiring expert adjudication is described.

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 video camera system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or reported.

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

Not applicable. The SciCan Classic is a hardware device (a camera system), not an algorithm. Standalone performance as typically described for AI/ML devices is not relevant here.

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

Not applicable. No explicit "ground truth" as would be used in a diagnostic performance study is mentioned. The device's "effectiveness" is tied to its ability to capture and display images, fulfilling its intended diagnostic and educational purposes, and its technical specifications compared to a predicate.

8. The sample size for the training set

Not applicable. This is a hardware device (video camera system), not a machine learning algorithm. 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, this question is not relevant.

Summary Explanation:

The K984556 submission for the SciCan Classic is for a general-purpose video camera system intended for dental use. Its clearance is primarily based on:

Substantial Equivalence: Demonstrated by comparing its design, power consumption, camera type, video system, illumination, light control, handpiece, probes, and standards met to the legally marketed predicate device, the Welch Allyn Reveal Intraoral Camera System (K981937).
Compliance with Standards: Adherence to safety standards like IEC 601-1-2 and IEC 601-2-18.
Stated Effectiveness: The device's ability to provide "video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology" for diagnostic, educational, and documentation purposes.

The rigor of clinical performance studies with acceptance criteria, test sets, expert ground truth, and statistical analyses (like those for AI/ML or complex diagnostic devices) is not typically required for this type of device, especially given its 1998 submission date. The FDA determined it substantially equivalent to a predicate, allowing it to proceed to market under general controls.

Summary

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Ka84556

510(k) Summary - Summary of Safety and Effectiveness Information_

Submitter's Name & Adress:	Schölly Fiberoptic GmbH
	Robert-Bosch-Strasse 1-3
	D-79211 Denzlingen
Contact Person;	Carsten Schlenker
Telephone &	Tel.: 00 49 - 76 66 - 9 08 - 2 05
Fax:	Fax: 00 49 - 76 66 - 9 08 - 385
Date Summary Prepared:	October 30, 1998
Device Name:	Device trade Name - SciCan Classic
	Common Name - Video Camera System and Accessories
	Classification Name - Unit, Operative Dental
Predicate Device:	Welch Allyn Reveal Intraoral Camera System
	(510(k) number K981937)

Device Description, Intended Use & Effectiveness:

The purpose of the SciCan Classic and accessories is to provide video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology. It is used to perform various diagnostic procedures, to provide educational information to patients as well as to other clinical personnel and to provide documentation for patient records and for insurance companies.

Comparison feature	SciCan Classic	Welch Allyn Reveal (K981937)
General
design	modular design due handpiecesystem with interchangeableoptics	modular design due handpiecesystem with interchangeableoptics (lenses)
power consumtion	150 Watt	144 Watt
Camera Typ	Video camera system	Video camera system
Video System	NTSC / PAL	PAL
Camera chip	CCD ½"	CCD 1/4"
Illumination	fiber optic illumination providedby an integrated light source	fiber optic illumination providedby an integrated light source
light control	CCD, automatic exposure control	CCD, automatic exposure control
handpiece	removable and interchangeableprobe options	removable and interchangeablelens (probe )options
probes	90° probes, 0° probe	90° probes, 0° probe
standards met	IEC 601-1, IEC 601-1-2 (DIN EN60601-1-2),IEC-601-2-18	IEC 601, EN 60601-1-2, AS3200.1.0

Technological Characteristics:

drawn up /by:	11/29/98/cs	file:	ANL03FDA.DOC
last change /by:	-	department:	R&D
revision:	0	page	12

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Summary of Safety:

The SciCan Classic was designed to provide safety to the patient as well as the user and assisting personnel. The device complies with IEC 601-1-2, and IEC 601-1-2, and IEC 601-2-18.

Summary of Effectiveness:

The SciCan Classic is effective for its intended use of providing video images for the above described purposes and procedures.

drawn up /by:	11/29/98 / cs	file:	ANL03FDA.DOC
last change /by:	-	department:	R&D
revision:	0	page	13

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Mr. Carsten Schlenker Regulatory Affairs Manager Scholly Fiberoptic GmbH Robert-Bosch-Strasse 1-3 D-79211 Denzlingen

Re: K984556 Scican Classic Trade Name: Requlatory Class: I Product Code: EIA Dated: November 29, 1998 December 23, 1998 Received:

Dear Mr. Schlenker:

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 The general controls controls provisions of the Act. 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. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Reqister. 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 - Mr. Schlenker

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 regulation 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,

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):	K984556
Device Name:	SciCan Classic

Indications For Use:

The SciCan Classic and accessories are indicated for use when video images are desired to provide visual information during dental examinations and procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runor

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 16 78 155 65 6 510(k) Number.

Image /page/4/Picture/7 description: The image shows the words "Prescription Use" and the phrase "(Per 21 CFR 801.109)" below it. There is a filled in circle to the left of the words "Prescription Use". There is also an arrow pointing down from the right.

Over-The-Counter Use

(Optional Format 1-2-96)

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.