The Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US is intended for use in automated color shade-matching to assist in dental restoration. The targeted teeth for color analysis are the left and right central incisors, lateral incisors and canines.

Device Description

The Crystaleye Device is an automated color shade-matching device, based upon a database of reference tooth shades. The Crystaleye Device is comprised of the following components: Spectrophotometer, AC Adapter, Cradle, Contact Cap (5 pcs.), AC Cable, USB Cable, Master CDs, and Instructions. A personal computer is also required to run the Master CDs. The reference color tooth shades of multiple dental restoration manufacturers are loaded into the computer. The spectrophotometer captures an image of the target tooth, and the software matches a patient's color tooth shade with the closest available shade in the computerized reference database.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance
Correct identification of manufacturer shade from its database	The Crystaleye Device correctly identified the color shade for each of the 225 test evaluations, achieving 100% accuracy in matching to the pre-loaded reference shades.
Consistency/Repeatability of shade identification	The test was performed three times for each set of manufacturer shades, and in all instances, the device "correctly identified the same manufacturer shade." This indicates high consistency/repeatability.
Automation of shade matching	The device successfully automates the shade matching function, enabling medical and dental personnel to "visually evaluate quickly without manually attempting to match multiple color shades" and "substantially improves the ease and accuracy of color shade-matching."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 5 shades per set * 3 measurement points per shade * 5 sets of manufacturer shades = 75 unique measurement points/combinations. Each of these was tested 3 times, leading to a total of 225 test evaluations.
Data Provenance: The study was a non-clinical bench test performed on the device itself. No information is provided regarding the country of origin of the reference shades or if they are representative of any specific geographic region. The "data" being evaluated is the device's ability to match to pre-loaded digital representations of these shades.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The text does not explicitly state that human experts were used to establish the ground truth for the test set.
The "ground truth" in this context appears to be the pre-defined, known shade from the reference shade guides that the device was designed to identify. The device's task was to match its spectrophotometer reading to one of these pre-loaded manufacturer shades. The test verified if the device's output matched the expected manufacturer shade, which themselves are standards.

4. Adjudication Method for the Test Set:

None directly stated or implied. Given that the test involved the device identifying a specific, known manufacturer shade from its database, it's a binary outcome (correct/incorrect match to a pre-defined standard). There was no panel or group adjudicating discrepancies as the correct answer was already established by the shades themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was NOT done. The document explicitly states: "The Premarket Notification does not rely upon any clinical performance data." The study described is a non-clinical bench test of the device's accuracy in matching pre-defined shades.
Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance. The device is intended to assist humans, but its direct impact on human reader performance was not evaluated in this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone test was done. The described "Bench testing" directly evaluates the "Crystaleye Device" without human intervention during the measurement and matching process. The device captures an image and then the software "matches a patient's color tooth shade with the closest available shade in the computerized reference database." The test then verifies if the device correctly identified the shade. While a human would visually evaluate the output of the device in clinical use, the test itself assesses the algorithm's performance in matching.

7. The Type of Ground Truth Used:

The ground truth used was pre-defined manufacturer reference shades. These shades come from established commercial shade guides (e.g., VITAPAN CLASSICAL Shade Guide, VITA SYSTEM 3D-MASTER Tooth Guide). The device's database contains digital representations of these known shades, and the test verified the device's ability to correctly identify these known shades when presented with them.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size for the training set. It mentions that "The Crystaleye Device utilizes the tooth shades from these shade guides in its shade-matching database," implying these shades form the database the device uses for matching, but it doesn't differentiate between training data for model development and the reference data used for operational matching.

9. How the Ground Truth for the Training Set Was Established:

The "ground truth" for the device's internal database (which it matches against) was established from existing, legally marketed shade guides and shade teeth sets for manual color evaluation and matching. These are commercial standards from dental restoration manufacturers (e.g., VITAPAN CLASSICAL Shade Guide, VITA SYSTEM 3D-MASTER Tooth Guide, etc.). The device incorporates the "reference color tooth shades of multiple dental restoration manufacturers" into its computer. This suggests that the ground truth for its internal database is derived from these established physical shade guides.

Summary

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	K072643
510(k) Summary
Owner/Submitter:	OLYMPUS CORPORATIONCorporate R&D Center2-3 Kuboyama-cho, Hachioji-shiNOV 1 6 2007Tokyo, 192-8512, Japan
	Telephone: 011-81-426-91-7427Facsimile: 011-81-426-91-7350Contact: Etsuya SawadaTitle: Manager, Quality Assurance andRegulatory AffairsDate of Preparation: September 10, 2007
Device Trade Name:	"Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US"("Crystaleye Device")
Common Name:	Scanner, Color
Classification Name:	Optical Impression Systems for CAD/CAM(21 C.F.R. §872.3661)

Legally Marketed Device for which equivalence is claimed:
The predicate devices for the Crystaleye Device are the multiple shade guides and shade teeth sets for manual color evaluation and matching, including the following: VITAPAN CLASSICAL Shade Guide, VITA SYSTEM 3D-MASTER Tooth Guide, IVOCLAR VIVADENT CHROMASCOP, NORITAKE Shade Guide, and VINTAGE HALO NCC. The Crystaleye Device utilizes the tooth shades from these shade guides in its shade-matching database.

Description of Device:

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Intended Use of Device:

Summary of Technological Characteristics Compared to Predicate Devices:

The Crystaleye Device utilizes the reference tooth shades of multiple dental restoration manufacturers, which are the predicate devices. Currently, use of the predicate devices requires the manual comparison of multiple tooth shades to a patient's individualized tooth shade to achieve the closest match. The Crystaleye Device automates that matching function through use of a Spectrophotometer and a computerized database of the tooth shades available from each manufacturer. The dental or medical personnel can then visually evaluate the "match" identified by the Crystaleye Device.

Discussion of Non-Clinical Tests:

Bench testing was conducted on the Crystaleye Device. Five tooth color shades (with three measurement points each) were randomly selected from each of the five sets of reference shades from multiple dental restoration device manufacturers. The Crystaleye Device was then tested three times for each set of manufacturer shades to determine if the device correctly identified the same manufacturer shade from its database of tooth shades available from each manufacturer. Thus, the Crystaleve Device was subjected to 225 test evaluations, i.e. 5 shades per set x 3 measurement points per shade x 5 sets x 3 tests. The Crystaleye Device correctly identified the color shade for each of the 225 test evaluations.

Assessment of Clinical Performance Data:

The Premarket Notification does not rely upon any clinical performance data. A summary of a presentation on clinical usage and experience is included as Ref. 1 S. Ishikawa-Nagai, et al., "Summary of Presentations Made at (Attachment 9). American Association of Dental Research 2006 and International Association of Dental Research 2006 and Clinical Cases from Ongoing Study" (2007).

Conclusions Drawn from Non-Clinical Tests:

The Crystaleye Device provides a color match identification which medical and dental personnel may visually evaluate quickly without manually attempting to match multiple color shades. The Crystaleye Device substantially improves the ease and accuracy of color shade-matching of teeth for dental restoration.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2007

Olympus Corporation C/O Fumiaki Kanai, Ph.D. President and Chief Executive Officer MIC International 4-2-1 Yushima, Bunkyo-ku Tokyo, 113-0034 JAPAN

Re: K072643

Trade/Device Name: Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: KZN Dated: September 18, 2007 Received: September 18, 2007

Dear Dr. Kanai:

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 - Dr. Kanai

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 clectronic 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,

Nuhrhpdgl
Chiu Lin, Ph.D. for

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

1207 2643 510(k) Number (if known):

Device Name: "Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US"

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)	or

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Runser

(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K072643

Regulation Number and Section

§ 872.3661 Optical Impression Systems for CAD/CAM.

(a)
Identification. An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.(b)
Classification. Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).