The MirroScope™ System is an intraoral camera that is mounted on a customary mirror and complimentary imaging accessories. The System consists of the following main components:

The MirroScope™: a handpiece comprised of a mirror (MirroLens), alignment of prisms and lenses, a miniature 1/4" CCD camera Remote Head Unit (RHU), located in the handle. The video signal from the RHU is transferred to the Camera Control Unit (CCU) located in a control box, via a lightweight cable. A set of six LED's illuminates the working area around the mirror. A disposable, single use protective sheath is provided to be mounted over the handpiece prior to each use, to ensure proper hygiene and to serve as a barrier cover.
Two complementary packages, the PRO-200™ and the VIEW-300™, to provide either an overall solution or an add-on solution to the existing infrastructure. The PRO-200™ includes a Control Box (Camera Control Unit (CCU), Video Processing Unit (VPU), Power Supply Unit (PSU), RF Transmitter (Optional), Infrared Receiver (IRR), Docking station for MirroScope™), R-400 Infrared remote control, External AC/DC adaptor, Foot pedal (Optional), and RF Receiver (Optional). The VIEW-300™ includes a Control box (Camera Control Unit (CCU), Video Processing Unit (VPU), Power Supply Unit (PSU), 12.1" TFT screen and Converter, Infrared Receiver (IRR), Docking station for MirroScope™), R-400 Infrared remote control, External AC/DC adaptor, Accessories, and Foot pedal (Optional).

AI/ML Overview

The provided text describes a 510(k) summary for "The MirroScope™ System", an intraoral camera. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets them.

The document primarily focuses on:

Administrative details: Applicant information, contact person, date prepared, trade name, classification, product codes, and regulation numbers.
Predicate devices: A list of previously cleared intraoral camera systems.
Performance standards: A list of voluntary standards (IEC, EN, ISO) the device complies with, but these are general safety and compatibility standards, not performance criteria for its dental imaging function.
Intended Use/Indications for Use: "The MirroScope™ System is indicated for use during dental examinations and procedures when a video image is desired."
Device Description: Details about the MirroScope™ handpiece and its complementary packages (PRO-200™ and VIEW-300™).
Substantial Equivalence: A statement asserting substantial equivalence to predicate devices and listing the types of testing performed to support this claim (electrical safety, EMC, software verification, performance testing, clinical images and use evaluation, hazard analysis).

The document mentions "Performance testing" and "Effective clinical images and use evaluation" as activities undertaken, but it does not provide any specific acceptance criteria (e.g., image resolution, clarity, color accuracy, or diagnostic accuracy) or the results of such studies. It does not present a table of acceptance criteria versus reported performance, nor does it detail the methodology, sample sizes, provenance, expert qualifications, or ground truth establishment for any performance study.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or the details of such a study based on the provided text. The document is too high-level and does not delve into the specifics of performance validation.

Summary

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SEP 2 1 2004 510(K) SUMMARY

510(k) Number K_______________________________________________________________________________________________________________________________________________________________

Applicant's Name:

Miras Mirror Imaging Solutions Ltd. 31 Habarzel St. Tel Aviv, 69710 Israel Tel.: 972-3-6442595 Fax: 972-3-6442597

Contact Person:

Dorit Winitz Ph.D Biomedical Strategy Ltd. 11 Menachem Begin Street. Ramat Gan 52521, Israel Tel: 972-3- 6123281 Fax: 972-3-6123282

Date Prepared:

June 2004

Trade Name:

MirroScope™ System

Classification Name:

UNIT, OPERATIVE DENTAL Product Code: Regulation No: Class: I Panel: Dental

Classification:

Product Code: EIA Regulation No: 872.6640 Class: I Panel: Dental

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Predicate Device:

The AcuCam Concept IV Intraoral Camera System (Dentsply 물 International, Inc.), cleared under K000112
The Cdr-Cam System (Schick Technologies, Inc.), cleared 비 under K963778
The FlexiScope Optomodul (Schoelly Fiberoptic, Gmbh), cleared under K984641
Class I Exempt Dental Mirror (product code EAX) I

Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the MirroScope™ System complies with the following voluntary standards:

IEC 60601-1(1988)+A1(1991)+A2(1995) .
IEC/EN 60601-1-2 (2001) .
CAN/CSA-C22.2 No. 601.1.2-94(R1999); CISPR 11(2003) . group 1 class B
. IEC 60601-1-4 (1999)
. EN 1441 (1997)
ISO 14971 (2000) .

Intended Use / Indication for Use:

The MirroScope™ System is indicated for use during dental examinations and procedures when a video image is desired.

Device Description:

The MirroScope™ System is an intraoral camera that is mounted on a customary mirror and complimentary imaging accessories. The System consists of the following main components:

1. The MirroScope™

The MirroScope™ is a handpiece comprised of a mirror (MirroLens), alignment of prisms and lenses, a miniature 1/4" CCD camera Remote Head Unit (RHU), located in the handle. The video signal from the RHU is transferred to the Camera Control Unit (CCU) located in a control box, via a lightweight cable. A set of six LED's illuminates the working area around the mirror. A disposable, single use protective sheath is provided to be mounted over the handpiece prior to each use, to ensure proper hygiene and to serve as a barrier cover.

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Two complementary packages, the PRO-200™ and the VIEW-300™, to provide either an overall solution or an add-on solution to the existing infrastructure:

The PRO-200™ includes the following:

Control Box: .
- o Camera Control Unit (CCU)
- o Video Processing Unit (VPU)
- Power Supply Unit (PSU) o
- RF Transmitter (Optional) o
- O Infrared Receiver (IRR)
- Docking station for MirroScope™ o
R-400 Infrared remote control .
External AC/DC adaptor .
Foot pedal (Optional) .
RF Receiver (Optional) .

The VIEW-300™ includes the following:

Control box: .
- o Camera Control Unit (CCU)
- O Video Processing Unit (VPU)
- o Power Supply Unit (PSU)
- o 12.1" TFT screen and Converter
- O Infrared Receiver (IRR)
- o Docking station for MirroScope™
R-400 Infrared remote control .
External AC/DC adaptor .
Accessories: .
Foot pedal (Optional) .

Substantial Equivalence:

The MirroScope™ System and its predicate devices share the same intended use and similar materials and design. A comprehensive testing program was developed and performed in order to verify that the MirroScop™ System does not raise any new safety and effectiveness issues in comparison to its predicate device. This includes the following testing and activities:

Electrical safety and electromagnetic compatibility testing . according to IEC 60601-1 (and amendments), and IEC 60601-2 standards.
Software verification and validation testing .
Performance testing .
Effective clinical images and use evaluation .

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Hazard analysis including risk level and solutions performed . in compliance with AAMI/ISO 14971-1, 2000 is attached
Altogether, Miras Mirror Imaging Solutions Ltd. believes that the MirroScope™ System is safe and effective for its intended use and is substantially equivalent to its predicate devices cited above without raising any new safety and/or effectiveness issue.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 2 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Miras Mirror Imaging Solutions, Limited C/O Dr. Dorit Winitz Company Consultant Biomedical Strategy Limited 11 Menachem Begin Street Ramat Gan 52521, ISRAEL

Re: K041805

Trade/Device Name: The MirroScope™ System Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: June 20, 2004 Received: July 6, 2004

Dear Dr. Winitz:

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 approvisions 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 (1 wr ), irence of 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 Eederal Register.

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Page 2 - Dr. Winitz

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1 DTC issuaires on that your device complies with other requirements Incall that I DA mas made a actessand regulations administered by other Federal agencies. of the Act of ally t oderal states the requirements, including, but not limited to: registration Tourinust comply with an the Hosever (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), labeling systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ijon 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) Fins letter will anow you to began finding of substantial equivalence of your device to a premarket notification. - The Fire 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), If you desire specific at not to pliance 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 may overn outer generalant and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Siva Runno

Chiu-Lin, Ph.D.

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K641805

Device Name:

The MirroScope™ System

Indications for Use:

The MirroScope™ System is indicated for use during dental examinations and procedures when a video image is desired.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number_

Prescription Use _ 1 (Per 21 CFR 801.109)

Over the Use

Counter 1

Susan Knapp

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

510(k) Number: K041605

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.