Win-100D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.

Device Description

Our device comprises of a light (0.6Kg), small (230mmX12mm), compact design and ergonomic handpiece along with a multi-docking system. The handpiece consists of a focusing mechanism and a capture button to assist the capture intraoral or full face images of the patient. The handpiece connects to a multi-docking system via a cable. The multi-docking system in turn can connect directly to a monitor and PC via a standard composite connection (RCA). It uses high definition imaging (460 TV-lines) to capture images at 80 degrees field of view. It can make the screen in 4 frames or full screen mode via a multi-docking system. It can change the side of the captured image.

AI/ML Overview

The provided text is a 510(k) summary for the Win-100D Intra-Oral Camera System and Accessories. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device meets specific acceptance criteria through novel studies. Therefore, much of the requested information regarding acceptance criteria and performance studies in a traditional sense is not directly applicable or available in this document.

The core of a 510(k) is to show that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or, if there are differences, that those differences do not raise new questions of safety and effectiveness.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

Instead of specific quantitative acceptance criteria, the "performance" is evaluated relative to the predicate device's characteristics. The acceptance criteria essentially boil down to demonstrating "substantial equivalence" in performance characteristics.

Acceptance Criteria Category (implied by "Similar")	Reported Device Performance (vs. Digital Doc, K981663)
Indications for use is Identical	Identical
Target population is Identical	Identical
Design is Similar	Similar (Light (0.6Kg), small (230mmX12mm), compact design and ergonomic handpiece; multi-docking system; focusing mechanism and capture button; composite connection (RCA); high definition imaging (460 TV-lines); 80 degrees field of view; 4 frames or full screen mode; change side of captured image)
Materials is Similar	Similar
Performance is Similar	Similar (Specific performance metrics are not given, but visual functions like 460 TV-lines and 80 degrees field of view establish similarity to accepted standards for intraoral cameras in 2004)
Sterility is Not Applicable	Not Applicable
Biocompatibility is Similar	Similar
Mechanical safety is Similar	Similar
Chemical safety is Not Applicable	Not Applicable
Anatomical sites is Identical	Identical
Human factors is Similar	Similar
Energy used and/or delivered is Similar	Similar
Compatibility with environment and other devices is Similar	Similar
Where used is Identical	Identical
Standards met is Similar	Similar
Electrical safety is Similar	Similar
Thermal safety is Similar	Similar
Radiation safety is Not Applicable	Not Applicable

The study that proves the device meets the acceptance criteria is the comparison presented in the 510(k) submission, which aims to demonstrate substantial equivalence to the predicate device K981663.

Additional Requested Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. A 510(k) submission for an intra-oral camera of this nature typically does not involve a "test set" in the sense of clinical trial data with patient samples. The performance evaluation is based on technical specifications and comparison to the predicate, rather than a clinical study with a patient sample. No specific clinical data or patient samples are mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. As no clinical "test set" or ground truth based on expert review is mentioned, this information is not relevant to this 510(k) summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None. No adjudication method is described because there is no clinical test set requiring adjudication.
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:
- No. This device is an intra-oral camera, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device (camera) and does not involve an algorithm with standalone performance evaluation in the context of diagnostic interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. The "ground truth" for this submission revolves around the technical performance specifications being comparable to the predicate device, not clinical outcomes or expert diagnoses.
The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established:
- Not applicable / Not provided. This is not an AI/ML device requiring a training set with ground truth.

Summary of the "Study" (510(k) Comparison):

The "study" in this context is the side-by-side comparison of technological characteristics between the WIN-100D and the predicate device (Digital Doc, K981663). This comparison is presented in a table format and detailed explanations within the main submission (which are not fully provided here). The core of the evidence is showing that the new device's features (design, materials, stated performance, safety aspects) are "identical" or "similar" to a legally marketed device. Performance is largely demonstrated through technical specifications (e.g., 460 TV-lines, 80 degrees field of view) which are deemed acceptable for the intended use of providing visual information to dentists and patients.

Summary

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MAR 2 3 2004

510(k) Summary As Required by 21 section 807.92 ( c )

1-Submitter Name: WIN-US TECHNOLOGY CO., LTD

2-Address: 3F Younbg-Pung B/D, #225-1 Poi-Dong

Kangnam-Ku, Seoul, Korea

3-Phone: 82-2-529-3785

4-Fax: 82-2-572-3784

4-Fax: 82-2-372-3704
5-Contact Person: (on behalf of the submitter) Jay Mansour, Mansour Consulting LLC
5-Contact Person: (on behalf of the Submitter) Jay Mansour, Mansour Co 5-Contact Person: (on behalf of the Submiter) buy Manocal, Marioun, Marines (678) 623-3765
1308 Morningside Park Dr Alpharetta, GA 30022 USA (770) 777-4146 Fax (678) 623-376 6-Date summary prepared: January 9th, 2004

7-Device Trade or Proprietary Name: Win-100D

7-Device Trade of Proprietary Nation in the Oral Camera system and accessories

9-Device Classification Name: Unit, Operative, Dental

10-Substantial Equivalency is claimed against the following device:

DIGITAL DOC from Digital Doc, Inc. .
- 510k # K981663

11-Description of the Device: (For technical specifications, refer to the user manual) 11-DeSCH(ption of the Devices (rec: (rol technour spotheaters) in refer to User Manual)

Our device comprises of a light (0.6Kg), small (230mmX12mm), compact design and ergonomic handpiece along with a multi-docking system.

The handpiece consists of a focusing mechanism and a capture button to assist the The nanapless intraoral or full face images of the patient.

The handpiece connects to a multi-docking system via a cable.

The multi-docking system in turn can connect directly to a monitor and PC via a standard composite connection (RCA).

It uses high definition imaging (460 TV-lines) to capture images at 80 degrees field of view.

It can make the screen in 4 frames or full screen mode via a multi-docking system. It can change the side of the captured image.

12-Intended use of the device: (refer to FDA form attached)

Win-100D intra oral camera system and accessories is indicated for use to provide the ville 100D intra oral camora cystem atta before and after the dental procedure, dentist and the pations with a vieribing the dental procedure being performed as well as showing the results.

13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above This is better expressed in the tabulated comparison (Paragraph 14 below)

Page 6

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14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially r lease in a below a tablated compansement of commercial distribution. Also, Equivalency overview chart path is attached. Refer to the detailed explanations within the main submission.

FDA file reference number	510k # K981663
Attachments inside notification submission file	510k FDA website print out
TECHNOLOGICAL CHARACTERISTICS	Comparison result
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Similar
Sterility	Not Applicable
Biocompatibility	Similar
Mechanical safety	Similar
Chemical safety	Not Applicable
Anatomical sites	Identical
Human factors	Similar
Energy used and/or delivered	Similar
Compatibility with environment and other devices	Similar
Where used	Identical
Standards met	Similar
Electrical safety	Similar
Thermal safety	Similar
Radiation safety	Not Applicable

Page 7 revised

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.

MAR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Win-US Technology Company Limited C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K040691

Trade/Device Name: Intra-Oral Camera System and Accessories, WIN-100D Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 16, 2004 Received: March 17, 2004

Dear Mr. Lehtonen:

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. Rivkowich

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 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) 594-5613. 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 vours.

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

510(k) Number (if known): |(0 \0(0(0)

Device Name: Intra-Oral Camera System and Accessories, WIN-100D

Indications For Use:

Prescription Use ﻟﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ (Part 21 CFR 801 Subpart D) AND/OR -

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runny

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

Page 1 of

510(k) Number: K040691

24(1)

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.