(51 days)
The DIFOTI USB 2.0 System (DIFOTI System for Dental Examinations, Model B) is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.
The device known as the DIFOTI USB 2.0 System, also known as the DIFOTI System for Dental Examinations, Model B, is a dental examination system that utilizes visible light from an internal diode laser source. delivered with fiberoptic technology, for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic (CMOS) camera is used to capture the image(s). The light and the camera are connected via a USB 2.0 cable to a small PC that serves for data acquisition and storage, and the computer monitor is used for image visualization.
The provided text states that "Safety and performance testing included image quality evaluation, software hazard analysis, in-vitro vs. in-vivo performance evaluation, and software verification and validation." However, it does not provide specific acceptance criteria or detailed results of these studies, nor does it provide information regarding sample sizes, expert qualifications, adjudication methods, or ground truth establishment relevant to the device's performance characteristics.
Therefore, I cannot populate the table or answer the questions with the requested level of detail based solely on the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Not provided in text) | Reported Device Performance (Not provided in text with specific metrics) |
|---|---|
| Specific performance metrics for caries detection (e.g., sensitivity, specificity, accuracy) are not detailed. | The text only generally states that the device was found to be "safe and effective for its intended use" based on various evaluations. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not provided.
- Data Provenance (Country of origin, retrospective/prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication method for the test set:
- Adjudication Method: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: Not indicated. The device description does not explicitly mention AI or human-in-the-loop assistance for the task, rather it presents as an imaging system for visualization.
- Effect Size: Not applicable/not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The device is described as an "examination system" that provides "visualization" of caries. While it captures images, the text doesn't explicitly detail an automated algorithmic detection or diagnosis, making the concept of "standalone performance" in the AI context difficult to assess from this document. It appears to be a tool for human examiners.
7. The type of ground truth used:
- Type of Ground Truth: Not explicitly stated. The "in-vitro vs. in-vivo performance evaluation" suggests comparison against some form of diagnostic standard, but the specific nature of this (e.g., comparison against histological confirmation, clinical consensus, etc.) is not detailed.
8. The sample size for the training set:
- Sample Size (Training Set): Not provided. (Note: This type of device, from 2004, is unlikely to have had a "training set" in the modern machine learning sense, as it appears to be a direct imaging and visualization tool rather than an AI-driven diagnostic algorithm).
9. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not provided. (See note for point 8).
Summary of available information:
The 510(k) summary focuses on establishing substantial equivalence to predicate devices and generally stating that the device is "safe and effective." It lists various testing activities (image quality, software hazard, in-vitro/in-vivo performance, software V&V) but does not provide the specific quantitative results, methodologies, or data characteristics (like sample sizes, ground truth details, or expert involvement) that would be needed to answer your questions comprehensively. This level of detail is often found in the full 510(k) submission, not typically in the summary provided for the public.
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510(k) Summary
DEC 2 9 2004 Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Electro-Optical Sciences, Inc. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Electro-Optical Sciences chooses to submit a summary of the safety and effectiveness information, as follows:
| Trade Name: | DIFOTI USB 2.0 System(a/k/a DIFOTI System for Dental Examinations, Model B) |
|---|---|
| Owner/Operator: | Electro-Optical Sciences, Inc.1 Bridge Street, Suite 15Irvington-on-Hudson, NY 10533 |
| Manufacturing Site: | Electro-Optical Sciences, Inc.1 Bridge Street, Suite 15Irvington-on-Hudson, NY 10533Establishment Registration # 2438478 |
| Device Generic Name: | Dental examination system |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the deviceclassification is Class I, General Controls (21 CFR 872.4620, and 872.6640),According to the regulations (21 CFR 1040.10(b)15) under the Radiation Controlfor Health and Safety Act of 1968, as amended, the device also is a Class I medicallaser product that incorporates a laser of higher class (Class IIa). |
| Predicate Devices: | Fiberoptic transillumination (FOTI) fiberoptic dental imaging systemspreamendment, various manufacturers |
| Computer Oral Radiography System (K933455) and CDR-CAM (K963778)Schick Technologies, Inc. | |
| DIFOTI System for Dental Examinations (K991098),Electro-Optical Sciences, Inc. |
Product Description:
The device known as the DIFOTI USB 2.0 System, also known as the DIFOTI System for Dental Examinations, Model B, is a dental examination system that utilizes visible light from an internal diode laser source. delivered with fiberoptic technology, for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic (CMOS) camera is used to capture the image(s). The light and the camera are connected via a USB 2.0 cable to a small PC that serves for data acquisition and storage, and the computer monitor is used for image visualization.
Indications for Use:
The DIFOTI USB 2.0 System (DIFOTI System for Dental Examinations, Model B) is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.
Safety and Performance:
Safety and performance testing included image quality evaluation, software hazard analysis, in-vitro vs. in-vivo performance evaluation, and software verification and validation.
Conclusion:
Based on the indications for use, technological characteristics, comparison to predicate devices and performance testing, the DIFOTI Dental Examination System has been shown to be safe and effective for its intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 2004
Michael Greenebaum, Ph.D. Director of Research Electro-Optical Sciences, Inc. 1 Bridge Street, Suite 15 Irvington-on-Hudson, New York 10533
Re: K043068
Trade/Device Name: DIFOTI USB 2.0 System Regulation Number: 21 CFR 872.1745 Regulation Name: Laser fluorescence caries detection device Regulatory Class: II Product Code: NTK Dated: November 4, 2004 Received: November 8, 2004
Dear Dr. Greenebaum:
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.
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.
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Page 2 - Michael Greenebaum, Ph.D.
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/dsma/dsmamain.html
Sincerely yours,
Mark A. Melkersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Electro-Optical Sciences, Inc. Special 510(k) Premarket Notification
November 1, 2004 DIFOTI System for Dental Examinations, Model B
Page
510(k) Number (if known):
Device Name: __ DIFOTI USB 2.0 System
Indications for Use:
The DIFOTI USB 2.0 System is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the -Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millerson
and New
510(k) Number K04 3068
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.