(90 days)
The DIFOTI System for Dental Examinations is indicated for detection of frank or incipient caries lessions above the gum line, and for monitoring the progression of such lesions.
The DIFOTI device is a dental examination system that utilizes visible light delivered with fiberoptic technology for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic charge-coupled device (CCD) camera is used to capture the image(s), a small PC serves for for data acquisition and storage, and a computer monitor is used for image visualization,
The provided text is a 510(k) Premarket Notification for the DIFOTI Dental Examination System. It includes basic information about the device, its intended use, and a general statement about safety and performance testing. However, it does not contain specific details about acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill all parts of your request with the input provided.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not detailed in the document. The document only generically states "Safety and performance testing included image quality evaluation, software/hardware hazard analysis, invitro vs. in-vivo performance evaluation, and software verification and validation." It concludes that the device "has been shown to be safe and effective."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). While "in-vitro vs. in-vivo performance evaluation" is mentioned, no details are provided.
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)
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned.
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
- MRMC Study: Not mentioned as being performed. The device is described as a "dental examination system" that utilizes visible light for transillumination imaging, and a CCD camera for image capture, data acquisition, and visualization. There's no indication of an AI component or a study comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not explicitly stated. The device functions as an imaging system for "detection" and "monitoring." While it captures images, it doesn't describe an automated diagnostic algorithm without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not mentioned.
8. The sample size for the training set
- Sample Size: Not mentioned. The device predates the common use of "training sets" in the context of AI/machine learning. This filing is from 1999.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not mentioned. (See point 8).
In summary, the provided 510(k) summary is very high-level and lacks the granular detail required to answer most of your questions regarding acceptance criteria and study particulars for device performance. It emphasizes the device's technical characteristics and comparison to predicate devices rather than detailed performance metrics from a specific study.
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Electro-Optical Sciences, Inc. 510(k) Premarket Notification
Trade Name:
JUN 3 O
510(k) Summary
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. The summary is as follows:
DIFOTI Dental Examination System
| 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 10533Registration # Not yet assigned |
| Device Generic Name: | Dental examination system |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, thedevice classification is Class I, General Controls (21 CFR 872.4620, and872.6640). |
| Predicate Devices: | Fiberoptic transillumination (FOTI) fiberoptic dental imaging systemspreamendment, various manufacturers |
| Computer Oral Radiography System (K933455) and CDR-CAM (K963778)Schick Technologies Inc |
Product Description:
The DIFOTI device is a dental examination system that utilizes visible light delivered with fiberoptic technology for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic charge-coupled device (CCD) camera is used to capture the image(s), a small PC serves for for data acquisition and storage, and a computer monitor is used for image visualization,
Indications for Use:
The DIFOTI System for Dental Examinations is indicated for detection of frank or incipient caries lessions above the gum line, and for monitoring the progression of such lesions.
Safety and Performance:
Safety and performance testing included image quality evaluation, software/hardware hazard analysis, invitro 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 30 1999
Electro-Optical Sciences, Incorporated c/o Ms. Pamela Papineau Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Aver, Massachusetts 01432
Re : K991098 DIFOTI™ System Trade Name: Requlatory Class: I Product Code: EIA Dated: March 29, 1999 Received: April 1, 1999
Dear Ms. Papineau:
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 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 controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Papineau
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation entitled, "Misbranding by reference to ene regaración Cherocod, "Theremonday" (21 CFR 807.97). Other general 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/dsmamain.html".
Sincerely yours,
Patrícia Cueriti/for
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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Electro-Optical Sciences, Inc.. 510(k) Premarket Notification
Page -1 of
510(k) Number (if known):
Device Name: __ DIFOTI System for Dental Examinations
Indications for Use:
The DIFOTI System for Dental Examinations is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR
Over-the -Counter Use _
Susan Quarn
(Division Sign-Off) Division of Dental, Infection Com and General Ho 510(k) Number
000008
§ 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.