(72 days)
For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries and uninfected demineralized dentin and serves as a guide for the dentist-user in conservative caries removal during restoration.
CARIES STAIN may be described as a water-soluble solution of dye in solvent that selectively stains carious, infected dentin. It differentiates between non-remineralizable and remineralizable dentin to serve as a guide for conservative caries removal while maintaining as much vital tooth structure as possible.
The provided text is a 510(k) summary for a dental product called "CARIES STAIN," which is a caries indicator/detector. It describes the product's intended use and lists equivalent devices, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill most of your request as the necessary data is not present in the provided document.
Here's what can be extracted based on the information given, and an explanation of why other parts cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document describes the product and its intended use but does not present any performance data or acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This information is not present in the 510(k) summary.
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)
- Cannot be provided. This information is not present in the 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This information is not present in the 510(k) summary.
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
- Cannot be provided. The device is a "water-soluble solution of dye in solvent," not an AI-powered device. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. As noted above, this is a chemical staining solution, not an algorithm. Therefore, "standalone" algorithmic performance is not applicable or discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. The document does not describe any studies with ground truth. The device itself is intended to help differentiate between carious and uninfected dentin to guide conservative caries removal. The "ground truth" in clinical practice would be the actual state of the dentin, likely confirmed by visual, tactile, and potentially histological examination during the procedure. However, the document does not detail how this was established for any regulatory study.
8. The sample size for the training set
- Cannot be provided. There is no mention of a training set as this is a chemical product, not a machine learning model.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable (see point 8).
The 510(k) summary focuses on the product description, its intended use, and its substantial equivalence to other existing devices, which is the primary purpose of a 510(k) application. It does not typically include detailed clinical study protocols, performance data, or ground truth establishment methods in the way a more comprehensive clinical trial report would.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and letters. The sequence appears to be K973200. The characters are written in a simple, slightly rough style, giving them a casual appearance.
510(k) SUMMARY
NOV - 6 1997
| Submitter: | Parkell Products Inc.155 Schmitt Blvd.Box 376Farmingdale, NY 11735TEL: 516-249-1134FAX: 516-249-1242 |
|---|---|
| Contact: | Nelson J. Gendusa, DDSDirector of ResearchParkell155 Schmitt Blvd.Box 376Farmingdale, NY 11735 |
| Submission Date: | 14 August, 1997 |
| Trade Name: | CARIES STAIN |
| Common Name: | Caries Indicator/Detector |
| Classification Name: | Caries Detection Device |
| Equivalence: | KAR-D-TEK; CARIES DETECTOR; SEEK; CARIES FINDER;TEAM CARIES INDICATOR; PULPDENT SNOOP |
| Description/Intended Use: | CARIES STAIN may be described as a water-soluble solution ofdye in solvent that selectively stains carious, infected dentin. Itdifferentiates between non-remineralizable and remineralizabledentin to serve as a guide for conservative caries removal whilemaintaining as much vital tooth structure as possible. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nelson J. Gendusa, DDS Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard Farmingdale, New York 11735
NOV - 6 1997
Re: K973200 Trade Name: Caries Stain Regulatory Class: II Product Code: LFC Dated: August 21, 1997 Received: Auqust 26, 1997
Dear Dr. Gendusa:
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 against 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Gendusa
through 542 of the Act for devices under the Electronic chrough 542 or the not il provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acbeing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predication with 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) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact ene promotion and (301) 594-4639. Also, please note ene regulation entitled, "Misbranding by reference to
premarket notification" (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,
Timothy J. Ulatowski
Timb 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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510(k) Number (if known):
Device Name:
CARIES STAIN
Indications For Use:
For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries water-soluble dye differentates occa a guide for the dentist-user in and unancecco demir and be? (es as a games restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumsis
(Division Sign-Off Division of Dental and General Ho 510(k) Number
Prescription Use رسم (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 872.1740 Caries detection device.
(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.