(164 days)
D-Carie is indicated for aiding in the diagnosis of dental carries
Similar to the Diagnodent the D-CARIE is indicated for use in aiding in the diagnosis of dental caries. The D-CARIE probe is similar in intended use, size, and shape to a Diagnodent probe tip. Identical to the technology in the Detectar the D-CARIE probe contains an optical fiber that reads the optical signature of suspicious areas and converts it into an electrical signal. From that electrical signal a computer analysis identifies areas that need further examination.
The provided 510(k) summary for the D-CARIE device offers limited details regarding specific acceptance criteria and the comprehensive study methodologies. However, based on the available information, here's an attempt to extract and describe the requested points:
The D-CARIE device is indicated for aiding in the diagnosis of dental caries.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Devices (Diagnodent) | "D-CARIE was found equivalent to Diagnodent." |
| Quality of detection in "special situations" | "D-CARIE was found equivalent to Diagnodent." |
| Aid in the diagnosis of dental caries | Indicated for aiding in the diagnosis of dental caries. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size for any of the evaluations. It mentions "two in vitro and one in vivo evaluations" and "a third in vitro evaluation."
- Data Provenance: The studies were conducted in Canada, as the submitter, NEKS Technologies, is located in Laval, Quebec, Canada. The document states "Two in vitro and one in vivo evaluations... were conducted by experienced clinicians." It does not specify if these were retrospective or prospective studies, but "conducted by experienced clinicians" suggests a prospective setup for the clinical evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states that the evaluations were "conducted by experienced clinicians." It does not specify the exact number of experts involved in establishing ground truth for the test set.
- Qualifications of Experts: The experts are described as "experienced clinicians." Specific qualifications like "radiologist with 10 years of experience" are not provided. Given the nature of dental caries detection, these
"clinicians" would likely be dentists.
4. Adjudication Method for the Test Set
The document does not provide details on the adjudication method used for the test set (e.g., 2+1, 3+1, none). It only mentions "conducted by experienced clinicians."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The comparisons mentioned are between D-CARIE and a predicate device (Diagnodent), not explicitly evaluating human reader improvement with D-CARIE.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
The information provided focuses on the device's performance in comparison to predicate devices, and its intended use is "aiding in the diagnosis." It mentions that the device "converts it into an electrical signal. From that electrical signal a computer analysis identifies areas that need further examination." This implies a degree of standalone algorithmic processing. However, the studies described don't explicitly isolate and report standalone performance metrics in a way that separates the algorithm's output from subsequent clinical interpretation or diagnostic decision-making. The "equivalence to Diagnodent" suggests comparing the overall diagnostic aid.
7. Type of Ground Truth Used
The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). For dental caries studies, ground truth is often established through a combination of visual inspection, tactile examination (using dental explorers, which are themselves listed as predicate devices), and sometimes histological examination (pathology) for in vitro studies or follow-up over time for in vivo studies. Given the comparison to Diagnodent, which measures fluorescence, the ground truth likely involved a standard for identifying caries presence and severity.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This suggests that the device either did not undergo a distinct machine learning "training" phase in the modern sense or that this information was not deemed necessary for the 510(k) summary given the predicates.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about a training set, there is no description of how ground truth for it was established.
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510(k) Summary
APR 2 8 2005
NEKS Technologies 1. Name/Address of Submitter : 230, Bernard-Belleau, Bureau 221 Laval, Quebec H7V 4A9 Canada
- Contact Person :
Nathalie H. Tremblay President and CEO Phone : (450) 973-3598 Fax : (450) 973-3881
- April 19, 2005 3. Date Summary Prepared :
- D-CARIE 4. Device Name :
- Predicate Devices :
Detectar System (K023367) DIAGNOdent Laser Fluorescence Caries Detection Device (K983658) Alpha 4 LS Automated Microtiterplate Processor (K973638) Dental explorers [510(k) exempt]
-
- Device Description and Intended Use :
Similar to the Diagnodent the D-CARIE is indicated for use in aiding in the diagnosis of dental caries. The D-CARIE probe is similar in intended use, size, and shape to a Diagnodent probe tip. Identical to the technology in the Detectar the D-CARIE probe contains an optical fiber that reads the optical signature of suspicious areas and converts it into an electrical signal. From that electrical signal a computer analysis identifies areas that need further examination.
- Device Description and Intended Use :
-
- Brief Description of Clinical and Non-clinical Testings :
Two in vitro and one in vivo evaluations comparing the D-CARIE with a Diagnodent were conducted by experienced clinicians. Moreover a third in vitro evaluation was conducted to examine the quality of detection on "special situations". In these tests, the D-CARIE was found equivalent to Diagnodent.
- Brief Description of Clinical and Non-clinical Testings :
-
Substantially equivalent to the cited predicate devices. 8. Conclusion Drawn :
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract shapes that could be interpreted as snakes or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2005
ﻴﻴ
NEKS Technologies, Incorporated C/O Mr. Charles H. Kyper Regulatory Affairs Consultant Kyper & Associates 208 Barrington Overlook Drive Durham, North Carolina 27703
Re: K043156
Trade/Device Name: D-Carie Regulation Number: 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: March 29, 2005 Received: April 1, 2005
Dear Mr. Kyper:
We have reviewed your Section 510(k) premarket notification of intent to market the device we flave reviewed your becalling to (1) the device is substantially equivalent (for the relerenced above and nave determined te to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to reay 20, 1978, as sectance with the provisions of Amendments, of to devices that nave obsitions that do not require approval of a premarket the Federal Food, Drug, and Cosment . For ( Prove, market the device, subject to the general approval application (1 Mr 2). - The general controls provisions of the Act include controls provisions of the rec. "The gisting of devices, good manufacturing practice, requirements for annual reagainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III II your device is classince (500 above) into scontrols. Existing major regulations affecting (PMA), it may be subject to such adala f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sous of Peachard - Soncerning your device in the Federal Register.
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Page 2 - Mr. Kyper
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualled of a substantial stacomplies with other requirements mean that FDA has made a decemination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regulations, but not limited to: registration You must comply with an the Act 5 requirements (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fart 807), laooling (21 CFR Part 877)
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirements as set form in the quality bystems (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) I his letter will anow you to begin mationing your alence of your device to a premarket notification. The 1271 milling of vilance of vour 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), a If you desire specific advice for your deries at (240) 276-0115. Also, please note the regulation please confact the Other or Somphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation of Consumer Assistance at its toll-free Division of Small or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ayittey-Michienzi, M.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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Indication for Use
510(k) Number (if known): K043156
Device Name: D-Carie
Indication for Use: D-Carie is indicated for aiding in the diagnosis of dental carries
Concurrence of CDRH Office of Device Evaluation
Prescription Use (per 21CFR 801.109) OR
Over-the-counter Use _________________________________________________________________________________________________________________________________________________________
Susan Russo
Tivision Sign-Off) ision of Anesthesiology, General Hospital, Intection Control, Dental De
310(k) Number: K043156
§ 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.