(22 days)
The Demetron I.D.S. is a L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
The LED based Demetron I.D.S. Curing Light is a device used for the polymerization of dental materials. It consists of an LED curing handpiece and flexible cord designed to be connected to a dental chair unit. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control 2 different curing modes and power to the LED. Each mode specifies LED curing output timing, fan timing and audible beep timing. A pushbutton "trigger" switch will be used to select the curing mode and activate the LED curing output. The dental chair manufacturer's transformer or power supply will provide power for the handpiece.
Here's an analysis of the provided text regarding the Demetron I.D.S. L.E.D. Curing Light, focusing on your requested information:
Unfortunately, the provided document (K042888) is a 510(k) summary for a dental light-curing unit, not an AI/algorithm-based diagnostic or triaging device. Therefore, the questions related to acceptance criteria for algorithmic performance, ground truth, expert adjudication, sample sizes for AI training/testing, or MRMC studies are not applicable to this type of device.
The 510(k) submission process for a device like a curing light focuses on demonstrating substantial equivalence to a predicate device already on the market, primarily based on similar intended use, technology, and safety/performance characteristics. It does not typically involve the rigorous statistical studies of diagnostic accuracy, sensitivity, and specificity that would be required for an AI-powered device.
However, I can extract the relevant information that is present in the document.
Device: Demetron I.D.S. L.E.D. Curing Light
Device Type: Ultraviolet activator for polymerization (L.E.D. Curing Light)
Intended Use: For the polymerization of visible light cured materials by dental professionals.
Predicate Device: Kerr Corporation, L.E. Demetron
Reason for K042888: To demonstrate substantial equivalence to the predicate device.
Here's how I can answer your questions, highlighting where they are not applicable to this specific device:
1. A table of acceptance criteria and the reported device performance
For a dental curing light, acceptance criteria are generally related to its ability to cure dental materials effectively and safely, matching the performance of a predicate device. This would typically involve measuring light output, wavelength, and the ability to cure various dental resins within specified times. The provided 510(k) summary does not contain a specific table of acceptance criteria or detailed performance data in the way you might find for an AI algorithm. Instead, it relies on the assertion that its function is "similar to" and its intended use is "the same as" the predicate device, implying it meets the same general performance standards.
| Acceptance Criteria (Conceptual for Curing Light - Not Explicitly Stated in Document) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Light Output/Irradiance: Sufficient power to polymerize dental resins | "Functions in a manner similar to," and "is intended for the same use as" the L.E. Demetron predicate device. This implies its light output and curing capability are comparable and adequate for its intended purpose, as demonstrated by the predicate's established performance. |
| Wavelength: Appropriate spectrum for visible light-cured materials | As an "L.E.D. visible light curing unit," it is implied to emit light in the necessary spectrum for available dental resins, similar to the predicate. |
| Curing Modes/Timing: Control over curing cycles | "A digital circuit and microprocessor will be utilized to control 2 different curing modes and power to the LED. Each mode specifies LED curing output timing, fan timing and audible beep timing," similar to predicate. |
| Safety: Electrical, thermal, and mechanical safety | Not explicitly detailed in the summary, but implied by adherence to general controls provisions of the Act and manufacturing practices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. The 510(k) summary does not describe a "test set" in the context of evaluating an AI algorithm's performance. For a medical device like a curing light, physical and electrical testing would be performed, but this is not typically presented as a "test set" in the same statistical sense for regulatory submissions.
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)
Not Applicable. Ground truth, in the context of algorithms relying on expert interpretation, is not relevant for a dental curing light. Its function is physical (light emission for polymerization), not diagnostic or interpretive.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As there is no "test set" from an algorithmic performance perspective, no adjudication method was used.
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
Not Applicable. An MRMC study is designed for evaluating diagnostic devices that assist human readers (e.g., radiologists, pathologists). A dental curing light does not involve human readers' interpretation or an AI component to assist them.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. There is no algorithm in this device that would have standalone performance. The device is a physical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. As explained above, the concept of "ground truth" for a physical device like a curing light is not relevant. Its performance is evaluated through engineering specifications and the demonstration of equivalent curing capability through laboratory tests (e.g., depth of cure, material hardness), which are not described in detail in this summary but are implied by substantial equivalence.
8. The sample size for the training set
Not Applicable. This device does not use machine learning or AI, and therefore has no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no AI component or training set, there is no ground truth to establish for such a set.
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Image /page/0/Picture/1 description: The image shows a logo with the letters 'sds' in a stylized font. A curved line extends from the left, arching over the letters. Below the letters, there is some text that is not clear enough to read.
NOV 1 0 2004
SYBRON DENTAL SPECIALTIES
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: October 2004
Device Name:
- Trade Name Demetron I.D.S. .
- . Common Name - L.E.D. Curing Light
- Classification Name -- Ultraviolet activator for polymerization, per 21 CFR § 872.6070 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, L.E. Demetron .
Device Description:
The LED based Demetron I.D.S. Curing Light is a device used for the polymerization of dental materials. It consists of an LED curing handpiece and flexible cord designed to be connected to a dental chair unit. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control 2 different curing modes and power to the LED. Each mode specifies LED curing output timing, fan timing and audible beep timing. A pushbutton "trigger" switch will be used to select the curing mode and activate the LED curing output. The dental chair manufacturer's transformer or power supply will provide power for the handpiece.
Intended Use of the Device:
The intended use of Demetron I.D.S. is for the polymerization of visible light cured materials.
Substantial Equivalence:
Demetron I.D.S. is substantially equivalent to other legally marketed devices in the United States. Demetron I.D.S. functions in a manner similar to and is intended for the same use as the L.E. Demetron designed by Kerr Corporation.
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Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of three wavy lines that are stacked on top of each other. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2004
Kerr Corporation C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K042888
Trade/Device Name: Demetron I.D.S. Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 15, 2004 Received: October 19, 2004
Dear Ms. Boswell:
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. Boswell
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 and itsments 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 (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,
Chiu, Lin, Ph.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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Indications for Use
K642888 510(k) Number (if known):
Device Name: Demetron I.D.S.
Indications for Use:
The Demetron I.D.S. is a L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
Prescription Use (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 Rimpere
(Division Sign-Off)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
Page 1 of 1
510(k) Number: P042XXX
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.