(54 days)
The Demetron A.2 is a L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
The Demetron A.2 is a Light Emitting Diode (LED) visible light curing unit used for the polymerization of light-cure materials. The Demetron A.2 consists of an LED curing handpiece and wall plug-in transformer. 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 two (2) different curing modes. Each mode specifies LED curing output, fan, and audible beep timing. A pushbutton "trigger" switch will be used to select the curing mode and activate the LED curing output.
The provided document is a 510(k) summary for the Demetron A.2 L.E.D. Curing Light. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include detailed scientific study data, acceptance criteria, or performance metrics in the way a typical clinical or AI device study report would.
Therefore, I cannot populate the requested table and sections with specific numbers and methodologies as they are not present in the provided text.
Here is what I can infer and state based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance results from a study. The basis for clearance is "substantial equivalence" to a predicate device. This typically means the new device performs as intended and is as safe and effective as the predicate, but specific performance metrics are not always presented as a direct comparison in the 510(k) summary itself.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a new medical device aiming for 510(k) clearance by demonstrating substantial equivalence, not reporting results from a clinical or performance study with a test set of data.
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. This is not a study involving expert annotation or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This device is an LED curing light, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does provide:
- Device Name: Demetron A.2 L.E.D. Curing Light
- Intended Use: For the polymerization of visible light-cure materials by dental professionals.
- Predicate Device: Demetron I.D.S. (Kerr Corporation)
- Substantial Equivalence: The device is claimed to be substantially equivalent to the predicate device, functioning in a similar manner and intended for the same use. This is the primary "proof" for 510(k) clearance in this context.
To truly answer the questions about acceptance criteria and study results, one would need to refer to the full 510(k) submission, which often includes engineering specifications, manufacturing controls, and potentially some basic performance testing results (e.g., light intensity, wavelength stability, temperature rise) against internal specifications or industry standards. These are not present in this "510(k) Summary of Safety and Effectiveness."
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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple, sans-serif font. The logo is black and white.
KO 63116
DEC - 5 2006
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: October 2006
Device Name:
- Trade Name Demetron A. 2 .
- 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, Demetron I.D.S.
Device Description:
The Demetron A.2 is a Light Emitting Diode (LED) visible light curing unit used for the polymerization of light-cure materials. The Demetron A.2 consists of an LED curing handpiece and wall plug-in transformer. 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 two (2) different curing modes. Each mode specifies LED curing output, fan, and audible beep timing. A pushbutton "trigger" switch will be used to select the curing mode and activate the LED curing output.
Intended Use of the Device:
The intended use of Demetron A.2 is for the polymerization of visible light-cure materials by dental professionals.
Substantial Equivalence:
Demetron A.2 is substantially equivalent to other legally marketed devices in the United States. Demetron A.2 functions in a manner similar to and is intended for the same use as the Demetron I. D.S. designed by Kerr Corporation.
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Image /page/1/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which is a stylized caduceus with three figures representing health, services, and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the logo. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, California 92660
DEC - 5 2006
Re: K063116
Trade/Device Name: Demetron A.2 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 11. 2006 Received: October 12, 2006
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. Colleen 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 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.
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" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Syrite y. Michael m.D.
Chiu S. Lin, PhD 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
510(k) Number (if known):
Device Name: Demetron A.2
Indications for Use:
The Demetron A.2 is a L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
Prescription Use _ V (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)
| (Branch Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
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| K Number | K062311 |
§ 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.