(147 days)
The American Dental Technologies, Inc. PulseMaster Dental Laser Systems are indicated for use for selective ablation of enamel (first degree) dental caries.
The American Dental Technologies PulseMaster Dental Laser Systems are Nd:YAG lasers producing laser emission at 1064 nm. The lasers consist of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.
The provided text describes the 510(k) summary for the American Dental Technologies PulseMaster Dental Laser Systems (K984486). While it discusses the device's intended use and general performance data, it does not explicitly state specific numerical acceptance criteria or detail a formal study designed to prove the device meets such criteria.
Here's an analysis based on the information provided, addressing your requested points where possible, and noting where information is absent:
Acceptance Criteria and Device Performance
The document states that the device is "substantially equivalent" to predicate devices, which is the primary mechanism for 510(k) clearance. This means the performance is deemed acceptable if it's comparable to existing, legally marketed devices for the same intended use.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety for Intended Use: (Based on historical safety of predicate devices and histology results) | "The histology indicated that the device is safe for the intended use." This is a qualitative statement without specific metrics or thresholds. |
| Effectiveness for Selective Ablation of First-Degree Enamel Caries: (Based on comparison to predicate laser and high-speed handpiece) | "Clinical data from a multi-center, blinded, randomized study comparing the PulseMaster to the highspeed handpiece established the safety and effectiveness of the PulseMaster Dental Laser Systems for the Intended use." No specific numerical performance metrics (e.g., success rate, ablation depth, side effect rates) are provided. |
| Equivalence in Temporal Pulse Structures and Effects on Enamel Caries: (Bench test comparison to a pulsed Er:YAG Dental Laser) | "Bench test data... measured the temporal pulse structures and effects on enamel caries and found the two lasers to be equivalent." Again, this is a qualitative statement of equivalence without specific numerical data. |
Study Details for Demonstrating Acceptance Criteria
The document mentions both nonclinical (bench) and clinical performance data.
2. Sample size used for the test set and the data provenance:
- Bench Test: No sample size is provided. The provenance is "under controlled scientific conditions" but no country or retrospective/prospective status is specified.
- Clinical Study: "An extracted tooth study" for histology and a "multi-center, blinded, randomized study" for safety and effectiveness. No sample sizes for either are provided. The provenance is not explicitly stated beyond "multi-center," so country of origin is unknown, but it was a prospective study (randomized).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench Test: Not applicable, as it involved physical measurements.
- Extracted Tooth Study (Histology): Not specified. Likely involved a pathologist or histologist, but their number and qualifications are not mentioned.
- Clinical Study: Not specified how ground truth (e.g., initial caries diagnosis, assessment of ablation) was established or by whom.
4. Adjudication method for the test set:
- Not specified for any of the studies 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:
- Not applicable. This device is a dental laser, not an AI-assisted diagnostic or imaging device for human readers. The clinical study compared the laser to a high-speed handpiece, which is a comparison of two treatment methods, not an AI-reader performance study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (laser system), not an algorithm. Its performance is inherent to its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Test: Physical measurements of temporal pulse structures and effects on enamel caries.
- Extracted Tooth Study: Histology (likely considered a form of pathology).
- Clinical Study: Not explicitly detailed, but would involve clinical assessment of caries and treatment outcomes, likely by dentists or dental professionals.
8. The sample size for the training set:
- Not applicable. This is a hardware medical device, not a machine learning model that requires a training set in that context.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
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K9844486
Attachment I 510(K) Summary American Dental Technologies PulseMaster Dental Laser Systems
This 510(K) Summary of safety and effectiveness for the American Dental Technologies Philo of of(x) Dammary of Submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | American Dental Technologies, Inc. |
|---|---|
| Address: | 18860 West Ten Mile RoadSouthfield, MI 48075-2657 |
| Contact Person: | John Sulewski |
| Telephone: | (248) 395-3900 - Phone(248) 395-3801 – Fax |
| Preparation Date: | 12-16-98 |
| Device Trade Name: | PulseMaster Dental Laser Systems |
| Common Name: | Nd:YAG Pulsed Laser |
| Classification Name: | Instrument, Surgical, Powered, Laser79-GEX21 CFR 878-48 |
| Legally Marketed Predicate Device: | The Centauri Dental Laser manufactured by PremierLaser Systems, #3 Morgan Street, Irvine, CA ,previously cleared for market under 510(k) numberK932683. |
| Description of the American DentalTechnologies PulseMaster DentalLaser Systems | The American Dental Technologies PulseMaster DentalLaser Systems are Nd:YAG lasers producing laseremission at 1064 nm. The lasers consist of twointerconnected sections: The cabinet which housesthe laser head, the power supply, the cooling systemand the microprocessor with control panel; and the fiberoptic delivery system. |
| Intended use of the American DentalTechnologies PulseMaster DentalLaser Systems | The American Dental Technologies, Inc. PulseMasterDental Laser Systems are indicated for use for selectiveablation of first degree enamel caries. |
| Nonclinical Performance Data: | Bench test data were collected under controlledscientific conditions to establish the substantialequivalence of the PulseMaster Dental Laser Systemsto a pulsed Er:YAG Dental Laser. We measured thetemporal pulse structures and effects on enamel cariesand found the two lasers to be equivalent. |
| Clinical Performance Data: | An extracted tooth study was conducted to evaluatethe histological effects of the laser treatment. Thehistology indicated that the device is safe for theintended use. Clinical data from a multi-center, blinded,randomized study comparing the PulseMaster to thehighspeed handpiece established the safety andeffectiveness of the PulseMaster Dental Laser Systemsfor the Intended use. |
| Conclusion: | The American Dental Technologies PulseMaster DentalLaser Systems are substantially equivalent to anotherexisting surgical laser system in commercial distributionfor selective ablation of enamel caries and tocommercially available High Speed Dental Handpieces. |
| Additional Information: | None requested at this time |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 1999
Mr. John G. Sulewski Product Manager American Dental Technologies, Inc. 18860 West Ten Mile Road Southfield. Michigan 48075-2657
Re: K984486 Trade Name: PulseMaster Dental Laser Systems Regulatory Class: II Product Code: GEX Dated: March 15, 1999 Received: March 16, 1999
Dear Mr. Sulewski:
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 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 (Premarket Approval), 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 895. A 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 (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. John G. Sulewski
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number. K 984486 New Submission
Device Name: PulseMaster Dental Laser Systems
Indications for Use:
The American Dental Technologies, Inc. PulseMaster Dental Laser Systems are indicated for use for selective ablation of enamel (first degree) dental caries.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K984486
510(k) Number
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.