(203 days)
This dental operating unit system is intended for use by professionally trained demists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic and restorative procedures performed within contemporary standards of dental patient care. When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.
Dental Operating Unit
This document is a 510(k) clearance letter from the FDA for a dental operating unit, not a study report or a detailed description of acceptance criteria and performance. Therefore, most of the requested information cannot be directly extracted from this document.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Training set sample size or how its ground truth was established.
However, based on the provided text, here's what can be gathered, addressing the relevant points:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document is an FDA clearance letter, which confirms substantial equivalence to a predicate device, but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.
- The "Indications for use" section states: "When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed." This is a general statement about effectiveness but not quantified performance against specific 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)
- Not available in the provided text.
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 available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text.
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 and not available in the provided text. This device is a dental operating unit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not available in the provided text. This device is a physical dental operating unit, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The only specific claim related to performance is the "reduction of microbes in the water dispensed" when equipped with an isolated patient water system. The "ground truth" for this claim would presumably be microbiological testing results comparing water samples with and without the system, but the specifics are not detailed.
8. The sample size for the training set
- Not applicable and not available in the provided text. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable and not available in the provided text. This is not an AI/algorithm-based device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1098 AUG
Mr. Frank A. Betush Quality Manager Proma, Incorporated 751 East Kingshill Place Carson, California 90746-1223
Re : K980106 The Proma Perception, Response and Compass Trade Name: System and Accessories Regulatory Class: I Product Code: EIA Dated: April 24, 1998 Received: May 5, 1998
Dear Mr. Betush:
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, Druq, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 requlations.
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Page 2 - Mr. Betush
This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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) 594-4692. 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,
S. Autman for
Timothy A. Ulatowski 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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Form revised at FDA request-2nd revision 24 Apr 98
Indications for use Form Page (1 of 1)
| 510 (K) number (if known): | K# 980106 |
|---|---|
| Device name: | Dental Operating Unit |
| Indications for use: |
This dental operating unit system is intended for use by professionally trained demists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic and restorative procedures performed within contemporary standards of dental patient care. When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.
(Please do not write below this line-continue on another page)
(concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Susan Runge
(Division Sisin-Off) (Division Sign-Off)
Division Sign-Off, Infection Control, . . . . Devices and Genera 169010 510(k) Number -
OR Over-The-Counter Use
(Optional Format 1-2-96)
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.