(81 days)
This device is intended to be used for the prescribed treatment of malocclusions by dentists. This device is intended for single use only.
Affirm Smart Releasable Force Module and Trade Name: Compliance Science™
This document is a 510(k) clearance letter from the FDA for the "Affirm Smart Releasable Force Module" and "Compliance Science™," indicating that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria. It is solely a regulatory approval based on demonstrating substantial equivalence, not performance against specific criteria.
Therefore, I cannot provide a detailed answer to your request based on the provided text. The document does not include information on:
- Acceptance criteria and reported device performance
- Sample sizes for test sets or training sets
- Data provenance
- Number or qualifications of experts for ground truth establishment
- Adjudication methods
- MRMC studies or effect sizes
- Standalone performance
- Type of ground truth used
- How ground truth was established for training data
To answer your request, you would need to refer to the actual 510(k) submission or supporting documentation that was reviewed by the FDA, as this clearance letter only summarizes their decision.
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Puhlic Health Service
SFP 4 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven O. Luse President Ortho Kinetics Corporation 1611A South Melrose Drive, Suite 16 Vista, California 92083-5407 USA
K982088 Re : Affirm Smart Releasable Force Module and Trade Name: Compliance Science™ Requlatory Class: II Product Code: DZB Dated: June 11, 1998 Received: June 15, 1998
Dear Mr. Luse:
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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Luse
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4692. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Susan Turner
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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Page
510(k) Number (if known):
Affirm Releasable Force Module svice Name:
Indications For Use:
This device is intended to be used for the prescribed treatment of malocclusions by dentists. This device is intended for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
Susan
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K982088
§ 872.5500 Extraoral orthodontic headgear.
(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.