(18 days)
The Planmeca IntraCam intra oral video camera is a dental operative unit accessory, which is intended for use by practitioners in the dental field for use as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images for later retrieval. The camera interfaces with video printers, TV/monitors, capture boards etc., and is designed to be located as an instrument in a dental unit.
The Planmeca IntraCam intra oral video camera is a dental operative unit accessory. The camera interfaces with video printers, TV/monitors, capture boards etc., and is designed to be located as an instrument in a dental unit.
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Planmeca Intracam" in 1997. This type of regulatory document typically does not contain the detailed study information requested, such as specific acceptance criteria for performance metrics, sample sizes, ground truth establishment, or expert qualifications for studies.
Therefore,Based on the provided document, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results of a standalone (algorithm-only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a marketing clearance letter, not a detailed technical report of a clinical or performance study. It states that the device is "substantially equivalent" to predicate devices, meaning it has met the regulatory requirements for marketing based on a comparison to existing, legally marketed devices. It does not elaborate on the specific performance studies that might have been conducted to demonstrate this equivalence in terms of quantitative metrics.
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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" around the perimeter. In the center of the seal are three stylized human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 1997
Mr. Lars Morinq Requlatory Affairs Manager Planmeca Oy Asentajankatu 6 FIN-00810 Helsinki, FINLAND
K972033 Re: Planmeca Intracam Trade Name: Regulatory Class: I Product Code: EIA Dated: May 29, 1997 Received: June 2, 1997
Dear Mr. Moring:
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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory 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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This letter will allow you to beqin 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) 594-4618. 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 Smakl Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
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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May 29, 1997
Ref.: 510(k) Notification Accessory to Dental Operative Unit Planmeca IntraCam
INDICATIONS FOR USE
The Planmeca IntraCam intra oral video camera is a dental operative unit accessory, which is intended for use by practitioners in the dental field for use as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images for later retrieval. The camera interfaces with video printers, TV/monitors, capture boards etc., and is designed to be located as an instrument in a dental unit.
Lus leoly
Lars Moring Regulatory Affairs Manager
Date: May 29, 1997
Swee Runner
(Division Sign-Off Division of Dental, Infection Con and General Hospital I 510(k) Numbai
§ 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.