(28 days)
The Scan300fp / Retropan (VDC) Digital X-ray Conversion Kit is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.
The Scan300fp sensor produces instant digital images. The Scan300fp allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K012439, which gives post processing capabilities to enhance images.
lt is faster to obtain images with the Scan300fp / Retrofit (VDC) than with conventional film since no chemical nor any other type of processing is required.
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This document is a 510(k) clearance letter from the FDA for the Scan300fp/Retropan (VDC) Digital X-ray Conversion Kit. It primarily focuses on the regulatory approval and indications for use, rather than a detailed study report describing acceptance criteria and device performance. As such, most of the requested information cannot be extracted directly from the provided text.
Here is what can be inferred or stated from the document:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary criterion for 510(k) clearance. However, specific performance metrics or acceptance criteria for that substantial equivalence are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is a digital X-ray conversion kit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly stated, but the device is a hardware component (conversion kit) that integrates with software. Its performance would be evaluated in the context of producing images for human interpretation, not as a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary from the provided text:
The provided document is a regulatory clearance letter. It confirms that the Scan300fp/Retropan (VDC) Digital X-ray Conversion Kit has been deemed substantially equivalent to predicate devices for its intended use.
Indications for Use:
The device is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films. It produces instant digital images, allowing for less exposure time than conventional films, thereby lowering patient dose. The sensor connects to DentalEye software, #K012439, which provides post-processing capabilities to enhance images. The device is faster than conventional film because no chemical or other type of processing is required.
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Image /page/0/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the circle.
JUL 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oy AJAT, Ltd. % Mr. Claude D. Berthoin President Video Dental Concepts, Inc. 110 E Granada Blvd., Suite 207 ORMOND BEACH FL 32176
Re: K051664 Trade/Device Name: Scan300fp/Retropan (VDC) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 20, 2005 Received: June 24, 2005
Dear Mr. Berthoin:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 system (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.
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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 promated 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) number: (if known): __ Kos 1664 _______________________________________________________________________________________________________________________________________
Scan300fp / Retropan (VDC) Device Name: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE:
The Scan300fp / Retropan (VDC) Digital X-ray Conversion Kit is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.
The Scan300fp sensor produces instant digital images. The Scan300fp allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K012439, which gives post processing capabilities to enhance images.
lt is faster to obtain images with the Scan300fp / Retrofit (VDC) than with conventional film since no chemical nor any other type of processing is required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEWDED)
CONCURANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| Prescription Use: | ✓ | OR | Over-the-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| Nancy C Brogdon | |||
| (Division Sign-Off) | |||
| Division of Reproductive, Abdominal, and Radiological Devices | |||
| 510(k) Number | K051664 |
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.