(16 days)
The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.
Cranex D is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. The device is upgradeable for cephalometric radiography. Cranex D utilizes digital image receptor(CCD).
Here's an analysis of the provided text regarding the Cranex D device, focusing on acceptance criteria and study details.
Based on the provided text, the Cranex D device is a dental panoramic x-ray system, and the 510(k) submission primarily focuses on establishing its substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI or diagnostic algorithm.
Therefore, many of the requested points related to AI performance, expert adjudication, MRMC studies, and standalone performance are not applicable or not explicitly mentioned in this document, as the submission deals with an X-ray imaging device itself, not an AI-powered diagnostic tool.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" or "reported device performance" in the way one would for a diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, the performance is described in terms of its ability to produce digital images of dentition and its equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Orthophos DS / DS Ceph and Cranex Basex D or Cranex Excel D) | "Verification and validation testing was successfully performed to confirm that Cranex D corresponds with the intended use." |
| Production of Digital Radiographs of Dentition, TM-joints, and other oral structures | "Cranex D utilizes digital image receptor (CCD)." "The technique factor settings for panoramic examinations are: 57 – 85 kVp, 10 mA DC and 17.6 s max. The technique factor settings for cephalometric radiographs are: 60 - 85 kVp, 10 mA DC and 8 - 20 s." |
| Upgradeability for Cephalometric Radiography | "The device is upgradeable for cephalometric radiography." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document states "Verification and validation testing was successfully performed," but does not detail the size or nature of the test set (e.g., number of patients, images).
- Data Provenance: Not specified. This typically isn't detailed in 510(k)s for X-ray equipment itself, but rather for diagnostic software that processes images.
- Retrospective or Prospective: Not specified.
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 applicable. This information is relevant for evaluating diagnostic output, not for a device that captures images. The "ground truth" for an X-ray machine is its physical and image-quality performance as per engineering and clinical standards, typically assessed through phantom studies and image quality evaluations rather than expert consensus on patient cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is mentioned, as the "test set" in this context likely referred to technical performance evaluations rather than diagnostic interpretation.
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. The Cranex D is an X-ray imaging device, not an AI-assisted diagnostic tool. Therefore, no MRMC study comparing human readers with and without AI assistance would have been performed or reported for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Cranex D is an X-ray imaging device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the diagnostic sense (e.g., pathology) is not applicable to the device itself. For an X-ray machine, "ground truth" relates to its technical specifications and image quality parameters, which would be verified against engineering standards and phantom measurements. The document does not specify the exact methods for verifying these, only that "Verification and validation testing was successfully performed."
8. The sample size for the training set
Not applicable. This device is an X-ray machine, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is an X-ray machine, not an AI algorithm requiring a training set with established ground truth.
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510(k) Summarv
DEC 17 2004
Date
November 26, 2004
Submitters Information
Soredex Instrumentarium Corporation Nahkelantie 160 FIN-04300 Tuusula Finland Phone: +358 10 394820 Fax .: Contact: Kai Lanér
Trade Name
Cranex D
Common Name
Dental panoramic x-ray equipment, digital, upgradeable for cephalometric radiography
Classification
Unit, x-ray, extraoral, with timer / EHD
Predicate Device
We consider that Cranex D is substantially equivalent in design, composition and function with Orthophos DS / DS Ceph (K972312) and with Cranex Basex D or Cranex Excel D (K040382).
Product Description
Cranex D is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. The device is upgradeable for cephalometric radiography. Cranex D utilizes digital image receptor(CCD).
The technique factor settings for panoramic examinations are: 57 – 85 kVp, 10 mA DC and 17.6 s max. The technique factor settings for cephalometric radiographs are: 60 - 85 kVp, 10 mA DC and 8 - 20 s.
Intended Use
The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto. .
Performance data
Verification and validation testing was successfully performed to confirm that Cranex D corresponds with the intended use.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Mr. Kai Lanér Soredex Instrumentarium Corporation Nahkelantie 160 FIN 00430 Tuusula FINLAND
Re: K043307 Trade/Device Name: Cranex D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: November 26, 2004 Received: December 1, 2004
Dear Mr. Lanér:
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 systems (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 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), 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/cdrl/dsma/dsmamain.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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KO43307 510 (k) NUMBER :
Cranex D DEVICE NAME :
INDICATIONS FOR USE :
.
The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.
Damil A. Shegmm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use
§ 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.