(115 days)
The Apixia Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. Phosphor plates and a scanner are the main components of the device. The device is used to capture x-rays from an external source and produce digital dental radiographs of a patient's mouth. The digital images can be used for analysis, archiving and electronic transmission.
Phosphor plates and a scanner are the main components of the device.
The provided text is a 510(k) clearance letter from the FDA for the Apixia Digirex Digital Dental Radiography System. It generally does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical study report. The letter focuses on the FDA's "substantial equivalence" determination to a predicate device.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
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A table of acceptance criteria and the reported device performance
- Not available in the provided text. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not specify performance acceptance criteria or report specific performance metrics for the Apixia Digirex system.
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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. The letter does not describe any specific testing data or its source.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text.
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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 available in the provided text. The Apixia Digirex system is described as a "Digital Dental Radiography System" that replaces film, and it does not appear to involve AI assistance for human readers based on this document.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available in the provided text. The device is a radiography system, not an algorithm for standalone performance evaluation in the typical sense of AI/CADe devices.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available in the provided text.
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The sample size for the training set
- Not available in the provided text.
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How the ground truth for the training set was established
- Not available in the provided text.
Summary based on the provided document:
The FDA 510(k) clearance document confirms that the Apixia Digirex Digital Dental Radiography System has been determined to be "substantially equivalent" to predicate devices for its stated "Indications for Use," which are: "The Apixia Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. Phosphor plates and a scanner are the main components of the device. The device is used to capture x-rays from an external source and produce digital dental radiographs of a patient's mouth. The digital images can be used for analysis, archiving and electronic transmission." However, the document does not elaborate on the specific acceptance criteria, study design, or performance data that led to this determination.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a wavy line representing the snake.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAY - 7 2012
Mr. Eric Huang Product Manager Apixia Inc. 18688 San Jose Avenue INDUSTRY CA 91748
Re: K120106
Trade/Device Name: Apixia Digirex Digital Dental Radiography System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 17, 2012 Received: April 23, 2012
Dear Mr. Huang:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K120106
Device Name: Apixia Digirex Digital Dental Radiography System
Indications for Use:
The Apixia Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. Phosphor plates and a scanner are the main components of the device. The device is used to capture x-rays from an external source and produce digital dental radiographs of a patient's mouth. The digital images can be used for analysis, archiving and electronic transmission.
Prescription Use X (Part 21 CFR 801 Subpart D)
510K
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
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§ 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.