(13 days)
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.
The device and its predicate are small digital imaging receptors that may be used in place of dental x-ray film. The new control mechanism differs from the predicate in that image acquisition may additionally be triggered through a hardwire to an x-ray tube. This modification allows for a quicker x-ray response time and may improve ergonomics as it eliminates the need for a standalone remote module. The existing firmware has been altered to support the modified and additional hardware. The new remote module may be housed within a specified x-ray source. The modification in no way effects the fundamental technology governing image acquisition.
Based on the provided document, here's an analysis of the acceptance criteria and the study (or lack thereof) to prove the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific, quantifiable acceptance criteria or reported device performance in a table format. It states generally:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined acceptance criteria were met. (General statement for risk analysis and validation) | Not explicitly detailed beyond the statement that criteria were met. The context implies that the device maintained its previously cleared performance characteristics despite the hardware/firmware modification. |
| Principal risk of unintended x-ray exposure evaluated; all validation activities demonstrated criteria were met. | "Bench, and third-party safety testing" was conducted. Specific results are not provided. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test set or the data provenance.
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)
The document does not provide information about any experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for a test set.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. The device in question is a digital X-ray imager, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a modification to a digital dental X-ray imaging system, which is a hardware and firmware update to improve image acquisition and ergonomics. It is not an algorithm-only or AI device, so a standalone performance study in that context is not applicable and was not performed. The "standalone" aspect in this context refers to the elimination of a "standalone remote module."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document does not describe the type of ground truth used, as it doesn't detail specific performance studies where ground truth would be established for diagnostic accuracy. The focus of this 510(k) submission is on demonstrating that a modification to an existing system maintains its safety and effectiveness relative to its predicate, rather than establishing primary diagnostic efficacy with new clinical data. The "ground truth" implicitly would be that the modified system continues to produce images suitable for dental x-ray examination without increased risk of unintended x-ray exposure.
8. The sample size for the training set
The document does not discuss a training set. This is not an AI/machine learning device that would require such data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning model mentioned in the document.
Summary of the Document's Focus:
This 510(k) submission focuses on a device modification to an already cleared Computed Oral Radiology System. The modification involves a change in the control mechanism (allowing image acquisition to be triggered via a hardwire to an x-ray tube rather than a standalone remote module) and corresponding firmware alterations.
The document emphasizes demonstrating substantial equivalence to the predicate device. The "studies" mentioned are risk analysis, bench testing, and third-party safety testing, which focused on ensuring the modification did not introduce new risks (specifically unintended X-ray exposure) or alter the fundamental technology or indications for use. The acceptance criteria were therefore primarily related to safety and the maintenance of equivalence to the predicate, rather than new performance benchmarks for diagnostic accuracy.
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JUN - 7 2004
Exhibit IV: 510(k) Summary Schick Computed Oral Radiology System
Common/Classification Name: Solid State X-ray Imager 21 CFR892.1650
Schick Technologies, Inc. 30-00 47th Avenue Long Island City, NY 11101 718-937-5765, 718-937-5962 (FAX) Contact: Daniel Michaeli, Prepared: May 24, 2004
A. Legally Marketed Predicate Devices
The original Computed Oral Radiology System notification was cleared on January 318, 1994 (K933455). The device and its predicate are small digital imaging receptors that may be used in place of dental x-ray film.
B. Modification Description
The new control mechanism differs from the predicate in that image acquisition may additionally be triggered through a hardwire to an x-ray tube. This modification allows for a quicker x-ray response time and may improve ergonomics as it eliminates the need for a standalone remote module.
The existing firmware has been altered to support the modified and additional hardware. The new remote module may be housed within a specified x-ray source. The modification in no way effects the fundamental technology governing image acquisition.
C. Indications for Use
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage. This device modification in no way alters the indications for use of this machine beyond what was originally cleared in K933455.
D. Substantial Equivalence Summary
A risk analysis established the areas of concern. The principal risk is unintended x-ray exposure. These areas have been evaluated following bench, and thirdparty safety testing. All validation activities have demonstrated that the
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predetermined acceptance criteria were met. Where appropriate, warnings have been incorporated within the user manual.
E. Conclusions
Schick Technologies has demonstrated through a risk analysis and validation studies that the device modification is substantially equivalent to the already cleared and marketed device.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is left-aligned and appears to be part of a document or presentation. The words are capitalized and spaced evenly.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Daniel Michaeli Director of Science Development Schick Technologies, Inc. 30-30 47th Avenue LONG ISLAND CITY NY 11101
AUG 23 2013
Re: K041385
Trade/Device Name: Computed Oral Radiology System Regulation Number: 21 CFR 892.1810 Regulation Name: Intraoral source x-ray system Regulatory Class: II Product Code: EAP and MOB Dated: May 24, 2004 Received: May 25, 2004
Dear Mr. Michaeli:
This letter corrects our substantially equivalent letter of June 7, 2004.
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 vour 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
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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Page 1 of 1
510(k) Number (if known): K041385
Computed Oral Radiology System Device Name:
Indications For Use:
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Nancy C Langdon
and Radiological Devic 510(k) Numl
Prescription Use
§ 872.1810 Intraoral source x-ray system.
(a)
Identification. An intraoral source x-ray system is an electrically 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 inside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.