(97 days)
ClearVision is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
ClearVision is a digital imaging system for dental radiographic application. The product is to be used for routine dental radiographic examinations such as bitewings, periapicals, etc. Two different sized sensors (size 1 and size 2) are utilized to image different anatomy and for different patient sizes. The CMOS sensor connects directly to a USB connection in a PC without the need for an intermediate electrical interface. ClearVision works with a standard dental intraoral x-ray source without any connection to the x-ray source. ClearVision captures an image automatically upon sensing the production of x-ray and after the x-ray is complete, transfers the image to an imaging software program on the PC. Disposable sheaths are used with each use to prevent cross-contamination between patients.
This provides an analysis of the provided text regarding the ClearVision Digital Sensor System.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ClearVision Digital Sensor System are derived from its comparison to predicate devices (Schick CDR and Gendex GXS-700) and general engineering requirements. The reported device performance indicates equivalency or superiority to these predicates.
| Acceptance Criteria Category | Specific Criteria/Test | Predicate Device A (Schick CDR) Performance | Predicate Device B (Gendex GXS-700) Performance | ClearVision Sensor Performance | Met? |
|---|---|---|---|---|---|
| Imaging Performance | Image Line Pair Phantom | - | - | Equivalent to GXS-700, Superior to Schick CDR | Yes |
| Image Aluminum Step Wedge | - | - | Equivalent to GXS-700, Superior to Schick CDR | Yes | |
| Image Tooth Phantom | - | - | Equivalent to GXS-700, Superior to Schick CDR | Yes | |
| Electrical Safety | IEC 60601-1 compliance | - | - | Meets requirements | Yes |
| EMI/EMC | IEC 60601-1-2 compliance | - | - | Meets requirements | Yes |
| Durability | Sensor housing and cable mechanical testing | - | - | Met all specified requirements | Yes |
| Reliability | Consistent image capture and transfer over extended life | - | - | Completely reliable | Yes |
| Image Quality Consistency | Consistent over expected lifetime exposures to radiation | - | - | Meets requirements | Yes |
| Hermetic Classification | IP67 per IEC 60529 | - | - | Meets requirements | Yes |
Note: The document states "found to be equivalent to the Gendex GXS-700 in all three tests and superior to the Schick sensor in all three imaging tests," implying that the performance level of the GXS-700 served as the primary benchmark for "equivalency" for the ClearVision's imaging performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical sample size for the test set used in the imaging performance comparison. It mentions "each sensor to image a line pair phantom, an aluminum step wedge, and a tooth phantom." This implies at least one instance of imaging each of these phantoms per sensor.
The data provenance is not explicitly stated. Given the context of a 510(k) submission and the nature of the tests (imaging phantoms), it is highly likely that this was prospective data generated in a controlled laboratory or engineering setting, likely within the United States where the company is based. There is no mention of patient data or clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of human experts to establish ground truth for the test set. The tests performed ("imaging a line pair phantom, an aluminum step wedge, and a tooth phantom") are objective, physical measurements against established standards for image quality and resolution (e.g., line pairs, step wedge density differences). Therefore, the "ground truth" would be inherent in the physical phantoms themselves and the objective metrics used to evaluate the images.
4. Adjudication Method for the Test Set
No adjudication method is described, as the evaluation methods appear to be objective and quantitative (e.g., measuring line pairs, density differences). Human interpretation or consensus for ground truth was not mentioned or implied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a technical performance comparison of the device against predicate devices using physical phantoms, not a clinical study involving human readers or patient cases. Therefore, there is no effect size related to human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the described imaging performance comparison of the ClearVision sensor is a standalone assessment. The evaluation focuses solely on the device's ability to capture and produce images from phantoms, without any involvement of a human interpreter in the loop for diagnostic decision-making during the testing process. The device itself is a digital sensor, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for the imaging performance tests was objective, physical standards provided by the phantoms:
- Line pair phantom: Provides known spatial frequencies (lines per millimeter) to assess resolution.
- Aluminum step wedge: Provides known material thicknesses/densities to assess contrast and dynamic range.
- Tooth phantom: Likely provides a realistic but standardized representation of dental anatomy to assess overall image quality and detail capture.
8. The Sample Size for the Training Set
The document describes a physical medical device (a digital X-ray sensor), not an AI/machine learning algorithm. Therefore, there is no training set in the context of an algorithm or AI model. The device's "training" or development would have involved engineering design, prototyping, and iterative testing to meet specifications, but not a dataset for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since this is a physical device and not an AI algorithm, the concept of a "training set" and establishing ground truth for it is not applicable. The device's "ground truth" during its development would have been established through engineering specifications, material properties, and performance targets derived from scientific principles and a comparison to existing technologies.
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K 1123 80 Page 1 of 3
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510(k) Summary
| Date: | June 9, 2011 |
|---|---|
| Submitter: | Midmark Corporation675 Heathrow DriveLincolnshire, IL 60069 USA |
| Contact Person: | Lisa BartakovicsDirector of Quality and Regulatory Affairs(847) 415-9800 |
| Device Name: | ClearVision Digital Sensor System |
| Predicate Devices: | Schick CDR (K072134)Gendex GXS-700 (K090458), approved under Dexis name |
| Description of Device: | ClearVision is a digital imaging system for dental radiographicapplication. The product is to be used for routine dental radiographicexaminations such as bitewings, periapicals, etc. Two different sizedsensors (size 1 and size 2) are utilized to image different anatomy andfor different patient sizes. The CMOS sensor connects directly to a USBconnection in a PC without the need for an intermediate electricalinterface. ClearVision works with a standard dental intraoral x-raysource without any connection to the x-ray source. ClearVision capturesan image automatically upon sensing the production of x-ray and afterthe x-ray is complete, transfers the image to an imaging softwareprogram on the PC. Disposable sheaths are used with each use toprevent cross-contamination between patients. |
| Intended Use: | ClearVision is intended to be used by dentists and other qualifiedprofessionals for producing diagnostic x-ray radiographs of dentition,jaws and other oral structures. |
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Substantial Equivalence:
| TechnicalCharacteristic | ClearVision | Schick CDR | Gendex GXS-700 (Dexis) |
|---|---|---|---|
| Sensor Sizes (mm) | 37 x 2443 x 30 | 31 x 2237 x 2443 x 30 | 37 x 2542 x 31 |
| Sensor Technology | CMOS | CMOS | CMOS |
| Pixel Size (µm) | 19.0 | 40.0 | 19.5 |
| Scintillator | CsI | CsI | CsI |
| Interface to PC | USB | USB | USB |
| ElectronicInterfaceAssembly? | No | Yes | No |
| Intended Use | ClearVision isintended to be usedby dentists and otherqualified professionalsfor producingdiagnostic x-rayradiographs ofdentition, jaws andother oral structures. | The Computed OralRadiology System isintended for intra-oralexaminations and indicatedfor dental patients. Itproduces instant, digital,intra-oral x-ray images of apatient's mouth whilereducing the necessary x-raydosage. | The DEXIS sensor is a USB-driven digital sensor whichis intended to acquiredental intra-oralradiography images. TheDEXIS sensor shall beoperated by healthcareprofessionals, who areeducated and competentto perform the acquisitionof dental intra-oralradiographs. The DEXISsensor can be used eitherin combination withspecial positioning devicesto facilitate positioningand alignment with the x-ray beam or it may also bepositioned by hand withthe assistance of the. |
Tests Conducted:
An imaging performance comparison was done of the ClearVision sensor versus the Schick CDR and Gendex GXS-700 sensors. The details of this testing can be found in Section 18. This testing consisted of using each sensor to image a line pair phantom, an aluminum step wedge, and a tooth phantom. In this testing, the ClearVision sensor was shown to be equivalent to the Gendex GXS-700 in all three tests and superior to the Schick sensor in all three imaging tests.
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Significant electrical, mechanical, and imaging tests were performed on the sensors as part of engineering verification. The full details of this testing is found in Section 18. In all cases, the sensor was found to meet the requirements identified earlier in the design phase. Extensive imaging performance testing was done in various configurations of connections of the sensor to a PC workstation (varying lengths of cable and the presence of USB hubs and extenders). The sensor showed itself to be completely reliable in capturing an image and transferring the image to the workstation over an extended life period. Image quality of the sensor was shown to meet requirements and to be consistent over the expected lifetime exposures to radiation. The sensor was put through extensive mechanical testing that tested the durability of the sensor housing and cable. Once again, the sensor met all specified requirements. An external test laboratory confirmed the ClearVision system meets the electrical safety and EMI/EMC provisions of IEC 60601-1 and 60601-1-2. Testing by the sensor supplier by an external laboratory confirmed the sensor met hermetic classification IP67 per IEC 60529.
Conclusion:
The ClearVision sensor system is substantially equivalent to other legally marketed devices in the United States. The ClearVision sensor system is substantially equivalent in technical characteristics and intended use to the CDR sensor marketed by Schick Technologies and the GXS-700 sensor marketed by Gendex Dental Systems (approved under the Dexis name).
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three curved lines that resemble a bird in flight or a symbolic representation of human services.
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
NOV 2 2 2011
Ms. Lisa Bartakovics Director, Quality and Regulatory Affairs Progency Dental Midmark Corporation 675 Heathrow Drive LINCOLNSHIRE IL 60069
Re: K112380
Trade/Device Name: Progeny ClearVision Digital Sensor System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 18, 2011 Received: October 18, 2011
Dear Ms. Bartakovics:
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,
Mary Pastel
Mary S. Pastel, Sc.D. 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 Form
510(k) Number (if known): _ K \2380__________________________________________________________________________________________________________________________________________
Device Name: Progeny ClearVision Digital Sensor System
Indications for Use: ClearVision is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112380
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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.