(131 days)
The indications for use of the Progeny Vantage Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometic radiographic examinations for use in orthodontic treatment planning and evaluation.
The Progeny Vantage Panoramic X-Ray System is an extraoral radiographic imaging system for producing digital radiographs in panoramic and cephalometric views of the teeth, jaw and oral structure. The Progeny Vantage Panoramic Extraoral Radiographic Imaging System consists of the following main components: X-ray tubehead with integrated collimation, Digital Image Receptor, Rotating C-Arm for tubehead and image receptor mounting, Overhead Arm, Elevating Column, Patient Positioning Table, Electronic Control Unit, Computer Display Workstation, 8 ft. coil cord with exposure switch, Optional cephalometric extension arm.
Here's an analysis of the acceptance criteria and the study performed for the Progeny Vantage Panoramic X-Ray System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for image quality. Instead, the acceptance is based on a determination of "at least as effective as" predicate devices by expert consensus.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image quality deemed acceptable for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. | Two licensed dentists deemed image quality acceptable and effective. |
| Image quality deemed at least as effective as predicate devices (Instrumentarium OP200D and Planmeca ProMax). | Two licensed dentists concluded Progeny Vantage images were at least as effective as Instrumentarium and Planmeca images. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The clinical test involved images taken of "a skull phantom". This suggests a sample size of one skull phantom.
- Data Provenance: The images were specifically generated for the purpose of this K122643 submission through a clinical test using the Progeny Vantage device itself, as well as images from predicate devices. The text doesn't specify a country of origin beyond the device manufacturer being based in Lincolnshire, IL, USA. This appears to be a prospective test conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two licensed dentists.
- Qualifications of Experts: They are described as "licensed dentists." No further details regarding their years of experience or specialization (e.g., oral radiologist) are provided in the document.
4. Adjudication Method for the Test Set
The document states: "Both dentists deemed that the image quality was acceptable..." and "...concluded that the Progeny Vantage images were at least as effective as the Instrumentarium and Planmeca images."
This indicates an unspecified consensus or individual agreement model. There's no mention of a formal adjudication process like 2+1 or 3+1, but rather a collective conclusion from both reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- No AI assistance is mentioned in the context of this device. The device is an X-ray system, not an AI-powered diagnostic tool. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is an X-ray imaging system. Its "performance" is the quality of the image it produces, which is then interpreted by a human (dentist). It does not have an autonomous algorithm that would perform a standalone diagnostic function.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's image quality was established through expert consensus/opinion by the two licensed dentists. They reviewed the images and made a subjective judgment on their acceptability and comparative effectiveness against predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This document describes a traditional medical device (an X-ray system), not a machine learning or artificial intelligence algorithm that would typically require a training set. The device's operation is based on established physics and engineering principles, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device.
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510(k) Summary
| Date: | November 8, 2012 |
|---|---|
| Submitter: | Midmark Corporation675 Heathrow DriveLincolnshire, IL 60069 USA |
| Contact Person: | Mark GreenwoodDirector, Engineering and Product Development(847) 415-9800 |
| Device Name: | Vantage Panoramic X-Ray System |
| Classification Name: | System, x-ray, extraoral source, digital(21 CFR 872.1800, Product Code MUH) |
| Predicate Devices: | Instrumentarium Orthopantomograph OP200D (K043612)Planmeca ProMax (K011619) |
| Description of Device: | The Progeny Vantage Panoramic X-Ray System is an extraoralradiographic imaging system for producing digital radiographs inpanoramic and cephalometric views of the teeth, jaw and oral structure. |
| The Progeny Vantage Panoramic Extraoral Radiographic Imaging Systemconsists of the following main components: | |
| X-ray tubehead with integrated collimation | |
| Digital Image Receptor | |
| Rotating C-Arm for tubehead and image receptor mounting | |
| Overhead Arm | |
| Elevating Column | |
| Patient Positioning Table | |
| Electronic Control UnitComputer Display Workstation | |
| 8 ft. coil cord with exposure switch | |
| Optional cephalometric extension arm | |
| Intended Use: | The intended use of the Progeny Vantage Extra Oral X-Ray System is toprovide dental radiographic examination and diagnosis of diseases ofthe teeth, jaw and oral structures. When the system is equipped withthe cephalometric option, the system will also provide cephalometric |
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radiographic examinations for use in orthodontic treatment planning and evaluation.
Substantial Equivalence Comparison:
| TechnicalCharacteristic | ProgenyVantage | InstrumentariumOP200D | PlanmecaProMax |
|---|---|---|---|
| kVp | 60-84 kVp | 57-85 kVp | 50-84 kVp |
| mA | 4-14 mA | 2-16 mA | .5-16 mA |
| Sensor type | CCD | CCD | CCD |
| Image Pixel size | 96 um | 96 um | 66, 99, or 132 um |
| Panoramic Scan Time | 2.5-16s | 2.7-14s | 2.7-16s |
| X-Ray tube focal spot | 0.5mm | 0.5mm | 0.5mm |
| Ceph option | Yes | Yes | Yes |
Intended Use for Each Device:
Progeny Vantage:
The intended use of the Progeny Vantage Extra Oral X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evaluation.
Instrumentarium OP200D:
Planmeca ProMax:
Orthopantomograph OP200 (film unit) and OP200D (digital unit) devices are intended to be used for producing x-ray radiographs of dentition, TM-joints, and other oral structures. The units are capable of taking panoramic, TM-joint, maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph OC200 (film unit) and OC200D (digital unit) units can be used for cephalometric radiography and examinations related thereto. OP200 or OC200 units can also be equipped with Ortho Trans (OT) option, which is capable of taking both cross and longitudinal slices of region of interest. Ortho Trans uses linear tomography imaging principle.
The ProMax, Panoramic X-Ray Imaging System with Cephalostat, is an extraoral source X-Ray System, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. The device can be equipped with accessories to fulfill different diagnostic needs. In digital configuration the images are
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displayed on a monitor, and image manipulation, archiving, and communication are performed via a computer.
Technical Analysis: A review of the technical characteristics indicates no significant differences between the Vantage unit and the predicate devices. The radiographic technique factors which would determine patient radiation dosage are almost identical. In fact, many of the key components (x-ray tubes, detectors, etc) are sourced from the same suppliers.
The intended uses of the Vantage unit and the predicate devices also have no significant differences. All three devices' intended use focuses on providing radiograph examination of the teeth, jaw, and oral structures. The Progeny Vantage and Instrumentarium IFU statements specifically describe cephalometric while the Planmeca refers to more general "different diagnostic needs." The Instrumentarium unit IFU describes a linear tomography feature which is NOT present in Vantage unit or IFU and therefore should not be considered.
Non-Clinical Tests: The Progeny Vantage Panoramic unit was tested per IEC 61223-3-4 which is an FDA recognized standard for acceptance testing of dental xray equipment, specifically Section 7 which is for Cephalometric equipment. The Progeny Vantage with ceph option passed this testing which is a confirmation that the product is safe and effective.
Clinical Tests: Two licensed dentists reviewed images taken of a skull phantom with the Progeny Vantage with Ceph. Both dentists deemed that the image quality was acceptable and that they would be effective as effective as cephalometric images. In addition, the two dentists reviewed images taken of the skull by the Instrumentarium OP200D of the skull phantom and Planmeca sample cephalometric images and concluded that the Progeny Vantage images were at least as effective as the Instrumentarium and Planmeca images.
Conclusion: The Vantage Panoramic X-Ray system is substantially equivalent to other legally marketed devices in the United States. Specifically, the Vantage Panoramic X-Ray system is substantially equivalent in technical characteristics, intended use, and effectiveness to the OP200D marketed by Instrumentarium and the ProMax marketed by Planmeca.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 7, 2013
Progeny Dental, A Midmark Company Mr. Mark Greenwood Director, Engineering and Product Development 675 Heathrow Drive LINCOLNSHIRE IL 60069
Re: K122643
Trade/Device Name: Progeny Vantage Panoramic X-Ray System Regulation Number: 21 CFR §872.1800 Regulation Name: System, x-ray, extraoral source, digital Regulatory Class: II Product Code: MUH Dated: December 19, 2012 Received: December 26, 2012
Dear Mr. Greenwood:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2-Mr. Greenwood
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_____K122643
Device Name:___ Progeny Vantage Panoramic X-Ray System
Indications For Use:
The indications for use of the Progeny Vantage Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometic radiographic examinations for use in orthodontic treatment planning and evaluation.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K/22643
Page 1 of
§ 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.