(48 days)
The intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
The Progeny, Inc. Progeny Imaging Software is a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
Here's an analysis of the provided text regarding the Progeny Imaging Software's acceptance criteria and study information.
It's important to note that this 510(k) summary is for a software display system and not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study components for AI medical devices (like sensitivity, specificity, reader studies, ground truth establishment using expert consensus or pathology) are not present or applicable in the provided document. The focus is on demonstrating substantial equivalence to existing predicate devices for image display functionality.
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain a formal table of acceptance criteria with specific quantitative performance metrics like sensitivity, specificity, or AUC, as these types of metrics are typically associated with diagnostic algorithms or AI. Instead, the acceptance criteria are implicitly defined by demonstrating equivalence to predicate devices in terms of functionality and safety, as well as meeting product specifications and undergoing software testing.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| - Display Dental X-rays | Yes (Displays dental x-rays) |
| - Display Intra-oral images | Yes (Displays intra-oral images) |
| - PC Compatible | Yes (PC compatible) |
| - USB Support | Yes (Has USB support) |
| - Ethernet Support | Yes (Has Ethernet support - note: predicate devices did not have this, but it doesn't indicate non-equivalence) |
| - Operating System Compatibility | Windows XP compatible |
| - Display Resolution (SVGA equivalent or better) | SVGA |
| Safety and Effectiveness: | |
| - Meet product specifications | Verified |
| - Software design validation | Validated |
| - Performance validation | Validated |
| - Hazard analysis and risk assessment | Completed |
| - Same Indications for Use as Predicates | Yes |
Study Details (Based on the provided 510(k) summary)
-
Sample size used for the test set and the data provenance:
The document does not specify a test set in the context of evaluating diagnostic performance from patient data. The "performance testing and verification to meet product specifications" would have involved testing the software against a variety of inputs and scenarios, but the number of images or cases used for this is not detailed, nor is the provenance of any data used for functional testing. Given it's a display software, such "test sets" would likely refer to various image formats, sizes, and simulated user interactions rather than a clinical dataset for diagnostic accuracy. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable / not provided. As it's a software display system, there is no "ground truth" in the diagnostic sense needed for clinical evaluation. The ground truth for functional verification would be whether the software correctly displays images as expected, which is determined by technical specifications, not expert clinical consensus. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable / not provided. No clinical ground truth adjudication method is mentioned or required for this type of device. -
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:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, which this device is not. The device is a display system, not an AI or diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable in the context of diagnostic performance. The device is a standalone software component that displays images. Its "performance" is whether it correctly displays images, which is evaluated against its technical specifications, not clinical diagnostic metrics. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As previously noted, the concept of clinical "ground truth" (e.g., from pathology or expert consensus) is not applicable to this device. The "ground truth" for the software's functionality would be its defined specifications (e.g., "display image A correctly," "allow zoom function B," etc.). -
The sample size for the training set:
This information is not applicable / not provided. This device is not an AI algorithm that undergoes training on a dataset. It is a software program developed to perform specific display functions. -
How the ground truth for the training set was established:
This information is not applicable / not provided. As explained above, there is no AI training set for this device.
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510(k) Summary
APR 26 2007
as required by CFR section 807.92(c)
I. General Information
March 1, 2007 Date:
Applicant: Progeny, Inc. 1807 Barclay Blvd. Buffalo Grove, III. 60089
Alan Krema Contact Person:
847-850-3800 x785 Telephone:
847-850-3800 Fax:
II. Names
Device Name:
PROGENY IMAGING SOFTWARE Trade Name: Common Name: Exra Oral X-Ray System Classification Name: 90 MUH Extra oral source x-ray system
III. Predicate Devices
Gendex Vix Win Pro Schick CDR software
IV. Product Description
The Progeny, Inc. Progeny Imaging Software is a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
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V. Indications for Use / Rationale for Substantial Equivalence
The Progeny Imaging Software is to be used as a display of intraoral radiographic images in Dental radiography.
The Progeny Imaging Software shares the same indications for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed in section III of this summary.
There are several major independent manufacturers of Intra Oral diagnostic Radiographic software display systems on the U.S. market. One is the Gendex Vix Win Pro. The 510(k) number is K060178 . The classification of the Dentsply device is listed as product code 90 MUH.
Another currently marketed device is the Schick CDR software, manufactured by Schick, Inc. The 510(k) number is K022953. The classification of the Schick CDR is listed as product code 90 MUH .
| Comparison Table: | |||
|---|---|---|---|
| Characteristic | Vix Win Pro | CDR | Progeny Imaging |
| K060178 | K022953 | ||
| Implementation | Software Only | Software and Sensor | Software Only |
| Computer | PC | PC | PC |
| Operating System | Windows 98,2000, & XP | Windows 98,2000, XP | Windows XP |
| Display Resolution | 1024 x 768 true colorrecommended | SVGA | |
| USB support | Yes | Yes | Yes |
| Ethernet support | No | No | Yes |
| Images Displayed | Dental x-rays,Intra oral images | Dental X-rays,Intra oral images | Dental x-rays,intra oral images |
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VI. Safety and Effectiveness Information
Safety and effectiveness is demonstrated by:
Performance testing and verification to meet product specifications. Software testing to validate software design and performance. Hazard analysis and risk level assessment. Same indications for use as predicate devices.
All of the above steps and evaluations combine to demonstrate that the Progeny Imaging Intraoral Dental X-Ray Software is safe and effective when the device is used as labelled.
VII. Conclusion
The Progeny, Inc. Progeny Imaging Software is determined to be substantially equivalent to the predicate devices, the Gendex Vix Win Pro, and the Schick CDR software. The Progeny Imaging software shares the same indications for use, materials, design, operational and functional features to the currently marked predicate devices listed in section III of this summary. The Progeny Imaging software is safe and effective when the device is used as labelled.
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized abstract symbol consisting of three curved lines that resemble human figures or waves. The text "DEPARTMENT OF HEALTH & HU" is arranged vertically along the left side of the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Alan Krema Director of Product Development Progeny, Inc. 1407 Barclay Blvd. BUFFALO GROVE IL 60089
APR 2 6 2007
Re: K070664
Trade/Device Name: Progeny Imaging software Regulation Number: 21 CFR §872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 28, 2007 Received: March 9, 2007
Dear Mr. Krema:
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.
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Protesting and Promoting Public Health
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Page 2 --
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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlvindustry/support/index.html.
Sincerely yours,
Nancy Chogdon
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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KM0664
Statement of Indications for Use:
Intended Use for the Progeny Imaging software:
The intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
Prescription Use
Daniel G. Bergman
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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.