The AFP Imaging Sens-A-Ray Digital Dental X-Ray System with ProImage Software is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support. It is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support.

Device Description

The ProImage Software is essentially identical to the Sens-A-Ray software described in K923067. The AFP Imaging ProImage Software and Sens-A-Ray System are intended to be used in conjunction with standard X-Ray systems. X-Ray images are sent by a digitized processor to a computer screen for image presentation. As with the Sens-A-Ray Software, the ProImage Software provides and controls the following functions: A patient/image database, which logs a patient's statistical and image data, Image exposure, Image storage, Image processing, Image retrieval and post-processing, Image hardcopy. The modifications to the Sens-A-Ray software involve enabling video images and intraoral images to be manipulated within the same software package. The minor modifications involve better database search and structure to allow the user to catalog patient images in an easier and more intuitive format. The other improvements are feature improvements resulting from user input. The feature improvements include: Colorizing image, auto-contrast, re-expose, and "view histogram" functions, Importing multiple images and adjusting the size and resolution of images, Adding an endodontic mode which allows full-screen X-rays. The modifications above were made to accommodate more advanced digital X-ray systems and to provide the user with better imaging capabilities within a single software package. These modifications remain within the scope of the intended use and fundamental technology of the original Sens-A-Ray system. The ProImage Software is intended for use with a sensor unit, image unit, and image grabber that were previously cleared under K923067. The ProImage Software is also compatible with the AFP IntraOral camera, subject of K922942 and other legally marketed intraoral cameras.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sens-A-Ray System with ProImage Software:

The provided 510(k) summary is for a special 510(k), which typically means the modifications being made are minor and do not significantly alter the fundamental technology or intended use of a previously cleared device. Therefore, the level of detailed performance testing and clinical study data often found in a traditional 510(k) or PMA submission is not present.

Based on the provided document, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on demonstrating substantial equivalence and confirming that the modified software functions as intended without adverse effects.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (Implicit from 'Testing' section)
Functional Equivalence	Capture, enhance, and deliver dental images for viewing and storage (similar to predicate).	"Verification and validation testing was successfully performed to confirm that the modified software functions as intended."
Intended Use	To be used with digital dental imaging systems for capture, evaluation, and storage of high quality digital dental X-rays using existing X-ray equipment.	"Verification and validation testing was successfully performed to confirm that the modified software functions as intended." (Implicitly, this includes maintaining the intended use).
Safety	No new safety concerns introduced by modifications.	Not explicitly stated as a separate criterion, but implied by demonstrating functional equivalence and 'as intended' performance.
Performance Characteristics	Essentially identical performance characteristics to the predicate device in terms of image capture, enhancement, and delivery.	"The AFP Imaging ProImage Software and the predicate devices have essentially identical performance characteristics."
Software Functionality	All advertised/implemented new features (colorizing, auto-contrast, import multiple images, endodontic mode, database improvements) function correctly.	"Verification and validation testing was successfully performed to confirm that the modified software functions as intended."

Study Details

Sample Size(s) Used for the Test Set and Data Provenance:
- Sample Size(s): The document does not specify any sample sizes for testing.
- Data Provenance: Not mentioned. Given the nature of a Special 510(k) for software modifications, it's highly likely that testing was done internally by the manufacturer using internal data or simulated data, rather than a large clinical test set. It's not specified if it was retrospective or prospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not mention the use of experts to establish ground truth for a test set. This type of extensive ground truth establishment is typically reserved for devices making diagnostic claims where accuracy against a gold standard needs to be proven. This device is an accessory for image capture and enhancement, not making a new diagnostic claim.
Adjudication Method for the Test Set:
- Not applicable/Not mentioned, as there's no indication of a test set requiring adjudication in the context of comparative performance or diagnostic accuracy.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document is for software modifications to an existing device, focusing on functional equivalence and "as intended" performance, not an assessment of human reader improvement with or without AI assistance.
Standalone (Algorithm Only) Performance Study:
- Yes, in spirit, a standalone performance assessment was conducted. The "Verification and validation testing" mentioned would assess the software's functional performance on its own, ensuring that the image processing, database management, and other features work as programmed. However, this is not a clinical standalone performance study in the sense of demonstrating diagnostic accuracy or sensitivity/specificity for a specific clinical task. It's more of a software quality assurance and functional verification.
Type of Ground Truth Used:
- The document does not explicitly mention "ground truth" in the context of a clinical or diagnostic study. For software modifications like these, the "ground truth" for "verification and validation testing" would typically be derived from:
  - Functional Specifications: Ensuring the software's output matches its design requirements (e.g., if a filter is applied, the image should visibly change as expected).
  - Predicate Device Behavior: Ensuring the modified software functions similarly to the original cleared device.
  - User Expectations: Addressing improvements requested by users.
Sample Size for the Training Set:
- The document does not mention a training set. This is not an AI/machine learning device in the modern sense (it's from 2000 and primarily descriptive in its function). The software is rule-based and functional, not "trained" on data to learn patterns.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set or AI/machine learning component.

Summary of Device and Study Context:

This Special 510(k) is for minor software modifications to an already cleared digital dental X-ray system. The focus is on demonstrating that these modifications do not change the fundamental technology or intended use, and that the modified software continues to function as intended. Therefore, the "study" described is primarily software verification and validation testing rather than a clinical trial or a performance study to establish diagnostic accuracy metrics. The criteria are largely implicit in demonstrating functional equivalence to the predicate device and proper operation of the new/improved features.

Summary

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Special 510(k) Summary

for

Koi 3176

Sens-A-Ray System with ProImage Software

SPONSOR 1.
AFP Imaging Corporation 250 Clearbrook Road Elmsford, NY 10523

Contact Person: Tzipora Halevi 914-592-6100 Telephone:

Date Prepared: September 21, 2000

2. DEVICE NAME

Proprietary Name:	Sens-A-Ray Digital Dental X-Ray System withProImage Software
Common/Usual Name:	Accessory to Extraoral X-Ray System
Classification Name:	Extraoral Source X-Ray System Accessory

3. PREDICATE DEVICES

AFP Imaging Corporation Sens-A-Ray System K923067

4. DEVICE DESCRIPTION

The ProImage Software is essentially identical to the Sens-A-Ray software described in K923067. (K923067 was submitted to FDA by the former owner of AFP Imaging, Regam Medical Systems AB.) The AFP Imaging ProImage Software and Sens-A-Ray System are intended to be used in conjunction with standard X-Ray systems. X-Ray images are sent by a digitized processor to a computer screen for image presentation. As with the Sens-A-Ray Software, the ProImage Software provides and controls the following functions:

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A patient/image database, which logs a patient's statistical and image data ●
Image exposure .
Image storage ●
Image processing ●
Image retrieval and post-processing ●
Image hardcopy .

The modifications to the Sens-A-Ray software involve enabling video images and I ho mountread on a manipulated within the same software package. The minor modifications involve better database search and structure to allow the user to catalog patient images in an easier and more intuitive format. The other abor to cannoly feature improvements resulting from user input. The feature improvements include:

Colorizing image, auto-contrast, re-expose, and "view histogram" functions .
Importing multiple images and adjusting the size and resolution of images .
Adding an endodontic mode which allows full-screen X-rays .

The modifications above were made to accommodate more advanced digital X-ray systems and to provide the user with better imaging capabilities within a single software package. These modifications remain within the scope of the intended use and fundamental technology of the original Sens-A-Ray system.

The ProImage Software is intended for use with a sensor unit, image unit, and image grabber that were previously cleared under K923067. The ProImage Software is also compatible with the AFP IntraOral camera, subject of K922942 and other legally marketed intraoral cameras.

INTENDED USE પં

The ProImage Software is intended to be used with the Sens-A-Ray system and standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support.

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The AFP Imaging ProImage Digital Dental X-Ray System Software is similar in intended use and fundamental technology to the Sens-A-Ray Software, subject of K923067. The AFP ProImage Software and the predicate Sens-A-Ray Software have the same intended use. They are both intended to be used with digital dental imaging systems for the capture, evaluation, and storage of high quality digital dental X-rays using existing X-ray equipment. Both devices are indicated for patients receiving routine dental radiography.

The AFP ProImage Software and the predicate device are operational software packages that support system operation, image capture, and enhancement, patient data, and support. They are both installed into digital dental systems intended for use with standard X-ray equipment.

The AFP Imaging ProImage Software and the predicate devices have essentially identical performance characteristics. These devices use an extraoral source of X-rays for intraoral images in dental radiography. They provide a means for capturing, enhancing, and delivering dental images for viewing and storage

TESTING 7.

Verification and validation testing was successfully performed to confirm that the modified software functions as intended.

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Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH &" are vertically oriented and curve along the left side of the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2001

Re: K013176

AFP Imaging Corporation % Mary-McNamara-Culline, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Trade/Device Name: AFP Imaging Sens-A-Ray Digital Dental X-Ray System Software Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: September 21, 2001 Received: September 24, 2001

Dear Ms. McNamara-Cullinane:

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 (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); 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.

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This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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510(k) Number (if known): KO/3/7

Device Name: AFP Imaging Sens-A-Ray System with ProImage Software

Indications for Use:

The AFP Imaging Sens-A-Ray Digital Dental X-Ray System with ProImage Software is intended for use with standard digital dental X-ray systems and computer stations for intended for use with standard digital Genea. It is 'systems and enhancement, and patient data and support.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leagson

(Division Sign-OM)
Division of Reproductive, Abdominal,
and Radiological Deviens K013176
510(k) Numbe

Prescription Use
✓

Over-The-Counter Use

(Optional Format 1-2-96)

AFP Imaging Special 510(k) ProImage Software

September 21, 2000

Regulation Number and Section

§ 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.