PatientGallery is a Windows-based image management system indicated for use primarily by dentists to acquire, archive, display, edit, print, email, and import/export digital images.

Device Description

PatientGallery Imaging Software is a Windows-based image management database, or system used primarily by Dentists for the indications of acquiring, archiving, displaying, editing, printing, emailing, and importing or exporting digital images.

The database is organized like a file cabinet by patient folder accommodates grayscale and color images which may also include textual and graphic notes and annotations. Images may be assembled into layouts which can be customized as required. Optional modules provide editing and viewing functions.

Image acquisition from x-ray sensors, intra-oral video cameras, digital cameras and flatbed scanners can be distributed among several workstations. The software provides direct interfaces to many industry standard devices through OEM toolkits. PatientGallery Imaging Software uses standard Windows peer-to-peer networking. By default, images are stored in the native format provided by the hardware manufacturers. PatientGallery Imaging Software may be invoked by other practice management applications so that specific patient information is accessed.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the PatientGallery Imaging Software:

This submission (K070954) for the PatientGallery Imaging Software does not contain the detailed information requested regarding specific acceptance criteria for diagnostic performance or a study demonstrating such performance.

Instead, the submission focuses on the functionality and safety of the software as an image management system, demonstrating substantial equivalence to a predicate device based on its intended use and general software verification and validation.

Therefore, many of the requested fields cannot be directly populated from the provided document. I will fill in what can be inferred or explicitly stated, and note when information is missing.

Acceptance Criteria and Device Performance Study (K070954)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance in Study
Functional Performance	Ability to acquire digital images from various sources (x-ray sensors, intra-oral video cameras, digital cameras, flatbed scanners).	"The software provides direct interfaces to many industry standard devices through OEM toolkits."
	Ability to archive digital images.	"database... used primarily by Dentists for the indications of acquiring, archiving..."
	Ability to display digital images (grayscale and color).	"displaying... digital images."
	Ability to edit digital images (including textual and graphic notes/annotations).	"editing... digital images... Optional modules provide editing and viewing functions."
	Ability to print digital images.	"printing... digital images."
	Ability to email digital images.	"emailing... digital images."
	Ability to import/export digital images.	"importing or exporting digital images."
	Ability to store images in native format provided by hardware manufacturers.	"By default, images are stored in the native format provided by the hardware manufacturers."
	Ability to be invoked by other practice management applications to access specific patient information.	"PatientGallery Imaging Software may be invoked by other practice management applications so that specific patient information is accessed."
Safety and Reliability	No unacceptable hazards identified; all identified hazards appropriately mitigated.	"A Hazard Analysis was performed... which led to the development of Software Requirement Specifications (SRS)."
	Software performs as indicated in specifications.	"The V&V testing was passed, demonstrating that the PatientGallery Imaging Software performs as indicated."
Substantial Equivalence	Device functions as described and is substantially equivalent to predicate device (TigerView Professional, K061035).	"The information contained in this Pre-market Notification is sufficient to demonstrate that the PatientGallery Imaging Software functions as described, and is substantially equivalent to the TigerView Professional software..."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in terms of clinical images or cases. The "Test Cases" mentioned refer to software verification and validation testing, not a clinical performance study with patient data.
Data Provenance: Not applicable, as no clinical test set using patient data is described. The "Test Cases" would typically involve synthetic or controlled data to verify software functions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for the software's functional performance would be its adherence to predefined software requirements, not clinical diagnoses established by medical experts.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication is described. Software V&V testing typically involves comparing actual software output to expected output based on specifications.

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

No. An MRMC comparative effectiveness study was not done. The device is an image management system, not an AI diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The "V&V testing" refers to standalone software testing to ensure it meets its functional requirements. This is not a "standalone (algorithm only)" performance in the context of diagnostic accuracy, but rather functional software performance.

7. The type of ground truth used

The "ground truth" for the V&V testing was the Software Requirement Specifications (SRS). The software was tested to ensure it performed according to these written specifications.

8. The sample size for the training set

Not applicable. This device is an image management system, not a machine learning or AI algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. No training set is used for this type of software.

Summary

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K070954

510(k) SUMMARY

General Information

Submitted by:	Raster Builders, Inc.650 South Eliseo DriveGreenbrae, CA 94904	APR 20 2007
	Phone: (800) 925-2134
Contact Person:	Eric Chasanoff650 South Eliseo DriveGreenbrae, CA 94904
	Phone: (800) 925-2134
Date Prepared:	February 23, 2007

Device Information

Trade Name:	PatientGallery Imaging Software
Common Name:	Picture archiving and communications system
Classification:	Class II
Classification Name:	System, Image Processing, Radiological
Reference:	21 CFR 892.2050

Predicate Device

Manufacturer510(k) No.	Product Name
Televere SystemsK061035	TigerView Professional

Device Description

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Intended Use

PatientGallery Imaging Software will be used primarily by Dentists for the indications of acquiring, archiving, displaying, editing, printing, emailing, and importing or exporting digital images.

Safety Information

A Hazard Analysis was performed for the PatientGallery Imaging Software, which led to the development of Software Requirement Specifications (SRS). The SRS was used to develop a Verification & Validation (V&V) plan executed through a series of Test Cases. The V&V testing was passed, demonstrating that the PatientGallery Imaging Software performs as indicated.

Conclusion

The information contained in this Pre-market Notification is sufficient to demonstrate that the PatientGallery Imaging Software functions as described, and is substantially equivalent to the TigerView Professional software manufactured by Televere Systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Raster Builders, Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131

APR 2 0 2007

Re: K070954

Trade/Device Name: Patient Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 4, 2007 Received: April 5, 2007

Dear Mr. Christensen:

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.

Image /page/2/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the letters "FDA" in a stylized font. The word "Centennial" is written in cursive below the letters. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.

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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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Indications for Use

510(k) Number: None KO70954

Name of Device: PatientGallery Imaging Software

Indications for Use:

PatientGallery is a Windows-based image management system indicated for use primarily by dentists to acquire, archive, display, edit, print, email, and import/export digital images.

Prescription Use	X
(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 Device Evaluation (ODE)

Deith. leym

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070954

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Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).