CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.

Device Description

Curve Image is a web-based dental practice image management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer.

Curve Image may be sold as a stand-alone product, or may be bundled with a suite of web applications to form a comprehensive dental practice management application called HERO.

AI/ML Overview

The provided text describes a 510(k) submission for the "Curve Image" dental PACS system. However, the document does not contain specific acceptance criteria, performance metrics (like sensitivity, specificity, accuracy), sample sizes for test or training sets, details on expert ground truth establishment, or clinical study results typical for AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices by comparing intended use, environment of use, performance characteristics, and technological characteristics. This type of submission relies on the similar nature of the device to already-cleared devices, rather than a clinical trial demonstrating new performance.

Therefore, many of the requested sections regarding acceptance criteria and study details cannot be filled from the provided text.

Here's an analysis of what information is available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, F1 score, AUC). The "acceptance criteria" for this 510(k) is implicitly demonstrating substantial equivalence to the predicate devices through a comparison of features and capabilities, and successful non-clinical testing.
Reported Device Performance:
- Non-Clinical Testing Summary: "Curve Dental, Inc. has conducted extensive non-clinical and validation testing of the Curve Image system, as a PACS system that is capable of providing reliable post-processing and display of images for dental applications. All of the different components of the Curve Image software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate in a manner substantially equivalent to the predicate devices."
- Tests performed included:
  - Product Risk Assessment
  - Software modules verification tests
  - Software validation test

Acceptance Criterion (Implicitly based on substantial equivalence to predicates & non-clinical testing)	Reported Device Performance
Reliable post-processing and display of images for dental applications	Extensive non-clinical and validation testing conducted, including product risk assessment, software modules verification tests, and software validation tests. The system "provides all the capabilities necessary to operate in a manner substantially equivalent to the predicate devices."
Functional equivalence to ChairSide Software Application (K982422)	The comparison table (pages 4-7) details feature-by-feature equivalence in image acquisition, editing, storage, browsing, annotation, manipulation (zoom, crop, rotate, contrast, brightness), as well as administrative, patient management, scheduling, billing, insurance, claims, dental charting, perio charting, patient notes, and prescriptions.
Functional equivalence to Centricity PACS Web Diagnostic (Web DX) PACS (K083018)	The comparison table (pages 4-7) details feature-by-feature equivalence in web-based application, secure data transmission (HTTPS), database management, secure server infrastructure, user login, account management, security administration, patient management, image viewing, manipulation (zoom, rotate, brightness, contrast), and DICOM compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. This document does not detail specific image datasets used for a "test set" in the context of clinical performance evaluation. The non-clinical testing is described generally as "software modules verification tests" and "software validation test" without specifying sample sizes for images or data.
The device is a PACS system, so it manages images from "standard dental imaging devices" or uploads from the user's computer, implying a wide range of potential data, but not a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This information is not relevant to a 510(k) submission for a PACS system that acts as an image management tool, not an AI diagnostic aid requiring expert-established ground truth for its own diagnostic performance. The device is for "diagnostic use" by dental professionals, but it doesn't perform automated diagnosis itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

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. This type of study is not mentioned or undertaken for this device. The Curve Image system is a PACS, not an AI diagnostic tool designed to assist human readers directly in interpretation (beyond displaying images clearly and providing basic manipulation tools).

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

Not applicable. The device is a Picture Archiving and Communications System (PACS); it is not an AI algorithm performing diagnostic tasks. Its performance is related to its functionalities as an image management system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For a PACS system, the "ground truth" would relate to its ability to accurately store, retrieve, display, and manipulate images, which is assessed through software validation and verification, not against clinical ground truth like pathology for specific diagnoses.

8. The sample size for the training set

Not provided. The device is not an AI/ML system that undergoes "training" in the traditional sense on a dataset. It's a software application.

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

Not applicable. See point 8.

Summary

{0}------------------------------------------------

edental

510(k) Summary (in accordance with 21 CFR 807.92)

510(k) Number K_______________________________________________________________________________________________________________________________________________________________

I. Applicant Information

Applicant:	Curve Dental, Inc.424 W. 800 N.Suite 202Orem, UT 84057
Contact Person:	George StantchevDirector ImagingTel: (888) 910-4376Fax: (801) 805-5175e-mail: george.stantchev@curvedental.com

June 20, 2011 Date Prepared:

11. Device Name and Classification

Proprietary Name:	Curve Image 2.0
Classification Name:	Picture Archiving and Communications System
Common/Usual Name:	PACS
Classification:	Class II
Regulation Number:	892.2050
Product Codes:	LLZ
Classification Panel:	Radiology Devices

III. Predicate Devices

The Curve Image device is substantially equivalent to the following FDA cleared predicate devices with regard to indications for use, performance and technological characteristics:

510(k) Number:	K982422
Trade Name:	ChairSide Software Application
Manufacturer:	EagleSoft
Classification Name:	Picture Archiving and Communications System
Common/Usual Name:	PACS
Classification:	Class II
Regulation Number:	892.2050
Product Codes:	LLZ

{1}------------------------------------------------

K112974 Page Zof 9 curvedental

510(k) Number: Trade Name: Manufacturer: Classification Name: Common/Usual Name: PACS Classification: Regulation Number: Product Codes:

K083018

Centricity PACS Web Diagnostic (Web DX) PACS GE Healthcare Dynamic Imaging Solutions Picture Archiving and Communications System Class II 892.2050 LLZ

IV. Device Description

Curve Image may be sold as a stand-alone product, or may be bundled with a suite of web applications to form a comprehensive dental practice management application called HERO.

V. Intended Use

Curve Image is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.

VI. Summary of the Technical Characteristics

Curve Image software provides the following high-level features:

. Browsing Images by Date and/or Source
. Viewing an Image

{2}------------------------------------------------

K112974
Page 3 of 9

curvedental

Uploading an Image File .
Acquiring an Image from a Web Camera .
Acquiring an Image from a TWAIN Device ●
Acquiring image from Dental Imaging Device ●
Copying an Image to the Local Computer .
Saving a Modified Image .
Annotating an Image t
Zooming In on an Image .
Cropping an Image
Inverting Colors of an Image .
Rotating an Image (increments of 90 degrees) �
Flipping an Image Horizontally or Vertically ●
Increasing/Decreasing Image Brightness
Increasing/Decreasing Image Contrast

The main technical characteristics of the software are:

. Web-based Application and Interface
Secure Data Transmission (HTTPS) .
. Database Management and Storage
Secure Server Infrastructure .

Expanded software features:

Administration .
Patient management .
Scheduling ●
Billing �
Insurance Management .
. Claims Management
Dental Charting
Perio Charting .
Patient Notes and History .
. Prescriptions
Patient Education ●

The following table compares Curve Image to the predicate devices with respect to intended use, environment of use, limitations of use, technical performance and technological characteristics, providing more detailed information regarding the basis for the determination of substantial equivalence.

{3}------------------------------------------------

redenta




188



Cur

Device Name	Curve Image	ChairSide Software Application(K982422)	Centricity PACS Web Diagnostic (Web DX) PACS (K083018)
Product Code	LLZ	LLZ	LLZ
Regulation #	892.2050	892.2050	892.2050
Class	II	II	II
Intended Use	CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported.	EagleSoft's ChairSide is a clinical software program that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audit recording and clinical exam data. In addition, it also offers an imaging module for image acquisition, editing, and storage of digital images. It is designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use when serving the general public.Images can be acquired from standard dental imaging devices including Digital Radiographic Devices, Digital Video Capture Devices and General Image Devices such as scanners. Images can be edited (e.g., resized, contrast, cropped, etc.), as well as	Centricity PACS Web Diagnostic (Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

CONFIDENTIAL

Page 4 of 7

510(k) – Curve Image

K112974
Page 4 of 9

{4}------------------------------------------------

ﺘﺤﻘﻴﻘﺔ ﺗﻨﻪdents
ﻟﻤﺴﺎ ﺍﻟﻤﺴﺎ
gAmerican1
35C
1୍ତ1- • • • •
. .사

Device Name	Curve Image	ChairSide Software Application (K982422)	Centricity PACS Web Diagnostic (Web DX) PACS (K083018)
	The system is designed to provide images for diagnostic use.	imported or exported.	Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Environment of Use	Dental offices.	Dental offices.	Hospitals, clinics and physicians offices.
Performance Characteristics & Principles of Operation	Basic Technology:Web-based, software application.	Basic Technology:PC-based, software application.	Basic Technology:Web-based, software application.
	Features:Browsing Images by Date and/or Source Viewing an Image Uploading an Image File Acquiring an Image from a Web Camera Acquiring an Image from a TWAIN Device	Features:Browsing Images by Date and/or Source Viewing an Image Uploading an Image File Acquiring an Image from a Web Camera Acquiring an Image from a TWAIN Device Acquiring image from standard dental imaging devices Copying an Image to the Local Computer Saving a Modified Image	Features:Browsing Images by Date and/or Source Viewing an Image Uploading an Image File Acquiring an Image from a Web Camera Acquiring an Image from a TWAIN Device Copying an Image to the Local Computer Saving a Modified Image
Device Name	Curve Image	ChairSide Software Application (K982422)	Centricity PACS Web Diagnostic (Web DX) PACS (K083018)
	Annotating an Image Zooming In on an Image Cropping an Image Inverting Colors of an Image Rotating an Image (increments of 90 degrees) Flipping an Image Horizontally or Vertically Increasing/Decreasing Image Brightness Increasing/Decreasing Image Contrast Adjusting Gamma Function Lossless image compression Zoom dept: absolute 1x, Fit and relative Technical Characteristics: Web-based Application and Interface Secure Data Transmission	Annotating an Image Zooming In on an Image Cropping an Image Inverting Colors of an Image Rotating an Image (increments of 90 degrees) Flipping an Image Horizontally or Vertically Increasing/Decreasing Image Brightness Increasing/Decreasing Image Contrast Adjusting Gamma Function Image measurements DICOM Compliance Video Capture 3D Image view JPG image lossy compression Zoom depth: absolute 1x, Fit and relative Technical Characteristics: PC-based Application and Interface	Annotating an Image Zooming In on an Image Inverting Colors of an Image Rotating an Image (increments of 90 degrees) Flipping an Image Horizontally or Vertically Increasing/Decreasing Image Brightness Increasing/Decreasing Image Contrast Adjusting Gamma Function Image measurements DICOM Compliance 3D Image view JPEG and wavelet lossy image compression Zoom depth: absolute 1x, 2x, 4x, 8x and relative Technical Characteristics: Web-based Application and Interface Secure Data Transmission

CONFIDENTIAL

Page 5 of 7

510(k) — Curve Image

义 112974 。そ ــ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ـ ్ర Page

{5}------------------------------------------------

curvedenta

CONFIDENTIAL

Page 6 of 7

510(k) - Curve Imag

{6}------------------------------------------------

Device Name		Curve Image		ChairSide Software Application(K982422)	Centricity PACS WebDiagnostic (Web DX) PACS(K083018)
		(HTTPS)			(HTTPS)
		• Database Management andStorage		• Database Management andStorage	• Database Management andStorage
		• Secure Server Infrastructure			• Secure Server Infrastructure
Administration		• User login		• User login	• User login
		• Account management	•	• Account management	• Account management
		• Security administrationprivileges for Administrator,Basic User, Clinical Userand Practice ManagementUser		• Security administrationprivileges for Administrator,Basic User, Clinical Userand Practice ManagementUser	• Security administrationprivileges for Administrator,Basic User and Clinical
Patientmanagement		• Patient profile and datamanagement		• Patient profile and datamanagement	• Patient profile and datamanagement
Scheduling		• Appointment managementsfunctions with calendar		• Appointment managementsfunctions with calendar
Billing	•	Setting up billing andinsurance information		Setting up billing andinsurance information
InsuranceManagement		Retrieve Insurancepayments		Retrieve Insurancepayments
Claims		Create and manage		Create and manage

curvedental

CONFIDENTIAL

Page 7 of 7

510(k) – Curve Image

K112974
Page 7 of 9

{7}------------------------------------------------

curvedental

Device Name	Curve Image	ChairSide Software Application(K982422)	Centricity PACS WebDiagnostic (Web DX) PACS(K083018)
Management	Insurance claims	Insurance claims
Dental Charting	• Dental Chart layout andtreatment plans management	• Dental Chart layout andtreatment plans management
Perio Charting	• Perio Chart, perio exam andperio graph management	• Perio Chart, perio exam andperio graph management
Patient notes andHistory	• Patient text notes, notehistory	• Patient text notes, notehistory	• Keynotes on patient data
Prescriptions	• Prescription notepad writer	• Prescription notepad writer
Patient Education	• Patient education moviesand interface	• Patient education moviesand interface

Page 8 of 7

510(k) — Curve Image

K112974
Page 8

್ಲಾ

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the text "K112974" at the top, followed by "Page 9 of 9". Below this text is the logo for "curvedental". The logo features a circular arrangement of dots on the left, followed by the word "curve" in bold and "dental" in a regular font.

VII. Summary of Non-Clinical Testing

Curve Dental, Inc. has conducted extensive non-clinical and validation testing of the Curve Image system, as a PACS system that is capable of providing reliable post-processing and display of images for dental applications. All of the different components of the Curve Image software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate in a manner substantially equivalent to the predicate devices.

The tests performed included:

. Product Risk Assessment
. Software modules verification tests
Software validation test .

VIII. Conclusions

Based on the comparison of intended use and technological characteristics, the Curve Image system is substantially equivalent to the ChairSide Software Application manufactured by EagleSoft (K982422) and the Centricity PACS Web Diagnostic (Web DX) PACS manufactured by GE Healthcare Dynamic Imaging Solutions.

Curve Image combines the web-based technology of the Centricity PACS, with the features and functionality of the ChairSide Software. Therefore the Curve Image device is substantially equivalent to the predicate devices.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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

Curve Dental, Inc. % Mr. Casey Conry Staff Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747

OCT 2 0 2011

Re: K112974

Trade/Device Name: CURVE IMAGE Trade/Don Number: 21 CFR 892.2050 Regulation Name: 21 CF FC 69212001 - 12 communications system Regulatory Class: II Product Code: LLZ Dated: October 3, 2011 Received: October 5, 2011

Dear Mr. Conry:

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

{10}------------------------------------------------

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. S 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

{11}------------------------------------------------

4. Indication for Use Statement

510(k) Number (if known):

Device Name: CURVE IMAGE

Indications for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

May S. Pastel

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112974

Page 1 of 1

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).