CLIOSOFT is a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data.

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute images using standard PC hardware.

Device Description

CLIO/CLIOSOFT is a system for general dental diagnostic imaging. CLIO is an intraoral x-ray sensor and CLIOSOFT is a software program. CLIO has size 1 and size 2 sensors. CLIO sensor connects to the PCcompatible computer via an USB port. CLIOSOFT controls capture, display, treatment, review, store, print, and distribute digital x-ray images from CLIO sensors. It can also handle other types of images acquired by digitizing film with a flatbed scanner, or color images from an intraoral dental camera such as the Claris i310 series. CLIO/CLIOSOFT runs on standard PC-compatible computers.

CLIO connects to the computer via USB port.

When properly installed in your computer, CLIOSOFT lets you:

. Control the direct capture of digital x-ray images from the intraoral sensor CLIO.
. View and capture live image from intraoral cameras via USB 2.0 or video capture card.
. Import images from various sources such as radiographic devices, flatbed scanner, digital camera, and generic image devices.
. Export, e-mail, and print images.
. Process digital images with several tools to enhance their diagnostic value.
. Create a database of patients and store images in patient folders.

AI/ML Overview

The provided text describes CLIO/CLIOSOFT, a dental imaging system, and its substantial equivalence to predicate devices, but does not contain information about explicit acceptance criteria or a study designed to prove the device meets those criteria, as typically found in a clinical performance study for a novel device.

The submission is a 510(k) for a device that is seen as substantially equivalent to existing, legally marketed devices. The "study" referenced implicitly in the document is a comparison to predicate devices and adherence to relevant safety and performance standards.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance

There are no specific quantitative acceptance criteria or reported device performance metrics in the document that would typically be found in a clinical performance study (e.g., sensitivity, specificity, accuracy). The submission focuses on demonstrating substantial equivalence based on technical characteristics and adherence to safety and EMC standards.

Acceptance Criteria (Not explicitly stated as clinical performance criteria)	Reported Device Performance (as comparison to predicates)
Safety: Device adheres to medical device safety standards.	Passed CB TEST CERTIFICATE for IEC 60601-1:1988 +A1:1991 +A2:1995, IEC 60601-1:2005.
EMC: Device adheres to electromagnetic compatibility standards.	Passed EMC TEST ACCORDING TO THE STANDARD EN 60601-1-2:2007.
Software Validation: Software functions as intended.	Software Validation conducted (details not provided in the summary, referenced as "Exhibit 14").
Technical Equivalence: Key technical specifications are comparable to predicate.	Sensor Technology: CMOS (same as predicate K092537)Dynamic Range: 4096:1 (same as predicate K092537)Interface: USB (same as predicate K092537)Indications for Use: Comparable to predicate VixWin Pro (K060178) and Toshiba Digital X-ray Sensor (K092537).

Description of the "Study" (Implicitly, the Basis for Substantial Equivalence)

The "study" in this context is not a clinical trial with performance endpoints but rather a demonstration of technical equivalence and compliance with regulatory standards.

Sample size used for the test set and the data provenance:
- Test Set: Not applicable in the context of a clinical performance study with "test sets" for diagnostic accuracy. The assessment relies on the inherent design, specifications, and compliance with standards.
- Data Provenance: The 'data' underpinning the claims of safety and effectiveness comes from technical testing reports (IEC 60601-1, EN 60601-1-2) and the product specifications themselves compared against predicate devices. No information on geographical origin is given for these technical tests. They are not "retrospective" or "prospective" in the sense of a patient data study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" establishment by medical experts mentioned for a diagnostic performance test set. The validation is based on engineering and regulatory compliance.
Adjudication method for the test set:
- Not applicable. No diagnostic ground truth was established necessitating adjudication.
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 MRMC study was done. This device is a dental image management system and sensor, not an AI-powered diagnostic tool, and therefore, an MRMC study related to AI assistance is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an imaging acquisition and management system, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for clinical performance. The "ground truth" for the claims made relates to adherence to specified engineering standards (e.g., electrical safety, EMC) and technical specifications (e.g., dynamic range, sensor size) being equivalent to an already cleared device.
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

Summary:

The K110886 submission for CLIO/CLIOSOFT is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices, primarily based on technical specifications, indications for use, and adherence to recognized safety and EMC standards. It does not involve a clinical performance study with patient data, diagnostic accuracies, or expert-established ground truths. The "study" mentioned within the document implicitly refers to the technical testing and comparisons outlined to support the substantial equivalence claim.

Summary

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K110886

. JUN 3 0 2011

510(k) Summary

As Required by 21 CFR Section 807.92 (c)

1. Submitter Information

ﺘﻴ

Name:	SOTA Imaging
Address:	1073 North Batavia Street Suite BOrange, CA 92867 USA
Telephone Number:	(714) 532-6100
Fax Number:	(714) 532-6107
Contact Person:	Brian Kim, President
Date Prepared:	March 23, 2011

2. Identification of the Device

Trade Name:	CLIO/CLIOSOFT
Common/Usual Name:	Dental Image Management System
Classification Name:	Picture Archiving and Communications System orSystem, X-ray, Extraroal Source, Digital
Product Code:	LLZ or MUH
Regulation:	21 CFR 892.2050 or 21 CFR 892.1800, Class II

3. Equivalent legally Marketed Device

Manufacturer:	GENDEX DENTAL SYSTEMS
Product Name:	VixWin Pro
Product Code:	MUH and LLZ
Regulation:	21 CFR 892.1800 and 21 CFR 892.2050, Class II
510(k) Number:	K060178
Manufacturer:	TOSHIBA AMERICA ELECTRONIC COMPONENTS, INC.
Product Name:	Digital X-ray Sensor
Product Code:	MUH
Regulation:	21 CFR 892.1800, Class II
510(k) Number:	K092537

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4. Device Description

CLIO connects to the computer via USB port.

When properly installed in your computer, CLIOSOFT lets you:

. Control the direct capture of digital x-ray images from the intraoral sensor CLIO.
. View and capture live image from intraoral cameras via USB 2.0 or video capture card.
. Import images from various sources such as radiographic devices, flatbed scanner, digital camera, and generic image devices.
. Export, e-mail, and print images.
. Process digital images with several tools to enhance their diagnostic value.
. Create a database of patients and store images in patient folders.

5. Indications for Use

CLIOSOFT is indicated for use as a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data.

lt is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware.

6. Safety and Effectiveness, Comparison to Predicate Device

CLIO/CLIOSOFT is safe and effective as the predicate device cited above.

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6.1 Substantial Equivalence Chart

Description	VixWin Pro(K060178)	Toshiba Digital X-ray Sensor(K092537)	CLIO/CLIOSOFT
Indications for use	Controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral or extraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner.	Toshiba Digital X-ray Sensor is an intraoral receiver of X-ray energy by the dentist to obtain instant images of teeth and the oral cavity of patients. Images are transmitted to a computer for display.	CLIOSOFT is indicated for use as a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data. It is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc), review, store, print, and distribute images using standard PC hardware.
Implementation	Software only	Sensor only	Sensor and/or Software
Number of sensors	-	4two for size 1 andtwo for size 2	2Size 1 and size 2
Sensor size (mm)	-	Size 1: 40.1 x 25.1Size 2 soft: 44.4 x 32.6Size 2 hard: 43.7 x 31.9	Size 1: 36.73 x 24.35Size 2: 42.80 x 30.49
Technology	-	CMOS	CMOS
Interface to PC	-	USB	USB
Dynamic Range	-	4096:1	4096:1
Sensor cable length (m)	-	2.5	3
Host platform	PC	-	PC
Operating system	Windows 98, 2000, XP	-	Windows XP, Vista, 7 (32/64 bit)
Host RAM	32 MB	-	512 MB
Host Magnetic Storage	4 GB, 9 GB or higher recommended	-	80 GB, 250 GB or higher recommended
CD-ROM	Yes	-	Yes
Host Processor	Intel Pentium 133 MHz, 200 MHz or higher recommended	-	Intel Pentium 4 2.0 GHz or higher
Host Monitor Size	SVGA, XGA recommended	-	XGA, SXGA recommended
Display Resolution	800x600, 1024x768 recommended	-	1024x768, 1280x1024 recommended

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6.2 Meaningful Differences

The sensor included in the CLIO/CLIOSOFT system is provided as OEM and the specification and configuration is similar to TOSHIBA Digital X-ray Sensor (K092537) that already approved. The sensor is safe and effective based on the following references:

CB TEST CERTIFICATE for IEC 60601-1:1988 +A1:1991 +A2:1995 and CB TEST CERTIFICATE for IEC 60601-1:2005 (except 60601-1-6) see Appendix C
SAFETY TEST ACCORDING TO THE STANDARD IEC 60601-1:1988 +A1:1991 +A2:1995 see Appendix D
SAFETY TEST ACCORDING TO THE STANDARD IEC 60601-1:2005 (without 60601-1-6) see Appendix E
EMC TEST ACCORDING TO THE STANDARD EN 60601-1-2:2007 ' see Annex Document No. 4 in Appendix D
EMC TEST ACCORDING TO THE STANDARD EN 60601-1-2:2007 see Attachment No. 9 in Appendix E
Software Validation see Exhibit 14
Reference 510(k) sensor: K092537

7. Conclusion

CLIO/CLIOSOFT is substantially equivalent to legally marketed Image Processing Systems (i.e. PACS).

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Bram Kim President SOTA Precision Optics, Inc. DBA SOTA Imaging 1073 North Batavia Street Suite B ORANGE CA 92867

JUN 3 0 201

Re: K110886

Trade/Device Name: CLIO/CLIOSOFT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 9. 2011 Received: June 14, 2011

Dear Mr. Kim:

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 of

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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 Patel

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

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Indications for Use Form

510(k) Number (if known): Kli 0880

Device Name: CLIO/CLIOSOFT

Indications for Use:

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute images using standard PC hardware.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Mairy S. Padell

Division Sigh-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K 110886

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).