The Cuattro UnoMD, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations. The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device. The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.

Device Description

The Cuattro UnoMD software is a Windows based software application capable of acquiring x-ray images from commonly commercialized digital flat panels. The software can use traditional mouse and keyboard inputs as well as touch screen monitors as an alternative. The use of the software enables the user to use a separate traditional x-ray generator and capture x-ray images without film. The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure. The software also has capabilities to send images to hospital medical PACS systems and digital media for archival.

AI/ML Overview

The Cuattro UnoMD system, as described in the provided 510(k) summary (K093480), relies on demonstrating substantial equivalence to a legally marketed predicate device (DEL-IMS, K063188) rather than meeting specific performance acceptance criteria through a clinical study with a predefined set of metrics. The submission focuses on non-clinical performance data and bench testing.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence to Predicate Device: The Cuattro UnoMD should perform similarly to the predicate device (DEL-IMS, K063188) in terms of image acquisition, processing, and display for radiographic examinations.	Technological Characteristics: "The technological characteristics are the same as the legally marketed predicate device, in that they provide a network connection via DICOM protocol to various devices from a radiographic system that utilizes a digital image capture device."
Image Processing and Presentation Speed: Images should be processed and presented to the user within a specified timeframe.	"The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure."
DICOM 3.0 Compliance: The system should adhere to DICOM 3.0 standards for connectivity and interoperability.	"The Cuattro UnoMD, as the predicate device, utilize software on a workstation computer with Ethernet capability, and provide DICOM 3.0 compliant connectivity."
Safety and Effectiveness: Demonstrate overall safety and effectiveness for its intended use.	"Based upon the analysis of the Intended Use, Technological Characteristics, and the results of the Bench Testing performed on the device, we have determined that the Cuattro UnoMD is safe and effective, and substantially equivalent to the Predicate Device."
Compatibility with Cleared Digital Image Capture Devices: The software must function correctly with cleared digital image capture devices.	"Testing was performed utilizing the cleared digital image capture device, Samsung LTX240 (K090742)."
No Mammography or Fluoroscopy Applications: The device is not intended for these specific applications.	"The product is not intended for mammography or fluoroscopy applications." (Stated in Intended Use)

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

The document explicitly states that "Bench testing has been performed on the device following Cuattro's design control processes, as well as the applicable FDA guidance documents, in particular the guidance on Content of Premarket Submissions for Software Contained in Medical Devices."

Sample Size: The document does not specify a quantitative sample size for a "test set" in the context of clinical images or patient data. The evaluation was non-clinical performance data and bench testing.
Data Provenance: Not applicable in the context of a clinical test set. The evaluation focuses on the software's functional characteristics and compliance with standards, not on an analysis of clinical image data from a specific origin.

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

Not applicable. This was a 510(k) submission based on non-clinical performance data and bench testing, not a clinical study involving expert interpretation of images or establishment of ground truth for a diagnostic task.

4. Adjudication method for the test set

Not applicable, as there was no test set of clinical images requiring adjudication by experts.

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 MRMC comparative effectiveness study was performed or mentioned in the provided text. The submission focuses on the software's functionality and its equivalence to a predicate device, not on its impact on human reader performance. This device is a PACS system component; it's not described as an AI-powered diagnostic aid meant to directly improve human reader accuracy.

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

This point is somewhat addressed. The device is a "software application capable of acquiring x-ray images from commonly commercialized digital flat panels" and "processes and then presents" images. It's an image acquisition and archiving system, not an "algorithm" in the sense of a standalone diagnostic or analytical tool. Its performance is standalone in its core function (acquiring, processing, and presenting images) without human intervention in the image processing itself, but it still requires a human for interpretation. The bench testing performed would evaluate this standalone functionality.

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

Not applicable in the conventional sense. The "ground truth" for this type of submission (focusing on substantial equivalence for an image acquisition/management system) would be:

Compliance with DICOM 3.0 standards.
Successful acquisition and display of images.
Processing time within specifications (e.g., 12 seconds).
Correct interfacing with cleared digital image capture devices.
Adherence to software design control processes.

These are verifiable through technical specifications, testing protocols, and direct observation, rather than clinical ground truth like pathology.

8. The sample size for the training set

Not applicable. The Cuattro UnoMD is a software system for image acquisition and management, not an AI/ML diagnostic algorithm that requires a training set of images.

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

Not applicable, as there is no training set mentioned for this type of device.

Summary

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K093480

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T

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MAR - 5 2010

5 510(k) Summary

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510(k) summary

October 25, 2009

510(k) Owner

Cuattro, LLC 2946 Court Street Pekin, IL 61554 Phone: 309-349-8901 309-349-8902 Facsimile:

510(k) Submitter

Mark Skeels Cuattro, LLC 40 Bram Bay Road Hopatcong, NJ 07843 Phone: 973-294-4363 973-770-8486 Facsimile:

Device Trade Name: Cuattro UnoMD System, Image Processing, Radiological Common Name: Classification Name: Picture archiving and communications system (21 CFR 892.2050, Product Code LLZ)

Substantial equivalence is claimed to the following Legally Marketed Device:

Manufacturer:	Del Medical Imaging
Device:	DEL-IMS
510(k) number:	K063188

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Device Description

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Intended Use

Technological Characteristics

The technological characteristics are the same as the legally marketed predicate device, in that they provide a network connection via DICOM protocol to various devices from a radiographic system that utilizes a digital image capture device. The Cuattro UnoMD device is a software solution intended for use with already cleared digital image capture devices. The Cuattro UnoMD, as the predicate device, utilize software on a workstation computer with Ethernet capability, and provide DICOM 3.0 compliant connectivity.

Determination of Substantial Equivalence

The determination of substantial equivalence is based upon non-clinical performance data. Bench testing has been performed on the device following Cuattro's design control processes, as well as the applicable FDA guidance documents, in particular the guidance on Content of Premarket Submissions for Software Contained in Medical Devices. The results of this bench testing have demonstrated that the device is substantially equivalent to the referenced predicate device. Note: Testing was performed utilizing the cleared digital image capture device, Samsung LTX240 (K090742).

Conclusion

Based upon the analysis of the Intended Use, Technological Characteristics, and the results of the Bench Testing performed on the device, we have determined that the

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Cuattro UnoMD is safe and effective, and substantially equivalent to the Predicate Device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

MAR - 5 2010

Cuattro LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology services LLC 1394 25" Street NW BUFFALO MN 55313

Re: K093480 Trade/Device Name: Cuattro UnoMD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 8, 2010 Received: February 16, 2010

Dear Mr. Job:

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, Jrug, 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, isting 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 24, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA roay publish finther 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 af 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

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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,

Donald J. Trump

Donald J. St.Pierre Acting 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 Statement ব

Indications for Use

510(k) Number (if known):

Device Name: Cuattro UnoMD

Indications for Use:

The Cuattro UnoMD, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations.

The device is intended to be available for retrofit on existing or planned x-ray . machines with a cleared digital image capture device.

The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.

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 Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093480

Page _ of __

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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).