The CO pilot is intended for installation on an off-the-shelf PC (REGIUS Unitea / 510(K) number: K071436) meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The CO pilot must not be used for primary image diagnosis in mammography.

Device Description

The "CO Pilot Software" is intended for installation on REGIUS Unitea (510(K) number: K071436), and provides unit for creating display-use annotation such as line, curve, and character information, unit for measuring the distance between 2 points and angle formed between 3 points and Transfer GUI data to the GUI control module to REGIUS Unitea System Control Program

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "CO Pilot" and the associated FDA clearance letter. It states that the CO Pilot is a software intended for installation on REGIUS Unitea (a Picture Archiving Communications System) and provides functions for creating annotations (line, curve, character information), measuring distances and angles, and transferring GUI data. It can process and display images from various modalities but "must not be used for primary image diagnosis in mammography."

The summary explicitly states: "Verification and Validation showed equivalent evaluation outcome with the predicate devices, which has supported a fact that no impacts in technological characteristics such as design, material chemical composition energy sauce and other factors of the proposed device were recognized. The all evaluation results can assure that there is no safety, effectiveness and performance issue or no differences were found in further than the predicate devices have which has been regally marketed the United States. Therefore, we confirmed that the function quality of proposed device has the substantial equivalency with orthopedic or chiropractic supporting functions quality that predicate devices have."

This indicates that Konica Minolta relied on demonstrating substantial equivalence to predicate devices rather than conducting a separate study with specific acceptance criteria and performance metrics for the CO Pilot itself. The summary does not include a detailed study that defines specific acceptance criteria, test sets, ground truth establishment, or multi-reader studies for the CO Pilot's performance. Instead, it argues that its performance is equivalent to already cleared devices through verification and validation activities.

Therefore, many of the requested details cannot be extracted directly from the provided text because these types of studies were not presented in this 510(k) summary as a means to prove the device meets acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not provide a table of acceptance criteria for the CO Pilot's performance beyond stating that its "function quality" is substantially equivalent to predicate devices. It doesn't report specific performance metrics like sensitivity, specificity, accuracy, or measurement precision for the CO Pilot itself.

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

This information is not provided in the 510(k) summary. The summary refers to "Verification and Validation" but does not detail the datasets or studies used for these activities.

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)

This information is not provided.

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

This information is not provided.

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

A MRMC comparative effectiveness study is not mentioned. The device's primary function is annotation and measurement, not necessarily to assist human readers in diagnosis in a way that would typically be evaluated by an MRMC study demonstrating improved diagnostic accuracy.

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

The document does not describe a standalone performance study in the traditional sense for diagnostic accuracy. The device "primarily facilitates processing and presentation of medical images on display monitors" and provides "display-use annotation" and "measuring" functions. Its performance would likely be assessed on the accuracy of these functions rather than diagnostic output.

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

This information is not provided. Given the device's functions (annotation, measurement), ground truth would likely refer to the accuracy of these measurements relative to a known standard or expert measurement, but the details are not here.

8. The sample size for the training set

This information is not provided. Given the device's functions as annotation and measurement tools, it's less likely to involve a "training set" in the context of machine learning, unless specific automation features exist that weren't elaborated.

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

This information is not provided.

Summary of available information regarding acceptance criteria and study:

The 510(k) summary for CO Pilot (K133730) does not present specific acceptance criteria in a quantitative manner or a detailed study with performance metrics for the device itself. Instead, it relies on demonstrating substantial equivalence to its predicate devices (REGIUS Unitea K071436, Acies K101842, Opal-RAD TM K063337) through "Verification and Validation."

The core argument is:

Acceptance Criteria (Implicit): The CO Pilot's "function quality," safety, effectiveness, and performance should be equivalent to or not inferior to the legally marketed predicate devices.
Study Proving Acceptance (Method): "Verification and Validation" activities were conducted. These activities "showed equivalent evaluation outcome with the predicate devices" and confirmed "no impacts in technological characteristics" and "no differences were found" in comparison to the predicates.

No specific data related to test sets, ground truth, expert involvement, or quantitative performance metrics for the CO Pilot itself are provided in this summary.

Summary

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K133730

510(k) Summary

as required by 807.92

1. Company Identification

Konica Minolta Medical & Graphic, Inc. No.1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Establishment Registration Number: 3004485675

2. Submitter's Name and Address

Shigeyuki Kojima Manager Requlations and Standards Section, Quality Assurance Center No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Telephone: 81-42-589-8429 Fax: 81-42-589-8053

3. Date of Submission November 29, 2013

November 29, 2013

1. Device Trade Name CO Pilot

5. Common Name

Picture Archiving Communications System

6. Classification, Product Code Class II , 90LLZ

7. Predicate Device

REGIUS Unitea, 510(k) number K071436 Acies, 510(k) number K101842 Opal-RAD TM, 510(k) number K063337

8. Device Description

9. Indications for Use

The CO pilot is intended for installation on an off-the-shelf PC (console of REGIUS Unitea / 510(K) number: K071436) for meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and

JAN 3 1 2014

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other DICOM compliant modalities. The CO pilot must not be used for primary image diagnosis in mammography.

10. Substantial Equivalence to Predicate Device

The predicate devices of CO Pilot are Picture Archiving Communications System (K071436, K101842, and K063337).

A comparison of the Indications for Use. Configuration. Specifications, and Principal of Operation of this proposed device and the predicate devices are almost identical or within a scope of substantial equivalent, the materials, the electrical safety (JEC 60601-1) and the electromagnetic compatibility testing (IEC 60601-1-2) won't be issue for this proposed device.

In technological characteristics, Verification and Validation, Risk management based on ISO14971 had been completed without problem. Verification and Validation showed equivalent evaluation outcome with the predicate devices, which has supported a fact that no impacts in technological characteristics such as design, material chemical composition energy sauce and other factors of the proposed device were recognized

The all evaluation results can assure that there is no safety, effectiveness and performance issue or no differences were found in further than the predicate devices have which has been regally marketed the United States. Therefore, we confirmed that the function quality of proposed device has the substantial equivalency with orthopedic or chiropractic supporting functions quality that predicate devices have. .

11. Conclusion

Comprehensively, we conclude that the CO Pilot has the same technological characteristics as the predicate devices. This 510(k) has demonstrated substantial equivalence as the predicate devices.

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Page 3—Mr. Munves

-------------REMOVE THIS PAGE WHEN PRINTING OR EMAILING TO SPONSOR---------510(k) Number: K133730 - Konica Minolta, Inc.

Digital Signature Concurrence Table
Reviewer Sign-Off	Yanna KangJanuary 29, 2014
Branch Chief Sign-Off	Robert OchsJanuary 29, 2014
Division Sign-Off	Sean M. Boyd -S2014.01.3115:34:53 -05'00'

QC: FMEba:fme:1729/2014

Template Name: OIR Letter Generator v1.10 - Letter type: SE

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms, representing care and protection.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60S Silver Spring, MD 20993-0002

January 31, 2014

Konica Minolta Inc. % Mr. Russell Munves STORCH, AMINI & MUNVES, P.C. 140 East 45th Street, 25th Floor Two Grand Central Tower NEW YORK NY 10017

Re: K133730

Trade/Device Name: Co Pilot/REGIUS Unitea Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 2, 2013 Received: December 6, 2013

Dear Mr. Munves:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Munves

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/Safets/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

ரொ

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) : K133730

Device Name

CO Pilot

Indications for Use:

Prescription Use_ x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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)

Division Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(k)_K133730

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).