The AeroDR Stitching System is used with Konica Minolta AeroDR SYSTEM which is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. This device is used for examinations of long areas of anatomy such as the leg and spine. This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Device Description

The AeroDR Stitching System is used with 510(k) cleared Konica Minolta AeroDR SYSTEM (K102349) which is indicated for use in generating radiographic images of human anatomy. The AeroDR Stitching System is an accessory of stationary X-ray system which extends the capability of the AeroDR SYSTEM to allow the capture of long length images with an image area up to 1196mm x 349mm. It consists of AeroDR Stitching Unit, AeroDR Stitching X-ray Auto Barrier Unit and Power Supply Unit. The AeroDR Detecter (K102349) loaded in the AeroDR Stitching Unit takes up to 3 images and transfer them to the Console CS-7 (K102349). Combining the transferred images in the CS-7 enables diagnosis of long images.

AI/ML Overview

The provided 510(k) summary for the Konica Minolta AeroDR Stitching System (K120752) focuses primarily on substantial equivalence to a predicate device and adherence to general safety and EMC standards. It does not contain detailed performance study data, acceptance criteria, or ground truth establishment relevant to the device's image stitching capability.

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document unfortunately does not explicitly state specific acceptance criteria in a quantitative or qualitative manner for the imaging performance of the stitching system, nor does it report detailed device performance metrics against such criteria.

The "Performance-Testing" section states generically that: "Performance testing was conducted to verify the design output met the design input requirements and to validate AeroDR Stitching SYSTEM conformed to the defined user needs and intended uses upon the quality of the device software. Through validation results of sample images and non-clinical testing under simulated use conditions, safe, effectiveness and performances are confirmed the achievement of predefined acceptance criteria..."

However, these predefined acceptance criteria and the corresponding performance results are not detailed in the summary. The focus is on demonstrating substantial equivalence to a predicate device and compliance with safety and EMC standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size of "sample images" used for performance testing (if any were used beyond engineering testing). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical image data used in testing. The phrase "validation results of sample images and non-clinical testing under simulated use conditions" suggests that testing might have involved a limited set of images, possibly generated internally, rather than a broad clinical dataset.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The 510(k) summary does not provide any information regarding the use of experts to establish ground truth for a test set. This type of detail would typically be found in a clinical performance study report, which is not included here.

4. Adjudication Method for the Test Set

Since no information is provided about expert review or a "test set" in the context of clinical evaluation, there is no mention of an adjudication method (e.g., 2+1, 3+1, none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The focus of the submission is on demonstrating substantial equivalence to a predicate device through technological characteristics and safety standards, not on comparative clinical performance with human readers. Therefore, no effect size of human readers improving with AI vs. without AI assistance is mentioned.

6. Standalone (Algorithm Only) Performance Study

While the device's stitching capability is an algorithm, the document does not present a standalone performance study in terms of specific metrics like stitching accuracy, artifact detection, or image quality assessments related only to the algorithm's output. The "Performance-Testing" section vaguely refers to "validation results of sample images and non-clinical testing under simulated use conditions" to confirm "safe, effectiveness and performances," but concrete results of the stitching algorithm's standalone performance are absent.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for any performance evaluation. Given the nature of a stitching system for long-length imaging, ground truth might ideally involve physical measurements on phantoms, or expert assessment of stitching lines and image continuity. However, this information is not provided.

8. Sample Size for the Training Set

The document does not provide any information about a training set size. As a 510(k) for a relatively early-stage digital radiography accessory (2012), and based on the summary, it's possible the device relied more on rule-based or deterministic algorithms for stitching rather than extensive machine learning requiring a large training set. Even if machine learning was used, the details are not presented.

9. How the Ground Truth for the Training Set Was Established

Since no information is provided about a training set, the document also does not explain how ground truth for a training set was established.

Summary of Missing Information:

The provided 510(k) summary is typical for a device primarily seeking substantial equivalence based on technological similarity and compliance with recognized standards. It lacks the detailed performance study information, including acceptance criteria, sample sizes, expert involvement, and ground truth methodologies, that would be expected for a more in-depth clinical performance evaluation or an AI-intensive device requiring specific validation of its intelligent features. The "Performance-Testing" section is very general and does not disclose the specific data or methods used to "confirm the achievement of predefined acceptance criteria."

Summary

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K120752

510(k) Summary

as required by 807.92

JUN - 8 2012

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 Regulations 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

1. Date of Submission
  March 9, 2012
1. Device Trade Name AeroDR Stitching System
1. Classification, Product Code Class II, 21CFR892.1680, 90 KPR

6. Predicate Device

REGIUS MODEL 170. 510(k) number K051998

7. Indications for Use

8. Device Description

The AeroDR Stitching System is used with 510(k) cleared Konica Minolta AeroDR SYSTEM (K102349) which is indicated for use in generating radiographic images of human anatomy.

The AeroDR Stitching System is an accessory of stationary X-ray system which

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extends the capability of the AeroDR SYSTEM to allow the capture of long length images with an image area up to 1196mm x 349mm. It consists of AeroDR Stitching Unit, AeroDR Stitching X-ray Auto Barrier Unit and Power Supply Unit.

The AeroDR Detecter (K102349) loaded in the AeroDR Stitching Unit takes up to 3 images and transfer them to the Console CS-7 (K102349). Combining the transferred images in the CS-7 enables diagnosis of long images.

9. Risk Analysis (Summary of Design Control Activities)

The Risk Analysis for the AeroDR Stitching System was conducted on the basis of ISO14971, "Medical devices - Application of risk management to medical devices". As a result of risk control measures, the risk associated with all of the identified hazards was reduced to an acceptable level or ALARP (as low as reasonably practicable).

10. Compliance of Recognized Consensus Standard

In terms of Indications for use of this AeroDR Stitching System, it has been tested and · shown to meet the requirements of IEC 60601-1 and IEC 60601-1-2 as follows. Safety standard: IEC60601-1 Ed.2 (1988) + A1 (1991)+A2(1995) Electromagnetic Compatibility: IEC60601-1-2 Ed.3(2007)

11. Substantial Equivalence to Predicate Device

The predicate device is our REGIUS MODEL 170, 510(k) number K051998. Both AeroDR Stitching System and the predicate are used for examinations of long areas of anatomy such as the leg and spine.

Comparison of the principal characteristics of these devices, please refer to the Substantial Equivalence Comparison Table as follows.

		Medical Device Applied for Clearar
Applicant, etc.	Company : KonicaMinoIta Medical	Company: KonicaMinoIta Medical &Graphic.
	&Graphic, Inc.	Inc.
	Product Name : REGIUS MODEL 170	Product Name: AeroDR Stitching System
	CR cassette:RC-110T/RC-110R
	K Number : K051198
Configuration	The REGIUS MODEL 170 is an X-ray	The AeroDR Stitching System is used with
	image reader which uses a stimulable	510(k) cleared Konica Minolta AeroDR
	phosphor plate (Plate) as X-ray detector	SYSTEM (K102349).
	installed in a separate cassette.	The AeroDR Stitching System extends the
	The REGIUS MODEL 170 consists ofREGIUS MODEL 170 image reader and CRCassette / Plate.It reads the image recorded on the Plateand transfers the image data to anexternally connected device such asConsole CS3000 (K051523).Using the CR cassette with multiple (three)stimulable phosphor plates aligned alongthe long side, latent images are produced,and the visual image is generated byscanning with a separate reader device.Combining the transferred images in theCS3000 enables diagnosis of long images.	capability of the AeroDR SYSTEM to allowthe capture of long length images.AeroDR Stitching System consists ofAeroDR Stitching Unit, AeroDR StitchingX-ray Auto Barrier Unit and Power SupplyUnit.The AeroDR Detecter (K102349) loaded inthe AeroDR Stitching Unit takes up to threeimages and transfers them to the ConsoleCS-7 (K102349). Combining the transferredimages in the CS-7 enables diagnosis of longimages.
Principle ofOperation	Using the CR cassette with multiplestimulable phosphor plates aligned alongthe long side, position the cassette at theback of the patient and make a single X-rayexposure over the necessary area. Reloadthe exposed image into the other cassettes,and feed these cassettes into the readerdevice in order so that the image isindependently scanned and multipleimages are stitched and displayed on theconsole by the image processing.	Position the AeroDR Stitching unit at the backof the patient. The AeroDR Stitching Systemproduces long length images of subjects bymoving a 14 x 17 inch AeroDR Detector upand down inside the AeroDR Stitching Unitand takes up to 3 images. Transfer thesemultiple images to the Console CS-7(K102349) and stitch multiple images byimage processing on the console.
Specifications	REGIUS MODEL 170CR cassette:RC-110T1) Vertical Exposure range14×42inch (14×14×3plates)11×24inch (11×12×2plates)10×36inch (10×12×3plates)14×51inch (14×17×3plates)2) Sampling Pitch : 87.5/175μm3)Operation EnvironmentTemperature : 15~~30 CHumidity : 30~~80%RH	AeroDR Detector (K102349) : 14×17inchFPDPixel Size: 175μAeroDR Stitching System (Device)1) Vertical Exposure rangeSID=2.4m : Max. 50"(3shoots)SID=2.0m : Max. 41"(2shoots)SID=1.5m : Max. 31"(2shoots)Width 14inch only2)Operation EnvironmentTemperature : 15~~30 CHumidity : 30~~80%RH
Indications forUse	The Direct Digitizer, REGIUS MODEL 170is an X-ray image reader which uses astimulable phosphor plate (Plate) as X-raydetector installed in a separate cassette. It	The AeroDR Stitching System is used withKonica Minolta AeroDR SYSTEM which isindicated for use in generating radiographicimages of human anatomy. It is intended to
reads the image recorded on the Plate andtransfers the image data to an externallyconnected device such as a host computer,an order input device, an image displaydevice, a printer, an image data filingdevice, and other image reproductiondevices.REGIUS MODEL 170 is used to obtainimage data of long areas of anatomy suchas the whole spine or the whole lower leg.REGIUS MODEL 170 is also used to obtainimage data to verify the position for aradiotherapy location.It is designed intended to use in a clinic, aradiology department in a hospital and inother medical facilities. It is not intended foruse with digital mammography system.	replace radiographic film/screen systems ingeneral-purpose diagnostic procedures.This device is used for examinations of longareas of anatomy such as the leg and spine.This device is not indicated for use inmammography, fluoroscopy, tomographyand angiography applications.

AeroDR Stitching System Substantial Equivalence Comparison Table

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12. Performance-Testing

Performance testing was conducted to verify the design output met the design input requirements and to validate AeroDR Stitching SYSTEM conformed to the defined user needs and intended uses upon the quality of the device software. Through validation results of sample images and non-clinical testing under simulated use conditions, safe, effectiveness and performances are confirmed the achievement of predefined acceptance criteria, as well as substantially equivalence to the predicate device, besides product safety and electromagnetic compatibility.

13. Conclusion

Comprehensively, we judged that the AeroDR Stitching System has the same technological characteristics as the predicate devices. This 510(k) has demonstrated substantial equivalence as the predicate devices.

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Image /page/4/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

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

Konica Minolta Medical & Graphic, Inc. % Mr. Russel Munves Official Correspondent Storch, Amini & Munves, P.C. 140 East 45th Street, 25th Floor Two Grand General Tower NEW YORK NY 10017

Re: K120752

Trade/Device Name: AeroDR Stitching System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II . Product Code: KPR Dated: May 22, 2012 Received: May 23, 2012

JUN - 8 2012

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.

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

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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 nredicate 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,

Janine M. Morris

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

510(k) Number (if known)

: KI20752

Device Name

AeroDR Stitching System

Indications for Use:

Prescription Use_ × (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)

Arshad D'Silva

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

510(k) K120752

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.