The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with AeroDR SYSTEM. This device 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 not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Device Description

The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with our AeroDR SYSTEM, K102349. It adds minor change for our cleared AeroDR SYSTEM. It eliminates the need for an electrical connection between the AeroDR SYSTEM and X-ray generator. It can be detected X-ray irradiation without cables connected to X-ray generator.

AI/ML Overview

The provided text describes the Konica Minolta AeroSync for AeroDR SYSTEM, a software device intended to eliminate the need for an electrical connection between the AeroDR SYSTEM and X-ray generator, thereby detecting X-ray irradiation without cables.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing substantial equivalence to a predicate device (AeroDR SYSTEM, K102349) rather than defining specific new acceptance criteria in terms of numeric thresholds for performance metrics. The core "acceptance criteria" here appear to be demonstrating equivalence to the predicate in key areas.

Acceptance Criterion (Implicit / Stated Goal)	Reported Device Performance
Safety	Complies with IEC 60601-1 Ed.2 (1988) + A1 (1991)+A2(1995) and IEC 60601-1-2 Ed.3 (2007). Risk analysis (ISO14971) shows all identified hazards reduced to acceptable levels (ALARP). Meets FCC Part15 Subpart C, E for RF wireless technologies.
Electromagnetic Compatibility	Complies with IEC 60601-1-2 Ed.3 (2007). Meets FCC Part15 Subpart C, E for RF wireless technologies.
Image Quality (Equivalence to Predicate)	"The results of performance testing shows that the image quality of proposed device is equivalent to the predicate device." (No specific metrics or quantitative comparisons are provided in this summary).
Substantial Equivalence to Predicate Device	Demonstrated through comparison of Indications for Use, Configuration, Specifications, Principals of Operation, Risk Analysis, Compliance to Standards, and performance testing. "Comprehensively, we conclude that the AeroSync for AeroDR System has the same technological characteristics as the predicate device."

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

The provided summary does not specify the sample size used for performance testing (e.g., number of images, patient cases). It also does not mention the data provenance (country of origin, retrospective/prospective).

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

The document does not provide information on experts used to establish ground truth or their qualifications. Given the focus on "image quality equivalence," it is possible that image quality assessments were performed by qualified personnel, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention an MRMC comparative effectiveness study or any effect size for human reader improvement with/without AI assistance. This is a software device facilitating X-ray detection, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes "performance testing" leading to the conclusion that "the image quality of proposed device is equivalent to the predicate device." This suggests standalone testing of the system's ability to produce images. However, no specific details of this testing (e.g., what was measured, how it was performed) are provided in this summary. The device's primary function is X-ray detection and image generation, not an interpretation independent of a human.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

The document does not specify the type of ground truth used for performance testing. Given the context, ground truth for image quality equivalence would likely involve a comparison against images produced by the predicate device under controlled conditions, possibly evaluated by imaging experts.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This device is described as a "software device" for X-ray detection and image generation, not a machine learning or AI algorithm that typically requires a training set in the conventional sense for feature learning or classification. It adds a "minor change" to an existing system, suggesting an engineering modification rather than a complex algorithm requiring extensive algorithmic training data.

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

Since no training set is mentioned in the context of machine learning, there is no information on how its ground truth was established.

Summary

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510(k) Summary

APR - 9 2012

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

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

3. Date of Submission

February 10, 2012

4. Device Trade Name

AeroSync for AeroDR SYSTEM

5. Common Name

Digital Radiography

6. Classification, Product Code

Class II, 90MQB and 90LLZ

7. Predicate Device

AeroDR SYSTEM, 510(k) number K102349

8. Indications for Use

This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

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9. Device Description

10. Risk Analysis

The Risk Analysis for the AeroSync for AeroDR System (X-ray perception software) 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).

Please refer to Section 13, Appendix-G

11. Compliance of Recognized Consensus Standard

In terms of Indications for use of this AeroSync for AeroDR SYSTEM, it has been tested and shown to meet the requirements of IEC 60601-1 and IEC 60601-1-2 as follows. Please refer to the Section 7, STANDARD DATA REPORTS FOR 510(k)s.

Safety standard: IEC60601-1 Ed.2 (1988) + A1 (1991)+A2(1995)

Electromagnetic Compatibility: IEC60601-1-2 Ed.3 (2007)

Besides, AeroSync for AeroDR SYSTEM includes RF wireless technologies (which customer can select), so that to ensure safety of device in case of wireless use, it also has been tested and shown to meet the requirements of FCC part15 Subpart C,E.

12. Substantial Equivalence to Predicate Device

The predicate devices of AeroSync for AeroDR SYSTEM is our AeroDR SYSTEM, K102349.

The proposed device is a minor changed system of our cleared AeroDR SYSTEM. It eliminates the need for an electrical connection between the AeroDR SYSTEM and X-ray generator.

A comparison of the Indications for Use, Configuration, Specifications and Principals of operation by this proposed device and the predicate device has shown in Section 9, Substantial Equivalence Comparison Table.

The result of the Section 9, above mentioned the Risk Analysis and the

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Compliance of Recognized Consensus Standard showed that there is no new safety and efficacy issue of the proposed device. Also, the results of performance testing shows that the image quality of proposed device is equivalent to the predicate device. Please refer to the section 14 and 15 Performance Testing.

The AeroSync for AeroDR SYSTEM is substantially equivalent to AeroDR SYSTEM, 510(k) Number, K102349.

9. Conclusion

Comprehensively, we conclude that the AeroSync for AeroDR System has the same technological characteristics as the predicate device. This 510(k) has demonstrated substantial equivalence as the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is black.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

APR - 9 2012

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

Konica Minolta Medical & Graphics, Inc. % Mr. Ressell Munves Consultant Storch, Amini & Munves, P.C. 140 East 45th Street, 25th Floor Tow Grand Tower NEW YORK NY 10017

Re: K120477

Trade/Device Name: AeroSync for AeroDR SYSTEM Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: February 14, 2012

Received: February 16, 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 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,

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)

AeroSync for AeroDR SYSTEM Device Name

Indications for Use:

This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

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

Rummellious

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

510(k) K.120477

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.