The AeroDR SYSTEM with P-31 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. The AeroDR SYSTEM with P-31 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Device Description

The AeroDR SYSTEM with P31(K130936) is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Detector, Console CS-7 (operator console). Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice.

The following modifications were added to the AeroDR SYSTEM (K102349/ the predicate device) for the AeroDR SYSTEM with P-31(K130936/ the proposed device). The panel size of 10 x 12 inches (P-31) is added to 14 x 17 inches. The materials of the proposed panel also had been evaluated with the latest ISO 10993-1, and had been assured the safety as same as the predicate device. Two accessories were added: one is AeroDR Interface Unit2 designed to be able to replacement and function of both AeroDR Interface Unit and AeroDR Generator Interface Unit. The other is AeroDR Battery Charger2 designed for the 10X12 inches proposed panel (P-31) which can function as same as the AeroDR Battery Charger of predicate device. Irrespective of those minor modifications, the AeroDR SYSTEM (102349) and AeroDR SYSTEM with P-31(K130936) perform same, and also device design, material used and physical properties of both devices are substantially equivalent.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AeroDR SYSTEM with P-31 (K130936).

Crucially, the provided document does not contain detailed acceptance criteria or the specifics of a comprehensive study proving the device meets said criteria in the way typically expected for an AI/ML medical device submission. This document is a 510(k) summary for a digital radiography system, likely focusing on demonstrating substantial equivalence to a predicate device rather than a de novo submission with extensive performance studies.

The document primarily focuses on demonstrating that the new model (AeroDR SYSTEM with P-31) is substantially equivalent to a previously cleared device (AeroDR SYSTEM, K102349) despite minor modifications (panel size, specific accessories).

Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, AI performance metrics) are not present in this type of submission. The "study" here is primarily a comparison to the predicate device and testing to ensure basic functionality and safety.

I will populate the table and answer the questions based on the information available and explicitly state when information is not provided.

Acceptance Criteria and Device Performance Study (K130936)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Performs the same as the predicate device (AeroDR SYSTEM, K102349) in generating radiographic images.	"perform same" as the predicate device.
Safety: Meets relevant safety standards and is as safe as the predicate device.	Materials of the proposed panel evaluated with ISO 10993-1, assured safety as same as predicate device. Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) assured as the predicate device safety.
Effectiveness: No issues or differences in effectiveness compared to the predicate device.	Performance testing (Bench testing), including Non clinical and clinical testing referring to the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Device, conducted and showed equivalent evaluation outcome. "no impacts in technological characteristics such as design, material chemical composition energy source and other factors of the proposed device were recognized." "no safety and effectiveness and performance issue or no differences were found in further than the predicate device has." "no safety and effectiveness and performance issue or difference as the predicate devices has."
Material Compatibility: New panel materials are safe.	Materials of the proposed panel evaluated with ISO 10993-1, assured safety.
Software/Hardware V&V: Completed without problems.	Software and Hardware verification and validation completed without problem.
Risk Management: ISO 14971 based risk management completed.	Risk management based on ISO14971 completed without problem.

Interpretation: The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate device. The primary "performance" reported is that the new device performs "the same" and has "no differences" in safety, effectiveness, or technological characteristics compared to the predicate.

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

Not provided. The document refers to "Non clinical and clinical testing" but does not specify sample sizes for any test set or data provenance. This 510(k) summary focuses on equivalence, not a detailed performance study with specific test populations.

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)

Not provided. Given that this is a digital radiography system aiming for equivalence and not an AI/CAD/image analysis device, the concept of "ground truth" and expert adjudication in this context is likely different or not explicitly detailed in this summary. The "clinical testing" mentioned likely refers to ensuring image quality is comparable, rather than disease detection/diagnosis.

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

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

No. This is not an AI/CAD device. The AeroDR SYSTEM with P-31 is a digital X-ray imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

No. This is not an AI/CAD device. Standalone algorithm performance is not relevant for a digital X-ray capture system itself.

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

Not explicitly stated in terms of diagnostic ground truth. For a digital radiography system, "ground truth" regarding image quality might be based on established phantom testing, expert visual assessment of image fidelity, and comparison against images from the predicate device. Actual disease-specific ground truth (like pathology or outcomes) is not mentioned as this device is a general imaging system, not a diagnostic aid for specific conditions.

8. The sample size for the training set

Not applicable/Not provided. This device is a hardware imaging system, not a machine learning algorithm that requires a "training set" in the typical sense.

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

Not applicable/Not provided. As above, no training set for an AI/ML algorithm is mentioned or relevant to this device type.

Summary of what the document does communicate about the "study":

The "study" or evaluation of the AeroDR SYSTEM with P-31 was primarily focused on demonstrating substantial equivalence to its predicate device (AeroDR SYSTEM, K102349). This involved:

Engineering and Performance Testing: "Bench testing" and "Non clinical and clinical testing" were performed. These likely involved technical measurements of image quality, dose efficiency, and physical properties, as well as comparison of images to those produced by the predicate device.
Safety Testing: Evaluation of new materials (ISO 10993-1), electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2).
Verification and Validation: For software and hardware.
Risk Management: Based on ISO 14971.

The conclusion is that, despite minor modifications (a new panel size and updated accessories), the proposed device performs the same as the predicate and has no new safety or effectiveness issues.

Summary

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K130936
Page 1 of 3

510(k) Summary

as required by 807.92

1. Company Identification

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

AUG 2 2 2013

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 25, 2013
1. Device Trade Name AeroDR SYSTEM with P-31
1. Common Name

Digital Radiography

6. Classification regulation

21 CFR 892.1680 (Solid State X-ray Imaging System with MQB)

7. Classification, Product Code

Class II , 90MQB and 90LLZ

8. Predicate Device

AeroDR SYSTEM, 510(k) number K102349 /Class II , 90MQB and 90LLZ

9. Indications for Use

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P-31 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

10. Device Description

10. Substantial Equivalence to Predicate Device

Although the AeroDR SYSTEM with P-31 has minor differences from AeroDR SYSTEM as described in 9.Device Description, Indications for Use of proposed device and predicate devices are identical, the materials of the proposed panel had been evaluated with the latest ISO 10993-1, and had been assured the safety as same as the predicate device. The electrical safety (IEC 60601-1) and the electromagnetic compatibility testing (IEC 60601-1-2) had been assured as the predicate device safety as well.

In technological characteristics, Software and Hardware verification and validation, Risk management based on ISO14971 had been completed without problem, performance testing (Bench testing) including Non clinical and clinical testing referring to the FDA Guidance for the Submission of510 (k)'s for Solid State X-ray Imaging Device had been conducted and showed equivalent evaluation outcome, which has supported a fact that no impacts in technological

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K130936
Page 3 of 3

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 are no safety and effectiveness and performance issue or no differences were found in further than the predicate device has which has been regally marketed the United States.

Therefore, we confirmed that. AeroDR SYSTEM with P-31 has the same substantial equivalency to the predicate device, AeroDR SYSTEM has.

11. Conclusion

Comprehensively, we concluded that the AeroDR SYSTEM with P-31 has no safety and effectiveness and performance issue or difference as the predicate devices has. This 510(k) is substantial equivalence as the predicate device.

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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 and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

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

August 22, 2013

Konica Minolta, Inc. % Mr. Russel Munves STORCH AMINI & MUNVES. P.C. 2 Grand Central Tower 140 East 45th Street., 25th Floor NEW YORK NY 10017

Rc: K130936

Trade/Device Name: AcroDR SYSTEM with P-31 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB, LLZ Dated: July 11, 2013 Received: July 18, 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 10 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. Ilisting 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/ResourcesforYou/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/MedicalDevices/Safety/ReportalProblem/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.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara fo

for

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): K130936

AeroDR SYSTEM with P-31 Device Name:

Indications for Use:

The AeroDR SYSTEM with P-31 is not indicated for use in mammography, fluoroscopy, tomography and angiography 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 In Vitro Diagnostics and Radiological Health (OIR)

Michail D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130936 510(k)

Page 1 of

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.