The AS-10 / CXDI-401RF is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

Device Description

The AS-10 / CXDI-401RF is a solid state x-ray imager. It intercepts x-ray photons and the scintillator of the AS-10 / CXDI-401RF emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the AS-10 / CXDI-401RF, an x-ray imager. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a detailed clinical study with acceptance metrics for a diagnostic device.

Therefore, the requested information cannot be fully extracted as it pertains to a diagnostic AI/CADe device, which this submission does not explicitly detail. This submission focuses on the safety and effectiveness of new imaging hardware (a flat panel detector) and its comparability to existing technology.

However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its equivalence.

Here's an attempt to answer based on the provided text, recognizing the limitations of the document's content for your specific questions:

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

The document does not explicitly state "acceptance criteria" in the context of a diagnostic performance study with specific metrics (like sensitivity, specificity, or AUC) as one might find for an AI/CADe device. Instead, it compares the technical specifications and non-clinical performance of the AS-10 / CXDI-401RF to its predicate devices. The "performance" is implicitly demonstrated by showing that the new device's technical parameters are comparable to or improved upon the predicates and that it is safe and effective.

Characteristic	Predicate Devices (CXDI-50RF K092439 & CSX-30 K162909) (Implicit "Acceptance Criteria" for Equivalence)	AS-10 / CXDI-401RF (Reported Device Performance)	Comparison to Predicates
Application	Fluoroscopy and Spot Radiology	Fluoroscopy and Spot Radiology	Identical
Technology	Flat panel detector: Scintillator and a-Si	Flat panel detector: Scintillator and a-Si	Identical
Scintillator	CsI(TI)	CsI(TI)	Identical
Pixel Pitch	160 x 160 µm	160 x 160 µm	Identical
Pixels	a) 2,208 x 2,688 (≈ 5.9 million)b) 2,496 x 1,856 (≈ 4.6 million)	2,688 x 2,688 (≈ 7.2 million)	Modified (Increased)
Image Size	a) 350 x 430 mmb) 399 x 297 mm	430 x 430 mm	Modified (Increased)
Overall Dimensions	a) 493 x 503 x 26 mmb) 470 x 363 x 82.5 mm	469 x 468 x 58 mm	Modified
Weight	a) 5.7 kgb) 19.0 kg	13 kg	Modified
Acquisition Mode (Binning)	a) Up to 15 fps (1x1)b) Up to 30 fps (2x2)	Up to 15 fps (1x1)Up to 30 fps (2x2)Up to 30 fps (3x3)	Identical (1x1, 2x2), Modified (3x3 added)
DQE @ 1 µGy in 0 lp/mm, RQA5	a) 0.6b) 0.79	0.75	Modified
Spatial Resolution [MTF@2cycle/mm, RQA5]	a) 0.3b) 0.22	0.28	Modified
A/D Conversion	a) 14-bitb) 16-bit	16-bit	Modified (from 14-bit to 16-bit for predicate a), Identical (for predicate b)

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

The document mentions "non-clinical image comparisons involving flat panel display static and dynamic images taken with the new device and the predicate device CXDI-50RF." However, it does not specify a "sample size" in terms of number of patients or specific images, nor does it provide details on data provenance (country, retrospective/prospective). The testing focused on technical performance rather than clinical data sets.

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. The non-clinical tests described focus on technical image quality and system performance rather than a diagnostic evaluation requiring expert readers to establish ground truth.

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

Not applicable, as no expert human readers or adjudication process for diagnostic interpretations are described.

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

Not applicable. This submission is for new imaging hardware, not an AI/CADe device designed to assist human readers.

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

Not applicable. This is not an algorithm.

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

For the "non-clinical image comparisons," the "ground truth" would likely be objective measurements of image quality (e.g., DQE, MTF, noise characteristics) comparing the new device's output to the predicate device's output, rather than a clinical ground truth established by medical experts or pathology.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 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 image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

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

May 24, 2017

Canon, Inc. – Medical Equipment Group % Diane Rutherford Submission Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson, Texas 75080

Re: K171194

Trade/Device Name: AS-10, CXDI-401RF Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, MQB Dated: April 24, 2017 Received: April 24, 2017

Dear Diane Rutherford:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Michael D. O'Hara

For

Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171194

Device Name AS-10 CXDI-401RF

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image contains the word "Canon" in red font. The font is bold and slightly italicized. The word is centered and takes up most of the image space.

5. 510(k) SUMMARY

Submitter:	Canon, Inc. - Medical Equipment Group9-1, Imaikami-cho, Nakahara-kuKawasaki, Kanagawa 211-8501, Japan
Contact Person:	Canon, Inc. – Medical Equipment GroupMr. Shinji MoriManager9-1, Imaikami-cho, Nakahara-kuKawasaki, Kanagawa 211-8501, JapanTEL: 81-3-3758-2111FAX: 81-44-739-6493mori.shinji@canon.co.jp
Date Prepared:	April 18, 2017
Proposed Device	Manufacturer: Canon, Inc. - Medical Equipment GroupTrade Name: AS-10Common Name: CXDI-401RFClassification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)Interventional Fluoroscopic X-ray SystemPrimary Product Code / Regulatory Standard: OWB892.1650, Image-intensified fluoroscopic x-ray systemSubsequent Product Codes: JAA, MQB
Predicate Devices:	Clearance: K092439 dated November 30, 2009Manufacturer: Virtual Imaging, A Canon USA CompanyTrade Name: Model CXDI-50RFCommon Name: Fluoroscopic Digital X-Ray Receptor PanelClassification Name: Image-Intensified Fluoroscopic X-Ray SystemProduct Code(s) / Regulatory Standard(s): OWB, JAA, IZI [SE Letter correction July 30, 2012]892.1650, Image-intensified fluoroscopic x-ray system892.1600, Angiographic x-ray system[Originally cleared under MQB, 892.1680]
	Clearance: K162909 dated January 27, 2017Manufacturer: Canon, Inc. - Medical Equipment GroupTrade Name: Model CSX-30Common Name: Solid State X-ray Imager (Flat Panel/Digital Imager)Classification Name: Stationary X-ray systemPrimary Product Code MQBRegulatory Standard: 892.1680, Stationary X-ray SystemSubsequent Product Code JAARegulatory Standard: 892.1650, Image-intensified fluoroscopic x-ray system
Device Description:	The AS-10 / CXDI-401RF is a solid state x-ray imager. It intercepts x-ray photons andthe scintillator of the AS-10 / CXDI-401RF emits visible spectrum photons thatilluminate an array of photo-detectors that create electrical signals. After the electricalsignals are generated, it is converted to digital value.

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Image /page/4/Picture/0 description: The image shows the word "Canon" in red. The font is bold and slightly italicized. The background is white.

Indications for Use: The AS-10 / CXDI-401RF is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Summary of Comparison with the predicate devices shows the technological characteristics of the Technological AS-10 / CXDI-401RF is substantially equivalent to the predicate devices. The flat Characteristics: panel detector units are functionally identical.

The AS-10 / CXDI-401RF is a successor model of the CXDI-50RF; however, the AS-10 / CXDI-401RF is for integration only like the CSX-30. The differences between the AS-10 / CXDI-401RF and the predicates CXDI-50RF and CSX-30 are primarily overall dimensions, increased pixels, and increased image size.

The differences between the AS-10 / CXDI-401RF and the predicates are primarily increased size. Increased size results in larger dimensions, larger image area, more pixels, and weight differences over the predicate. An additional binning mode has been added to the AS-10 / CXDI-401RF in an effort to improve the marketability. The proposed indications for use statement differs slightly in wording from the predicates, but does not impact the intended use. The proposed and both predicate devices are indicated for fluoroscopic and radiographic use.

In the table below, the predicates are identified as a) CXDI-50RF or b) CSX-30. If no letter precedes the predicate information, the information applies to both predicates.

	New Device:AS-10 / CXDI-401RFK171194	Predicate Devices:a) CXDI-50RF K092439b) CSX-30 K162909
Application	Fluoroscopy and Spot Radiology	Fluoroscopy and Spot Radiology	Identical
Technology	Flat panel detector:Scintillator and a-Si	Flat panel detector:a) Scintillator and a-Si	Identical
Scintillator	CsI(TI)	CsI(TI)	Identical
Pixel Pitch	160 x 160 µm	160 x 160 µm	Identical
Pixels	2,688 x 2,688 (≈ 7.2 million)	a) 2,208 x 2,688 (≈ 5.9 million)b) 2,496 x 1,856 (≈ 4.6 million)	Modified
Image Size	430 x 430 mm	a) 350 x 430 mmb) 399 x 297 mm	Modified
Overall Dimensions	469 x 468 x 58 mm	a) 493 x 503 x 26 mmb) 470 x 363 x 82.5 mm(Except tubes protrusions)	Modified
Weight	13 kg	a) 5.7 kgb) 19.0 kg	Modified
Acquisition Mode(Binning mode)	Up to 15 fps (1x1)Up to 30 fps (2x2)Up to 30 fps (3x3)	a) Up to 15 fps (1x1)b) Up to 30 fps (2x2)	IdenticalIdenticalModified
DQE@ 1 µGy in 0 lp/mm,RQA5	0.75	a) 0.6b) 0.79	ModifiedModified
Spatial Resolution[MTF@2cycle/mm,RQA5]	0.28	a) 0.3b) 0.22	ModifiedModified
A/D Conversion	16-bit	a) 14-bitb) 16-bit	ModifiedIdentical

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Image /page/5/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly italicized. The word is easily readable and takes up most of the image.

Summary of Tests were performed on the device which demonstrated that the device is safe and Non-Clinical /Test effective, performs comparably to and is substantially equivalent to the predicate devices. Data: Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display static and dynamic images taken with the new device and the predicate device CXDI-50RF. Documentation was provided demonstrating compliance of the AS-10 / CXDI-401RF to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation_plus_traceability of_verification/validation_tests_to_software requirements and software risk hazards. Documentation was provided demonstrating that the AS-10 / CXDI-401RF complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The evaluations of the AS-10 / CXDI-401RF compared to the CXDI-50RF, show the AS-10 / CXDI-401RF to be equivalent to the CXDI-50RF. Testing confirmed that the AS-10 / CXDI-401RF complies with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-54, 62304, and 62366 as well as ANSI/AAMI ES60601-1. Testing also confirmed compliance to relevant voluntary safety standard IEC 60825-1. Together, these verification/validation activities successfully demonstrated that the AS-10 / CXDI-401RF correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate devices. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the AS-10 / CXDI-401RF device. Integration: The AS-10 / CXDI-401RF is a hardware only FPD for integration into dynamic and static imaging systems. The AS-10 / CXDI-401RF connects to the image capture unit (compliant with IEC 60601-1 or IEC 60950-1) through a wired connection and does not connect directly to an x-ray generator. The Installation Manual provides detailed instructions and information for safe and effective system integration including: system configuration; electrical, mechanical, and cooling requirements; installation conditions; interfaces (image, command and service, and power input). Integrators are expected to adhere to the instructions and other information in the published Installation Manual. Conclusion: Canon, Inc. - Medical Equipment Group considers the AS-10 / CXDI-401RF to be substantially equivalent to the predicate devices listed above. This conclusion is based on the same intended use and similar principles of operation, functional design, and established medical use for the flat panel detector.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.