Models IRIS 20 or IRIS 41 SSXI detector combined with IRIS-View Image Acquisition control, display viewing, and archiving console is indicated for use as a SSXI Portal Imaging Device used in conjunction with Medical Accelerator Radiotherapy Devices as an alternative to Conventional Portal Film.

Device Description

The IRIS flat panel X-ray detector is available in two sizes, 20 x 20 cm (IRIS 20) and 41 x 41 cm (IRIS 41), with an Element Matrix of 256 x 256 and 1024 x 1024 respectively. X-rays are converted to light using a Gd202S(Tb) opto-mechanical luminescent screen coupled to an Amorphous Silicon Thin Transistor Photodiode Integrating Storage Matrix Array. The IRIS-View console accepts the digital signals from the detectors through a PC card interface into a standard PC with a Microsoft Windows operating system. Software processing of the data is applied to enhance the visibility of the viewed image seen on a standard PC Color Monitor.

AI/ML Overview

The provided text describes the Bio-Scan IRIS Solid State X-ray Imager, a device intended for use as a Solid State X-ray Imager (SSXI) Portal Imaging Device in conjunction with Medical Accelerator Radiotherapy Devices, serving as an alternative to Conventional Portal Film.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for clinical effectiveness in a pass/fail manner. Instead, the effectiveness study focuses on comparing the quality of IRIS images to conventional X-ray film images, with the implicit goal being that IRIS images are at least equivalent, if not superior, to film. Regulatory requirements are met through substantial equivalence to a predicate device and adherence to various standards (ISO, CEI, EN).

However, based on the nonclinical and clinical considerations, we can infer some key performance aspects and their reported values.

Acceptance Criteria (Inferred)	Reported Device Performance
Nonclinical Performance (Technical Specifications)
Active Area (IRIS 20)	192 x 192 mm
Active Area (IRIS 41)	409.6 x 409.6 mm
Matrix (IRIS 20)	256 x 256 (750 x 750 µm)
Matrix (IRIS 41)	1024 x 1024 (400 x 400 µm)
Fill Factor	80%
Maximum Energy Detection	Up to 30 MeV accelerator beam source
Measured Linear X-ray Range	From 50kV to 117kV
Detector Materials	Gd2O2S(Tb) opto-mechanical luminescent screen; Amorphous Silicon Thin Film Transistor Photodiode Integrating Storage Matrix Array
Data Output Format	DICOM III standard format (Bitmap also available)
DQE (Detective Quantum Efficiency)	> 65% at 0.3 mm^-1 frequency for 10 µGy exposure
SNR (Signal-to-Noise Ratio)	Proportional to square root of exposure; SNR vs. Entrance Kerma measured from 0 to 25 µGy for 50kV to 117kV, showing SNR from 25 to 275
MTF (Modulation Transfer Function)	Measured from 0.1 to 1.275 mm^-1 frequency, showing MTF from 0.98 to 0.01
Aliasing	Matrix doubling algorithm utilized to eliminate aliasing
Dynamic Range	Slice Profile of a 45° wedge filter image shows input energy from 18MeV vs. 16 bit digital intensity output. Dose Response plotted from 0 µGy to 40 µGy for 50 to 117 kV, showing linear response from 0 to 65,535 intensity units.
Lag Time	35 µsec signal charge transfer and reset to zero; 280 msec total before new integration
Pixel Defects	Up to 5% may be noisy or inefficient, corrected by adjacent pixel averaging algorithm and calibration protocol.
Device Ready Time	One hour after power turn-on; Can acquire a new image 280 msec after an exposure.
Dose Requirement (for Acceptable SNR)	Acceptable SNR of 100 achieved at Entrance Air Kerma of 2 µGy from 50 to 117kV
Stability	Stable after one hour of power on.
Uniformity	Weekly QA protocol produces a calibration matrix which corrects for non-uniformity of gain of individual pixels and X-ray beam non-uniformities.
Frame Rate (Reuse Rate for static images)	4 fps to 10 fps depending on field of view selected (not for fluoroscopic applications).
Clinical Effectiveness
Image Quality compared to X-ray film (Implicit Acceptance: Equivalent or better)	Better: 27 out of 30 comparison images (90%) rated better than X-ray film. Equivalent: 3 out of 30 comparison images (10%) rated equivalent to X-ray film. Poorer: In no situation was any quality of the Bio-Scan Image rated of poorer quality than the X-ray film image.
Compliance with Regulatory Standards	Met ISO 9001, ISO 13585/EN 46001, EN 1441, EN1041, CEI 61223-3-1, CEI 61223-3-3, EN 980, EN 540, EN 60601 (FCC Class A), EN 60950-A4. Certified by SGS Yarsley International Certification Services Ltd and INTERTest Systems.

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

Sample Size: 30 patients were included in the clinical trial. For each patient, two images were compared (one X-ray film and one IRIS SSXI image), leading to a total of 30 comparison images (60 images in total: 30 film + 30 IRIS).
Data Provenance: The study was sponsored and conducted by the University of Pennsylvania Radiation Oncology Department, Division of Medical Physics. This suggests the data originated from the United States. The study was a prospective clinical trial, carried out under Local IRB approval, with patients scheduled to undergo radiation therapy.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: 7 physicians were involved in reading and comparing the images.
Qualifications: "Specialists in the radiation treatment of the specific target organ lesions to be irradiated" and "Physicians with expertise in the Speciality of Radiation Oncology for the target organ." Specific years of experience or board certifications are not provided.

4. Adjudication Method for the Test Set

The document mentions that "Reading was done by specialists... A table of reader responses was developed comparing the results..." It then states that "three out of the total of 30 image comparisons by 7 physicians, the rating was considered equivalent." This implies that the 7 physicians individually rated each comparison. It does not explicitly state an adjudication method (like 2+1 or 3+1 consensus). It sounds more like individual ratings were collected, and then a summary of these individual ratings was compiled to describe the overall outcome (e.g., how many times IRIS was rated better/equivalent/worse by the group across all images). Without further detail, we cannot confirm a formal adjudication process beyond individual expert evaluation.

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

Was it done? Yes, a comparative effectiveness study was conducted where 7 physicians compared IRIS images to conventional X-ray film images for 30 patients.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: This study was not a "human reader with AI vs. human reader without AI" study. It was a direct comparison of the image quality from the new device (IRIS) against the existing standard (X-ray film), as interpreted by human readers. The readers were assessing the image quality produced by two different imaging modalities, not the performance of an AI assisting a human reader. Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable here. The study concluded that for 90% of cases, IRIS images were rated better by the physicians than X-ray film, and for 10% of cases, they were equivalent.

6. Standalone (Algorithm Only) Performance

Was it done? No, the device is an imaging system (hardware and associated software for image acquisition, viewing, and archiving), not an AI algorithm designed to interpret images independently. The effectiveness study involved human physicians interpreting the images produced by the device. Therefore, a standalone (algorithm only) performance assessment, as understood for AI systems, was not performed or relevant in this context.

7. Type of Ground Truth Used

The ground truth for the clinical effectiveness study was established through expert consensus/opinion (or rather, expert comparison and rating). The radiologists/oncologists directly compared the quality of the IRIS images against the X-ray film images, which was the existing standard of care. There was no mention of an independent, definitive "ground truth" like pathology for image interpretation accuracy, but rather a direct comparison of imaging modalities based on visual assessment of image quality for the purpose of radiation treatment.

8. Sample Size for the Training Set

The document does not mention a separate "training set" in the context of machine learning. The IRIS device is a digital X-ray imager, and its image processing is described in terms of "Software processing of the data is applied to enhance the visibility of the viewed image." This suggests traditional image processing algorithms rather than a machine learning model that requires a distinct training dataset. If such an algorithm exists internally, its training set is not described.

9. How Ground Truth for the Training Set Was Established

As no training set (in the machine learning sense) is explicitly mentioned, the method for establishing its ground truth is not applicable/not provided. The device's characteristics and performance are described through physical testing, regulatory compliance, and a reader study comparing image output.

Summary

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K01389/s/

January 15, 2002

MAY 2 1 2002

Bio-Scan

— See life in real-time

SUMMARY of SAFETY and EFFECTIVENESS

I. GENERAL INFORMATION PER 21 CFR 807.87

Device Classification Name:	Solid State X-Ray Imager (flat panel/digital imager)
510(k) Submission Type:	New Device
Regulation Number:	892.1650
510(k) Number:	K013897 filed on November 26, 2001
Device Names:	IRIS 20 , IRIS 41 , IRIS-View
Device Product Code	90 MQB
Device Classification:	Class II, per FDA guidance for the submission of510(k) 's for Solid State Imaging Devices, FDA, CDRH,ODE issue date August 6, 1999
Predicate Device:	Generic X-Ray film/screen (a preamendment device)
Registration Action:	Device Listing Document Number 103059 for IRISDevice Models submitted to FDA, CDRH, InformationProcessing and Office Automation Branch (HFZ-308)was filed on 07/24/2001
Applicant:	Bio-Scan SA
Manufacturer's Address:	Bio-scan SA,Pre Bouview 27,CH-1217 Meyrin/Geneva, Switzerland
United States Contact:	Richard M. SanoConsultant to Bio-Scan SA153 Sanford Lane,Stamford, Connecticut 06905Phone: 212-305-1831Page Number: 917-424-0330FAX: 203-323-3329E-mail: rsano50390@aol.com
Proposed Labeling:	Operators Manual, Preliminary Product Data Sheets,CE, ISO, and EN Labels are included in the abbreviated510(k) submission

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II. DEVICE DESCRIPTION

IRIS SOLID STATE X-RAY IMAGER RECTANGULAR SSXI FLAT PANEL X-RAY TRANSDUCER

Applicable elements contained in FDA guidance for the submission of 5100x) 's for Solid State Imaging Devices, FDA, CDRH, ODE issue date August 6, 1999

Indications for Use.

Detectors

Viewing Console

The IRIS-View console accepts the digital signals from the detectors through a PC card interface into a standard PC with a Microsoft Windows operating system. Software processing of the data is applied to enhance the visibility of the viewed image seen on a standard PC Color Monitor.

REGULATORY REQUIREMENTS III.

Under MDA, the IRIS Device in this abbreviated 510(k) submission is being shown to be substantially equivalent to a legally marketed predicate device, Generic X-ray film/screen (a preamendment device). Even though the preamendment device is exempt from 510(k) requirements, FDA guidance for the submission of 510(k) 's for Solid State Imaging Devices, FDA, CDRH, ODE issue date August 6, 1999, assigns a classification of Class II and a Product Code "90 MQB" for these SSXI devices.

IV. NONCLINICAL CONSIDERATIONS

A. Physical Characteristics:

1. Overall Dimension: IRIS 20, 26 x 53 x 7 cm. IRIS 41, 69.2 x 59.9 x 5 cm
2 Active Area: IRIS 20, 192 x 192 mm. IRIS 41 409.6 x 409.6mm
3 Matrix : IRIS 20, 256 x 256 (750 x 750um), IRIS 41, 1024 x 1024 (400 x 400μm)
4 Fill Factor: 80%
5 Drawings: Cutaway of the SSXI panel, System Components and Connections
6 Power: 110vac ±10% 60 cycle or 230vac ±10% 50 cycle

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B. Operational Functions:
- 1. Exposure Characteristics: There is no physical or electrical control of the Medical Accelerator possible through any manual or automatic IRIS or IRIS-View control interactions. The Medical Accelerator which is used with IRIS is not manufactured or marketed by Bio-Scan SA. When used in conjunction with a Medical Accelerator, the IRIS device is as passive as X-ray film, and does not control output of Energy from the Medical Accelerator Device.

Frame rate: Typically single static images, IRIS is not intended for fluoroscopic applications

Dynamic Mode: dependent on field of view, from 10 fps for 10 x 10cm partial area to 4 fps for 41 x 41cm

Integration time: 285mecs to 10,000msec (user selected)

1. X-ray Absorber: 25mm thick aluminum absorber
  Detection properties: Up to 30 MeV accelerator beam source Measured linear from 50kV to 117kV
Energy Conversion: Gd2O2S(Tb) opto-mechanical luminescent screen 3.
1. Readout Mechanism: Amorphous Silicon Thin Film Transistor Photodiode Integrating Storage Matrix Array, 35us signal charge transfer time, minimum integration time 285msec
Output Signal: Internal between SSXI Detector and IRIS-View PC Computer ర్ is 16 bit intensity data and serial matrix addressing output signal for images into a network or onto CD-R or CD-RW are DICOM III standard format. (Bitmap format is also available for standard PC graphic presentation archiving)
C. Functional Characteristics:
- No video Signal output, Output to Monitor is SVGA PC display standard 1.
- DQE: over 65% at 0.3 mm 1 frequency for 10μGy exposure 2.
- 1. SNR: proportional to square root of exposure, SNR vs. Entrance Kerma is measured and graph submitted from 0 to 25 µGy for 50kV to 117kV showing SNR from 25 to 275
- MTF: measured and graph submitted from 0.1 to 1.275mm1 frequency 4. showing MTF from 0.98 to 0.01
- ડ. Aliasing: Matrix doubling algorithm is utilized to eliminate aliasing
- Dynamic Range: Slice Profile of a 45° wedge filter image shows input energy 6. from 18MeV vs. 16 bit digital intensity output. Dose Response is plotted from 0 uGy to 40 uGy for 50 to 117 kV, showing linear response from 0 to 65,535 intensity units.
- 1. Lag Time: Lag time includes 35usec signal charge transfer and reset to zero
- Underscanning: Field of View is user selected from the IRIS-View Console 8.

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1. X-ray Beam Alignment: Equipment installation function, Detector is mounted in alignment directly behind X-ray film cassette housing on the Medical Linear Accelerator Arm.
1. Pixel Defects: up to 5% may be noisy or inefficient and are ignored by a calibration protocol. These defects are corrected by adjacent pixel averaging algorithm
1. Device Ready: After one hour after power turn-on, IRIS Device is "Ready" and after an exposure in 280 msec the IRIS Device can acquire another image.
1. Latent image: Part of the readout cycle is the reset to zero. After 35 usec, the integrator is reset to zero with in a few milliseconds. A time of 280 msec total is set before a new integration
D. Exposure Characteristics:
- 1. Dose Requirement: Acceptable SNR or 100 can be achieved at Entrance Air Kerma of 2uGy from 50 to 117kV
- Stability: After one hour of power on, the IRIS system is stable. 2
- 1. Uniformity: Weekly Quality assurance protocol produces a calibration matrix, which corrects for any non uniformity of the gain of individual pixels and also corrects for X-Ray beam non uniformities.
- 1. Frame Rate: This device is not indicated for Fluoroscopic applications.
- 1. Reuse Rate: Serial static images can be acquired from 4 fps to 10 fps depending on field of view selected. The limitation is related to readout rate from the photosensors.
V. SAFETY
- A. Ready Indicator: An indicator with the word "READY" is seen on the monitor when the system is prepared to accept and process an X-ray input
- B. Passive System: The IRIS detector is passive as is x-ray film, and does not control the x-ray beam or movements of the Therapy accelerator. Bio-Scan does not manufacturer or distribute the Medical Accelerator Therapy devices.
- C. Leakage Currents: The detector is mounted under the treatment table and not in contact with the patient. However, as with UL testing. conformity with all provisions of the directive 93/42/EEC certifies through testing by an authorized body that the system passes ISO 13485/EN46001 Quality system for medical devices.
- D. RF Emissions: The FCC Class A Verification testing by an authorized body was performed to assure that EMC emissions are within levels that do not interfere with other devices.

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VI. CLINICAL CONSIDERATIONS - EFFECTIVENESS

A. Concurrence Effectiveness Study: A clinical trial under Local IRB approval was sponsored and conducted by University of Pennsylvania Radiation Oncology Department, Division of Medical Physics with 30 patients scheduled to undergo radiation therapy. A table of reader responses was developed comparing the results from x-ray film with simultaneously acquired IRIS SSXI Images. Reading was done by specialists in the radiation treatment of the specific target organ lesions to be irradiated.
B. Effectiveness Results:
- 1. In no situation was any quality of the Bio-Scan Image rated of poorer quality than the X-ray film image
- 1. In 27 out of 30 comparison images, the Bio-Scan Images were rated better than the X-ray images
- 1. In three out of the total of 30 image comparisons by 7 physicians, the rating was considered equivalent
C. Effectiveness Conclusion: Physicians with expertise in the Speciality of Radiation Oncology for the target organ, rated the Bio-Scan IRIS results better in 90% of the comparison images or equivalent in 10% of the studies to the practice standard used, X-ray film/screen cassette acquired images.
D. Sample Images: Copies of all 60 comparative images are printed in the submission and samples of films are provided in the submission. Copies of the IRIS images are provided in CD for review as bitmap images.
E. Other findings: Written comments by Oncology readers of the comparative images
- 1. "Windowing (on IRIS-View) allows much more dynamic range so that each aspect of the assessment can be individually optimized."
- 1. "Increased dynamic range (of IRIS) helps assessment"
- 1. "Table edge interferes with assessment of both modalities (IRIS and film)."
- "Film assessment is very difficult. Very simple with IRIS." র্ব
- "Study is good, but technique not as good as other films (study # 9010)." న్న

VII. LABELING

Indication for use, promotional PowerPoint presentation, promotional product data sheets, user manual, installation instructions, and scientific papers (bibliography) are provided in this submission.

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VIII. QUALITY ASSURANCE PROGRAM

The ISO 9001 "Quality Documentation including the CE 0120 "Quality Manual Master File" is available on-site for inspection. Upon request, a copy can be made and submitted for review by FDA ODE.

The declaration of Conformity is included in the submission per directive 93/42 CE:

0	ISO 9001	Quality system
0	ISO 13585/EN 46001	Quality system, medical devices
ロ	EN 1441	Risk Analysis
0	EN1041	Information supplied by the manufacturer withmedical devices
0	CEI 61223-3-1	Evaluation & routine testing in
ם	CEI 61 223-3-3	medical imaging departments
D	EN 980	Graphical Symbol for use in the labeling of medicaldevices
D	EN 540	Clinical investigation of medical devices for humansubjects
0	EN 60601	Electromagnetic Compatibility (FCC Class A)
0	EN 60950-A4	Safety on information technology equipment
The Testing was done by:		SGS Yarsley International Certification Services Ltdas Notified Body CE 0120
		INTERTest Systems, GMBH, internationalZulassungen und Testsysteme

Copies of the Certificates of Compliance are included in the submission.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo is black and white.

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

Bio-Scan, SA % Mr. Richard M. Sano, Consultant Columbia University The Neurological Institute Mail Box #48 710 West 168th Street NEW YORK NY 10032

AUG 23 2013

Re: K013897

Trade/Device Name: Solid State X-Ray Imaging Systems (IRIS) Model 20 & 41 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and LHN Dated: February 16, 2002 Received: February 20, 2002

Dear Mr. Sano:

This letter corrects our substantially equivalent letter of May 21, 2002.

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. Iisting 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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510(k) Number (it known): Kll13897

Devica Namo:_IRIS 20 and 41 with IRIS-View

Models IRIS 20 or IRIS 41 SSX1 detector combined with IRIS-View Indications For Use: image acquisition control, display viewing, and archiving console is indicated for use as a SSXI Portal Imaging Device used in conjunction with Medical Accelerator Radiotherapy Devices as an alternative to Conventional Portal Film.

(PLEASE DO NOT WRITE: BEI OW THIS LINE-CONTINUE (IN ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Por 21 CFR 801. 104)

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Over - The-Counter Use . . ..

Page,

(Optional Formal 1-2-96)

David A. Seguin

(Division Sign-Off) Division of Repre and Radiological Da 510(k) Number

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.