The intended use of the Giotto Image 3D is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

The intended use of the Giotto Image 3D-L is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

Device Description

GIOTTO IMAGE-3DL Full field digital mammography unit with amorphous Selenium detector 24x30.

Versatile unit conceived for screening, but ideal for diagnostic. Very low x-ray dose emission, automatic and fast 3D movements of the circular arm, isocentric rotation, prearranged for stereotactic biopsy. x-ray tube with W/Re double track bi-angular anode 10°/16°, 0.1/0.3 mm focal spot, High Frequency/High Power 8 kW generator, Ag/Rh filters with automatic and manual insertion. Double digital display showing rotation and tilting angles of the circular gantry, compression force and compressed thickness.

The system includes:

Giotto IMAGE mammography unit with motorized tube rotation ± 24° for . stereotactic biopsy.
Amorphous Selenium detector 24 x 30 cm .
MAW (Management & Acquisition Workstation) ) with 21" LCD 2Mpixel . monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.
Raffaello® (AWS) software: Graphic User Interface for visualization and . processing of digital mammographic images. DICOM 3 interface.

The Giotto Image 3DL consists of gantry with a vertical column, a circular support for the x-ray tube, and compression mechanism, and an x-ray generator all of whip are very similar to the Giotto Image analog mammography system previously cleared under 510(k) K012953. It incorporates an 24 X 30 amorphous selenium detector that directly captures x-rays and converts the them into electronic signal from which the images are constructed. The images are displayed on am monitor for review by the operator.

The x-ray tube used is a Varian with tungsten anode and Ag/Rh filters. The gantry can be positioned automatically via motorized movement in 3 dimensions.

Images are produced with proprietary acquisition and processing algorithms and displayed at an operator acquisition where the operator may enter patient data (o it is received from a DICOM worklist). The images are transmitted from the acquis (ion station to a workstation for interpretation.

AI/ML Overview

Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance Study for Giotto Image 3D/3D-L

Based on the provided 510(k) summary, the Giotto Image 3D and 3D-L devices were cleared based on a demonstration of substantial equivalence to predicate devices rather than meeting specific performance metrics with predefined acceptance criteria in a clinical study. The "study" described is a radiological examination of images to establish substantial equivalence in image quality, not a clinical trial with predefined performance endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantitative "acceptance criteria" (e.g., sensitivity, specificity, AUC) or corresponding "reported device performance" values in the way a clinical trial typically would. Instead, the "acceptance criterion" was effectively the opinion of expert radiologists that the image quality was "sufficiently acceptable for mammographic usage to allow determination of substantial equivalence" to previously cleared devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Perceived image quality by expert radiologists is "sufficiently acceptable for mammographic usage to allow determination of substantial equivalence" to a predicate mammography device (Giotto Image analog [K012953] and GE Senographe Essential [P990066]).	Expert radiologists assessed images from 6 patients and provided an opinion that the images were "of sufficiently acceptable quality for mammographic usage to allow determination of substantial equivalence" to a previously approved/cleared mammography device. The FDA concurred with the finding of substantial equivalence.
Compliance with specified medical device safety standards (IEC 60601-1 series, IEC 60601-2-32, IEC 60601-2-45, IEC 62304, ISO 14971).	The devices have been evaluated for electrical, electromagnetic, radiation, and mechanical safety and "have been found to conform" to these standards.

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

Sample Size: 6 patients.
Data Provenance: Images and associated information from screening and diagnostic examinations. The images were selected by IMS and Giotto USA, LLC staff and radiologists at various mammography facilities in Europe. This indicates the data is retrospective and of European origin.

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

Number of Experts: Unspecified, but referred to as "Expert radiologists." The plural suggests more than one.
Qualifications: "Expert radiologists." No further specific qualifications (e.g., years of experience, subspecialty certification) are provided in the document.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated as a formal adjudication process (e.g., 2+1, 3+1). The text states, "Expert radiologists assessed the image sets and provided an opinion as to whether or not the images in each case are of 'sufficiently acceptable quality for mammographic usage to allow determination of substantial equivalence'." This suggests a consensus-based opinion or potentially independent assessments without further adjudication specified in this summary.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical tests were performed." The assessment focused on the quality of images rather than reader performance with and without AI assistance.

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

Not applicable / No. The device is a full-field digital mammography unit, not an AI algorithm intended for standalone interpretation. The assessment was of the image output from the device, which is then interpreted by human radiologists.

7. The Type of Ground Truth Used

The "ground truth" for the patients used in the image examination was their BI-RADS® Assessment Categories (1 or 2). This indicates that the patients had benign findings or were considered normal. The purpose was to assess image quality for typical examinations, not to diagnose difficult cases.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of an AI/algorithm being developed or trained. This device is a digital mammography unit, not primarily an AI diagnostic tool. Its acquisition and processing algorithms are proprietary, but the submission pertains to the hardware and its image output, evaluated by human experts.

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

Not applicable. As no training set for an AI algorithm is mentioned, this information is not provided.

Summary

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OCT 2 7 2011

Page 13

Traditional 510(k) Summary

K///434

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR1807.92(a).

807.92(a)(1)Submitter Information	Giotto USA, LLC7324 Greenbriar CircleWichita, KS 67226
Official Correspondent	Mr Robert RuskPresidentGiotto USA, LLCPhone: 316-393-5966E-mail: bobr@giottousa.com
Date:	May 19, 2011
807.92(a)(2)Device Trade Name	Giotto Image 3DGiotto Image 3D-L
Common Name	Full field digital mammography unit with amorphousSelenium detector
Device Classification Name	Full-Field Digital Mammography System
Product Code	MUE
Device Classification No.:	Part 892.1715
Regulatory Status	Class II
807.92(a)(3)Predicate Devices

GE Healthcare Senographe Essential Digital Mammography System PMA Number P990066

Giotto Image 510(k) Number K012953

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807.92 (a)(4) Device Description

GIOTTO IMAGE-3DL Full field digital mammography unit with amorphous Selenium detector 24x30.

The system includes:

Giotto IMAGE mammography unit with motorized tube rotation ± 24° for . stereotactic biopsy.
Amorphous Selenium detector 24 x 30 cm .
MAW (Management & Acquisition Workstation) ) with 21" LCD 2Mpixel . monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.
Raffaello® (AWS) software: Graphic User Interface for visualization and . processing of digital mammographic images. DICOM 3 interface.

The x-ray tube used is a Varian with tungsten anode and Ag/Rh filters. The gantry can be positioned automatically via motorized movement in 3 dimensions.

p. 2 of 5

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807.92(a)(5) Intended Use(s)

to pro duce digital images suitable for The intended use of the Giotto Image 3D is screening and diagnostic examination of the breast for detection of breast cancer.

is to produce digital images suitable for The intended use of the Giotto Image 3D-L screening and diagnostic examination of the breast for detection of breast cancer.

p. 3 of 5

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807.92(a)(6) Technological Characteristics

The Giotto 3D and 3D-L systems employ the same fundamental technological characteristics as their predicate devices. The X-ray technology for both the 3D and 3D-L systems is substantially equivalent to the Giotto Image cleared by FDA via K012953. The Giotto 3D and 3D-L incorporate full-field flat panel detector similar to that used by the GE Senographe Essential.

· Clinical uses for which the Giotto I mage 3D and 3D-L are designed, are equivalent to those cleared for Giotto Image and GE's Senographe.
· Giotto Image 3D and 3D-L are designed to meet the IEC60601-1. IEC 60601-2-45. and IEC60601-2-32 safety requirements.
· The Giotto Im age 3D and 3D-L use a differe nt technology for converting x-rays to electric signal than GE's Senographe. The e Giotto detector us es a direct energy conversion technology (from x-ray photons to el ectrical charges) while the GE detector uses an indirect energy conversion technol ogy (from x-ray photons to light photons and from light photons to electrical charges) However, they are Substantially Equivalent with respect to safety and effectiveness.
· The Giotto Image (analog) is a sc reen film system and the Giotto Im age 3D and Giotto Image 3DL and the GE Senographe Essential incorporate a full field flat Panel detector.

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807.92(b)(1) Summary of Non-Clinical Tests

The devices have been evaluated for as electrical, electromagnetic, radiation, and mechanical safety, and have been found to conform to the following medical device safety standards.

. IEC 60601-1
. IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-4
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-32
IEC 6060 1-2-45
IEC 62304
ISO 14971

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Summary of Clinical Tests

No clinical tests were performed, but radiological examination of images was performed. Innage sets and associated information from screening and diagnostic examinations of six patients with BI-RADS® Assessment Categories of 1or 2. The image sets consist of four images: craniocaudal (CC) and mediolateral oblique (MLO) views of each breast. Three of these image sets also contain diagnostic images (spot and/or magnification). At least two sets of images are from patients having fatty breasts and two from patients having dense breasts, as described in the BI-RADS @Atlas.

The images were selected by IMS and Giotto USA, LLC staff and radiologists at various mammography facilities in Europe as representative of typical mammography examinations performed with the Giotto Image 3DL. Expert radiologists assessed the image sets and provided an opinion as to whether or not the images in each case are of "sufficiently acceptable quality for mammographic usage to allow determination of substantial equivalence" to a mammography device previously approved or cleared by FDA.

807.92(b)(3) Conclusion

The Giotto 3D and 3D-L are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

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Image /page/5/Picture/0 description: The image shows the logo and text for the Department of Health & Human Services. The logo is on the left side of the image and consists of a stylized design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written in a bold, sans-serif font. The text is aligned to the right of the logo.

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

OCT 2 7 2011

Giotto USA, LLC % Mr. Patrick Mooney Consultant The Anson Group 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K111434

Trade/Device Name: Giotto Image 3D, Giotto Image 3D-L Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: September 9, 2011 Received: September 12, 2011

Dear Mr. Mooney:

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); mcdical 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.

Mary Patel

Mary S. Pastel, Sc.D. 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 Form

510(k) Number (if known): KIJ/ 434

Device Name: Giotto Image 3D, Giotto Image 3D-L

Indications for Use

The intended use of the Giotto Image 3D is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

The intended use of the Giotto Image 3D-L is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

Prescription Use YES (21 CFR801 Subpart C) (Part 21 CFR 801 Subpart D)

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

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

Muthal S. Othman

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111434

Page 1 of 1

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.