(157 days)
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.
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.
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.
§ 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.