(255 days)
HESTIA is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. HESTIA is intended to be used in the same clinical applications as traditional film/screen systems.
HESTIA is a Full-Field Digital Mammography (FFDM) System for screening, diagnostic on standing or seated patients. The system consists of a control unit with x-ray generator, a compression device(C-arm) with tube housing assembly, and X-ray tube stand, including detector and a console with an operation panel. The HESTIA comes with a variety of compression plates for diagnostic adjunct procedures.
The system is mainly used in internal medicine, examination centers, obstetrics and gynecology, women's medicine, breast surgery, and imaging. Mammography X-rays are used to obtain diagnostic images of the breast's internal structure to diagnose changes more accurately in breast tissue or potential signs of breast cancer, such as micro-calcification or tumors.
HESTIA has three output control mode, Manual mode, Semi-auto mode, and Auto mode.
It is customized and dedicated acquisition workstation and can PACS accessibility with full DICOM capability.
The provided FDA 510(k) clearance letter and summary for the HESTIA Mammography System DOES NOT CONTAIN the detailed information typically found in a study proving a device meets acceptance criteria, particularly for AI/CAD devices. The HESTIA device is a Full-Field Digital Mammography (FFDM) System, a hardware device for generating mammographic images, not an AI/CAD software for interpreting them.
The summary specifically states:
- "A clinical image evaluation... was conducted with the HESTIA and determined that the images, reviewed by MQSA qualified expert radiologists, were of sufficiently acceptable quality for mammographic usage and that the images are substantially equivalent to those from predicate device."
This indicates a human-in-the-loop comparison of image quality (visual assessment by radiologists for diagnostic suitability) rather than an AI/CAD performance study with metrics like sensitivity, specificity, or AUC, which are common for AI algorithms. The "clinical image evaluation" mentioned is likely focused on demonstrating that the images produced by the HESTIA system are diagnostically acceptable and equivalent to those from the predicate device, not on assessing the performance of an AI against a ground truth established by experts.
Therefore, many of the requested items related to AI/CAD study design (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not provided in this document as it describes a hardware imaging system, not an AI interpretation software.
However, based on the information provided, here's what can be extracted and inferred, addressing as many points as possible:
Acceptance Criteria and Study for HESTIA Mammography System
As the HESTIA is a hardware Full-Field Digital Mammography (FFDM) system, not an AI/CAD software, the acceptance criteria and study design are primarily focused on demonstrating the system's ability to produce diagnostically acceptable images and its substantial equivalence to a predicate device in terms of image quality and safety. There is no indication of an AI component or AI performance metrics in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a FFDM system like HESTIA are typically related to image quality metrics, safety standards, and functional equivalence to predicate devices. The document summarizes compliance with these, rather than providing a quantitative table of specific acceptance thresholds and measured values for image interpretation performance (which would be relevant for AI).
| Acceptance Criteria Category | Description/Reported Performance |
|---|---|
| Non-Clinical Testing | - Safety & Effectiveness: Demonstrated through compliance with internal requirements and international standards. |
- Electromagnetic Compatibility (EMC): Compliant with IEC 60601-1-2.
- Radiation Protection: Compliant with IEC 60601-1-3.
- Usability: Compliant with IEC 60601-1-6.
- Mammographic X-ray Equipment Specifics: Compliant with IEC 60601-2-45.
- Biocompatibility: Compliant with ISO 10993-1, -5, -10.
- Software Life Cycle: Compliant with IEC 62304.
- Risk Management: Compliant with ISO 14971.
- Physical Laboratory Testing (Image Quality): Met all requirements for: Sensitometric response, Spatial resolution, Noise analysis, Signal-to-Noise Ratio Transfer-DQE, Dynamic range, Repeated exposures Test (Lag Effect), AEC Performance (CNR and SRN), Phantom tests (ACR Map, CDMAM), Patient radiation dose (Mean Glandular Dose). All tests demonstrated substantial equivalence to the predicate device. |
| Clinical Image Evaluation | - Images reviewed by MQSA qualified expert radiologists were determined to be of "sufficiently acceptable quality for mammographic usage." - Images were found to be "substantially equivalent to those from predicate device." |
| Intended Use | - "Generating mammographic images that can be used for screening and diagnosis of breast cancer." - "Intended to be used in the same clinical applications as traditional film/screen systems." (Met, as indications for use are identical to the predicate device). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in terms of patient cases for clinical evaluation, nor does it detail data provenance (country of origin, retrospective/prospective). The "clinical image evaluation" often involves a small number of images for visual quality assessment rather than a large clinical trial with diverse patient populations for diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The statement refers to "MQSA qualified expert radiologists."
- Qualifications: "MQSA qualified expert radiologists." (MQSA stands for Mammography Quality Standards Act, which sets federal standards for mammography facilities and personnel in the U.S. This implies they are board-certified and meet specific continuing education and interpretation requirements for mammography.)
4. Adjudication Method for the Test Set
Not specified, as this was an image quality assessment by radiologists rather than a diagnostic performance study requiring ground truth establishment through adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No information regarding an MRMC comparative effectiveness study for human readers with vs. without AI assistance. This type of study is relevant for AI/CAD devices, which is not what HESTIA is. The clinical evaluation focuses on the image quality produced by the HESTIA system being comparable to the predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Not applicable. HESTIA is a hardware imaging system, not a standalone AI algorithm.
7. The Type of Ground Truth Used
For the clinical image evaluation, the "ground truth" was based on the consensus/judgment of MQSA qualified expert radiologists regarding the diagnostic acceptability and equivalence of the image quality produced by the HESTIA system compared to the predicate device. This is distinct from establishing a clinical ground truth (e.g., biopsy-proven cancer) for an AI's diagnostic performance.
8. The Sample Size for the Training Set
Not applicable. HESTIA is a hardware device; thus, there is no mention of a training set as would be required for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a hardware device.
§ 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.