(314 days)
Contrast Enhanced Spectral Mammography (CESM) is an extension of the existing indication for diagnostic mammography with the Senographe Essential or Senographe DS. The CESM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and ultrasound exams to localize a known or suspected lesion.
The Senographe DS and Senographe Essential are both full field digital mammography systems consisting of a digital detector, a dual track x-ray tube (molybdenum / rhodium) and an x-ray generator with control. The digital detector is a flat panel of amorphous silicon on which cesium iodide is deposited to maximize the detection of x-rays. The x-ray filter is a wheel with both a molybdenum and a rhodium filter to allow various combinations of x-ray tube track and filter when imaging breasts of different radiological densities. The system includes a feature called Automatic Optimization of Parameters (AOP) that automatically selects the kVp, the optimal x-ray tube track and beam filtration and then terminates the exposure based on the breast density to provide consistent image quality for the user across a wide range of breast sizes and densities.
The subject of this submission is a modification that will introduce a new imaging option based on a method of image acquisition involving a x-ray exposures at two energy levels. The two exposures will be completed at the simultaneously using a technique known as "dualenergy". This x-ray acquisition methodology has been previously cleared by GE Healthcare in K013481, although that clearance excludes mammography. This Premarket Notification will implement this technology on GE Healthcare's existing Full Field Digital Mammography systems as an upgrade to existing systems, or as an option to new installations. The dualenergy exposures will be done with a single breast compression and will be following an iodine based contrast injection of an existing approved x-ray contrast agent, using the approved rate, route of administration, and dosage of the contrast agent. The new mode of operation is referred to as Contrast Enhanced Spectral Mammography (CESM) due to the nature of taking an exposure with the x-ray spectrum optimized for general mammographic imaging and a second exposure with the x-ray spectrum optimized for the iodine based contrast image. The modification also includes the implementation of an additional x-ray beam filter. The change in x-ray exposure energy, plus the change in beam filtration allow the system to optimize the x-ray spectrum for the iodine based contrast when acquiring the second exposure of the dual-energy acquisition. This filtration change is done by rotating the filter wheel and changing the beam filter selected for the high energy exposure.
These two images are combined to allow visualization of the breast tissue in a way that is typical and familiar for mammographic imaging, while being able to visualize the x-ray contrast enhancement in the breast at the same time.
The provided text is a 510(k) Summary for a medical device called Contrast Enhanced Spectral Mammography (CESM). It describes the device, its intended use, and the regulatory review process. However, it does not contain the detailed clinical study information needed to fill out most of the requested table and answer the study-specific questions.
The document states, "The subject of this premarket submission, Contrast Enhanced Spectral Mammography, included clinical testing to quantify the effect of dual energy acquisition and CESM's contribution when compared to standard FFDM mammography and ultrasound breast imaging." However, it does not report the results, acceptance criteria, sample sizes, ground truth methodology, or expert qualifications from that clinical testing.
Therefore, I can only provide limited information based on the text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance | Not explicitly stated in the provided text. The text indicates clinical testing was done "to quantify the effect of dual energy acquisition and CESM's contribution when compared to standard FFDM mammography and ultrasound breast imaging." | Not explicitly stated in the provided text. The document concludes that CESM is "as safe, as effective, and performance is substantially equivalent to the predicate device(s)." This is a general statement of equivalence rather than specific performance metrics from a clinical study. |
| Safety | Implied to meet general safety standards and substantial equivalence. | The device is considered "as safe" as the predicate device(s). |
| Effectiveness | Implied to meet general effectiveness standards and substantial equivalence. | The device is considered "as effective" as the predicate device(s). |
| Functionality | "delivers functionality of comparable type that is substantially equivalent to our currently marketed systems" | Functionality is stated to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text. The text only mentions "clinical testing."
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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:
- An MRMC study is not explicitly mentioned, nor is any AI involved in this device description. The device is described as "Contrast Enhanced Spectral Mammography," a hardware and software modification for image acquisition and processing following an iodine-based contrast injection. It is not an AI-assisted interpretation tool. Therefore, an effect size of human readers with vs. without AI assistance is not applicable based on this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not an AI algorithm in the context of standalone performance for interpretation. It's an imaging technique. The "clinical testing" mentioned would likely involve evaluation of the images produced by the CESM system, potentially by human readers, but not in a standalone algorithm-only context for diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified in the provided text.
8. The sample size for the training set:
- This document describes a modification to an existing mammography system and its associated clinical testing. It does not explicitly discuss a "training set" in the context of machine learning. The non-clinical tests mentioned include "Performance testing (Verification)" and "Simulated use testing (Validation)," which are general software/system validation terms. If "training set" refers to data used to develop the image reconstruction algorithm, that information is not provided.
9. How the ground truth for the training set was established:
- Not applicable as a "training set" in the machine learning sense is not described.
Summary Limitations:
The provided 510(k) Summary focuses on the device description, intended use, and substantial equivalence argument. It outlines that clinical testing was performed but does not provide the details of that clinical testing or its results, which would typically be found in a more comprehensive clinical study report. The questions largely pertain to specifics of clinical trial design and outcomes that are beyond the scope of this particular summary document.
§ 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.