Search Results

The flat panel detector when used with a radiographic imaging system is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.

When the dual energy subtraction is enabled, it is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.

This device is not intended for use in mammography applications.

The Reveal 35C Flat Panel Detector is similar to the FDA cleared Yushan X-ray Flat Panel Detector. The detectors consist of amorphous silicon flat panel image sensors with cesium iodide scintillators. The light is captured by an amorphous silicon photodetector and the resulting signal is transferred via amorphous silicon thin film transistor (TFT) switches to external readout electronics to obtain X-ray images. The Reveal 35C Flat Panel Detector is a portable digital detector that can be integrated with a PC workstation and an X-ray source to acquire digital X-Ray images for general radiography. The detector supports wireless and wired data communication and can be used wherever a conventional screen-film, digital radiography, or computed radiography detector is used for general purposes.

The Reveal 35C Flat Panel Detector synchronize their image capture cycle with the X-Ray exposure in either of the two modes:

• 1. Wired Mode
• Wireless Mode 2.

The subject device, Reveal 35C Flat Panel Detector includes an optional Dual-Energy subtraction function. When the Dual-Energy Subtraction function is enabled, it will provide additional dual energy subtracted X-ray images. The images are intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.

Here's a summary of the acceptance criteria and study information for the KA Imaging Reveal 35C Flat Panel Detector, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria or quantitative performance metrics for the Reveal 35C Flat Panel Detector. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, design features, operating principles, functional and performance characteristics, and intended uses.

The text states that:

• Non-clinical bench testing has determined that the device hardware and software requirements conform to its specification. (A general statement of performance.)
• The image quality validation confirmed that the image quality of KA Imaging Reveal 35C Flat Panel Detector is substantially equivalent to that of the predicate device. (A comparative statement.)

Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported device performance directly from this document. The "acceptance criteria" here is implicitly that the device performs equivalently to the listed predicate devices in its general function and image quality.

Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "non-clinical bench testing" and "image quality validation" but no details on patient data or specific test sets for clinical performance.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • This information is not provided in the document.

3. Adjudication Method for the Test Set:

   • This information is not provided in the document.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • An MRMC comparative effectiveness study is not mentioned in the document. There is no information about human readers improving with or without AI assistance, as the focus is on the device's technical equivalence rather than a clinical reader study of the dual-energy subtraction feature.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • The document implies that the device's dual-energy subtraction function produces images (soft-tissue and bone) that are "equivalent to those of reference predicate devices (K122454 and K013481)." This suggests a standalone comparison of the image output itself, but details of a formal standalone performance study are not explicitly described. The text states the images are "intended to assist the physician," but doesn't quantify this assistance through a standalone algorithm performance metric.

6. Type of Ground Truth Used:

   • The document does not explicitly state the type of ground truth used for any evaluations. Given the focus on image quality equivalence and the absence of clinical outcome studies, it's likely that technical image quality metrics and visual comparison to predicate devices' outputs formed the basis of "validation," but specific ground truth types (e.g., pathology, clinical outcomes) are not mentioned.

7. Sample Size for the Training Set:

   • The document does not provide any information regarding the sample size for a training set. This is not uncommon for 510(k) submissions that focus on device equivalence rather than novel AI/ML algorithm performance where extensive training data details are typically required.

8. How the Ground Truth for the Training Set Was Established:

   • Since no training set is mentioned, this information is not provided.

Ask a specific question about this device

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:

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.

Ask a specific question about this device