(257 days)
AmCAD-US is a software device intended to visualize the statistical distributions of backscattered signals echoed by tissue compositions in the body. The backscattered signals are subject to the RF or Envelope data made available by an FDA-cleared general-purpose ultrasound system. The US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.
AmCAD-US (model number 1.0) is intended to visualize and analyze the statistical distributions of backscattered signals echoed by tissue compositions in the body. AmCAD-US, which uses the proprietary technology and algorithms, is a software package designed to quantify and visualize the backscattered statistics contained in ultrasound image data obtained from an FDA-cleared general purpose ultrasound system. The device provides dual mode images, including conventional B-mode ultrasound image in gray scale and color-mapped US (ultrasound structure) mode image. The US-mode provides a means for viewing and displaying the backscatter statistical values. The device uses parametric model or nonparametric statistics that best describes the distribution curve of the backscattered signals. The parameters vary by the US method (backscattered statistics) selected. The preferences include options to set the parameters mapped onto the image and US method options applied to the data. The user can also select a specific region of interest (ROI) on the image for quantification analysis. The histogram view of the data provides a different view to accommodate the variation between tissue and tissue states. AmCAD-US has a data export function to record and save the analysis results. Note that the US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.
The provided text describes AmCAD-US, a software device for visualizing and analyzing statistical distributions of backscattered signals from ultrasound data. However, the text does not include specific quantitative acceptance criteria for the device's performance that would typically be found in a 510(k) submission (e.g., specific accuracy, sensitivity, or specificity targets). Instead, it focuses on demonstrating that the device functions as intended and is safe and effective as compared to its predicate device.
Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific metrics like sensitivity, specificity, etc., as these are not provided in the document. The document describes types of studies performed to validate the device's utility and safety, but not specific quantitative performance targets or results against those targets.
Below is a summary of the information that is available in the provided text, structured according to your request, with an explicit note where information is not present.
Acceptance Criteria and Study for AmCAD-US
The provided 510(k) summary for AmCAD-US does not explicitly list quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the studies demonstrate the utility and functionality of the device for its intended use, focusing on its ability to analyze various tissue compositions and showing a correlation between its output and physiological changes. The conclusion of the submission states that the data demonstrates the proposed device is as safe and effective as the primary predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not Explicitly Stated as Quantitative Criterion in Document) | Reported Device Performance (Summary from Studies) |
|---|---|---|
| Utility in analyzing cell compositions | Device should demonstrate utility in analyzing various cell compositions. | Demonstrated utility in analyzing various cell compositions in phantom studies. |
| Correlation with physiological changes | Device should show utility in analyzing tissue composition variation and correlation with induced physiological changes. | Demonstrated strong correlation between backscattered statistics and dosage of DMN injections in animal liver fibrosis model, showing utility in analyzing tissue composition variation. |
| Applicability to human body parts and various ultrasound systems | Device should be applicable to various tissue parts in the human body and capable of using data from various FDA-cleared ultrasound systems. | Indicated applicability to various tissue parts in the human body (thyroid and abdomen modes) and usability with RF/Envelope data from two different FDA-cleared ultrasound systems in human tissue validation study. |
| Software Functionality and Specification Compliance | Software should meet all functional and specifications for its indication for use. | Software unit, integration, and system tests were conducted, ensuring the device meets functional and specification requirements. |
| Safety and Effectiveness Equivalence to Predicate | Device should be as safe and effective as the predicate device. | Concluded to be as safe and effective as the predicate device, with technological differences not raising new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Phantom Study: Not specified, but involved "cell phantoms with different concentrations of one cell type and with different constitutions of mixed cell types."
- Animal Study: 6 rats with liver fibrosis induced by dimethylnitrosamine (DMN) injection.
- Human Tissue Validation Study: Not specified, but involved "two common ultrasound scanning modes, e.g. thyroid and abdomen modes."
- Data Provenance: Not explicitly stated for each study, but the submitting company (AmCad BioMed Corporation) is located in Taiwan, ROC, suggesting the studies likely originated there. The studies appear to be prospective in nature, designed specifically for the validation of this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the test sets in the phantom, animal, or human tissue validation studies.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for establishing ground truth in the test sets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly mentioned or performed. The indications for use explicitly state: "The US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation," implying it is an assistive tool rather than a standalone diagnostic.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described (phantom, animal, human tissue validation) appear to be standalone evaluations of the algorithm's performance in analyzing backscattered signals and demonstrating correlation with tissue compositions, rather than evaluations of human reader performance with or without the device. The device's output (color-coded images and statistical values) is presented as a visualization and quantification tool.
7. The Type of Ground Truth Used
- Phantom Study: Ground truth was based on controlled "different concentrations of one cell type and with different constitutions of mixed cell types" in the phantoms.
- Animal Study: Ground truth was based on the "dosage of DMN injections" to induce liver fibrosis and likely confirmed by histological examination (though not explicitly stated, this is standard for fibrosis models).
- Human Tissue Validation Study: Ground truth was derived from the "tissue compositions in the human body" as seen through "two common ultrasound scanning modes" (thyroid and abdomen). The exact method for confirming tissue composition ground truth (e.g., pathology, clinical diagnosis) is not detailed.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. It mentions the "proprietary technology and algorithms" but does not detail the development or training process.
9. How the Ground Truth for the Training Set was Established
The document does not describe how the ground truth for any training set was established. It focuses on the validation studies, not the development or training phase of the algorithm.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).