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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

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.

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The LipiScan Coronary Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden.

The LipiScan Coronary Imaging System is comprised of the catheter, catheter accessories, pull-back and rotation device and laser console with accessories.

The provided text describes a 510(k) summary for the LipiScan Coronary Imaging System. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria. The document focuses on establishing substantial equivalence to a predicate device, highlighting similar intended use, operating principles, catheter design, shelf life, packaging, and compliance with general safety and performance standards.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document. The 510(k) summary states, "Further preclinical testing has shown that the product can function as intended and meets all internal design specifications," but it does not list these specifications or acceptance criteria. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy for detecting lipid-core-containing plaques) presented as acceptance criteria or reported device performance.

2. Sample Size Used for the Test Set and Data Provenance

Not explicitly provided for any specific performance study. The document mentions "Ex vivo and in vivo data is presented to support expanded indications for use," but no details about the sample size, type of test set, or data provenance (e.g., country of origin, retrospective/prospective) are given for these studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not explicitly provided. Since no specific performance study with a test set is detailed, information about experts, their number, or their qualifications for establishing ground truth is absent.

4. Adjudication Method for the Test Set

Not explicitly provided. As no specific performance study is detailed, there is no information about any adjudication methods (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not mentioned and likely not performed or reported in this summary. The document focuses on demonstrating substantial equivalence, not on comparative effectiveness with or without AI assistance. The device is for imaging, and there's no mention of AI assistance for human readers.

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

Not applicable/not described. The LipiScan Coronary Imaging System is presented as an imaging system that provides an image of the artery wall. It's a diagnostic tool intended for use by clinicians, not an autonomous AI algorithm. Therefore, a "standalone algorithm only" performance study is not relevant in the context described.

7. Type of Ground Truth Used

Not explicitly stated for specific performance evaluations. The summary does not detail the nature of the ground truth for any studies supporting "expanded indications for use." For such devices, ground truth might involve histology, pathology, or correlative imaging modalities, but this is not specified here.

8. Sample Size for the Training Set

Not applicable/not provided. The device is an imaging system, not explicitly an AI/machine learning algorithm that requires a training set in the conventional sense. The "preclinical testing" and "ex vivo and in vivo data" likely refer to validation and verification testing for safety and performance, not training data for a learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable/not provided. As explained in point 8, there's no mention of a training set or an AI algorithm that would necessitate establishing ground truth for training.

In summary, the provided 510(k) summary serves to demonstrate substantial equivalence to predicate devices and adherence to general safety and performance standards. It mentions "preclinical testing" and "ex vivo and in vivo data" to support its expanded indications, but it lacks the detailed information about specific acceptance criteria and the comprehensive study methodology asked for in the prompt. This level of detail is often found in the full 510(k) submission, not typically in the public summary.

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