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ClearRead CT CAC is image processing software designed to aid physicians in assessing coronary artery calcification on non-gated, non-contrast, standard, or low-dose chest CT scans of adult patients 30 years of age or older. The primary output of ClearRead CT CAC is the Agatston score. ClearRead CT CAC locates calcified coronary lesions and assigns them to one of several coronary arteries: the right coronary artery (RCA), the left main artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (LCX). The software calculates the Agatston score as the sum for each artery while also providing the total across all coronary arteries. The total Agatston score is calibrated to 3.0mm slice thickness and is used to derive a CAC category and the arterial age. The provided segmentations are for illustrative purposes only and are not intended for diagnostic use.

ClearRead CT CAC provides adjunctive information and is not intended to be used without clinical expert review.

ClearRead CT CAC is a computer aided quantification system intended to aid in the assessment of coronary artery calcification. The system receives chest Computed Tomography (CT) studies as input, in DICOM® format, and generates output in DICOM (or other) format.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Non-clinical testing: Approximately 400 cases. Data provenance is not specified, but it's referred to as "internal investigation."
• Clinical testing: 491 cases (143 cases with no CAC, 348 with CAC). The data included samples from four CT manufacturers across five clinical sites. The specific country of origin is not mentioned, nor is it explicitly stated whether the data was retrospective or prospective, though the mention of "cases collected and held out from development" suggests retrospective.

3. Number of Experts and Qualifications for Ground Truth

• Clinical testing: Three radiologists established the consensus ground truth review. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed in the provided text.

4. Adjudication Method for the Test Set

• Clinical testing: A "consensus ground truth review by three radiologists" was used. This implies that the three radiologists collectively determined the ground truth for each case. The specific mechanism (e.g., majority vote, discussion until agreement) is not specified, but it suggests a form of 3-reader consensus.

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

• No MRMC comparative effectiveness study was done. The study performed was a standalone model performance assessment comparing the algorithm's output to ground truth measurements. The document does not describe human readers improving with AI vs. without AI assistance.

6. Standalone Performance Assessment

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The document explicitly states: "This study was a standalone model performance assessment of ClearRead CT CAC."

7. Type of Ground Truth Used

• Clinical testing: "Consensus ground truth review by three radiologists." This is a form of expert consensus.

8. Sample Size for Training Set

• The sample size for the training set is not provided in the given document. The document mentions that approximately 400 cases were "held out from development of any kind to estimate the test performance," implying these were for the test set, not training.

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

• The document does not provide information on how the ground truth for the training set was established, as the details focus on the "held out" test set for performance estimation. For the test set, "Regions associated with coronary artery calcification were manually outlined, including the particular artery, from which the ground truth Agatston score was obtained."

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ClearRead CT is comprised of computer-assisted reading tools designed to aid the radiologist in the detection and characterization of pulmonary nodules during the review of screening and surveillance (low-dose) CT examinations of the chest on a non-oncological patient population. ClearRead CT requires both lungs be in the field of view and is not intended for monitoring patients undergoing therapy for lung cancer or limited field of view CT scans. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.

ClearRead CT Compare is a post-processing application which processes a prior chest CT to determine whether a nodule detected in the current exam was present in the prior exam using the same detection algorithm used on the current exam. ClearRead CT Compare requires both lungs to be in the field of view. ClearRead CT Compare provides adjunctive information and is not intended to be used without the original CT series and is only invoked on those patients where a prior exam exists and if a nodule is detected in the current exam. ClearRead CT Compare receives images according to the DICOM® protocol, processes the Lung CT series, and delivers the resulting information through the same DICOM network interface in conjunction with results provided for the current exam, specifically whether the nodule is present on the prior exam and if so, the percent volume change between the current and prior exam along with the volume doubling time. Series inputs are limited to Computed Tomography (CT). The ClearRead CT Compare Processor processes each prior series received. The ClearRead CT Compare output is sent to a destination device that conforms to the ClearRead CT DICOM Conformance Statement, such as a storage archive. ClearRead CT Compare does not support printing or DICOM media. ClearRead CT Compare is a product extension of our FDA cleared and marketed ClearRead CT device (K161201). The initial device contained ClearRead CT Vessel Suppress as well as ClearRead CT Detect. ClearRead CT (the base system), includes normalization, segmentation, and characterization of nodules, and provides the following key features: ● ClearRead CT Vessel Suppress aids radiologists by suppressing normal structures in the input chest CT series. . ClearRead CT Detect aids radiologists in the detection and characterizations of nodules in the input chest CT series. ● ClearRead CT Compare includes Scan Registration and Nodule Matching functions and adds the following key features: ClearRead CT Compare aids radiologists in ● tracking nodule changes over time, providing additional characterizations per nodule, including percent nodule change and volume doubling time.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Quantitative Nodule Matching Performance: A total of 900 nodules were used for assessment.
• Vessel Suppress Thicker Slice Evaluation: The same data previously used to assess vessel suppression performance for 1mm to 3mm slice thickness was used, extended to include 3.5mm, 4.0mm, 4.5mm, and 5.0mm.
• Clinical Performance Testing (Real Nodules): A 25-patient cohort containing 40 real nodules (42 actionable nodules identified by radiologists, with 39 having prior counterparts and 3 being new).

Data Provenance:
The document does not explicitly state the country of origin for the data. It also does not specify whether the data was retrospective or prospective for the 900 nodules or the vessel suppress evaluation. For the "clinical performance testing," the use of "real nodules" from a "25 patient cohort" suggests existing patient data, which is typically retrospective.

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

• Quantitative Nodule Matching Performance: The document does not explicitly state how the ground truth for the 900 nodules was established, nor the number or qualifications of experts involved. It only states that "detected nodules were split into three categories based on their attenuation pattern."
• Clinical Performance Testing (Real Nodules): Ground truth for the 42 actionable nodules was established by "the radiologist." The document uses "radiologist" in the singular, implying one expert, but does not provide specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for establishing the ground truth of the test sets. For the "clinical performance testing," it states "42 actionable nodules were ground-truthed by the radiologist," implying a single observer established the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers' improvement with AI vs. without AI assistance was not explicitly described or presented in the provided text. The studies focused on the performance of the ClearRead CT Compare algorithm itself, not its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented primarily focus on standalone (algorithm only) performance.

• The nodule matching performance tables (Tables 5.2 and 5.3) report the algorithm's match and mismatch rates.
• The VDT and % change calculation accuracy was checked against "manual computation," implying a comparison of algorithm output to a reference, not human interaction.
• The vessel suppress evaluation directly assesses the algorithm's output (residual changes).
• The "clinical performance testing" assessed the algorithm's ability to detect and match nodules and identify new ones, again without a human-in-the-loop component for the reported metrics.

The device's indication for use explicitly states it provides "adjunctive information and is not intended to be used without the original CT series," suggesting it is designed to aid radiologists, but the studies described focus on its internal performance metrics rather than its performance in an assisted reading workflow.

7. The Type of Ground Truth Used

• Quantitative Nodule Matching Performance: The type of ground truth used for the 900 nodules is not explicitly stated beyond classification by attenuation pattern.
• Volume Doubling Time and % Change Calculation: Manual computation of these values was used as ground truth.
• Vessel Suppress Performance for Thicker Slices: The ground truth for this evaluation appears to be based on a baseline performance (1mm data) and a predefined significance threshold for residual changes. The "residual analysis" implies comparing the algorithm's output to an expected or ideal output for vessel suppression.
• Clinical Performance Testing (Real Nodules): Expert radiologist assessment ("ground-truthed by the radiologist") was used to identify "actionable nodules" and their presence in prior scans.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set for any component of ClearRead CT or ClearRead CT Compare.

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

The document does not provide information regarding how the ground truth for the training set was established, as the training set details are not mentioned.

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ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of a pneumothorax 5 mm or larger; it makes case-level output available to a PACS/workstation for worklist prioritization or triage. Identification of cases suspected of containing a pneumothorax is not for diagnostic use beyond notification. ClearRead Xray Pneumothorax is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. The device does not replace review and diagnosis of the Xrays by trained professionals. The device is not intended to be used with plain film X-ray.

ClearRead Xray Pneumothorax is comprised of a computer assisted triaging tool, designed to prioritize chest X-rays based on the suspected presence of a pneumothorax (PTX) 5mm or larger. ClearRead Xray Pneumothorax requires both lungs to be in the field of view. ClearRead Xray Pneumothorax provides adjunctive information and is not intended to be used for diagnosis. ClearRead Xray Pneumothorax receives images according to the DICOM® protocol (via a standard IEEE 802.3 network connection), processes the image, and delivers the resulting information through the same DICOM network interface. Image inputs are limited to adult, digital frontal chest radiographs. The output results are sent to facilitate prioritization of chest Xrays for radiologist review on one or more devices that conform to the ClearRead Xray Pneumothorax DICOM Conformance Statement. ClearRead Xray Pneumothorax does not support printing or DICOM media.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: ClearRead Xray Pneumothorax (K213566)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" per se. However, it indicates key performance metrics that were measured and met through the clinical evaluation. The primary objective was to demonstrate the device meets or exceeds expected performance. The specific metrics, measured on an independent test set, and their reported values are:

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