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ProFound Detection V4.0 is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting Physician.

ProFound Detection V4.0 is a computer-assisted detection and diagnosis (CAD) software device that detects malignant soft-tissue densities and calcifications in digital breast tomosynthesis (DBT) images. The ProFound Detection V4.0 software allows an interpreting physician to quickly identify suspicious soft tissue densities and calcifications by marking the detected areas in the tomosynthesis images. When the ProFound Detection V4.0 marks are displayed by a user, the marks will appear as overlays on the tomosynthesis images. Each detected finding will also be assigned a "score" that corresponds to the ProFound Detection V4.0 algorithm's confidence that the detected finding is a cancer (Certainty of Finding). Certainty of Finding scores are a percentage in range of 0% to 100% to indicate CAD's confidence that the finding is malignant. ProFound Detection V4.0 also assigns a score to each case (Case Score) as a percentage in range of 0% to 100% to indicate CAD's confidence that the case has malignant findings. The higher the Certainty of Finding or Case Score, the higher the confidence that the detected finding is a cancer or that the case has malignant findings.

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

Acceptance Criteria and Device Performance

The core acceptance criterion is non-inferiority to the predicate device (ProFound AI V3.0) on key performance metrics.

Table of Acceptance Criteria and Reported Device Performance

Summary of Performance vs. Criteria:
The study demonstrated that ProFound Detection V4.0, particularly when using prior images, achieved superior performance across all three metrics (Sensitivity, Specificity, and AUC) compared to the predicate device, thus meeting the non-inferiority acceptance criteria and additionally showing superiority in specificity.

Study Details

2. Sample size used for the test set and the data provenance:

• Sample Size: 952 cases
  • 251 biopsy-proven cancer cases (with 256 malignant lesions)
  • 701 non-cancer cases
• Data Provenance:
  • Country of Origin: U.S. image acquisition sites
  • Retrospective or Prospective: Retrospectively collected
  • Independence: The data was collected from sites independent of those included in the training and development sets. iCAD ensured this independence by sequestering the data.
  • Manufacturer: 100% Hologic DBT system exam data.
  • Exam Dates: 2018 - 2022.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: The text states, "Each cancer case was a biopsy proven positive, truthed by an expert breast imaging radiologist". While it explicitly mentions "an expert breast imaging radiologist" in the singular for truthing, it does not specify the exact number of unique "expert breast imaging radiologists" involved in truthing the entire dataset or their specific years of experience.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• The text does not specify a formal adjudication method (like 2+1 or 3+1) for establishing ground truth from multiple readers. Ground truth was established based on clinical data including radiology report, follow-up biopsy, and pathology data, and then truthed by an expert radiologist.

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:

• No, an MRMC comparative effectiveness study was NOT done. The study described is a standalone performance assessment of the AI algorithm itself, comparing it to a predicate AI algorithm. It does not evaluate the performance of human readers, either with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone study was done. The text explicitly states: "A standalone study was conducted, which evaluated the performance of ProFound Detection version 4.0 without an interpreting physician." This study directly compared the algorithm's performance (V4.0) against the predicate (V3.0) on an independent test set.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth was a combination of biopsy-proven pathology data and clinical data, including radiology reports and follow-up data. Specifically, "These reference standards were derived from clinical data including radiology report, follow-up biopsy and pathology data. Each cancer case was a biopsy proven positive, truthed by an expert breast imaging radiologist who outlined the location and extent of cancer lesions in the case."

8. The sample size for the training set:

• The sample size for the training set is not provided. The text only refers to the test set being "independent of those included in the training and development" and that iCAD "ensures the independence of this dataset by sequestering the data and keeping it separate from the test and development datasets."

9. How the ground truth for the training set was established:

• How the ground truth for the training set was established is not explicitly detailed. The text mentions that the test set's ground truth was established by "biopsy proven cancer cases" and "truthed by an expert breast imaging radiologist." While it implies a similar process would likely be used for training data, the specific method for the training set's ground truth establishment is not provided in the submitted document.

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PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not a diagnostic aid.

PowerLook Density Assessment 4.0 is a software application intended for use with mammography exams containing synthetic 2D images generated from Digital Breast Tomosynthesis (DBT) data. The PowerLook Density Assessment software assesses breast tissue composition and provides a breast density category aligned with BI-RADS® 5th Edition density lexicon. The PowerLook Density Assessment 4.0 algorithm is designed to be used with cases containing up to four synthetic 2D views. When exams contain only DBT and synthetic 2D images generated from DBT, the 4.0 algorithm is used. The PowerLook Density Assessment software is designed to work in conjunction with iCAD's PowerLook DICOM server platform, which is a Class I exempt medical device. The PowerLook Density Assessment 4.0 utilizes data management capabilities of PowerLook for controlling input to and output from the PowerLook Density Assessment algorithm. Results of the PowerLook Density Assessment software application can be displayed on a mammography review workstation, mammography reporting application or radiology information system (RIS), or printed case report.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the PowerLook Density Assessment V4.0.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission for PowerLook Density Assessment V4.0 (K211506) does not explicitly state numerical acceptance criteria in terms of metrics like accuracy, sensitivity, or specificity. Instead, it refers to a qualitative acceptance criteria: "The performance of the system on all three datasets were above the desired performance, demonstrating that PowerLook Density Assessment 4.0 accurately calculates the BI-RADS breast density category for Hologic C-View and GE V-Preview data."

However, based on the nature of breast density assessment devices, the implicit acceptance criteria would typically involve a high level of agreement between the device's output and expert-determined ground truth, particularly concerning the assignment of ACR BI-RADS breast density categories. While specific percentages are not provided, the claim of "accurately calculates" suggests that substantial agreement was achieved.

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

• Sample Size for Test Set: The document does not specify the exact number of cases (images/patients) used in the test set. It mentions "Hologic C-View, GE V-Preview V3 and GE V-Preview V4.1 cases were run through Density Assessment 4.0."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

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

The document does not specify the number of experts used or their qualifications (e.g., years of experience as a radiologist) for establishing the ground truth for the test set. It implicitly refers to "BI-RADS® 5th Edition density lexicon," suggesting that expert radiologists were involved in the ground truth labeling process, as this lexicon is used by radiologists.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set ground truth.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is an effect size for human readers improving with AI assistance. The device is intended to provide "adjunctive information" to aid healthcare professionals, rather than directly assisting in a diagnostic reading task where reader performance would be measured.

6. Standalone Performance

Yes, a standalone performance study was done. The document states: "The performance of the system on all three datasets were above the desired performance, demonstrating that PowerLook Density Assessment 4.0 accurately calculates the BI-RADS breast density category for Hologic C-View and GE V-Preview data." This indicates that the algorithm's performance was evaluated independently in calculating the breast density categories.

7. Type of Ground Truth Used

The ground truth used is based on the ACR BI-RADS Atlas 5th Edition breast density category. This strongly implies expert consensus or expert-assigned categories, as radiologists are trained to use this lexicon.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It primarily focuses on the validation of the device.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. However, given the device's function and the ground truth used for validation (BI-RADS 5th Edition), it is highly probable that the training data's ground truth was also established by expert radiologists adhering to the same BI-RADS lexicon.

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PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not a diagnostic aid.

The PowerLook Density Assessment Software analyzes digital breast tomosynthesis 2D synthetic images to calculate the dense tissue area of each breast. The measured dense tissue area is then used to provide a Category of 1-4 consistent with ACR BI-RADS 5th edition a-d. The top-level design sub-systems are as follows: Initialization, Breast Segmentation, Breast Thickness Correction, and Breast Density Computation. The assessment results in a final density map and, in conjunction with its pixel size (in square cm), is used to compute the area of the dense tissue (square cm). The area of the breast (square cm) is computed by counting the total number of pixels in the valid regions of the breast segmentation mask). The ratio of the dense area to the total breast area gives the percent breast density (PBD) for the given view. The dense areas, breast areas, percent breast densities, and dispersion for the CC and MLO views are averaged in order to report measurements for each breast. The average PBD and the average dispersion are then taken, and mapped to a density category from 1 through 4 consistent with ACR BI-RADS 5th edition a-d for each breast, using a set of calibrated boundaries. The higher category of the two breasts is reported as the overall case score. The PowerLook Density Assessment is designed as a stand-alone executable operating within the larger software framework provided by PowerLook AMP. As such, the PowerLook Density Assessment software is purely focused on processing tomosynthesis 2D synthetic images and is not concerned with system issues such as managing DICOM image inputs or managing system outputs to a printer, PACS or Mammography Workstation. The PowerLook Density Assessment software is automatically invoked by PowerLook AMP. The results of PowerLook Density Assessment are designed to display on a mammography workstation, high resolution monitor, or in a printed case report. PowerLook Density Assessment is designed to process approximately 60-120 cases per hour.

Here's a summary of the acceptance criteria and the study details for the PowerLook Density Assessment Software, based on the provided FDA 510(k) document:

Acceptance Criteria and Device Performance

The document states that the PowerLook Density Assessment Software performed "substantially equivalent to the predicate device." While specific numerical acceptance criteria (e.g., minimum kappa score, percentage agreement) are not explicitly listed in the provided text as pass/fail thresholds, the performance was assessed based on:

• Kappa score: A statistical measure of inter-rater agreement, commonly used for categorical data.
• Percent correct in each BI-RADS category: Measures the accuracy of the software's classification into each of the four BI-RADS density categories (1, 2, 3, 4).
• Combined A/B and C/D BI-RADS categories: Assesses performance when categories are grouped (e.g., non-dense vs. dense).

The document states: "PowerLook Density Assessment performed substantially equivalent to the predicate device." This implies that the device's performance metrics were within an acceptable range compared to the already cleared predicate.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in the provided text. The document mentions "a set of digital breast tomosynthesis synthesized 2D images."
   • Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study used "digital breast tomosynthesis synthesized 2D images from." It is retrospective, as it refers to images for which BI-RADS scores "were obtained from radiologists."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not explicitly stated. The document mentions "BI-RADS scores were obtained from radiologists." It does not specify if this was a single radiologist or multiple.
   • Qualifications of Experts: The experts are identified as "radiologists." No specific experience level (e.g., "10 years of experience") is provided.

3. Adjudication method for the test set:

   • The document states that BI-RADS scores "were obtained from radiologists," but it does not specify an adjudication method (such as 2+1, 3+1, or none) for determining a consensus ground truth if multiple radiologists were involved.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study primarily focused on the standalone performance of the PowerLook Density Assessment Software against radiologist assessments (ground truth). It did not describe a scenario where human readers' performance with and without AI assistance was compared.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone study was performed. The described validation involved running the "PowerLook Density Assessment Software... followed by a comparison of the results between the predicate results, desired results, and observed performance..." This indicates the algorithm's performance was evaluated independently against the established ground truth.

6. The type of ground truth used:

   • Expert Consensus (Radiologist BI-RADS Scores): The ground truth was established by "BI-RADS scores... obtained from radiologists." This implies the radiologists' interpretations served as the reference standard for breast density categorization.

7. The sample size for the training set:

   • Not specified. The document does not provide any information regarding the training set's sample size or characteristics.

8. How the ground truth for the training set was established:

   • Not specified. Since information about the training set size or its establishment is absent, the method for establishing ground truth for training data is also not provided.

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The Axxent Cervical Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.

The Axxent Cervical Applicator is a component of the Axxent Electronic Brachytherapy System (cleared under K122951) which utilizes a proprietary miniaturized X-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR X-ray source to deliver high-dose rate, low energy radiation treatment to the uterus, cervix, endometrium and vagina. The Axxent HDR X-ray source mimics the penetration and dose characteristics of Iridium-192.

The Axxent Cervical applicator is provided non-sterile and can be reused. The user must sterilize the device using steam sterilization before each use. An Applicator Clamp is a required accessory to stabilize the Cervical Applicator during radiation treatment.

The provided document is a 510(k) premarket notification for the Axxent® Cervical Applicator, primarily focused on adding MRI compatibility and MR Conditional labeling. It is not an AI/ML device, and therefore, many of the requested criteria related to AI/ML device performance and studies are not applicable.

However, I can extract information related to the acceptance criteria and the study performed for the MRI compatibility of the device, as that is the specific new claim being sought.

Here's the information regarding the MRI compatibility study:

1. A table of acceptance criteria and the reported device performance

Note: The document states that the results of the testing "indicated that, in accordance with the guidance of relevant ASTM standards, Xoft's Cervical Applicator should be labeled MR Conditional." This implies that the device successfully met the established thresholds and requirements outlined in each ASTM standard for magnetic displacement, torque, artifact, and heating, thereby qualifying for MR Conditional labeling. Specific numerical thresholds or measured values are not provided in this summary.

2. Sample sized used for the test set and the data provenance

• Sample size: "Test samples were provided in their final manufactured condition." The exact number of samples tested is not specified, but it implies a sufficient number of devices were used for each test to achieve reliable results as per the ASTM standards.
• Data provenance: Not explicitly stated, but given it's a submission to the FDA by a US-based company, the testing was likely conducted in a controlled laboratory environment, presumably in the US. It is a prospective study as tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable as this is a device compatibility test, not an AI/ML diagnostic or prognostic study requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" here is adherence to engineering standards for MRI safety.

4. Adjudication method for the test set

• Not applicable. This involves objective physical measurements and adherence to ASTM standards, not subjective interpretation requiring adjudication among experts.

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

• Not applicable. This is not an AI/ML device and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" in this context is established by the ASTM consensus standards (ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182) for evaluating MRI compatibility. Performance is judged against the objective physical criteria and thresholds defined within these standards.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no training set.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device; there is no training set.

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The Axxent® Electronic Brachytherapy System is a high dose rate Brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated.

The Axxent Electronic Brachytherapy System consists of three primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Source); and an Axxentcompatible applicator (Applicator). The System is designed to deliver doses of X-ray radiation to the tissue in proximity to the applicator using a disposable, miniature X-ray tube powered by the Controller.

The Axxent Electronic Brachytherapy Controller is a mobile, computer-controlled platform that is responsible for the overall operation of the System. The Controller is designed to work with the Source, which is a disposable, miniature X-ray tube located at the end of a flexible cable. The Source is inserted into a lumen of the appropriate Applicator.

Here's an analysis of the provided text regarding the Axxent Electronic Brachytherapy System, focusing on acceptance criteria and study details.

Important Note: The provided text is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices and general safety/effectiveness. It does not contain the detailed information typically found in a clinical study report addressing specific performance metrics, sample sizes for ground truth, expert qualifications, or MRMC studies for AI devices. This device is a radiation therapy system, not an AI-powered diagnostic tool, so many of the requested categories (like MRMC, standalone AI performance, and AI-specific ground truth details) are not directly applicable or reported in this type of submission.

Acceptance Criteria and Reported Device Performance

Given that this is a radiation therapy system and the submission focuses on substantial equivalence, the "acceptance criteria" here refer more to the successful demonstration of the device meeting its performance, functional, and system requirements during verification and validation testing, rather than specific diagnostic accuracy metrics.

Study Details (Based on Available Information)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in the provided documents. The validation testing likely involved a series of engineering and functional tests on the device itself, rather than a "test set" of patient data in the way an AI diagnostic device would.
   • Data Provenance: Not applicable in the context of patient data for a performance study. The "data" here refers to the outcomes of the engineering and software validation tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not directly applicable to a hardware/software system validation in the way it would be for a diagnostic AI system requiring expert consensus on images. The "ground truth" for this device's performance would be established by engineering specifications and regulatory standards. Expert oversight would be from the development and testing engineers and regulatory affairs personnel within iCAD/Xoft.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy to resolve discrepancies between readers, particularly for ground truth establishment or comparative reader performance. This submission describes performance and functional testing of a radiation delivery system.

4. 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:

   • No MRMC study was done or reported. This device is a therapeutic device (radiation delivery system), not an AI-assisted diagnostic tool. Therefore, human reader (e.g., radiologist) improvement with AI assistance is not a relevant metric for this submission.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Standalone performance (algorithm only) is partially relevant in that the device's control system and dose delivery algorithm operate in a "standalone" fashion to execute a treatment plan. The "Assessment of Non-Clinical Performance Data" indicates "Validation testing was performed according to a Software System Test Plan. All performance, functional and system requirements were met." This implies the software and system were tested independently to ensure they meet their specifications. However, this is not an "AI algorithm only" performance as conceptualized for diagnostic AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the device's function and performance is its adherence to predefined engineering specifications, design requirements, and regulatory standards. This is assessed through various verification and validation tests (e.g., electrical safety, radiation output accuracy, software functionality, mechanical integrity). For safety, a risk analysis identifies potential hazards.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning system that requires a "training set" of data for model development. Its software and control algorithms are developed through traditional engineering and programming methods.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of medical device as described in the provided document.

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The VersaVue™ Enterprise Suite consists of the MR Analysis Server software and the VersaVue Enterprise Workstation software.

The MR Analysis Server software, which includes the SpectraLook®, VividLook® and OmniLook modules is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.

The VersaVue Enterprise Workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.

The VersaVue Enterprise Suite serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the Suite's underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.

The VersaVue Enterprise Suite is intended for post-processing of MR datasets to provide a reliable means for visualizing MR datasets and supports the evaluation of dynamic and non-dynamic MRI datasets. It is also designed to provide study review and mathematical. and/or statistical analysis. The VersaVue Enterprise Suite serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis.

The VersaVue Enterprise Suite consists of the following two products; each product in turn incorporates individual modules:

1. MR Analysis Server Software_consists of:

• SpectraLook, for Breast MR analysis .
• VividLook, for Prostate MR analysis .
• OmniLook, for analysis of other MR datasets .
• 2. VersaVue Enterprise Workstation Software
  • PrecisionPoint, for MR Breast Interventional Planning (K090223) o

The MR Analysis Server Software is intended to be used as a post-processing software package designed to provide a reliable means for visualizing MR data. The data analysis supports the evaluation of dynamic and non-dynamic MR datasets. The MR Analysis Server software also analyzes contrast enhanced magnetic resonance imaging (DCE-MRI) studies. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained. physician the information provided by the software yields information that may assist in the interpretation of dynamic contrast enhanced studies.

The VersaVue Enterprise Workstation Software is intended for use in conjunction with SpectraLook, VividLook and OmniLook MR post-processing analysis software to provide study review and additional mathematical and/or statistical analysis. The Workstation software does not change the SpectraLook, VividLook or OmniLook software algorithm or the image series produced by the algorithm. It supports the analysis and presentation of the original MR datasets and the results generated by the software algorithm and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.

The Workstation software also works with iCAD's PrecisionPoint Breast Interventional biopsy software. The Breast Interventional Planning Software cleared under K090223 integrates intervention planning ability into the existing iCAD viewing workstation, allowing physicians to read images followed by subsequent planning of MRI-guided percutaneous breast biopsies and other interventional procedures. Biopsy planning, puidance and all necessary documentation are generated through the same Workstation interface.

The provided text describes modifications to an existing device, the VersaVue Enterprise Suite, and claims substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) Summary for a Special 510(k) Device Modification. This type of submission typically focuses on demonstrating that changes to an already cleared device do not alter its fundamental scientific technology, intended use, or safety and effectiveness, by showing equivalence to previously cleared predicates or the modified version of the same device. It does not generally include detailed performance studies with acceptance criteria as would be found in a de novo or traditional 510(k) submission for a novel device or significant change.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

The text does state:

• "Validation testing was performed according to a Software System Test Plan. All performance, functional and system requirement were met. Test data was used that met the requirements to validate system performance." (Page 4, Section 6.7)

This generally indicates that internal testing was conducted to ensure the software functions as designed and that changes introduced by the modification did not negatively impact its operation. However, no specific metrics, acceptance criteria, or study details are provided.

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iCAD's VeraLook™ CTC CAD is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.

The VeraLook is a software-based CAD system for detecting the location and extent of polyps in CTC exams. The product is intended to receive CTC images in standard DICOM format from any 3D workstation manufacturer, perform automated analysis on the images to identify polyps, and then produce information about the identified regions that can be received and displayed by CTC review workstations to help radiologists in the detection of polyps.

This looks like a medical device submission, specifically a 510(k) summary for iCAD's VeraLook™ CTC CAD Software. The provided text doesn't contain a detailed study report with specific acceptance criteria and performance metrics. Instead, it offers a high-level overview of the device, its intended use, and a general statement about clinical data being supplied to satisfy the FDA's requirements.

Therefore, I cannot populate all the requested information directly from the provided text. I can only extract what is explicitly stated or can be reasonably inferred. Many of the requested details (like sample sizes, number of experts, adjudication methods, ground truth types for training and testing, and specific performance metrics) are not present in this summary document.

Here's a response based on the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary states that "iCAD has supplied clinical data in addition to bench testing and simulations to assess safety and effectiveness of this claim" (referring to the claim of identifying "additional potential polyps that may not have been identified on initial review"). However, the summary does not provide specific acceptance criteria or the detailed results of that study.

Based on the provided text, the specific acceptance criteria and the detailed study proving the device meets them are not described. The summary only mentions that clinical data was supplied to address potential safety and effectiveness issues related to the device's specific claim.

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be fully populated from the provided text. The document does not list specific acceptance criteria (e.g., sensitivity, specificity thresholds) nor does it provide a table of reported device performance metrics against such criteria.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally states that "clinical data was supplied."

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

The provided text does not specify the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The provided text does not explicitly state whether an MRMC comparative effectiveness study was done. It mentions the intent to identify "additional potential polyps that may not have been identified on initial review," which suggests an assist-read paradigm, but the details of such a study are not included. Therefore, the effect size of human readers' improvement with AI vs. without AI assistance is not provided.

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

The provided text does not explicitly state whether a standalone (algorithm only) performance study was done. The indication for use describes the device as providing "highlighted" polyps "after initial review of the CTC exam," implying human-in-the-loop performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The provided text does not specify the type of ground truth used for either the test set or the training set.

8. The Sample Size for the Training Set

The provided text does not specify the sample size for the training set.

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

The provided text does not describe how the ground truth for the training set was established.

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The iCAD Breast Interventional Planning Software supports the use of interventional breast coils and MR stereotactic localization devices to perform magnetic resonance (MR) guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates. the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion relative to the interventional device.

The iCAD Breast Interventional Planning Software (BIPS) is intended to extract certain image information and display them to a user. The software allows the user to select a target lesion in the breast as well as fiducial markers, and get accurate information about the optimal positioning of the biopsy needle or other interventional device, including visualization of the appropriate position, distances and other applicable settings. iCAD's BIPS is a software tool, which can assist the radiologist in planning and performing MRI guidance of percutaneous breast biopsies and other interventional procedures. When interpreted by a skilled physician, this device provides information that may be useful in interventional planning and monitoring.

The BIPS is a DICOM 3.0 compliant post-processing software package for viewing magnetic resonance imaging (MRI) data sets and supporting interventional breast coils and MR stereotactic localization devices when performing MRI-guided breast interventional procedures.

The provided document, K090223, primarily serves as a 510(k) summary for the iCAD Breast Interventional Planning Software. It establishes substantial equivalence to predicate devices and outlines the device's intended use and technological characteristics.

Crucially, this document does not include detailed information about specific acceptance criteria, a standalone performance study with metrics, or an MRMC comparative effectiveness study. The regulatory submission focuses on demonstrating equivalence to previously cleared devices rather than presenting novel performance data against predefined criteria.

Therefore, many of the requested items cannot be extracted directly from this document. However, I can provide the information that is available and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary states that "Test data was supplied that met the requirements of the Software Test Plan and Software Unit Test Plan," but it does not specify what those requirements (acceptance criteria) were or what the actual test data showed in terms of quantitative performance (e.g., accuracy of calculations, efficiency gains, etc.).

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

This information is not provided in the document. The document mentions "Test data was supplied," but it does not specify the size of the test set or the origin of the data (e.g., country, retrospective/prospective).

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

This information is not provided in the document. The document refers to the device assisting a "skilled physician" but does not detail any expert involvement in establishing ground truth for testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. The regulatory submission primarily focuses on the device's technical equivalence and functionality rather than comparative effectiveness studies with human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study with specific metrics is not explicitly described in the document. The submission states that testing was done to meet software test plan requirements, implying some form of standalone validation of the software's calculations and features, but no detailed performance report is included.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document for any testing.

8. The Sample Size for the Training Set

This information is not provided in the document. Given the description focusing on calculations based on user-selected points and fiducial markers, it's possible the software relies on deterministic algorithms rather than a machine learning model that would require a "training set" in the conventional sense. If machine learning was used, the training set size is not disclosed.

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

This information is not provided in the document. (Please see point 8 regarding the potential absence of a traditional "training set.")

Summary of Device and Regulatory Context (Based on Provided Document):

• Device Name: iCAD Breast Interventional Planning Software (BIPS)
• Purpose: Assists radiologists in planning and performing MRI-guided percutaneous breast biopsies and other interventional procedures. It extracts image information, allows users to select target lesions and fiducial markers, and calculates optimal positioning (location and depth) for interventional devices.
• Regulatory Path: 510(k) Premarket Notification (K090223).
• Predicate Devices: CADstream™ Version 4.0 (Confirma, Inc.), DynaCAD™ V1.0 (MRI Devices Corporation), MICS Intervention Aid (Machnet BV).
• Basis for Clearance: Substantial equivalence to these predicate devices, based on same intended use, principles of operation, and characteristics, with differences primarily in visual interface design that do not raise new questions of safety or efficacy.
• Safety and Effectiveness Concerns Addressed: Risk management via risk analysis, controls through software development, verification, and validation testing.
• Performance Data Mentioned: "Test data was supplied that met the requirements of the Software Test Plan and Software Unit Test Plan." This indicates internal validation, but the details of the performance are not public in this filing.

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