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A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.

The TrueView 200 Pro-US is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised. The TrueView 200 Pro-US includes the following major components: system monitor, touch-screen control display, and an imaging cabinet.

This all-in-one system includes shielding that is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters for easy transportation.

The provided document is a 510(k) premarket notification for the TrueView 200 Pro-US Specimen Radiography System. It primarily focuses on demonstrating substantial equivalence to a predicate device (TrueView 100 Pro) rather than describing a study proving the device meets specific acceptance criteria for AI performance.

Therefore, many of the requested details, particularly those related to AI algorithm performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, specific acceptance criteria for AI metrics), are not present in this document. This device is a cabinet X-ray system, suggesting it's hardware for imaging, not an AI-powered diagnostic tool. The document doesn't mention any AI components or algorithms that would require such specific performance testing.

Here's what can be extracted from the document, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of AI performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating compliance with recognized standards and functional performance of the radiography system.

• IEC 61010-2-091:2019
• IEC 61010-2-101:2018
• IEC 61326-1 Edition 3.0 2020-10
• IEC 61326-2-6 Edition 3.0 2020-10
• ISTA 3B-2017
• 21 CFR 1020.40 | Complies with applicable IEC-61010 standards (general electrical safety including mechanical hazards plus particular standards for cabinet x-ray systems) and international EMC standards. Compliance demonstrated by Intertek (third-party test house). |
  | Functional Performance (Bench Testing) | - Functional testing
• Usability testing | Successfully performed design control verification tests and validation tests. Results support substantial equivalence. |
  | Imaging Performance Parameters | - Limiting Spatial Resolution
• Output Image
• Display Monitor
• Time to Preview
• Cycle Time | - 10 lp/mm
• 14-bit image data
• 2.3 MP High luminescence diagnostic monitor

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A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.

The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised. The TrueView Core 100Pro-US includes the following major components: touch-screen control display, and an imaging cabinet. This all-in-one system includes shielding that is incorporated within the cabinet chamber system design, eliminating the need for separate shielding.

The provided FDA submission for the TrueView Core 100Pro-US Core Specimen Radiography System is not an AI/ML device. It is a cabinet X-ray system used for digital X-ray imaging of surgical and core biopsy specimens. Therefore, the specific criteria requested for AI/ML devices regarding acceptance criteria, study details, human reader improvement, and ground truth establishment (for training/test sets) are not applicable to this submission.

The document discusses performance data related to the device's electrical safety, mechanical hazards, and electromagnetic compatibility, as shown by compliance with IEC 61010 standards and various functional and usability tests.

Here is a summary of the information that is applicable and found in the document:

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

The document primarily focuses on compliance with standards rather than specific acceptance criteria in the context of diagnostic accuracy for AI/ML.

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The Solas OR is a cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, the time the patient needs to be under examination.

The Solas OR cabinet x-ray system is a self-contained, direct-detection digital imaging system for imaging small to medium surgical and biopsy specimens. The system is comprised of the x-ray cabinet, optional cart and the PC with DICOM compliant software which provides the user interface, the means to enter patient details (either directly or from a DICOM Modality Worklist, if available) and the means to acquire, review and save or transmit DICOM images to the Picture Archiving and Communication System (PACS). The cabinet incorporates shielding and interlock circuits to meet regulatory requirements. The cabinet cart is mounted on casters to allow for easy transportation.

Specimen radiography units are utilized to confirm removal of the intended tissue, lesion, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution x-ray image of the specimen, the presence of a lesion, marker or calcification in the extracted sample can be confirmed by the user reviewing the digital image.

The provided text does not contain detailed acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) Summary for the Solas OR, focusing on its substantial equivalence to a predicate device.

However, I can extract the information that is present and indicate what is missing:

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

The document mentions compliance with various standards and image quality tests. Here's a table based on the information provided, noting that specific numerical acceptance criteria and direct performance metrics against those criteria are not detailed:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "Non-Clinical Testing included image quality tests with accredited phantom test objects and High Contrast resolution targets" and that "the device performance has been benchmarked against the predicate in a clinical setting," but no details on sample size or data provenance for these tests are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The text indicates "benchmarked against the predicate in a clinical setting," but does not mention expert involvement or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes the device as a "cabinet X-ray system used to provide digital X-ray images." It is a hardware device for image acquisition, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" is not applicable and not mentioned. The benchmarking mentioned is against a predicate device, not in the context of human reader performance with or without AI.

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

The device is an imaging system, not an algorithm, so this question is not directly applicable in the context of "algorithm only." The document states, "Non-Clinical Testing included image quality tests with accredited phantom test objects and High Contrast resolution targets," which implies standalone performance evaluation of the imaging system's technical specifications.

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

This information is not explicitly stated for the "benchmarking against the predicate in a clinical setting." For the non-clinical tests, "accredited phantom test objects and High Contrast resolution targets" were used, which serve as a form of ground truth for image quality measurements.

8. The sample size for the training set

This device is an X-ray imaging system, not an AI/machine learning model that typically requires a "training set." Therefore, the concept of a training set sample size is not applicable in the context of the information provided for this device.

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

As the device is an X-ray imaging system and not an AI/machine learning model, the concept of a "training set" and its associated ground truth establishment is not applicable here.

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The MOZART® Supra® Specimen Tomosynthesis System is a cabinet X-ray system that is used to provide 2-dimensional and 3-dimensional tomographic digital X-ray images of harvested specimens from various anatomical regions.

The MOZART SUPRA (XPERT84) Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens both in two-dimensional and three-dimensional tomosynthesis views.

• It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology.
• Creates images in 1mm digital slices of the specimen, allowing physicians to evaluate the specimen layer by layer.
  Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these slices multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.
  Tomosynthesis provides visualization of human anatomy by
• 1. Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a two dimensional presentation, and
• 2. Producing a number of slice images throughout the entire volume of the anatomy
     The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software.
     To support the Tomosynthesis application, the predicate device, MOZART SUPRA (XPERT84), K200756, has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock X-ray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and an Amorphous Selenium detector mounted stationary in the bottom of the cabinet xray unit

The Kubtec MOZART SUPRA (XPERT 84) Radiography System is a Cabinet X-ray System for generating 2D and 3D tomographic digital X-ray images of harvested specimens.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document only mentions "excised breast biopsies" for clinical validation and "line-pair gauges and phantoms" for internal validation. No specific number of cases or images for the test set is provided.
• Data Provenance: The data provenance for the clinical validation is "reads of excised breast biopsies by a board certified radiologist." This implies retrospective processing of existing biopsies, but does not specify the country of origin. The data for line-pair gauges and phantoms would be generated during internal testing.

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

• Number of Experts: "A board certified radiologist" (singular) is mentioned for the clinical validation.
• Qualifications: "board certified radiologist." No specific years of experience are provided.

4. Adjudication Method for the Test Set

• Given that only a single board-certified radiologist is mentioned for clinical validation, there is no adjudication method described beyond the single expert's assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The document describes a substantial equivalence submission, which typically focuses on demonstrating that the new device performs as well as, or is equivalent to, legally marketed predicate devices, rather than comparing human reader performance with and without AI assistance.

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

• The document describes a radiographic system that produces images, not an AI algorithm for image interpretation. Therefore, the concept of a "standalone" AI algorithm performance is not applicable in this context. The device's performance relates to the quality of the images it produces. The software (DIGICOM) primarily handles image processing and DICOM functionalities, not autonomous diagnostic interpretation.

7. The Type of Ground Truth Used

• For clinical validation reported, the ground truth was established by an expert assessment ("reads of excised breast biopsies by a board certified radiologist").
• For technical performance validation (resolution, DQE, MTF), the ground truth relies on physical measurement standards using "line-pair gauges and phantoms."

8. The Sample Size for the Training Set

• The document does not describe a "training set" in the context of an AI algorithm learning from data. The device is a radiographic system, and its software (DIGICOM) is for image handling and processing, not for AI-driven image analysis that requires a training set.

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

• As there is no mention of a training set for an AI algorithm (see point 8), this question is not applicable.

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The MOZART (XPERT42) is a Cabinet x-ray system that is used to provide two dimensional and three dimensional tomographic digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. It is not used for mammography

The MOZART Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens both in two-dimensional and three-dimensional tomosynthesis views. It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology. Creates images in 1mm digital slices of the specimen, allowing physicians to evaluate the specimen layer by layer. It has been clinically proven for the following: Provides more anatomical information than single planar 2-D imaging alone. The subject x-ray cabinet system Kubtec Mozart Xpert 42 is not intended for mammography. Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of inters (ROI). To produce these slices multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices. Tomosynthesis provides visualization of human anatomy by Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a two dimensional presentation, and Producing a number of slice images throughout the entire volume of the anatomy. The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software. To support the Tomosynthesis application, the predicate device, MOZART (XPERT42), has a low-voltage screw drive linear actuator installed in the enclosed head of the cabinet with the same 50 kVp monoblock Xray tube as the predicate to allow motion of the X-ray source to capture the multiple projection images and an Amorphous Selenium detector mounted stationary in the bottom of the cabinet x-ray unit.

This document describes a 510(k) premarket notification for the KUBTEC MOZART (XPERT42) system, a cabinet x-ray system for imaging excised specimens. The 510(k) submission seeks to demonstrate substantial equivalence to a previously cleared device (K183624, also KUBTEC MOZART (XPERT42)) despite a change in detector technology. This is a notification for a device change rather than a new AI/CAD system. Therefore, much of the requested information regarding AI study design (like ground truth establishment, training sets, multi-reader multi-case studies, and specific performance metrics like F1-score or AUC) is not applicable or explicitly stated in this type of submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a medical imaging system with a component change), "acceptance criteria" primarily relate to safety, effectiveness, and substantial equivalence to a predicate device. Performance is generally demonstrated by showing that the new component (Amorphous Selenium detector) is comparable or improved in relevant technical specifications compared to the old component (CMOS detector), without adversely affecting the overall device's stated indications for use.

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

The document does not describe a clinical study in the traditional sense with a "test set" of patient data. This is a 510(k) for a device modification, relying on technical comparison and a claim of substantial equivalence to a predicate device. Therefore, there is no mention of a specific test set formed from clinical images or data provenance in this context. The evaluation is based on technical specifications and conformance to standards.

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

Not applicable. As noted above, this submission focuses on device modification and substantial equivalence based on technical specifications and safety standards, not on a clinical performance study using expert-derived ground truth.

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

Not applicable. No clinical test set and thus no adjudication method described.

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 device is not an AI/CAD system used to assist human readers, nor is an MRMC study described. It is a specimen imaging system.

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

Not applicable. This is not an algorithm-only device. It is a hardware imaging system.

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

Not applicable. As explained, the submission is about a detector change in an x-ray system, not about the diagnostic accuracy of the images produced using a specific ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set for an algorithm.

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

Not applicable. There is no training set for an AI/ML algorithm.

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The Kubtec XPERT 80 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. It is not used for mammography

The XPERT 80 Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Kubtec DIGICOM Specimen Radiography software. It has been designed to comply with 21 CFR 1020.40.

The provided text is a 510(k) Summary for the Kubtec XPERT 80 Specimen Radiography System. It details the device, its intended use, and its substantial equivalence to predicate devices, but does not contain information about the acceptance criteria or a study proving the device meets those criteria, especially in the context of AI performance or human-in-the-loop studies.

The document discusses:

• Device Description: The XPERT 80 Specimen Radiography System is a Cabinet X-ray System for high-detail radiographic imaging of surgically excised medical specimens.
• Comparison to Predicate Devices: The key difference from the primary predicate (K071233) is the addition of an Amorphous Selenium detector. The document asserts that this new detector's performance has been verified and cleared via 510(k) K193166 as incorporated into the Siemens MAMMOMAT Revelation.
• Standards Compliance: The device successfully completed internal and external safety testing to various IEC, ISO, NEMA, and CFR standards related to medical electrical equipment, software life cycle processes, risk management, and radiation safety.
• Conclusion: The device is considered as safe and effective as the predicate device, with technological differences limited to the detector type, and no new indications for use.

Therefore, I cannot provide the requested information from the given text as it does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance for such a test.
3. Number of experts or their qualifications.
4. Adjudication methods.
5. MRMC comparative effectiveness study or human-AI improvement effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence based on technical specifications and compliance with safety standards rather than a performance study involving AI or human interpretation of images.

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A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

The TrueView 100 Pro is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The TrueView 100 Pro includes the following major components: a system monitor, touch-screen display, a touchpad, and an imaging cabinet. The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters to allow for easy transportation.

This document, a 510(k) Premarket Notification Summary for the TrueView 100 Pro Specimen Radiography System, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable metrics.

The information provided does not include:

• A table of acceptance criteria with reported device performance.
• Specific sample sizes for test sets, data provenance, or details about ground truth establishment for a test set.
• Information on the number or qualifications of experts, or adjudication methods for ground truth in a test set.
• Details of a multireader multicase (MRMC) comparative effectiveness study or standalone algorithm performance.
• Sample size for a training set or how ground truth for a training set was established.

Instead, the submission relies on comparing the technical specifications and performance characteristics of the TrueView 100 Pro to its predicate device, the Trident® HD Specimen Radiography System (K182727), to argue for substantial equivalence.

Here's an analysis of the information available in the provided text:

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

The document provides a comparative table between the TrueView 100 Pro and the predicate device. While this table lists various technical specifications and operational parameters, it does not explicitly define acceptance criteria for each parameter and then report the TrueView 100 Pro's performance against those criteria. Instead, it compares the TrueView 100 Pro's specifications directly to the predicate's specifications to demonstrate "similarity" or "improvement."

Here's a summary of the technical comparison presented in the document, which can be interpreted as the basis for performance claims relative to the predicate:

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The MOZART SUPRA Specimen Tomosynthesis System is a Cabinet x-ray system that is specifically designed to provide high detail radiographic imaging of surgically excised medical specimens from various anatomical regions, i.e. breast, both in 2-dimensional and 3-dimensional tomosynthesis views.

The MOZART SUPRA(XPERT84) Specimen Radiography System is a Cabinet X-ray System specifically designed to provide 3-D high detail radiographic imaging of surgically excised medical specimens utilizing tomosynthesis. The MOZART SUPRA(XPERT84) is a fully self-contained and shielded cabinet system equipped with a 90kVp micro-focus x-ray source and a 10'' x 12" 49.5 micron high resolution CMOS Digital Detector. It is the only cabinet specimen imaging system to utilize 3-D Tomosynthesis technology. Creates images in 1mm digital slices of the specimen, allowing physicians to evaluate the specimen layer by layer.

The provided document is a 510(k) premarket notification for a medical device, the Kubtec MOZART SUPRA (XPERT 84) Radiography System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating performance against specific metrics for AI-powered device functionality.

The document describes a stationary X-ray system designed for high detail radiographic imaging of surgically excised medical specimens, including breast specimens, in both 2D and 3D tomosynthesis views. It highlights the device's capability to provide more anatomical information, precisely identify lesion locations, exclude overlying tissue, and identify surgical margins. There is no mention of an Artificial Intelligence (AI) component within this device or its functionality. The "software" mentioned (KUBTEC DIGICOM) relates to image acquisition and processing, not AI for diagnosis or analysis.

Therefore, many of the requested elements regarding acceptance criteria and study design for an AI-powered device cannot be extracted from this document. The document describes a traditional medical imaging device, not an AI/ML product.

However, I can extract information related to the device's performance based on the general information provided for its intended use as a radiography system.

Here's an attempt to address the request based on the available information, noting the absence of AI-specific details:

Acceptance Criteria and Device Performance (as a Radiography System, NOT AI)

The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards (electrical safety, EMC, software V&V for function, not AI performance). There are no explicit quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) for diagnostic performance laid out in a table, as one would expect for an AI algorithm. The closest to "performance" is the device's technical specifications and the claim that it "produces diagnostic quality images."

Table of Acceptance Criteria and Reported Device Performance (Proxy)

Since this is not an AI device, I will create a table based on the device's technical specifications and claimed imaging capabilities, which implicitly serve as performance indicators for a radiography system, rather than diagnostic accuracy metrics.

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The Volumetric Specimen Imager is a Cabinet x-ray system that is used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.

The Clarix Imaging Volumetric Specimen Imager (VSI) is a portable, fully shielded cabinet X-ray system that provides high resolution 2D and 3D radiographic images of surgically excised specimens. The VSI system consists of an image-acquisition device and software for image reconstruction, visualization, and archival. Enabled by optimized imaging geometry and iterative image reconstruction algorithm, VSI provides superior spatial and contrast resolution for visualizing specimens with soft tissues or boney structures. VSI is designed to comply with 21 CFR 1020.40 and DICOM standards.

The provided text is a 510(k) summary for the Clarix Imaging Volumetric Specimen Imager (VSI). It describes the device, its intended use, and a comparison with a predicate device. However, it explicitly states that clinical data was not required to demonstrate substantial equivalence to the predicate device. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria through clinical performance.

The "Non-clinical Performance Data" section lists several tests performed, but these are primarily for electrical safety, electromagnetic compatibility, compliance with regulations and standards (IEC, CFR, DICOM), phantom imaging, and user testing. The "Tissue Verification" listed here would likely refer to non-clinical verification of image quality for tissue, not a clinical study involving human patients or complex diagnostic assessments.

Given the information provided in the 510(k) summary, I cannot fill out the requested table or describe a study that proves the device meets specific acceptance criteria based on clinical performance. The 510(k) pathway for this device relied on demonstrating substantial equivalence to a predicate, not on new clinical performance data to establish specific diagnostic accuracy or efficacy metrics.

Therefore, many of the requested fields about ground truth, expert readers, MRMC studies, and effect sizes cannot be answered from this document. If such a study were performed, its details would be found in a separate clinical study report, not typically summarized in this manner for a 510(k) submission where clinical data was explicitly not required for substantial equivalence.

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The CoreLite device is a cabinet X-ray system used to provide digital X-ray images of specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Performing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

The CoreLite Specimen Radiography System is a self-contained digital imaging system for verification of breast biopsy specimens at the point of care which enables the procedure to be completed faster. The system is comprised of the x-ray cabinet and the PC with DICOM compliant software which provides the user interface, means to enter patient details (either directly or from a DICOM Modality Worklist, if available) and the means to acquire, review and save or transmit DICOM images to the Picture Archiving and Communication System (PACS). The cabinet incorporates shielding and interlock circuits to meet requlatory requirements.

The provided FDA 510(k) summary for the Cirdan Imaging Limited CoreLite device indicates that it is a cabinet X-ray system for verifying breast biopsy specimens. It states that the device was benchmarked against a predicate device (Faxitron CoreVision Digital Specimen Radiography (DSR) System) in a clinical setting to demonstrate substantial equivalence. However, the document does not provide detailed acceptance criteria or the specifics of a study proving the device meets particular quantitative performance metrics with associated sample sizes, ground truth establishment, or expert involvement as typically requested.

Based on the provided text, here is the information that can be extracted and a clear indication of what is not present:

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

The document does not provide a table of explicit quantitative acceptance criteria for image quality or clinical performance, nor does it present specific numerical performance results. It only states a qualitative outcome for the comparison study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified. The document only mentions "a clinical setting" for benchmarking.
• Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified. The document states "the results were judged to be equivalent to the predicate," implying expert judgment, but does not detail the number or qualifications of these experts.

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

Not specified.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study described was a benchmarking of the device (CoreLite) against a predicate device, focusing on image quality and clinical equivalence. There is no mention of AI assistance or its effect on human readers. The CoreLite system is described as a digital imaging system, not an AI-powered diagnostic aid.

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

The CoreLite is an X-ray system itself, not an algorithm. Therefore, a "standalone algorithm-only" performance study is not applicable in the typical sense of AI algorithms. The system's performance revolves around its ability to produce digital X-ray images for verification. "Non-Clinical Testing included image quality tests with accredited phantom test objects and High Contrast resolution targets" which could be considered a standalone technical performance assessment of image quality.

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

The document implies a qualitative assessment against the predicate device in a clinical setting. It states "the results were judged to be equivalent to the predicate." This suggests the ground truth was likely established by comparison to the established predicate device's performance, potentially through expert comparison of images or assessment of successful specimen verification. Specific details about the ground truth (e.g., pathology confirmation of tissue presence) are not provided.

8. The sample size for the training set

Not applicable. The CoreLite is an X-ray imaging system, not a machine learning algorithm that requires a training set.

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

Not applicable, as it's not an AI/ML device requiring a training set.

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