Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Study Details (as a Diagnostic Imaging Device - No AI)

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

   • The document states: "Images attained by the system have been read and verified by a Board Certified Radiologist to product diagnostic quality images." This implies some form of review or test set, but it does not specify a sample size for this "test set" (if it was a formal one) nor any details on data provenance (e.g., country of origin, retrospective/prospective). This sounds more like an internal verification than a formal clinical study with a specified sample size.

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

   • One expert is explicitly mentioned: "a Board Certified Radiologist." No further details on experience level (e.g., 10 years of experience) are provided.

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

   • No formal adjudication method is described. The statement "read and verified by a Board Certified Radiologist" suggests a single reader's assessment.

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, an MRMC study was NOT done. This document pertains to a traditional X-ray imaging system, not an AI-assisted device. Therefore, a study comparing human readers with and without AI assistance is irrelevant and not performed.

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

   • No, this is not applicable. The device is a physical X-ray system that produces images for human interpretation. There is no AI algorithm to evaluate in a "standalone" fashion.

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

   • The "ground truth" implicitly refers to the assessment by the "Board Certified Radiologist" that the images are of "diagnostic quality." This points to expert assessment as the primary form of validation, likely against a gold standard like pathology where applicable (specimen imaging). However, the document does not explicitly state pathology as the ground truth for image quality. It implies the system accurately portrays the pathology of the specimen without directly stating pathology reports were used as ground truth for a quantitative study.

7. The sample size for the training set:

   • Not applicable for this device. This is a hardware imaging system, not an AI/ML algorithm that requires a training set. The software mentioned (DIGICOM) is for image acquisition and processing, not model training.

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

   • Not applicable. As there is no AI/ML algorithm with a training set, no ground truth establishment for a training set is relevant.

Ask a specific question about this device

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.

The MOZART Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimensional and threedimensional 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 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.
  To support the Tomosynthesis application, the predicate device, XPERT 40, 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 the same CMOS detector mounted stationary in the bottom of the cabinet x-ray unit.
  To support the Tomosynthesis application, the proposed device, MOZART, utilizes the predicate device, XPERT 40, having the addition of a low-voltage screw-drive linear actuator installed in the enclosed head of the cabinet, which ensures operator safety, 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 the same CMOS detector mounted stationary in the bottom of the same shielded cabinet x-ray unit with proprietary software installed into an off the shelf personal computer, Microsoft Windows 7 Operating System, and a 2 megapixel or greater portrait type monitor.
  The workstation on the MOZART utilizes a more powerful GPU to facilitate the handling of the collected projection data. It utilizes a method of dynamically reconstructing 3D tomographic images from a set of projections images. This includes loading the set of projection images into memory, selecting a region of interest, applying any necessary preprocessing, selecting a reconstruction method reconstructing an image according to said reconstruction method to produce a 3D tomographic image focusing on said region of interest, performing any post reconstruction processing on the 3D tomographic image and rendering said 3D tomographic image on a display. US Patent US 8,233,690 B2 displaying the complete algorithm and process is included.

The provided text describes a 510(k) premarket notification for the KUBTEC MOZART (XPERT42) system, which is a cabinet x-ray system for imaging excised specimens. However, the document does not contain a detailed study proving the device meets specific acceptance criteria through a clinical or comparative effectiveness study as would typically be described for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Kubtec XPERT 40) based on similar technology, materials, safety, effectiveness features, and design.

The core of the "proof" for this device lies in its demonstrated substantial equivalence to a predicate device rather than an independent performance study against set criteria. The new device, MOZART, has technological differences primarily related to the addition of a mechanism to move the x-ray source linearly and proprietary software to compile multiple images into 1mm slices and a 2-D image (tomosynthesis application).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a dedicated study, nor can I answer questions related to sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies, as these types of studies are not detailed in the provided text in the context of proving device performance against specific metrics.

Here's what can be extracted based on the provided document:

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

The document does not provide a table of specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the MOZART system itself, nor does it report such performance. The primary "acceptance" is that the device is substantially equivalent to its predicate.

However, a comparison of technical specifications between the MOZART (XPERT42) and the predicate XPERT 40 is provided, which serves as a basis for demonstrating equivalence in performance characteristics.

The "reported device performance" in this context is that the MOZART system, with its added technological features for tomosynthesis, is considered as safe and effective as the predicate device (XPERT 40) for its stated indications for use.

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

Not applicable, as no clinical performance study with a test set of patient or specimen images is described in the provided document. The 510(k) relies on technical specifications, safety testing (e.g., electrical, radiation control), and the established safety and effectiveness of the predicate device.

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 applicable, as no clinical performance study with a test set requiring expert ground truth establishment is described.

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

Not applicable.

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. The MOZART system is a specimen radiography system, not stated to be an AI/CADe device that assists human readers in diagnostics of patient images. Its "proprietary software" is for compiling images and reconstruction of tomosynthesis slices, not for AI-assisted image interpretation.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set

Not applicable, as there is no mention of a machine learning model requiring a training set for diagnostic performance. The "proprietary software" mentioned is for image reconstruction, not for AI diagnosis.

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

Not applicable.

Ask a specific question about this device