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.

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

The DIGIVIEW 395, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

The DIGIVIEW 395 is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:TI scintillator. The DIGIVIEW 395 detector has an active area of 43.2 cm x 35.5 cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi. The detector can be integrated into a fixed room X-ray system to enable digital radiography.

The provided document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of test set/training set sizes, ground truth establishment, or expert involvement in the way requested.

This document is a 510(k) summary for a medical device (Kubtec DIGIVIEW 395), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics against specific acceptance criteria.

Here's what can be extracted and what is missing based on your request:

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

• Not available in the document. The document states "Kubtec's DIGIVIEW 395 successfully completed internal safety testing requirements to recognized consensus standards listed below." However, it does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy) or the quantitative acceptance criteria for those metrics. The comparison chart (page 6) shows physical and technical specifications of the device and its predicate, not performance against clinical or technical acceptance criteria.

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

• Not available in the document. The document explicitly states: "No clinical studies were conducted in support of the DIGIVIEW 395 as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K140551). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence." This means there was no test set of patient data for evaluating performance.

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 studies were conducted, there was no test set and therefore no ground truth established by experts in this context.

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

• Not applicable. As no clinical studies were conducted, there was no test set requiring adjudication.

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 study was not done. The device is a stationary X-ray system (hardware), not an AI-powered diagnostic tool intended to assist human readers. The document states "No clinical studies were conducted."

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

• Not applicable. The device is a flat panel X-ray detector, which is hardware for image generation, not an algorithm being evaluated for standalone diagnostic performance.

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

• Not applicable. As no clinical studies were conducted, there was no ground truth for diagnostic performance evaluation. The device's "performance" was assessed against recognized consensus standards for physical and technical characteristics of X-ray imaging devices.

8. The sample size for the training set

• Not applicable. The device is a hardware component (a flat panel X-ray detector). While it uses "DIGICOM software to manage operation of detector," there is no mention of machine learning or AI that would require a "training set" in the context of diagnostic performance evaluation. The software mentioned is for detector operation, not for diagnostic interpretation.

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

• Not applicable. (See point 8).

Summary of what the document does state regarding validation:

• Basis for Equivalence: The primary method for demonstrating the safety and effectiveness of the Kubtec DIGIVIEW 395 was by proving its "substantial equivalence" to a legally marketed predicate device (PerkinElmer, XRpad 4336 MED, K140551). This means showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
• No Clinical Studies: Explicitly states "No clinical studies were conducted in support of the DIGIVIEW 395 as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K140551). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence."
• Technical Standards: Safety testing was completed to recognized consensus standards, including:
  • IEC 62220-1 (Determination of the detective quantum efficiency)
  • IEC 62220-1-3 (DQE for dynamic imaging)
  • IEC 62494-1 (Exposure index for general radiography)
  • IEC PAS 61910-1 (Radiation dose documentation)
  • NEMA PS 3.1 - 3.20 (DICOM Set)
  • IEC 60601-2-43 (Safety and essential performance of X-ray equipment)
  • NEMA XR 24-2008 (Primary user controls for interventional angiography x-ray equipment)
• Comparison Chart (Similarities to Predicate): The document provides a detailed comparison chart (pages 6-7) highlighting that the proposed device and the predicate device share identical intended use/indications for use, panel type, scintillator, pixel matrix, pixel pitch, active area, external dimensions, weight, housing material, communication interface, and power. The only difference noted is the utilization of Kubtec's DIGICOM software for detector operation, which itself was previously cleared in other 510(k) submissions.

In conclusion, for this specific 510(k) document, the device approval was based on substantial equivalence and compliance with engineering standards, not on clinical performance metrics or studies involving patient data or human readers.

Ask a specific question about this device

The Kub250 is intended for us by a qualified/trained physician or technician for generating, and displaying diagnostic radiographic images of neonatal patients. The Kub250 is not intended for mammography applications.

Not Found

This document is a 510(k) premarket notification decision letter for the Kubtec X250 (Kub250) mobile x-ray system, stating that the device is substantially equivalent to a predicate device. It indicates the intended use of the device for generating and displaying diagnostic radiographic images of neonatal patients, excluding mammography applications. It does not contain information about acceptance criteria, device performance studies, or details about AI algorithms.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment based on this document.

Ask a specific question about this device

The Digiview 250 is indicated for use in generating radiographic images of human anatomy. The device is intended to provide digital x-ray image capture for conventional film/screen radiographic examinations and replace radiographic film/screen systems in all general purpose diagnostic procedures. The device is not intended for mammography applications.

The Kubtec Digital Radiography DIGIVIEW 250 ® is a CMOS based solid state x-ray imager which has a 192 x 246 mm imaging area. The Digital Radiography DIGIVIEW 250® imager intercepts X-ray photons after they pass through anatomy and surrounding air and converts the X-ray photons into electrical signals. These resultant electric signals are converted into digital values which are transmitted for remote viewing. The DIGIVIEW 250 ® system features a DICOM 3.0 compliant software, DIGICOM. The DIGICOM software enables the display and analysis of x-ray images; either live (real time) or previously captured and the storage and transmission of these images to PACS systems.

The provided text describes a 510(k) submission for the Kubtec DIGIVIEW 250, a digital radiography system. The submission focuses on demonstrating substantial equivalence to a predicate device (Canon CXDI-60G) rather than a comprehensive study against specific acceptance criteria for a new medical AI device. Therefore, much of the requested information (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies) is not detailed in this document because it pertains to performance studies for an AI or novel diagnostic device, which is not the nature of this 510(k) submission.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (like sensitivity/specificity) against a clinical gold standard. Instead, it compares technical specifications to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" can be inferred as matching or exceeding the predicate device's technical specifications and intended use.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) is the non-clinical testing and design control activities mentioned. The submission states: "The performance data, non-clinical testing, and design process demonstrate that the Kubtec DIGIVIEW 250 ® is as safe and effective as the Canon CXDI-60G, and has no new indications for use, thus rendering it substantially equivalent to the predicate device." This typically involves laboratory testing of the physical and imaging characteristics of the device against industry standards and the specifications of the predicate.

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

• Test Set Sample Size: Not specified. The document does not detail a clinical test set with patient data. The "testing" referred to is non-clinical, likely engineering and performance measurements.
• Data Provenance: Not applicable in the context of clinical data for a test set. The testing is based on device performance in a lab setting.

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

• Not applicable. There is no mention of human experts establishing ground truth for a clinical test set, as this is a device for image capture, not an image interpretation AI.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set or human interpretation is detailed.

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

• No. The document makes no mention of an MRMC study. This type of study is typically done for AI-powered diagnostic tools to assess the impact of AI on human reader performance.

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

• Yes, in a way. The "performance data, non-clinical testing" can be considered a standalone assessment of the device's technical capabilities (e.g., resolution, dynamic range, readout speed) without human intervention in the specific output generation. However, it's a hardware device, not an AI algorithm.

7. Type of Ground Truth Used:

• For technical specifications: Engineering measurements, internationally recognized standards (e.g., for resolution, dynamic range), and the published specifications of the predicate device. There is no "ground truth" for clinical diagnoses as the device itself is not making diagnostic interpretations.

8. Sample Size for the Training Set:

• Not applicable. This device is a hardware digital radiography system, not an AI model that requires a training set of data.

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

• Not applicable, as there is no training set for an AI model.

Ask a specific question about this device

Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.

The XPERT Specimen Radiography System is a self contained, shielded cabinet x-ray system designed to meet imaging requirements for surgically excised and needle core biopsies. This device does not expose the patient to radiation, it is used for biopsy tissue samples only. The system design features an x-ray source that produces a high resolution, 5 -45 micron focal spot. The control system, coupled with a touch panel screen for operator interface. The XPERT system features a DICOM 3.0 compliant DIGICOM computer and software application. The DIGICOM enables the display and analysis of x-ray images, either live (real time) or previously captured, and the storage and transmission of these imagines to the PACS.

The provided text does not contain detailed information regarding acceptance criteria, specific device performance metrics, or a robust study design with sample sizes, expert qualifications, adjudication methods, or comparative effectiveness. The submission primarily focuses on establishing substantial equivalence to a predicate device based on physical and performance characteristics, and compliance with general safety and software validation.

Here's an analysis based on the limited information available:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific quantitative acceptance criteria or numerical performance metrics are outlined for the device itself. The "Performance Data" section states: "The subject device complies electrical and radiation safety requirements and utilizes software that has been validated." This suggests the "acceptance criteria" are related to established electrical and radiation safety standards and successful software validation, rather than clinical performance for tissue verification.

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

No information is provided regarding a specific "test set" in the context of clinical performance data used to demonstrate statistical equivalence or superiority. The submission focuses on substantial equivalence to the predicate device.

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

Not applicable. There is no mention of experts being used to establish ground truth for a test set, as no such test set for clinical performance is described.

4. Adjudication Method

Not applicable. No adjudication method is mentioned as there is no described study involving expert review of device outputs against a ground truth.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The submission does not discuss human readers or AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is an X-ray system, not an AI algorithm. Its performance is tied to its ability to generate images, not to interpret them autonomously.

7. Type of Ground Truth Used

Based on the available information, the "ground truth" implicitly refers to the expected functioning of an X-ray system for imaging tissue specimens. This would be assessed through technical validation against engineering and safety standards, and potentially comparison of image quality against the predicate device. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for a performance study.

8. Sample Size for the Training Set

Not applicable. The device is a hardware X-ray system that produces images; it does not explicitly describe an AI component that would require a "training set" in the machine learning sense. The software is validated, which implies testing, but not a "training set" for an AI model.

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

Not applicable, as there is no training set for an AI component.

Summary of what is present:

The submission for the KUB Technologies, Inc. XPERT Specimen Radiography System (K083510) is a 510(k) premarket notification. The primary argument for clearance is substantial equivalence to a predicate device (XPERT 40, K071233).

• Acceptance Criteria (Implied):
  • Compliance with electrical and radiation safety requirements.
  • Validated software.
  • Similar physical and performance characteristics to the predicate device.
  • Ability to provide digital X-ray images of harvested tissue specimens for rapid verification.
• Study That Proves Device Meets Criteria:
  • The document states that the "subject device complies electrical and radiation safety requirements and utilizes software that has been validated."
  • It also states, "The subject device represents a minor modification to the predicate device."
  • The "performance data" section in {1} is very brief and does not detail a specific clinical or technical study beyond stating compliance with safety requirements and software validation. The conclusion explicitly states: "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device."

In essence, the "study" demonstrating the device meets its (implied) acceptance criteria is the documentation of its technical specifications, compliance with relevant standards, successful software validation, and the argument that as a minor modification to a previously cleared predicate, its safety and effectiveness are maintained. No detailed clinical performance study with defined criteria, test sets, experts, or ground truth is described in the provided text.

Ask a specific question about this device

Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.

The XPERT Specimen Radiography System is a self contained, shielded cabinet x-ray system designed to meet imaging requirements for surgically excised and needle core biopsies. This device does not expose the patient to radiation, it is used for biopsy tissue samples only. This equipment provides high resolution, high contrast, X-ray images, using either radiographic file up to 10x12" or digitally with the DICOM compliant DIGIVIEW digital detectors up to 8x10" in size.

With its small focal spot x-ray source and adjustable sample positioning capability, the XPERT 40 provides variable magnification for increased visibility and sharpness of detail for lesions and abnormalities in biopsies.

The device is provided with a PC including the DICOM compliant software and an LCD monitor for high resolution imaging.

The provided text does not contain detailed acceptance criteria or a comprehensive study proving the device meets specific performance metrics. Instead, it describes a 510(k) submission for the XPERT Specimen Radiography System to demonstrate substantial equivalence to predicate devices, rather than establishing specific performance criteria through a detailed study.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria (e.g., sensitivity, specificity, resolution targets) are stated in the document. The document focuses on demonstrating substantial equivalence to predicate devices based on "physical and performance characteristics."

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

The document mentions "software validation testing" and "electrical and radiation safety requirements." These generally involve technical tests rather than a clinical "test set" of patient data. There is no information about a test set, its sample size, or data provenance (country of origin, retrospective/prospective).

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

This information is not provided. The "performance data" described refers to technical validation, not clinical evaluation requiring expert ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is described.

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

No MRMC study is mentioned. The document focuses on the device's technical performance and substantial equivalence, not its impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

While the device is a standalone X-ray system, the document doesn't describe an "algorithm only" performance study in the context of AI or automated analysis. The performance data refers to the system's ability to produce images and meet safety standards.

7. Type of Ground Truth Used

The "performance data" mentioned (electrical safety, radiation safety, software validation) would typically be evaluated against technical specifications and regulatory standards, not clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

No information about a training set is provided. This type of device (a specimen radiography system) typically doesn't involve machine learning models that require a "training set" in the conventional sense.

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

Not applicable, as no training set is mentioned.

Summary of the Study and Acceptance Criteria (Based on Provided Text):

The document describes a 510(k) submission for the KUBTEC XPERT 40, a specimen radiography system. The "study" referenced is primarily a technical validation to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The acceptance criteria, though not explicitly quantified in a table, revolve around the device successfully passing:

• Electrical safety requirements.
• Radiation safety requirements.
• Software validation testing.

The "proof" that the device meets these criteria is simply stated: "The subject device has been subjected to and passed electrical and radiation safety requirements, as well software validation testing."

This submission strategy relies on comparing the new device's technological characteristics and intended use to existing, legally marketed devices (the predicates: piXarray by Biotics K052433, Dx-50 by Faxitron K061361, MX 20 by Faxitron K953404) rather than conducting extensive new clinical performance studies with specific statistical endpoints and ground truth. The FDA's letter confirms their review and determination of substantial equivalence, allowing the device to be marketed.

Ask a specific question about this device