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ASTRA is software image management intended to receive, process, review, display, print and archive medical images and data from imaging modalities (e.g., CR and DR), Images and data can be stored, communicated, and displayed within the system or across computer systems. ASTRA is comprised with three configurations depending upon the requirements of the user and desired options: ASTRA Plus , ASTRA Lite, and ASTRA Mobile. ASTRA runs on a PC workstation, iPad, or iPhone and may be interfaced with verified and validated image acquisition devices from Candelis or other PACS systems. Diagnosis is not performed by the software but by Radiologists, Clinicians or referring Physicians. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

ASTRA Plus is used to:

• share reports and studies with other ASTRA peers .
• review reports and studies .
• . download and save reports
• send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send) .
• . route studies to PACS, Workstations, or other ASTRA peers

ASTRA Lite is used to:

• share reports and studies with other ASTRA peers .
• . review reports and studies
• download and save reports .
• send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send) .

ASTRA Mobile is used to:

• share reports with other ASTRA peers .
• review reports .
• . download and save reports
• . send reports to local EMR, EHR, RIS, HIS or PACS systems (HL7 send)

Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.

ASTRA is a web-enabled software application that provides image processing and viewing tools and access to studies and reports from a Local Area Network. Wide Area Network, remote workstation, personal computer, or an iPhone, or iPad via a Virtual Private Network connection. Diagnosis is not performed by the software but by Radiologists, Clinicians or referring Physicians. The software application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems.

The provided text is a 510(k) summary for the ASTRA Picture Archiving Communications System. It describes the device's function and its intended use, but it does not contain detailed information about specific acceptance criteria or the study used to prove the device meets those criteria, especially in the context of diagnostic accuracy or performance metrics of AI systems.

The document states:
"The complete system configuration has been assessed and tested at the factory and the device has passed all in-house testing criteria without significant failures. The data presented in the submission demonstrates that the ASTRA device performs all required actions according to the functional requirements specified in the SRS and User Manual with no errors that had an impact on safety or efficacy."

This indicates that there was internal testing against functional requirements, but it does not provide the specific metrics, methodologies, or results typically expected for a detailed AI device performance study.

Given the information provided, I cannot populate the requested table or answer most of the questions related to acceptance criteria and a definitive study demonstrating performance. The device, ASTRA, is described as a "Picture Archiving Communications System" and explicitly states: "Diagnosis is not performed by the software but by Radiologists, Clinicians or referring Physicians." This means it is a tool for image management and viewing, not a diagnostic AI system that would have performance metrics like sensitivity, specificity, or accuracy in lesion detection.

Therefore, many of the requested categories are not applicable to the information contained in this 510(k) summary. I will answer the questions based on the available information and explicitly state when the information is not present.

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

Note: This table reflects functional and interoperability criteria for an image management system, not diagnostic performance metrics for an AI algorithm.

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 testing described is "in-house testing criteria" based on functional requirements, not a clinical study with a defined test set of medical images from patients.

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 and is not applicable given that the device does not perform diagnosis and its testing focused on functional requirements rather than diagnostic ground truth.

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

This information is not provided and is not applicable for the reasons stated above.

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

There is no indication that an MRMC comparative effectiveness study was conducted. This device is an image management system, not a diagnostic AI that assists human readers.

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

A standalone performance study focused on diagnostic accuracy was not done as the device is not intended for diagnosis. The documentation explicitly states: "Diagnosis is not performed by the software but by Radiologists, Clinicians or referring Physicians."

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

Ground truth in the diagnostic sense (e.g., expert consensus for lesions, pathology results) was not used for the testing described, as the device is not a diagnostic AI. The "ground truth" for its testing was adherence to "functional requirements specified in the SRS and User Manual."

8. The sample size for the training set

This information is not provided as the device is not described as a machine learning/AI diagnostic tool that would typically involve a training set.

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

This information is not provided as there is no mention of a training set or associated ground truth in the context of an AI model.

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ImageGrid Radiology Viewer System™ is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.

Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

ImageGrid Radiology Viewer System™ is a client/server software application that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Radiology Viewer System™ can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The device is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images.

The provided text is a 510(k) summary for the "ImageGrid Radiology Viewer System™", a Picture Archiving Communications System (PACS). It describes the device, its indications for use, and a general statement about testing.

However, the document does not provide specific acceptance criteria or details of a study with quantitative results, sample sizes, expert qualifications, or ground truth methods that would allow for a complete answer to the request. The "Testing" section broadly states that "The complete system configuration has been assessed and tested at the factory and the device has passed all in-house testing criteria without significant failures." This is a general statement about internal validation rather than a detailed performance study suitable for evaluating specific acceptance criteria for AI or diagnostic performance.

Based on the provided text, I cannot complete the requested information for the following reasons:

• No specific acceptance criteria are listed. The document does not define measurable thresholds for performance metrics (e.g., accuracy, sensitivity, specificity, or image display quality) that the device must meet.
• No detailed study is presented. There is no mention of a formal clinical or technical study with a defined methodology, test set, ground truth, or statistical analysis.
• The device is a PACS viewer, not an AI diagnostic tool. The text explicitly states: "Diagnosis is not performed by the software but by Radiologists. Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis." Therefore, questions related to AI-specific performance metrics, multi-reader multi-case studies with AI assistance, or standalone AI performance are not applicable to this device as described.

Attempted Answer based on the absence of information in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Not specified in the document. The document mentions "all in-house testing criteria" and "functional requirements specified in the SRS and User Manual," but does not list specific, quantifiable acceptance criteria (e.g., display accuracy metrics, data transfer integrity, uptime).*	"The complete system configuration has been assessed and tested at the factory and the device has passed all in-house testing criteria without significant failures."

"The data presented ... demonstrates that the ImageGrid Radiology Viewer System performs all required actions according to the functional requirements specified in the SRS and User Manual with no errors that had an impact on safety or efficacy." |

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified. The "in-house testing" implies internal data, but no details on origin (e.g., country, retrospective/prospective) are given.

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

   • Not applicable/Not specified. The device is a viewer, not a diagnostic AI. The document does not describe a ground truth establishment process for diagnostic performance, as the software itself does not perform diagnosis.

4. Adjudication method for the test set:

   • Not applicable/Not specified.

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

   • No. The document does not mention any MRMC study. The device is a PACS viewer, not an AI to be used in conjunction with human readers in a comparative effectiveness study. The text explicitly states that diagnosis is performed by human professionals.

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

   • Not applicable. This device is a PACS viewer and is not intended to provide standalone diagnostic performance or an "algorithm only" interpretation. Its function is to display images for human interpretation.

7. The type of ground truth used:

   • Not applicable. As a PACS viewer, its primary function is display and communication, not independent diagnosis where a "ground truth" for disease presence/absence would be established for algorithm performance.

8. The sample size for the training set:

   • Not applicable. As a software application for image viewing and communication without an AI diagnostic algorithm, there would not be a "training set" in the context of machine learning.

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

   • Not applicable (no training set for an AI model).

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ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).

ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RiS, and ImageGrid Mammography Web Viewer.

Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

ImageGrid Web Viewer is a client/server software application and server that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Web Viewer can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The ImageGrid Web Viewer is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images. ImageGrid™ can be integrated with an institutions HIS or RIS for an integrated electronic patient record.

ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).

ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RIS, and ImageGrid Mammography Web Viewer.

Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, a study conducted, sample sizes, ground truth establishment, or expert involvement. The document is a 510(k) summary for ImageGrid™ PACS, primarily focusing on its description, intended use, and substantial equivalence to predicate devices, but lacks the specific details requested regarding performance validation.

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