Search Results

NovaPACS is intended for the viewing, archiving, analysis, annotation, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc.

NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images.

NovaPACS is not intended for diagnostic image review on a mobile platform.

While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light confirm image compression ratios are consistent with the generally accepted standards of the clinical application.

NovaPACS is a picture archiving and communication system software that retrieves, archives, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer.

The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual colonoscopy, and vessel analysis.

Images and data are stored on a digital archive with multiple redundancies; images and data are site and off-site. Novarad provides all software, including third party software (i.e. Windows® OS). NovaPACS software resides on third party hardware, which may vary depending on the client's PACS needs. All hardware is connected to the radiology department local area network.

NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities.

NovaPACS integrates with Novarad Mobile Rad application to display data on 3rd party mobile platforms. Mobile Rad is not intended to replace a full diagnostic workstation.

This K132853 510(k) summary for NovaPACS does not contain the specific information required to complete the request thoroughly. The document describes the device, its intended use, and substantial equivalence to predicate devices, but lacks detailed performance data and study specifics.

Here's a breakdown of what can and cannot be extracted from the provided text regarding acceptance criteria and a study proving fulfillment:

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

The document mentions "performance requirements" and "specifications" but does not provide a specific table of acceptance criteria with corresponding device performance values. It states:

• "NovaPACS software passes all performance requirements and meets all specifications prior to release, including:"
  • "All requirements in the iteration have a test case and the test case has run and passed a."
  • "All Acceptance tests have passed b."
  • "All Current tests have passed C."
  • "d. All high-impact bugs have been corrected and verified by Quality Assurance"
  • "e. Any unresolved anomalies have been assessed in a risk meeting, and it has been found that they do not pose a safety risk to the end user (or their patients) and do not substantially affect the performance of NovaPACS software."

It also states: "Performance testing results show that the software features of NovaPACS operate correctly and safely and meet equivalent objectives and perform equivalent functions as those represented in the predicate devices."

And more broadly: "Thorough software testing has been performed for NovaPACS to safety and efficacy of the device. Of over 1200 test cases run on the NovaPACS Software, 99% passed, 1% failed, and 0% were blocked on their latest run. Of the failed tests, the majority represent minor user interface errors."

Lacking Information: Specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, processing speed, image quality metrics) are not provided. The phrase "All Acceptance tests have passed" confirms the existence of such tests and their successful completion, but not the content of those tests or their specific targets.

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

• Test set sample size: The document mentions "over 1200 test cases run on the NovaPACS Software." It does not specify if these test cases correspond to a specific number of patient cases or images, nor does it detail the nature of the data used in these tests. It seems to refer more to functional and system-level tests rather than a clinical dataset.
• Data provenance: Not specified. It's likely internal testing data related to software function.
• Retrospective or prospective: Not specified, but given the nature of the "test cases," it's likely part of a software development and validation process rather than a traditional clinical study with patient data collected retrospectively or prospectively.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

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

• Not specified. The document primarily discusses software testing for functionality and bug resolution, not expert review of medical images.

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 performed. The document explicitly states: "There are no clinical tests to compare NovaPACS and predicate devices, as they are software products that send and store images and information." This implies no MRMC study or study comparing human performance with or without AI assistance was conducted or deemed necessary for this type of PACS device. NovaPACS is described as a system for viewing, archiving, and processing, not as an AI diagnostic aid.

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

• Not applicable in the typical AI sense. While the software has "features" like 3D rendering and vessel analysis, it's presented as a tool for "trained healthcare professionals" to "display, manipulate, archive, and evaluate images." It's not an autonomous diagnostic algorithm. The performance described ("99% passed" of 1200 test cases) relates to the correct functioning of the software itself, not its diagnostic accuracy in a standalone mode.

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

• Not explicitly stated in terms of diagnostic ground truth. For the stated "test cases," the ground truth would be the expected functional behavior of the software feature (e.g., whether an image loads correctly, a measurement tool accurately calculates distance, or a 3D rendering displays as designed). It's not referring to ground truth for clinical diagnoses on patient images.

8. The sample size for the training set:

• Not applicable/Not provided. This document describes a PACS software system, which typically does not involve a "training set" in the machine learning sense for pattern recognition or diagnostic AI. The software's capabilities are based on coded algorithms and functionalities, not on learning from a dataset.

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

• Not applicable/Not provided. (See point 8).

In summary, the provided K132853 document focuses on demonstrating the functional equivalence and safety of the NovaPACS software as a Picture Archiving and Communication System (PACS) through software testing, rather than reporting on a clinical study of diagnostic performance using AI, which would typically involve detailed acceptance criteria, ground truth, and reader studies.

Ask a specific question about this device

The product being submitted is going to be used as a PACS system and provide viewing tools for radiologists, technologists, other physicians, cardiologists, and patients. It will also provide archiving of images and data. The product will be sold to hospitals, imaging centers, and clinics. It is a software product sold with accompanying off-the-shelf hardware, It is substantially equivalent to other products now being sold as PACS. Further it is for using DICOM for presentation of Mammography studies, not for image processing. Will include the standard features for Mammo of window/level/zoom, as well as volumetric measurements and other Mammo tools. Mammo will only be interpreted on 510K approved 5 Mp LCD monitors. The Mammo images will be stored lossless (non-lossy compressed). Digitized conventional screen film mammograms will not be used in soft copy format for primary diagnosis.

The PACS product provides a system where images and accompanying data are sent from the modalities to the radiologists and technologists in digital format. The images are then viewed on a computer with such available tools a window, level, zoom, pan, roi, digital subtraction, ejection fraction, cross localize, and many other similar tools and with the ability to make notes and dictate a report. The images and report are then stored long term on a digital archive with multiple redundancy. All the information is also made available as a web based product where referring physicians or radiologists can access the information from anywhere using a secure system. The software is provided by NovaRad along with some 31d party software, principally from windows, and resides on off-the-shelf hardware hooked up to the radiology department local area network.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NovaRad PACS (K063153):

This 510(k) summary explicitly states that no clinical tests were performed to compare the device to a predicate. The justification provided is that the device is "merely software products that send and store images and information. Since the images are not changed or analyzed by the product, there is no safety issue, except possible related to the safety of the archived images."

Therefore, the following table and subsequent sections will reflect this lack of clinical study data.

Acceptance Criteria and Reported Device Performance

Study Details (or lack thereof)

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

   • Not applicable. No clinical test set was used, as no clinical study comparing the devices was conducted. The equivalence was based on functional comparison and safety considerations regarding image storage.

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

   • Not applicable. No clinical test set or ground truth establishment by experts was performed for comparison between the predicate and the NovaRad PACS. The submission primarily relies on the functional equivalency of a PACS system and its ability to store and display images without alteration.

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

   • Not applicable. No clinical test set was used, therefore no adjudication method was employed.

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 comparative effectiveness study was not performed. The device is a Picture Archiving and Communication System (PACS) and does not involve AI assistance for image interpretation.

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

   • No. This device is a PACS for image management and viewing, not an AI algorithm. Therefore, a standalone performance study as understood for AI devices was not conducted.

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

   • Not applicable. No clinical ground truth was established or used for the purpose of demonstrating substantial equivalence. The claim of substantial equivalence is based on the system's ability to perform the same functions as the predicate PACS without altering image data.

7. The sample size for the training set:

   • Not applicable. As this is a PACS system designed for image storage and viewing, and not an AI or image analysis device, there is no "training set" in the context of machine learning.

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

   • Not applicable. As there is no training set, there was no ground truth to establish for it.

Ask a specific question about this device

Picture Archiving and Communications for presenting images and information from the modalities to radiologists or others for reading. Includes standard viewing tools made to help the radiologist or cardiologist or others organize the images and read them in an efficient and easy manner.

The PACS product provides a system where images and accompanying data are sent from the modalities to the radiologists and technologists in digital format. The images are then viewed on a computer with such available tools a window, level, zoom, pan, roi, digital subtraction, ejection fraction, cross localize, and many other similar tools and with the ability to make notes and dictate a report. The images and report are then stored long term on a digital archive with multiple redundancy. All the information is also made available as a web based product where referring physicians or radiologists can access the information from anywhere using a secure system. The software is provided by NovaRad along with some 3 party software, principally from windows, and resides on off-the-shelf hardware hooked up to the radiology department local area network.

The provided text is a 510(k) summary for the NovaRad Corporation's PACS product (NovaPACS). It explicitly states that "There are no clinical tests to compare the two as they are merely software products that send and store images and information. Since the images are not changed or analyzed by the product there is no safety issue, except possible related to the safety of the archived images."

Therefore, based on the provided document, the following answers apply:

1. A table of acceptance criteria and the reported device performance
No acceptance criteria or reported device performance from a study are provided in the document. The device is a Picture Archiving and Communication System (PACS) and is not intended to change or analyze medical images, but rather to present and store them. Substantial equivalence was claimed based on functional similarity to a predicate device, not clinical performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical or performance studies using a test set were conducted or mentioned.

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. No clinical or performance studies using a test set were conducted or mentioned, hence no ground truth was established by experts for such a purpose.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical or performance studies using a test set were conducted or mentioned.

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. No MRMC study was conducted. The device is a PACS for image viewing and storage, not an AI-powered diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a PACS for image viewing and storage and does not involve a standalone algorithm for diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical or performance studies requiring ground truth were conducted or mentioned.

8. The sample size for the training set
Not applicable. No machine learning or AI components requiring a training set are described for this PACS device.

9. How the ground truth for the training set was established
Not applicable. No machine learning or AI components requiring a training set are described for this PACS device, therefore no ground truth for a training set was established.

Ask a specific question about this device