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The Nucleus Image Management System (Nucleus IMS) is a software based PACS, to be used by radiologists and other medical personnel. The Nucleus IMS is comprised of software modules that provide image receipt, diagnostic viewing, storage, distribution, enhancement, sharing, manipulation, and networking of medical 2D/3D images at distributed locations. All modules of the Nucleus IMS are web-based and can operate on off-the-shelf hardware, as needed. The Nucleus IMS consists of the following primary components: Nucleus Viewer with image streaming technology for use by medical professionals for diagnostic and clinical image review-Nucleus Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities-and Nucleus Image Store for secure cloud based image storage and management through HIPAA compliant encryption. Nucleus iX integrates with the Nucleus Viewer and Nucleus Image Store. Nucleus.io, a web based class I PaaS device, provides the basis for the system and for vendor neutral applications.

The Nucleus IMS interfaces with health information systems (HIS) using industry-standard image transfer and data exchange protocols—such as DICOM, HL7, and HTML—through web-based networked gateways and local and wide area networks. The Nucleus IMS is compatible with modalities including: Computed Tomography (CT), Magnetic Resonance Imaging (MR), Ultrasound (US), Computed Radiography (CR), Digital Radiography (DX), Nuclear Medicine (NM), Positron Emission Tomography (PT), and X-Ray Angiography (XA). When appropriate, the Nucleus IMS provides and installs software and, optionally, server hardware at client facilitate secure, web-based connections for image transmission to and from hospital central servers via the Internet. Additionally, industry standard HTTPS, VPNs, and other encryption methodologies are utilized to allow for optimal, secure, rapid streaming of image compression and encryption adhere to standard industry protocols. The Nucleus IMS can be used as a full featured PACS or as an independent viewer in clinical settings.

Nucleus Image Management System is not intended for display of mammography imaging for diagnosis.

The Nucleus Image Management System (Nucleus IMS) is a software based PACS, to be used by radiologists and other medical personnel. The Nucleus IMS is comprised of software modules that provide image receipt, diagnostic viewing, storage, distribution, enhancement, sharing, manipulation, and networking of medical 2D/3D images at distributed locations. All modules of the Nucleus IMS are web-based and can operate on off-the-shelf hardware, as needed. The Nucleus IMS consists of the following primary components: Nucleus Viewer with image streaming technology for use by medical professionals for diagnostic and clinical image review-Nucleus Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities-and Nucleus Image Store for secure cloud based image storage and management through HIPAA compliant encryption. Nucleus iX integrates with the Nucleus Viewer and Nucleus Image Store. Nucleus.io, a web based class I PaaS device, provides the basis for the system and for vendor neutral applications.

The Nucleus IMS interfaces with health information systems (HIS) using industry-standard image transfer and data exchange protocols—such as DICOM, HL7, and HTML—through web-based networked gateways and local and wide area networks. The Nucleus IMS is compatible with modalities including: Computed Tomography (CT), Magnetic Resonance Imaging (MR), Ultrasound (US), Computed Radiography (CR), Digital Radiography (DX), Nuclear Medicine (NM), Positron Emission Tomography (PT), and X-Ray Angiography (XA). When appropriate, the Nucleus IMS provides and installs software and, optionally, server hardware at client facilitate secure, web-based connections for image transmission to and from hospital central servers via the Internet. Additionally, industry standard HTTPS, VPNs, and other encryption methodologies are utilized to allow for optimal, secure, rapid streaming of image compression and encryption adhere to standard industry protocols. The Nucleus IMS can be used as a full featured PACS or as an independent viewer in clinical settings.

Nucleus Image Management System is not intended for display of mammography imaging for diagnosis.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) submission for the Nucleus Image Management System:

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 mentions "several full image data sets" were used for the Nucleus Viewer validation. It does not specify an exact number of cases or images.
• Data Provenance: Not explicitly stated. The study appears to be a retrospective technical and performance validation comparing the new device against a predicate, rather than a clinical study with patient outcome data. The country of origin of the data is not specified, but given the company location and FDA submission, it's likely U.S.-based.

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

• Number of Experts:
  • For the Nucleus Viewer validation (diagnostic quality and features): "a licensed Radiologist." (One expert mentioned.)
  • For the Nucleus Image Exchange validation (image exchange features): "a NucleusHealth Customer Service Supervisor." (One expert mentioned.)
• Qualifications:
  • Radiologist: "licensed Radiologist." No specific years of experience are mentioned, but implicitly, a licensed radiologist is qualified to assess diagnostic image quality.
  • Customer Service Supervisor: Their qualification for validating image exchange features is based on their role in NucleusHealth, implying familiarity with system operations.

4. Adjudication Method for the Test Set

• The document implies a none or single-reader adjudication method, as it states validations were performed by a single "licensed Radiologist" for the viewer and a "NucleusHealth Customer Service Supervisor" for the image exchange. There is no mention of multiple readers or consensus processes for resolving discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No MRMC study was done. The submission explicitly states, "No clinical trials were performed in the development of the device." The study focused on technical performance, feature validation, and substantial equivalence to a predicate device, not on human reader improvement with AI assistance. The device is a PACS system and viewer, not an AI diagnostic algorithm.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is not applicable in the typical sense of AI algorithms. The Nucleus Image Management System is a PACS (Picture Archiving and Communications System) and medical image viewer. Its "performance" refers to how well it functions as an image management and viewing system, not as an AI algorithm that provides diagnostic readings independently. The validations focused on system functionality, image quality for diagnostic review (by a human), and data exchange.

7. The Type of Ground Truth Used

• The ground truth was established by expert assessment/consensus against the predicate device's performance.
  • For diagnostic image quality: The licensed radiologist assessed the image quality of the Nucleus Viewer and compared it to "the image quality of the predicate device."
  • For features and functions: The experts validated that the features and functions performed as expected and were substantially equivalent to the predicate.
• It was not pathology, surgical outcomes, or a large-scale clinical outcomes data.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This is a PACS and viewer system, not an AI/machine learning model that undergoes a "training set" process in the typical sense for learning medical image features. Its development followed general software development and quality management procedures (ISO 13485, ISO 14971, FDA QSR).

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

• Not applicable. As noted above, there's no mention of a "training set" as understood in machine learning. The "ground truth" for the device's development (its requirements and expected behavior) would have been established through a Product Requirements Specification (PRS) and validated against through the verification and validation process.

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