Search Results

IntelliSpace PACS 4.x is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.

Lossy compressed mammographic images and digitized 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.

IntelliSpace PACS 4.x is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.

IntelliSpace PACS 4.x supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems.

The provided text describes the IntelliSpace PACS 4.x software system. However, it does not include information about specific acceptance criteria or a study designed to prove the device meets these criteria in the context of diagnostic performance.

The document focuses on the regulatory submission process (510(k) summary) and details the following:

• Device identification and classification: IntelliSpace PACS 4.x, Picture Archiving and Communications System, Class II, Product Code LLZ.
• Substantial equivalence: To iSite PACS v4.x (K063267).
• Device description and intended use: An image management system for trained professionals to acquire, store, distribute, process, and display images and associated data. It supports various DICOM modality types.
• Software Development: Designed, developed, tested, and validated according to written procedures.
• Performance Testing:
  • Verification: Ensured design output met functional and operational requirements, indicating safety, performance, and reliability.
  • Validation: Performed at the system level with production-ready software in actual/simulated environments, covering software and risk management. Confirmed meeting user needs and intended use.
  • Interoperability and compatibility: Conformance to DICOM, HL7, and IHE standards.
  • Regression testing: Demonstrated substantial equivalence to earlier versions.
• Safety and Effectiveness: Stated that labeling contains instructions, cautions, and warnings. Hardware components are "off the shelf."
• Conclusion: Substantially equivalent to the predicate device, with no new issues of safety or effectiveness.

Based on the provided text, I cannot complete the requested tables and information because the document does not contain:

• Specific acceptance criteria related to diagnostic performance. The performance testing mentioned is about meeting functional, operational, and regulatory standards (DICOM, HL7, IHE), not specific diagnostic metrics (like sensitivity, specificity, accuracy).
• A clinical study comparing the device's diagnostic performance against a ground truth. The testing described is verification, validation, interoperability, and regression testing, focused on system functionality and regulatory compliance rather than a clinical effectiveness study.
• Details about test set sample size, data provenance, expert qualifications, or ground truth establishment relevant to diagnostic performance.

Therefore, I must state that the requested information (acceptance criteria and study proving device meets them) is not present in the provided text. The document serves as a 510(k) summary establishing substantial equivalence based on functional and technical performance, not clinical diagnostic performance.

Ask a specific question about this device