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SUITESTENSA is an integrated software system for the management and reporting of diagnostic-instrumental procedures in Cardiology and Radiology departments. It is intended to support and assist trained professionals in the diagnostic process, through the acquisition, storage, viewing, processing and reporting of cardiology imaging studies and ECG traces. SUITESTENSA also allows transfer of images to CD/DVD.

SUITESTENSA may be used also for the display, manipulation, and interpretation of lossless compressed or noncompressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.

SUITESTENSA is intended to be used by qualified professionals, i.e. doctors (radiologists, etc.), ward technicians, paramedics, administrative personnel, specialist ward doctors.

SUITESTENSA Software is a RIS/CIS/PACS software suite managing the entire clinical workflow of a Radiology and Cardiology Department through the following software modules being part of the Software Suite:

• SUITESTENSA PACS Archiving Software System
• SUITESTENSA Review Diagnostic Reporting Software
• SUITESTENSA RIS – Radiology Information System
• SUITESTENSA CIS Cardiology Information System
• SUITESTENSA MPS Media Production Software System
• SUITESTENSA QC - Integration Process Quality Control

SUITESTENSA natively integrates SUITESTENSA RIS/CIS and may integrate with any other third party RIS/CIS software that has HL7 interface capabilities.

The provided text describes a 510(k) premarket notification for the device SUITESTENSA. It states that the software for this device was considered a "moderate" level of concern, meaning a software failure could "indirectly result in minor injury to the patient through incorrect or delayed information or through the action of the care provider."

The document mentions that "Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and in accordance with ISO 62304, Medical Device Software - Software Lifecycle Process." It further states that "Software verification and validation was performed to ensure it met all the specification requirements and conformance testing."

However, the provided text DOES NOT contain specific acceptance criteria, reported device performance data (e.g., sensitivity, specificity, accuracy, or any quantitative metrics), details of a study that proves the device meets acceptance criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, details of MRMC studies, standalone performance, or types of ground truth used.

The document primarily focuses on establishing substantial equivalence to a predicate device (FUJIFILM Synapse PACS 5.1.0) based on shared technological characteristics and intended uses for a PACS system, rather than presenting a performance study with quantitative acceptance criteria and results.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance study details from the provided text. The document confirms that some software verification and validation was performed to meet specifications, but it does not detail those specifications or the empirical results of such testing in the context of clinical performance metrics.

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