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Cedara WebAccess 2.4 is a software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.

Cedara WebAccess 2.4 is capable of being configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

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 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Cedara WebAccess 2.4 provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

With no application-specific installation required on the user's computer, qualified medical professionals can use Cedara WebAccess 2.4 with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Imaging Series and file attachments.

Cedara WebAccess 2.4 was designed with an easy and convenient workflow providing image viewing tools including zoom, pan, contrast, series/layout change, toggle on/off image text, MPR, CINE, reset and measurement.

The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.

The provided document is a 510(k) summary for Cedara WebAccess 2.4. It discusses the device description, indications for use, comparison to predicate devices, and a summary of testing. However, it does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report.

The "Summary of Testing" section (page 3) generally states:
"Nonclinical verification and validation test results established that the device meets its design requirements and intended use, and that it is as safe, as effective, and performs as well as the predicate devices and that no new issues of safety and effectiveness were raised. The results also demonstrated that the device complies with industry standards for medical data: the NEMA DICOM 3.0 standard for Digital Imaging and Communications in Medicine, the JPEG standard ISO/IEC 10918-1 for the Digital Compression and Coding of Continuous-Tone Still Images, and the ISO/IEC 15948 standard for Portable Networks Graphics (PNG)."

This statement indicates that verification and validation testing was performed to demonstrate compliance with design requirements, intended use, and industry standards, and to establish substantial equivalence to predicate devices. However, it does not provide specific quantitative acceptance criteria or detailed results of a study that would typically be used to "prove" meeting those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Therefore, based only on the provided document, I cannot fill out the requested table and information about acceptance criteria and a specific study proving device performance in the way you've outlined for a typical diagnostic AI device. The document describes a general medical image processing software (PACS-like) rather than a diagnostic AI algorithm. Its "performance" is more related to its functionality, interoperability, and safe display of images rather than diagnostic accuracy.

Here's what I can extract and what is missing, based on your request and the provided text:

Acceptance Criteria and Reported Device Performance

Missing Information based on the prompt (as it pertains to a diagnostic AI algorithm):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned. The testing focused on functional verification and validation, not diagnostic accuracy on a clinical test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic test set with ground truth in this context.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is an image viewer, not an AI diagnostic aid.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a viewing interface, not a standalone algorithm with diagnostic performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no diagnostic ground truth established for performance evaluation of the device itself. The device facilitates viewing images where a human establishes the ground truth (diagnosis).
7. The sample size for the training set: Not applicable. This is not an AI/ML algorithm that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the document describes the functional and technical compliance of an image viewing software (PACS) with industry standards and its substantial equivalence to predicate devices, rather than presenting a performance study for a diagnostic AI algorithm with specific clinical acceptance criteria like sensitivity or specificity.

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Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital.

Diagnostic Review Workstations - Assists medical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning through the flexible and interactive manipulation of multi-modality softcopy images.

Two and three-dimensional image coregistration (fusion) and segmentation of multiple imaging modality data including but not limited to functional MRI, PET, SPECT, and CT for user-selected regions of interest taken at different time points or generated using different scanning protocols.

Detailed measurement and reporting features assist clinicians in assessing and documenting changes in regions of interest such as pathologies (c.g., tumors, abscesses, AVMs), or other anatomical structures. The software can help track changes in morphology, functional activity, or other responses that may occur as a result of treatment therapy or disease progression.

The Cedara I-Response and Cedara PET/CT software products are line extensions to Cedara's medical image processing workstation product, Cedara I-SoftView™. The products are designed to facilitate the oncology or other clinical specialty workflow by comparing medical imaging data from different modalities and/or from different time points. The products are able to coregister functional MRI, PET, SPECT, CT, or other modality datasets. segment out Regions of Interest (ROI), and calculate, display, and report relative differences in Apparent Diffusion Coefficient (ADC). Standardized Update Value (SUV), or other values within those regions.

The products can be used as standalone applications or can be "plugged in" and launched from within other applications such as Cedara I-SoftView, or from another workstation or console.

The PROVIDED TEXT DOES NOT CONTAIN INFORMATION REGARDING THE ACCEPTANCE CRITERIA OR A STUDY DESIGNED TO PROVE THE DEVICE MEETS SUCH CRITERIA.

The document is a 510(k) summary for Cedara I-Response and Cedara PET/CT software, which describes the device, its intended use, and substantial equivalence to predicate devices. It also includes the FDA's clearance letter. However, it does not detail specific performance acceptance criteria or the results of a study demonstrating the device meets those criteria.

Therefore, I cannot provide the requested table and study information based on the provided text.

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Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital.

Productivity-Enhancing Second Console Workstations - Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians.

Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images including the use of prosthetic template overlays, and including mammography.

Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)

Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.

Cedara I-ReadMammo is medical image review workstation software that is comprised of features that are previously cleared in Cedara I-SoftView. The differences lie mainly in workflow and user interface that make mammography image viewing more convenient for the user. The product consists of features that allow the qualified medical professional to view patient medical images with the desired viewing protocol and workflow in order to optimize the efficient use of their time. Additionally, as with all Cedara I-SoftView offerings, measurements that are commonly required for diagnosis and surgical planning are available to the user.

The provided text describes a 510(k) premarket notification for Cedara I-SoftView and Cedara I-ReadMammo, which are PACS medical imaging software and a medical image review workstation, respectively.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or adjudication methods). The text focuses on the device description, indications for use, comparison to a previously cleared device, and the FDA's substantial equivalence determination.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital.

Productivity-Enhancing Second Console Workstations – Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians.

Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images. This includes the use of prosthetic template overlays

Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)

The Cedara Orthopedic tool set is a new option available in the Cedara I-SoftView product which is a line extension of Cedara's medical image processing workstation product, "Medical Imaging Family of Workstations". The Cedara Orthopedic tool set is a software accessory that will be typically used for orthopedic applications and consists of features that allow the qualified medical professional to make measurements that are commonly required when doing orthopedic surgical planning. In addition to circle, line and angle measurements, the physician can also display electronic implant templates that can aid in implant size and positioning determination prior to surgery.

The provided text is a 510(k) summary for the Cedara I-SoftView™ with Orthopedic Module, submitted to the FDA in 2002. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing a specific clinical study with acceptance criteria and performance metrics of the device itself.

Therefore, the requested information regarding acceptance criteria, study performance, sample sizes, expert qualifications, ground truth establishment, and MRMC studies is not available within this document.

The document describes the device, its intended use, and compares it to predicate devices to argue for substantial equivalence based on technological characteristics and intended use, not based on a rigorous performance study against specific acceptance criteria.

In summary, the provided text does not contain the information needed to answer the request.

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