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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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