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The Thoth ToPACS is an image management system whose intended use is to provide (scaleable ) DICOM compatible PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR and other devices) and information systems.

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 Mpixel resolution and meets other specifications reviewed and accepted by FDA

ToPACS is a stand-alone software package that is used on general purpose computing I of ACO is a bains aronivimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform micegrator is free to enouse minage processing, measurement, communication and The soltware and is alguing to the specifications that are documented in a Storage. 1011 System Test Plan. Testing is an integral part of Thoth software Thours Process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.

The provided text does not contain a study to prove acceptance criteria for the ToPACS device. Instead, it describes a 510(k) summary for the device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

The document explicitly states: "The determination of substantial equivalence is not based on an assessment of performance tests." This means a performance study as typically understood with acceptance criteria, sample sizes, ground truth, and expert adjudication was not conducted or, at least, not the basis for the substantial equivalence determination reported here.

Therefore, I cannot fill in the requested table and information as a performance study proving device meets acceptance criteria is not present in the provided document.

However, I can extract information relevant to the device's intended use and limitations, which might be construed as "acceptance criteria" for its operation, rather than its performance.

Implicit "Acceptance Criteria" (Operational, not Performance) and Device Description:

Since no performance study is detailed, the following sections cannot be answered:

• Sample sized used for the test set and the data provenance: Not applicable, no performance tests mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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, the device is a PACS system, not an AI-assisted diagnostic tool, and no such study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, the device is explicitly designed for human-in-the-loop interpretation.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable, as this is a PACS system not typically "trained" in the machine learning sense, and no training data is mentioned.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices, not on performance testing against specific acceptance criteria.

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