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The PRISMA M10 Pre Set is indicated for use with the PRISMA control unit only in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

The set is intended for use in the following veno-venous therapies:

• slow continuous ultrafiltration (SCUF)
• continuous veno-venous hemofiltration (CVVH)
• continuous veno-venous hemodialysis (CVVHD)
• continuous veno-venous hemodiafiltration (CVVHDF)

The PRISMA M10 Pre Set is intended for treatment of neonates and infants with a body weight ranging between 2 and 15 kg.

The PRISMA M10 Pre Set is a disposable, extracorporeal circuit for use with the PRISMA control unit. The PRISMA M10 Pre Set consists of a AN 69 hollow fiber hemofiter / dialyzer and tubing lines.

The filter is permanently connected:

• on the blood compartment to an access line (red-striped), a return line (blue-striped) .
• on the dialysate compartment to a dialysate inlet line (green-striped) and to anceff)vent . outlet line (yellow-striped).

Other lines of the set include a replacement solution line (purple-striped) and anticoagulant line.

• A 1-liter bag is connected to the end of the blood access line to collect the priming . liquid.
• A 5-liter bag is connected to the end of the effluent outlet line to collect the ultrafil trate . and/or dialysate.

Pre-dilution: the PRISMA M10 Pre Set is a set provided for addition of replacement solution before blood enters the filter.

The provided text describes a 510(k) premarket notification for the "PRISMA M10 Pre Set" device by Gambro Renal Products. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or performing a study to prove acceptance criteria for an AI/CADe device. Therefore, the information required to answer the prompt is not present in the provided text.

Here's why and what information is missing:

• Device Type: The PRISMA M10 Pre Set is a disposable extracorporeal circuit (a medical device hardware) for renal replacement therapies, not an AI/CADe system. The prompt, with its focus on "multireader multicas study," "human readers improve with AI," and "standalone (algorithm only)" performance, is clearly tailored for AI/CADe devices.
• Acceptance Criteria/Performance Table: The document states that "In vitro performance and clinical testing was performed to establish and compare performance characteristics to the predicate devices." However, it does not explicitly list the acceptance criteria (e.g., sensitivity, specificity, AUC) or the numerical results of these tests for the PRISMA M10 Pre Set. It only concludes that the device performs "as well as the predicate devices."
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): The document mentions "clinical testing" but does not provide any details about the study design, such as sample size, characteristics of the test data (e.g., country of origin, retrospective/prospective), the involvement of experts, adjudication methods, or whether it was a multi-reader multi-case study. These are standard elements for AI/CADe validation but not typically presented in this level of detail for a medical device hardware 510(k) submission.
• Ground Truth: For a hardware device like this, "ground truth" would relate to its physical and functional performance (e.g., ultrafiltration rate, solute clearance), rather than diagnostic accuracy established by expert consensus or pathology, which is relevant for AI/CADe systems. The document implies that the "performance data/specifications" are the "ground truth" for comparison to predicate devices, but no specifics are given.
• Training Set: Since this is not an AI/CADe device, there is no concept of a "training set" in the context of the device itself.

In summary, the provided content is a 510(k) summary for a medical device hardware, and thus does not contain the information requested about acceptance criteria and study data for an AI/CADe device.

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