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The Advantis ASC is intended to be used for intravascular administration of drugs, fluids, blood and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application.

The Advantis™ ASC (Alternate Site Care) is a multi-mode large volume infusion pump suitable for general and homecare applications. The instrument is a microprocessorcontrolled device designed to use a standard, single use, administration set (dedicated and non-dedicated). The large volume infusion pump provides control of infusion rates (0.1 ml/hr to 999 m/hr) due to the positive displacement action of the linear peristaltic mechanism. The instrument's features include multi programs (standard, micro, primary, secondary modes), TPN and 10-P delivery, free flow protection, user selectable occlusion pressures, automatic priming, and an anti-bolus system. This instrument incorporates both audible and visual alarms for Air-in-line, Upstream and Downstream Occlusion, Low Battery, Electrical or Mechanical Failure, Open Door and Incorrect IV Administration Set.

The provided text is related to a 510(k) premarket notification for an infusion pump, which is a medical device. This type of document is for regulatory clearance and does not typically include information about "acceptance criteria" and "studies" in the context of AI/ML device performance, as outlined in your request.

The questions you are asking (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are specific to the evaluation and validation of Artificial Intelligence/Machine Learning (AI/ML) medical devices, particularly those involving diagnostic or prognostic algorithms.

The document discusses:

• Device Name: Advantis™ ASC Infusion System
• Intended Use: Intravascular administration of drugs, fluids, blood, and blood products; also indicated for epidural applications.
• Technological Characteristics: Similar to predicate devices (Sabratek 3030 Volumetric Infusion Pump and Baxter Flo-Gard 6201 Infusion Pump), using similar technologies, software, materials, electronics, energy sources, and mechanical components, including standard PVC administration sets.
• Regulatory Clearance: A 510(k) premarket notification indicating substantial equivalence to predicate devices.

Since the Advantis ASC Infusion Pump is a traditional electromechanical medical device and not an AI/ML diagnostic or prognostic device, the information you've requested regarding AI/ML-specific acceptance criteria and validation studies (like those involving ground truth, expert consensus, MRMC studies, training/test sets) is not applicable to this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about AI/ML study design, as the provided text does not contain that kind of information.

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