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The PrisMax control unit is intended for:
• Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.

All treatments administered via the PrisMax control unit must be prescribed by a physician.

The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. The PrisMax System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous VenoVenous Hemodialysis (CVVHD), and Continuous Venovenous Hemodialfiltration (CVVHDF). The proposed device PrisMax consists of PrisMax Control Unit and accessories for removing effluent.

The provided text describes a 510(k) premarket notification for the PrisMax device, which is a high-permeability hemodialysis system. The core of this submission is to demonstrate the substantial equivalence of the PrisMax to a predicate device, the Prismaflex.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text. It's important to note that a 510(k) summary often summarizes extensive testing, so not all details of the actual studies might be present in this brief document.

First and foremost, this document describes a device comparison for substantial equivalence to a predicate, not a study evaluating clinical performance against a specific disease outcome or a MRMC study. Therefore, some of the requested information (like effect size of human readers improving with AI, or number of experts for ground truth) is not applicable to this type of regulatory submission. The acceptance criteria here are about equivalence to the predicate device's established performance parameters and safety.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally that the PrisMax device performs at least as well as or equivalently to the predicate Prismaflex device for various technical specifications. The reported device performance is the PrisMax's specification for that feature. The table below is extracted directly from the "Table 3. Substantial Equivalence Table Device Comparison" in the provided document. The "Acceptance Criteria" column reflects the predicate device's performance, as the goal is to demonstrate equivalence or improvement without raising new safety/effectiveness concerns.

Study Proving Device Meets Acceptance Criteria

The document states: "Performance testing was conducted on the PrisMax System to evaluate the functional performance of the system. The performance testing confirms PrisMax remains as safe and effective as Prismaflex and is substantially equivalent."

The nature of the "study" demonstrating this is predominantly nonclinical performance testing, verification, and validation against engineering and regulatory standards, and comparison to the predicate device's specifications.

Specifically, the document explicitly mentions:

• Design validation: The PrisMax design validation meets user needs and intended use and is substantially equivalent to the predicate.
• Compliance with IEC 60601-2-16 Hemodialysis Equipment: Testing confirmed by CSA, a recognized test laboratory, for essential performance.
• Electrical safety testing: According to IEC 60601-1 Edition 3.1. This includes reports for software, alarms, usability, safety, and performance.
• Electromagnetic compatibility (EMC) testing.
• Risk Assessment and risk control measures: Hazard analysis (therapy level, product level, process level) confirming the device does not perform in an unexpected or unsafe manner.
• Labeling, Software including cybersecurity, Human Factors: These have been successfully implemented.
• Verification and validation tests: These were performed subsequent to risk analysis and include Human Factors and Software Validation.

The key changes and their justification for not raising new safety/effectiveness concerns are footnoted in Table 3:

• Syringe Sizes (30ml removed): Due to infrequent use, device behavior unchanged.
• Dialysate Flow Rate / Replacement Solution Flow Rate Increment (50ml/hr to 10ml/hr): Allows for more precise settings, verified and validated to comply to updated specifications without new risks.
• Pre-Blood Pump Flow Rate (SCUF range clarification): Corrected the predicate's stated range to its actual operational range, showing PrisMax is equivalent. Verified and validated.
• Trans Membrane Pressure Alarms (Fixed default of +300 mmHg, removed user settable): Removes infrequent use case, reduces use-error risk, increases usability, lowers default to reduce risk. Verified and validated.
• Patient Fluid Removal Performance Increment (10ml/hr to 5ml/hr): Increases setting range, allows more precise setting. Verified and validated.
• The software update (version 1.0.6.0) was verified and validated subsequent to risk analysis and includes Human Factors and Software Validation.

Details based on the provided text:

• 2. Sample size used for the test set and the data provenance:

  • Sample Size: Not explicitly stated in terms of patient count or device unit count for the validation tests. These are typically engineering performance tests, not clinical trials with "patients." The performance tests would use a relevant number of devices or test conditions to ensure specifications are met.
  • Data Provenance: The testing appears to be internal "performance testing" and "verification and validation" conducted by Baxter Healthcare Corporation and by a recognized test laboratory (CSA) for specific standards like IEC 60601-2-16. This is non-clinical, laboratory-based data, not patient data from a specific country.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable in the context of a 510(k) submission based on technical performance and equivalence to a predicate device, rather than a clinical diagnostic study requiring expert interpretation of results. The "ground truth" here is adherence to engineering specifications and safety standards.

• 4. Adjudication method for the test set:

  • Not applicable, as this is not a study requiring human adjudication for diagnostic categorization. The "adjudication" is through engineering verification and validation processes against predefined technical specifications and standards.

• 5. 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:

  • No. This is a medical device for continuous renal replacement therapy, not an AI/diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study is not relevant here.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Not applicable in the way this question typically refers to AI algorithms. The device itself is a "standalone" system in its function, but its performance is verified through engineering tests against objective criteria, not an "algorithm only" performance separate from the device's integrated function. Its operation relies on physician prescription (human-in-the-loop for clinical application, but not for the device's technical performance evaluation).

• 7. The type of ground truth used:

  • Engineering Specifications and Performance Standards: The "ground truth" for this submission is compliance with established engineering specifications for flow rates, accuracy, pressure ranges, alarm settings, and adherence to international safety standards (e.g., IEC60601 series). Additionally, the predicate device's cleared performance serves as a comparative ground truth for equivalence.

• 8. The sample size for the training set:

  • Not applicable. This is not a machine learning or AI device that requires a "training set" in the conventional sense. The "training" for the device's development would be iterative engineering design and testing.

• 9. How the ground truth for the training set was established:

  • Not applicable, as there is no "training set" in the AI/ML context. The functional requirements for the device are derived from clinical needs, regulatory standards, and the performance of previous generations of such devices.

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