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The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician.

The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician. The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. Prismaflex® System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD), and Continuous Veno-venous Hemodialfiltration (CVVHDF).

The provided text is a 510(k) summary for the Prismaflex® System 3.20. It details the device's intended use, comparison to a predicate device, and non-clinical testing. However, it does not include the specific information requested about acceptance criteria for device performance studies, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, or any information regarding multi-reader multi-case studies or standalone algorithm performance.

The document states that the non-clinical testing for the Prismaflex® System 3.20 demonstrated its safety and effectiveness and that it "performs as well as or better than the legally marketed predicate device." This implies that the acceptance criteria for the new device were alignment with or improvement upon the performance of the predicate device (Prismaflex™ System 1.04).

Below is a summary of the available information and an explicit statement of what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly uses the performance of the predicate device as the acceptance criteria for the modified device. The table below compares the specifications of the modified device to the predicate device. For some parameters, the modified device's performance aligns with the predicate, while for others (like Dialysate Flow Rate Accuracy, Replacement Flow Rate Accuracy, Pre-Blood Pump Accuracy, and Patient Fluid Removal Performance Range Accuracy), the modified device states a specific accuracy, which could be considered its performance target (acceptance criteria) and reported performance.

Missing Information:

The document is a 510(k) summary for a medical device (Prismaflex® System 3.20), not an AI/ML-based device for diagnostic or prognostic purposes. As such, the requested information categories are largely not applicable as they pertain to studies involving algorithms, data sets, and human expert evaluation in a clinical/diagnostic context.

Here's a breakdown of why each item from your request is not present in the provided text:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document describes "non-clinical testing" including component-level hardware testing, software testing, and human factors evaluations. It does not mention clinical trials or data sets derived from human patients in the way an AI/ML device would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images or diagnoses) is not relevant here. The testing described is technical validation of a medical device's performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to review of cases, typically for diagnostic accuracy.
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: Not applicable. This device is a renal replacement therapy system, not an imaging or diagnostic AI. Human improvement with or without AI assistance is not a relevant outcome measure for this device type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical system with embedded software, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be engineering specifications and measurements (e.g., actual flow rates vs. set flow rates, pressure measurements, etc.), not clinical ground truth derived from expert consensus or pathology.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established: Not applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria (from the document):

The study consisted of non-clinical testing designed to demonstrate the safety and effectiveness of the Prismaflex® System 3.20. This testing included:

• Component-level hardware testing
• Testing to support declarations of conformity to standards cited in the 510(k) submission.
• Testing required by process to ensure compliance with other international standards applicable to hemodialysis machines.
• Static and dynamic software testing, including:
  • Unit testing
  • Code inspections
  • Testing targeted to the changes implemented in software version 3.20
  • Regression testing
• Human factors evaluations
• Testing performed by internal and external independent personnel with appropriate skills.

The "successful non-clinical testing" is stated to demonstrate that the Prismaflex® System 3.20 "performs as well as or better than the legally marketed predicate device (Prismaflex™ System 1.04)." This indicates that the performance criteria (acceptance criteria) for the new device were implicitly established by the performance of the predicate device, and the non-clinical tests confirmed that the modified device met or exceeded those established baselines across its operational specifications.

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