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The Prisma® System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with disease where removal of plasma components is indicated.

The Prisma System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with disease where removal of plasma components is indicated. All treatment administered via the Prisma® System must be prescribed by a physician. The Prisma® System is designed for use on critically ill patients in the intensive care unit to provide the following treatments: SCUD (slow Continuous Ultrafiltrtion), CVVH (Continuous Veno-Venous Hemofiltration), CVVHD (Continuous Veno-Venous Hemodialysis), CVVHDF (Continuous Veno-venous Hemodialfiltration) and TPE (Therapeutic Plasma Exchange). The Prisma® System consists of the Prisma Control Unit and a series of disposable extracorporeal blood circuits (Prisma Sets) to allow four types of continuous renal replacements therapies as well as therapeutic plasma exchange (TPE) therapy. The blood circuit utilized will be dependent on the individual patient's therapy and needs.

The Prisma Control Unit performs the following functions:

1. Loads and primes the Prisma Set automatically.
2. Pumps blood through the blood flowpath of the set.
3. Delivers anti-coagulant solution into blood flowpath.
4. Controls fluid removal/plasma loss from the patient.
5. Pumps sterile replacement solution/fluid and/or sterile dialysate. Pumps effluent.
6. Monitors the system and alerts the operator to abnormal situations through alarms.

Here's a breakdown of the acceptance criteria and the study information for the Prisma® 3.10 System, based on the provided document:

This document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It primarily focuses on comparing the new device (Prisma® R03.10A System) to a legally marketed predicate device (Prisma® System V 3.03) to demonstrate that it is as safe and effective. The "acceptance criteria" here refers to the performance specifications of the device itself and its equivalence to the predicate, rather than statistical performance metrics of an AI model.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate section, but the comparison table between the predicate and modified device effectively serves this purpose. The acceptance criterion is that the performance of the modified device (Prisma® R03.10A) must be equivalent to or better than the predicate device (Prisma® System V 3.03) across various operational parameters.

TMP Alarm Limits (same for both Prisma® 3.03 & 3.10):

Conclusion of Testing: "The successful non-clinical testing demonstrates the safety and effectiveness of the Prisma® R03.10A System when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed device."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical "sample size" for a dedicated test set in the context of clinical data or patient outcomes. The testing described is non-clinical, focusing on the device's functional performance.
• Data Provenance: The testing described is "non-clinical testing" including "unit testing, code inspections, testing targeted to the changes implemented in R03.10A, regression testing and human factors evaluations and testing that was performed by internal and external independent personnel with the appropriate skills." This indicates it was likely laboratory/bench testing and internal evaluations, not drawn from patient data. The country of origin for the data is not specified but is implied to be related to Gambro Renal Products (Lakewood, CO, USA). The study is prospective in the sense that the testing was conducted on the newly modified device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: The document mentions "external independent personnel with the appropriate skills" for human factors evaluations and testing. However, it does not specify a number or detailed qualifications for these experts.
• Qualifications: "appropriate skills" is the only stated qualification. This type of device (a dialysis delivery system) typically involves engineers, regulatory affairs specialists, and potentially clinical users (e.g., intensive care unit nurses, nephrologists) for human factors, but no specific professional backgrounds or years of experience are listed.

4. Adjudication Method for the Test Set

No formal adjudication method (like 2+1 or 3+1) is described. The non-clinical testing appears to involve a structured testing protocol against predefined specifications and regulatory requirements. The "adjudication" would largely be whether the device passed or failed the specified tests, with "internal and external independent personnel" conducting and likely reviewing the results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. This type of study is typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. The Prisma® 3.10 System is a hemodialysis delivery system, not a diagnostic imaging AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No "standalone" (algorithm-only) study was done in the context of an AI algorithm, as this device report predates the widespread regulatory discussions around AI and is a hardware/software system rather than a pure AI diagnostic. The device itself (the Prisma Control Unit) performs automated functions like pumping blood, delivering anticoagulants, controlling fluid removal, and monitoring with alarms, which could be considered its "standalone" functionality. The non-clinical testing assessed these automated functions.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on its functional specifications and comparison to the predicate device. It's established through:

• Engineering Specifications/Bench Testing: The device's ability to maintain flow rates, accurately measure pressures, and trigger alarms within defined limits during non-clinical, controlled tests.
• Performance Equivalence: The primary ground truth is demonstrating that the modified device performs "as well as or better than" the legally marketed predicate device (Prisma® System V 3.03) based on the operational parameters listed in the comparison table. This is a regulatory "ground truth" for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. The document is for a medical device (hemodialysis delivery system), not an AI algorithm that typically has a "training set." The software within the device has likely undergone development and verification, but the concept of a "training set" as used in AI/machine learning is not relevant here.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI/machine learning for this device.

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