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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.
• Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
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 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. 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 System Version 3 uses the current marketed device PrisMax System Version 2 as the predicate.

This document is a 510(k) Pre-market Notification for a medical device, the PrisMax System Version 3. The document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (PrisMax System Version 2), and therefore does not require a new premarket approval application (PMA).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study, organized by your requested points:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the technical specifications outlined in the "Substantial Equivalence Summary" tables (Table 3), comparing the PrisMax System Version 3 to the predicate PrisMax System Version 2. The reported device performance is stated as meeting these specifications, thereby achieving "substantial equivalence" to the predicate.

Table 1: Acceptance Criteria and Reported Device Performance

Summary of Device Performance: The document explicitly states that for all technical specifications listed, the "Proposed K19XXXX PrisMax Version 3" is identical ("SE" - Substantial Equivalence) to the "Proposed K190910 PrisMax Version 2," with the only explicitly identified difference being the Control Unit Software version (Version 3 vs. Version 2). The performance testing conducted confirms that PrisMax System Version 3 remains as safe and effective as the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical or imagery data. Instead, the evaluation relies on nonclinical performance testing of a physical device.

• Sample Size for Test Set: Not applicable in the traditional sense of patient data. The "test set" would refer to the instantiated PrisMax System Version 3 device(s) and its components undergoing rigorous engineering and functional tests. The document does not specify the number of units tested.
• Data Provenance: The tests are "nonclinical" and focus on functional performance. The document doesn't explicitly state the country of origin for the testing, but it is submitted to the U.S. FDA by Baxter Healthcare Corporation (Deerfield, Illinois, USA). The testing is prospective in the sense that newly manufactured or updated devices were tested to verify performance against established specifications.

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)

This is not applicable as the document describes a nonclinical, engineering-focused substantial equivalence demonstration for a medical device (Continuous Renal Replacement Therapy system), not a diagnostic AI/imaging device requiring expert ground truth in a clinical context. The "ground truth" here is the established functional and safety specifications of the device, typically defined by engineering standards, regulatory requirements, and performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data (e.g., medical images). This document describes nonclinical performance testing of hardware and software, where objective measurements and adherence to engineering specifications are the primary evaluation methods, not subjective expert reviews.

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

This is not applicable. An MRMC study is designed for evaluating the diagnostic performance of a system (often AI-assisted) in a clinical setting by comparing multiple readers' interpretations of multiple cases. The PrisMax System is a therapeutic and fluid management device, not a diagnostic tool, and its evaluation did not involve human "readers" or AI assistance in this context.

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

This is not applicable as the PrisMax System is a physical medical device. While it contains software (Control Unit Software Version 3), the performance evaluation is of the integrated system, and not an algorithm in isolation for diagnostic purposes. The software verification and validation are part of the overall system's nonclinical testing.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the nonclinical tests is based on:

• Established engineering specifications and performance limits: These are derived from general medical device standards (e.g., IEC60601-2-16, IEC60601-1, IEC60601-1-2), regulatory guidelines, and the proven performance of the predicate device (PrisMax System Version 2).
• Risk analysis: Ensuring the device does not perform in an unexpected or unsafe manner.
• User needs and intended use: The design validation aimed to meet these.

In essence, the ground truth is the successful demonstration of consistent functional performance within predefined, objective, and safety-critical parameters, validated against a well-established and previously cleared predicate device.

8. The sample size for the training set

This is not applicable. The PrisMax System is not an AI/machine learning model in the sense that it requires a "training set" of data to learn from for diagnostic or predictive purposes. It is a control unit for CRRT and TPE, meaning its software is deterministic and engineered to perform specific, pre-programmed functions and calculations based on input parameters.

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

This is not applicable for the reasons stated in point 8.

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