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The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane.

The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).

All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.

If patients suffer from acute kidney injury and / or volume overload, the Prismatlex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:

• · Slow Continuous UltraFiltration (SCUF)
• · Continuous Veno-Venous Hemofiltration (CVVH)
• · Continuous Veno-Venous HemoDialysis (CVVHD)
• Continuous Veno-Venous HemoDiaFiltration (CVVHDF)

to perform fluid management and reduction of uremic toxins.

The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (661b) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).

The Prismaflex ST60/ST100/ST150 set is a disposable, extracorporeal circuit for use with the PrismaFlex system, or with the PrisMax system. The Prismaflex ST60/ST100/ST150 set consists of an AN69 ST hollow fiber haemofilter/dialyser and tubing system.

These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed :

• SCUF: Slow Continuous Ultrafiltration
• CVVH: Continuous Veno-Venous Hemofiltration
• CVVHD: Continuous Veno-Venous Hemodialysis
• CVVHDF: Continuous Veno-Venous Hemodiafiltration

The fluid pathways of the Prismaflex set are guaranteed sterile and pyrogen-free. The Prismaflex set is sterilized by ethylene oxide (EO).

The shelf life of the Prismaflex ST60/ST100/ST150 sets is 24 months from the date of sterilization. The device is intended for single use.

The provided text describes a 510(k) premarket notification for the "Prismaflex ST set" (ST60/ST100/ST150 sets), a high permeability hemodialysis system. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The document focuses on non-clinical testing to support this claim.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance values like a clinical trial report would for specific endpoints (e.g., sensitivity, specificity for diagnostic devices, or specific measurable outcomes for therapeutic devices).

Instead, it states that the device was evaluated against established international standards and internal performance requirements. The "reported device performance" is described qualitatively as meeting these standards and requirements.

Here's a synthesized representation based on the information provided, inferring "acceptance criteria" from the standards and tests mentioned:

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

The provided text describes non-clinical bench and pre-clinical testing. These are laboratory-based tests of the device's physical and chemical properties, as well as its interaction with biological models (e.g., blood, cell cultures).

• Sample Size for Test Set: The document does not specify the exact number of units/sets tested for each performance characteristic. In bench testing for medical devices, this often involves a pre-defined number of samples per batch or according to a statistical sampling plan to ensure reliability and representativeness for the specific test (e.g., n=3, n=5, n=10 per test condition). However, these specific numbers are not disclosed in this summary.
• Data Provenance: The data provenance is from non-clinical (bench and pre-clinical) laboratory testing. There is no mention of human subject data, retrospective, or prospective studies involving patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable to the type of study described. "Ground truth" established by experts (like radiologists for image analysis) is relevant for clinical studies, especially those involving human interpretation or diagnostic accuracy. The studies detailed here are non-clinical, focusing on the device's physical and chemical performance, where "ground truth" is typically defined by objective measurements against established engineering specifications and international standards, not expert consensus.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) refer to procedures for resolving disagreements among multiple human readers/experts in clinical studies, particularly in diagnostic accuracy assessments. As this is a non-clinical device performance study, such a method would not be used.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states that the safety and performance were evaluated through non-clinical testing. There is no mention of human readers, AI assistance, or comparative effectiveness studies involving human-in-the-loop performance.

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

This question is not applicable. The device described, the "Prismaflex ST set," is a medical device for blood purification (hemodialysis/hemofiltration), not an AI algorithm or a diagnostic tool that would typically have a "standalone" algorithmic performance. The "performance" here refers to its physical and functional operation.

7. Type of Ground Truth Used

The "ground truth" for these non-clinical tests is established by:

• Objective Measurements: Directly measuring physical and chemical properties (e.g., ultrafiltration rate, clearances, pressure drop) using calibrated equipment.
• International Standards: Compliance with recognized international standards (ISO 8637-1, ISO 8638, ISO 10993 series) which define acceptable ranges and methodologies.
• Device Specifications: Meeting internal design specifications for the device.

There is no use of expert consensus, pathology, or outcomes data as "ground truth" in these non-clinical tests.

8. Sample Size for the Training Set

This question is not applicable. The Prismaflex ST set is a hardware medical device; its development and validation do not involve "training sets" in the context of machine learning or AI algorithms. The "training" that occurs is in the manufacturing and quality control processes to ensure consistency and adherence to specifications.

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

This question is not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device.

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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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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, which is the subject of this Traditional premarket notification (510(k)), consists of the PrisMax Control Unit System, Blood Tubing Sets and Accessories. Specific to this submission, is the accessory for blood warming and a blood tubing set for Therapeutic Plasma Exchange (TPE2000).

Here's a breakdown of the acceptance criteria and the study information for the PrisMax System Version 2, based on the provided document.

It's important to note that this document is a 510(k) summary for a medical device and not a study report for an AI/algorithm-based device. Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment for AI) are not applicable to this submission, as it concerns a physical medical device (CRRT/TPE system) and its software/accessories, not an AI model.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the safety and performance requirements for a high permeability hemodialysis system, as demonstrated by equivalence to predicate devices and compliance with recognized standards. The "performance" here refers to the functional performance of the device's physical and software components.

Study Information (Relevant to this device submission)

1. Sample size used for the test set and the data provenance: Not applicable. This is a submission for a physical medical device and its accessories/software, not an AI/algorithm. Performance was evaluated through non-clinical functional testing, verification, and validation of the device components and system.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's functional performance is typically based on engineering specifications, physical measurements using calibrated equipment, and compliance with recognized standards.

3. Adjudication method: Not applicable for an AI context. Device performance was assessed against predefined engineering specifications and regulatory standards in non-clinical testing.

4. 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 is a medical device, not an AI diagnostic/classification system requiring human reader studies.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI algorithm. Its software runs on the device to control its functions.

6. The type of ground truth used:

   • Engineering Specifications: The device's operating ranges, accuracies (e.g., flow rates, pressure sensors, fluid removal), and control parameters were tested against predetermined engineering specifications.
   • Regulatory Standards: Compliance with recognized international standards (e.g., IEC60601-2-16 for Hemodialysis Equipment, IEC60601-1 for Electrical Safety, IEC60601-1-8 for Alarms, IEC60601-1-2 for EMC, ISO10993-1 for Biocompatibility).
   • Successful Functional Performance: Verification and validation testing confirmed that the device and its accessories (including software) performed as intended and met user needs.

7. The sample size for the training set: Not applicable. No AI model training set is mentioned or relevant for this device submission. The "software" referred to is control software, not a machine learning model.

8. How the ground truth for the training set was established: Not applicable. There is no AI training set. Software verification and validation (V&V) involved testing against functional requirements derived from design specifications, risk analysis, and regulatory requirements.

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The Prismaflex control unit is intended for:
· Continuous Renal Replacement Therapy (CRT) 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 Prismaflex control unit must be prescribed by a physician.

The Prismaflex control unit is a software controlled device that performs the following functions:
Loads and primes the Prismaflex disposable set automatically.
• Pumps blood through the blood flow path of the Prismaflex disposable set.
· Delivers anticoagulant solution into the blood flow path.
• Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.
· Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
· Controls the patient fluid removal or plasma loss according to the therapy in use.
• Monitors the system and alerts the operator to abnormal situations through alarms.
· Provides treatment data to an external Patient Data Management Systems (PDMS)

The provided document, a 510(k) premarket notification letter from the FDA to Baxter Healthcare Corporation for the Prismaflex System 8.10, is a regulatory submission for a medical device. It does not contain information about an AI/ML-based medical device software or a study that proves a device meets acceptance criteria in the context of an AI/ML system's performance metrics (like sensitivity, specificity, or AUC).

The document details the device's substantial equivalence to a predicate device (Prismaflex System 7.10) based on its functional parameters, physical characteristics, and adherence to performance standards for a hemodialysis system. The "acceptance criteria" here refer to the predefined performance ranges and characteristics of the device itself (e.g., dialysate flow rate accuracy, blood flow rate accuracy, pressure sensor accuracy), and the "study" is the non-clinical testing (software and system verification and validation) done to prove that the updated Prismaflex System 8.10 meets these established parameters and functions equivalently to its predecessor.

Therefore, I cannot extract the requested information, which pertains to AI/ML device performance and testing, from this document. The document primarily focuses on demonstrating substantial equivalence for a non-AI/ML medical device based on established performance specifications and regulatory compliance.

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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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PrismaSATE solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

PrismaSATE dialysis solutions are ready to use sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are intended to be used with commercially available CRRT systems as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags. The composition of the fluid used in renal therapies mirrors normal plasma water, since normalization of the blood is the objective.

PrismaSATE solutions, like other currently available dialysate solutions, consist of various quantities of the following chemicals: sodium chloride, potassium chloride, magnesium chloride, calcium chloride, dextrose, and a buffer of lactose and/or bicarbonate. The solution is prescribed by a physician; the physician selects the appropriate formulation based on the patient's blood electrolyte level and desired traits. PrismaSATE dialysate solutions are offered in a range of electrolyte concentrations which mirror the range of electrolytes in plasma. The solution may be buffered using lactate, bicarbonate using lactic acid as a pH adjustor, or bicarbonate using hydrochloric acid as a pH-adjusting excipient.

This document is a 510(k) premarket notification for a medical device called "PrismaSATE dialysis solutions" by Baxter Healthcare Corporation.

Based on the provided text, the device is the PrismaSATE dialysis solutions buffered with bicarbonate using hydrochloric acid as a pH-adjusting excipient, packaged in polyolefin primary packaging materials. The purpose of this 510(k) is to expand the existing PrismaSATE solution formulations into a different packaging material.

Here's an analysis of the acceptance criteria and the "study" (design verification in this case) that aims to prove the device meets these criteria:

1. A table of acceptance criteria and the reported device performance:

The document states: "Baxter Healthcare Corporation performed design verification for the modification. The result met its acceptance criteria, and supports that the proposed device is appropriately designed for its intended use." However, it does not explicitly list the acceptance criteria or specific numerical performance results of this "design verification".

Instead, it refers to the modification of packaging material. The acceptance criteria would likely relate to the integrity and compatibility of the solution with the new polyolefin packaging, and the maintenance of the solution's properties.

Based on the "Device Comparison Table" (Table 3) and the "Discussion of Nonclinical Tests," the implied performance criteria and the device's reported ability to meet them are:

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 explicitly states: "No performance data is included in this Special 510(k)." This implies that no new testing with a specific test set was conducted or provided in this submission to demonstrate performance with the new packaging. The submission relies on the substantial equivalence to predicate devices, where performance data would have been established for the individual components (solution formulation and packaging material).

Therefore, specific sample sizes, country of origin, or retrospective/prospective nature of the data for this specific submission are not provided. The "design verification" mentioned is described broadly without these details.

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. No new test set data is presented for which ground truth would need to be established by experts for performance evaluation. The "design verification" would likely involve internal company experts in engineering, quality, and manufacturing, but their specific roles or number are not specified for "ground truth" establishment in a performance study context.

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

Not applicable. There is no mention of a performance study involving interpretation or scoring of data that would require an adjudication method.

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 dialysis solution and its packaging, not an AI or imaging diagnostic device that would require an MRMC study.

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

Not applicable. This device is not an algorithm.

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

Not applicable in the conventional sense of a clinical performance study for an AI or diagnostic device. The "ground truth" for this submission is effectively the established performance and safety profiles of the predicate devices. The "design verification" likely relied on manufacturing specifications, chemical analysis, stability testing, and packaging integrity tests, rather than a clinical "ground truth" established by external experts.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would require a training set.

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

Not applicable.

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The Prismaflex 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 Prismaflex control unit must be prescribed by a physician.

Not Found

I am sorry, but the provided text does not contain the information needed to answer your request. The document is a 510(k) premarket notification letter from the FDA regarding the Prismaflex System 7.10, indicating it has been found substantially equivalent to a predicate device. It defines the device, lists its intended uses, and outlines regulatory requirements. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth types and establishment methods for training sets.

Therefore, I cannot populate the table or answer the specific questions about the device's performance study based on the provided text.

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Gambro PrismaSate solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

Gambro PrismaSATE solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags.

The provided text is a 510(k) summary for a medical device (PrismaSATE Dialysis Solutions). It describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically expected for a diagnostic or machine learning-based device.

The "Testing, and Recognized Standards" section mentions:

• Expiration Dating: Stability studies were performed and results provided.
• Sterilization: Validation methods followed ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 11138-3.
• Biocompatibility: Primary packaging material was tested per Gambro's procedure for physico-chemical and biological evaluation.

These are compliance activities related to manufacturing and material safety, not performance criteria for a diagnostic or AI-driven system. The core of this 510(k) is based on substantial equivalence to predicate devices due to having the same intended use, indication for use, chemical concentration range, and packaging characteristics, with "no significant technological changes."

Therefore, I cannot populate the requested table and study information because the provided text does not contain a performance study with acceptance criteria for a device that would typically involve such metrics (like sensitivity, specificity, AUC, etc.). The "performance" here is demonstrating chemical and physical equivalence and safety.

Here's a breakdown of why the requested information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on chemical composition, packaging, and safety/sterilization standards rather than a quantifiable performance metric (e.g., accuracy for a diagnostic).
2. Sample size used for the test set and the data provenance: Not applicable in the context of this submission. The "tests" mentioned are for stability, sterilization validation, and biocompatibility, not for a "test set" of patient data for a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for an AI/diagnostic device is not discussed.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" here is adherence to specified chemical concentrations, sterility, and biocompatibility standards.
8. The sample size for the training set: Not applicable. There is no "training set" for an AI/ML algorithm mentioned.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a medical device (dialysis solutions) that is a consumable and is cleared based on substantial equivalence to existing products, as well as adherence to manufacturing and safety standards. It is not a diagnostic device or an AI-powered system that would typically undergo the kind of performance study outlined in your request.

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The Prismaflex® 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 Prismaflex® control unit must be prescribed by a physician.

The Prismaflex control unit is a software controlled device that performs the following functions:

• Loads and primes the Prismaflex disposable set automatically.
• Pumps blood through the blood flow path of the Prismaflex disposable set.
• Delivers anticoagulant solution into the blood flow path.
• Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.
• Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
• Controls the patient fluid removal or plasma loss according to the therapy in use.
• Monitors the system and alerts the operator to abnormal situations through alarms.
  The Prismaflex® has a touch screen user interface that provides operating instructions.
  The Prismaflex® provides color coding and bar-code identification of the filter sets that are automatically loaded. The Prismaflex continually monitors the operation of the machine and displays one of four (4) types of alarms if an abnormal situation occurs. The Prismaflex® has five (5) pumps that allow multiple therapeutic combinations; including a "pre-blood pump" that allows infusion of a supplemental solution for hemodilution or anticoagulation of the extracorporeal circuit.

The provided text describes a 510(k) submission for the Prismaflex® System, a hemodialysis delivery system. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific clinical acceptance criteria through a comparative effectiveness study in the same way an AI/ML device might. Therefore, many of the requested elements for an AI/ML study, such as sample size for test sets and training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable or not provided in the document.

The "acceptance criteria" here are implicitly the performance specifications of the device as compared to its predicate devices, along with compliance with relevant international standards for medical electrical equipment. The "study that proves the device meets the acceptance criteria" is broadly referred to as "Complete software and system verification and validation including functional, performance and safety requirements" and "Compliance has been demonstrated to the following international standards."

Here's the information extracted and adapted to the best extent possible given the nature of the document:

1. Table of Acceptance Criteria (as implied by comparison to predicates) and Reported Device Performance

The device's performance is implicitly evaluated against the predicate devices for key operational parameters. The document focuses on demonstrating that the Prismaflex® (Software Version 5.10) performs similarly to or within acceptable ranges of the predicate devices.

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

This information is not provided in the document. The submission details a medical device (a hemodialysis system) for which performance is typically verified through engineering tests, bench tests, and potentially clinical validation activities (which are not detailed here as a specific "test set" with patient data). The document states "Complete software and system verification and validation including functional, performance and safety requirements," but does not specify sample sizes or data provenance for these verification activities.

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 information is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is relevant for diagnostic devices that interpret signals or images. For a hemodialysis delivery system, "ground truth" would relate to accurate physical measurements and system functionality, not expert interpretation of patient data.

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

This information is not applicable as an adjudication method for expert consensus is not relevant to the type of device and testing described.

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 information is not applicable. This is not an AI/ML diagnostic device, and therefore, an MRMC study with human readers assisting AI is irrelevant.

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

This information is not applicable. The Prismaflex® system is a physical medical device with software, not a standalone algorithm.

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

The "ground truth" for this device's performance is based on engineering specifications, physical measurements, and compliance with recognized international standards. For example, the accuracy of flow rates would be verified against known calibrated standards, not expert consensus or pathology.

8. The sample size for the training set

This information is not provided and is largely not applicable in the context of device hardware and software verification for a 510(k) of this nature. "Training set" is primarily a concept used in AI/ML development.

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

This information is not applicable. There is no "training set" in the AI/ML sense for this device. The system's functionality and performance are verified against pre-defined engineering requirements and industry standards.

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The PRISMAFLO II is for warming dialysis fluid and returning blood flow.

The PRISMAFLO II is a modified version of the PRISMAFLO covered by K020103. The PRISMAFLO uses water in the heat transfer process. PRISMAFLO II is the same as PRISMAFLO except it is water free.

The PRISMAFLO II dialysis fluid and blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Barkey Prismacomfort 510(K) Number K071909. The PRISMAFLO II blood warmer is used to warm the return blood flow line in order to replace heat lost to the atmosphere and effluent flow during a Prismaflex or PRISMA treatment. The PRISMAFLO II blood warmer consists of one control unit and one sleeve warmer. The control unit (Stihler PRISMAFLO II) controls the sleeve warmer and displays alarm and status messages.

The PRISMAFLO II blood warmer warns the returning blood flow line by means of a silicon tube heat exchanger which covers the blood return flow line of the Gambro Prismaflex or Prisma system completely. The heat is transferred by the contact of the resistance heating system to the inscried blood return line. The complete enclosure of the returning blood flow line to be warmed ensures that there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the return blood flow at maximum efficiency.

The sleeve warmer is powered with 22 VDC which is derived from 115 VAC (or where required 230 VAC). 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Stihler PRISMAFLO II. Above the on-off switch is a display temperature monitor showing actual and set temperature. The temperature of the sleeve warmer and other performance characteristics of the sleeve warmer are controlled electronically, visual and audible alarms as well as cut-offs are hardware realized. Like the blood warmer Barkey Prismacomfort, the sleeve warmer PRISMAFLO II is constructed as a slotted enclosed silicon tube, which can completely enclose inserted blood return flow lines of up to 7.00 mm diameter. The PRISMAFLO II woighs approx 3.9 kg and is equipped with a holder at the rear side of the control unit, which allows mounting on hemodialysis system Gambro Prismatlex and Prisma system. Both products, the PRISMAFLO II and the Barkev Prismacomfort use sleeve warmers made of silicon. The flexibility of this material ensures a nearly complete enclosure of the blood return flow line on Gambro Prismallex and Prisma system.

Only the water free operation of the PRISMAFLO II differs to the PRISMAFLO.

This document describes the PRISMAFLO II blood warmer, a medical device. The information provided heavily emphasizes that the device is a modified version of an existing device (PRISMAFLO) and is substantially equivalent to a predicate device (Barkey Prismacomfort). The "study" described is a nonclinical performance verification.

Here's an analysis of the provided text in relation to your requested categories:

1. A table of acceptance criteria and the reported device performance

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

• Sample size used for the test set: Not explicitly stated. The document refers to "the following tests were carried out successfully" but does not give specific numbers of units tested or duration of tests. This is a non-clinical device so "samples" would refer to devices tested, not patient data.
• Data provenance: The tests were "carried out" by the manufacturer (Stihler Electronic GmbH), presumably in Germany given their address. The data is retrospective in the sense that the tests were completed before submission.

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

Not applicable. This is a non-clinical device safety and performance verification. "Ground truth" in this context would refer to engineering specifications and regulatory standards, not expert medical opinion on patient data. The tests verify compliance with these objective standards.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication, as there are no human readers or subjective interpretations of results described. The tests are presented as objective measurements against predefined 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

Not applicable. This is a medical device (blood warmer), not an AI-powered diagnostic or interpretive tool. There are no human readers involved in its direct operation that would be improved or assisted by AI within the scope of this device.

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

Not applicable. This is a physical medical device. The "standalone" performance refers to the device's ability to perform its function (warming blood) independently, which is what the non-clinical tests would have assessed. However, the term "algorithm only" is not relevant here as it's not a software-only device.

7. The type of ground truth used

The "ground truth" for the non-clinical tests was adherence to:

• Engineering specifications and design requirements for preventing blood cooling and ensuring safe operation (e.g., set temperature, alarm triggers, cut-off mechanisms).
• Mandatory and voluntary consensus standards for medical device safety and performance (e.g., DIN EN 60601-1, ASTM F 2172-02).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a physical medical device.

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