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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 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 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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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 Prismaflex M150 Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

The Prismatlex disposable sets are sterile disposable extracomoreal circuits containing an AN69 hemofilter/dialyzer and fluid circuit for use with the Prismatlex control Unit. 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 .
• Continuous Veno-Venous Hemodialysis CVVHD:
• CVVHDF: Continuous Veno-Venous Hemodiafiltration .

The provided text describes a 510(k) premarket notification for the "Prismaflex M150 Set," which is a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel effectiveness through studies that would typically involve acceptance criteria for artificial intelligence or image processing algorithms.

Therefore, many of the requested points are not applicable to this document as it pertains to a physical medical device (hemofilter and blood tubing set) and not a software algorithm or AI-powered diagnostic tool. The document explicitly states "Summary of Clinical Tests: Not applicable."

Here's a breakdown based on the provided text and the nature of a 510(k) for a physical device:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable as described for AI/algorithm performance. The submission focuses on demonstrating substantial equivalence to a predicate device (Prismaflex M100 Set). The "acceptance criteria" here relate to the non-clinical testing performed to show that the modified device performs as well as the predicate.

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

Not applicable. The "test set" and "data provenance" concepts are typically used for evaluating algorithms on specific datasets. For this physical device, "in vitro testing" was conducted to compare performance to the predicate device. The document does not specify sample sizes for these in vitro tests, nor does it refer to data provenance in the context of patient data for an algorithm.

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

Not applicable. Ground truth establishment by experts is relevant for diagnostic algorithms. This is a physical device, and its performance was assessed through in vitro and manufacturing controls, rather than expert consensus on diagnostic outputs.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements in expert interpretations for establishing ground truth for algorithmic evaluation. This process is not relevant to the 510(k) submission for this physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states, "Summary of Clinical Tests: Not applicable." MRMC studies are used to evaluate the impact of a diagnostic aid on human reader performance. This device is a hemofilter and blood tubing set, not a diagnostic aid, and no clinical studies were deemed necessary for this 510(k) submission.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical medical product, not an algorithm, so the concept of standalone algorithmic performance is irrelevant.

7. The Type of Ground Truth Used

Not applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) is for evaluating the accuracy of a diagnostic or predictive system against a gold standard. For this physical device, the "ground truth" relates to its physical and functional specifications and its performance metrics (e.g., fluid management, filtration efficacy) which are assessed through engineering and bench testing.

8. The Sample Size for the Training Set

Not applicable. Training sets are used for machine learning algorithms. This document describes a physical medical device.

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

Not applicable. As above, training sets and their ground truth are for machine learning.

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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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