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The MARS is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal and/or ion exchange resins.

The MARS is indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT).

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.
• Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS . system to conduct MARS treatments for patients weighing 20 kilograms or more.

All treatments administered via the Prismaflex control unit must be prescribed by a physician.

Not Found

This document is a 510(k) premarket notification for a medical device (Molecular Adsorbent Recirculating System (MARS®) Prismaflex® System). It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text. The document is primarily an FDA clearance letter and an "Indications for Use Statement," which lists the intended uses and contraindications of the device. It does not include details on performance studies, validation methods, or specific study results that would fulfill 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.

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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Revaclear™ 300 and 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

This device is intended for the treatment of chronic and acute renal failure by hemodialysis.
The intended population of this device is identical to those of the Polyflux HD-C4 (BIG), cleared for marketing in the United States under 510(k) notification K060195 and Polyflux HD-C4 (Small), cleared for marketing in the United States under 510(k) notification K072232.
The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone (PVP), which is equivalent to the membrane utilized in the Gambro Polyflux HD-C4 (BIG) and Polyflux HD-C4 (Small) single use hemodialyzers cleared for marketing in the United States under 510(k) Notifications (K060195 and K072232).
Blood enters a blood inlet port where it is distributed to the hollow fibers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

Here's an analysis of the acceptance criteria and study detailed in the provided K130039 document for the Gambro Revaclear™ 300 and 400 Dialyzer:

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

The document does not explicitly state numerical "acceptance criteria" against which a single "reported device performance" is measured in a clear, tabular format. Instead, it states that performance was determined according to ISO 8637 and compared to predicate devices, and that the device did not induce any adverse biological effects.

However, based on the information provided, we can infer the acceptance criteria and summarize the reported findings for comparability.

Inferred Acceptance Criteria and Reported Device Performance for Gambro Revaclear™ 300 and 400 Dialyzer

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

• In Vitro Performance Testing:

  • Sample Size: Not explicitly stated in the summary, but it notes that "Detailed measurement results are provided in Section 17."
  • Data Provenance: Not specified, but generally, in vitro testing is conducted in a laboratory setting, not usually tied to a specific country of origin in the same way clinical data is. It's prospective in nature for device evaluation.

• Biocompatibility Evaluation:

  • Sample Size: Revaclear 400 was chosen as a "master product" for testing, implying it represents the product family. The specific number of samples tested is not provided in this summary.
  • Data Provenance: Not specified, but similar to in vitro testing, it's typically prospective lab testing.

• Mechanical Hemolysis:

  • Sample Size: "three experiments. In each experiment three filters were tested in parallel" (i.e., at least 9 filters tested in total for Revaclear 300 and predicate devices).
  • Data Provenance: Not specified, likely prospective lab testing.

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 section is Not Applicable (N/A).
The studies described are non-clinical (in vitro, biocompatibility, mechanical hemolysis) and do not involve human subject data requiring expert interpretation or ground truth establishment in the way clinical diagnostic studies do. The "ground truth" for these tests is the objective measurement against established standards (ISO 8637, ISO 10993) and comparison to predicate device performance.

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

This section is Not Applicable (N/A).
Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly in image interpretation, to resolve discrepancies between readers. The studies described are non-clinical performance and safety tests, not clinical evaluations involving human readers.

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 section is Not Applicable (N/A).
No MRMC study was conducted. The device is a physical medical device (dialyzer), not an AI-powered diagnostic tool. The document explicitly states "Summary of Clinical Tests: N/A".

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

This section is Not Applicable (N/A).
The device is a physical medical device, not an algorithm.

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

As described in point 3, the concept of "ground truth" as it applies to clinical diagnostic studies is not directly relevant here. However, the closest equivalent is:

• In Vitro Performance: Compliance with ISO 8637 physical and chemical specifications and performance metrics (clearances, flow resistance, ultrafiltration coefficient) of the legally marketed predicate devices.
• Biocompatibility: Adherence to ISO 10993-1 and FDA Memorandum G-95-1 standards for biological endpoints (cytotoxicity, sensitization, systemic toxicity, genotoxicity, hemocompatibility) and characterization of materials and leachables based on chemical analysis.
• Mechanical Hemolysis: Measurement of free hemoglobin levels against established scientific principles indicating hemolysis, and comparison to the predicate device's performance.

8. The sample size for the training set

This section is Not Applicable (N/A).
There is no "training set" in the context of this device's evaluation. Training sets are relevant for AI/machine learning models where data is used to teach the algorithm. This document describes the testing of a physical medical device.

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

This section is Not Applicable (N/A).
As there is no training set, there is no ground truth for a training set.

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The MARS® is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal and/or ion exchange resins.

The MARS® is indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS® treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS® treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT).

The MARS® is a blood detoxification device comprised of dialyzers, adsorption columns, tubing connectors and a monitor unit. It is designed for the combined removal of watersoluble low and middle molecular weight substances and albumin bound molecules. The treatment is based on the dialysis of blood against an albumin-containing dialysate solution.

Here's an analysis of the provided text regarding the MARS® system, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving performance against predefined acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are implicitly linked to the performance claimed for the new indication, and the "study" is the information provided to support that new indication and equivalence.

Acceptance Criteria and Reported Device Performance

The core "acceptance criterion" in this 510(k) summary is the demonstration that for a new specific indication, the MARS® system performs at least as safely and effectively as the identified predicate devices, and achieves a specific clinical outcome.

Study Details

The document mentions "clinical trials" but provides very limited detail about their methodology. The primary purpose of this 510(k) is to extend the indications for use based on existing (or newly provided) clinical data, not to detail the full protocol of those trials.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the provided text for the Hepatic Encephalopathy (HE) indication. The text only mentions "Clinical trials conducted with MARS® treatments in HE patients."
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The wording "Clinical trials conducted" generally implies prospective studies, but this is not confirmed.

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

   • Not specified. This document summarizes the device's regulatory submission, not the detailed clinical trial report.

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

   • Not specified.

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 device is a medical apparatus (Molecular Adsorbent Recirculating System), not an AI imaging or diagnostic algorithm that involves human "readers." The "comparative effectiveness" mentioned is between MARS® treatment and Standard Medical Therapy (SMT) for HE patients. The effect size stated is a "decrease [in] hepatic encephalopathy scores by at least 2 grades."

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

   • Not applicable. As noted above, this is a medical device for blood detoxification, not an algorithm.

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

   • The "ground truth" for the HE indication appears to be the "hepatic encephalopathy scores" themselves. These scores are clinical assessments, typically made by medical experts (e.g., neurologists, hepatologists) based on standardized scales. So, it would likely involve expert clinical assessment and outcomes data (change in HE scores).

7. The sample size for the training set:

   • Not applicable. As this is not an AI/ML device, there isn't a "training set" in the conventional sense. The "clinical trials" mentioned would be considered the main data set used to demonstrate performance.

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

   • Not applicable due to the device type. The outcomes (HE scores) were established through clinical assessment during the trials.

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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.

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The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.

Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies. The system consists of the Hemodialysis Machine in use with a blood tubing set designed for the machine, a dialyzer, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates. The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments. The Phoenix Hemodialysis Machine pumps blood from the patient, in a blood tubing set properly designed for the machine, through the dialyzer where purification takes place, and back to the patient. In the dialyzer, the blood and the dialysate fluid flow on opposite surfaces of a thin Semipermeable membrane. As the blood passes through the filter, the desired treatment processes take place. Depending upon the therapy in use, the treatment processes can include fluid removal and/or solute clearance. Phoenix has a modular structure. It is made up of five modules that carry out independent functions: Master Module, Hydraulic Module, Blood Module, Protection Module and Bio Module. The unit consisting of the Master, Hydraulic and Blood Modules is called the Control System. The Control System manages the implementation of the physical functions.

The provided document describes a Special 510(k) submission for the Phoenix® Hemodialysis Delivery System - version 3.40. This type of submission is used when the modification to a previously cleared device (the predicate device, in this case, Phoenix® version 3.35) does not affect the intended use or fundamental scientific technology. Therefore, the acceptance criteria and the study performed focus on demonstrating that the updated software (version 3.40) maintains equivalence and does not degrade the safety or effectiveness of the device compared to the predicate.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this Special 510(k) are primarily based on maintaining the performance parameters of the predicate device (Phoenix® version 3.35) and ensuring that the new software version (3.40) does not negatively impact these. The "reported device performance" is essentially that the updated device meets or exceeds the specifications of the predicate.

The key "performance improvement" highlighted in relation to the acceptance criteria is the elimination of manual calculations for low weight - low volume sets with software version 3.40. Previously, users had to divide displayed blood flow, liters processed, and pump speed by 4 to get actual values. The new software directly displays the actual values, which is a usability and safety enhancement.

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

The document does not explicitly state a "sample size" in the conventional sense (e.g., number of patients or cases) for a test set. This is because no clinical studies were performed for this software modification (Page 4). The testing performed was non-clinical performance data, consisting of verification and validation activities for the software and the system.

The data provenance is internal to the manufacturer's development and testing processes; there's no mention of external data sources or country of origin for a specific "test set" in the context of clinical data. It falls under "retrospective" in the sense that the testing was based on the existing device design and specifications.

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

Since no clinical studies were performed and the testing was non-clinical, there isn't a "ground truth" derived from expert clinical opinion in the traditional sense for a test set of patient data.

Instead, the "ground truth" for the non-clinical testing was established by:

• System and software requirements and specifications.
• International safety standards (IEC 60601-1-2, 60601-2-16, 60601-1-4, 60601-1-6, 62366).
• The performance of the legally marketed predicate device (version 3.35).

The experts involved would be the manufacturer's software engineers, quality assurance personnel, regulatory affairs specialists, and potentially clinical representatives who defined and verified these requirements and standards. Their qualifications would be in their respective technical and domain expertise.

4. Adjudication Method for the Test Set

Again, given the non-clinical nature of the testing, there was no "adjudication method" in the sense of multiple experts reviewing and reaching a consensus on clinical outcomes or images.

The verification and validation activities inherently involve review and approval processes by qualified personnel. These would include:

• Static activities: impact analysis, final phase reviews, code inspections.
• Dynamic tasks: baseline verification, system and software test protocols execution, regression testing, Graphical User Interface and Use Cases test execution.

These processes ensure that the software performs as intended and meets specifications, which is a form of "adjudication" through technical review and testing.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed for the software modification." Therefore, there is no effect size reported for human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a hemodialysis delivery system, which is a piece of medical equipment, not an AI algorithm in the contemporary sense. It is microprocessor-controlled and performs automated functions, but it always operates with a human-in-the-loop (trained operators). The "standalone" performance thus encompasses the device's ability to execute its programmed functions accurately and safely on its own, but within the context of human use and oversight.

The non-clinical performance data focuses on this "standalone" (device-only) functionality through:

• Static activities (code reviews, impact analysis).
• System and software functional tests.
• Regression testing.
• Graphical User Interface and Use Cases test execution.

These tests verify the algorithm's (software's) internal logic and its interaction with the hardware.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Technical specifications and performance requirements defined by the manufacturer.
• Compliance with international safety standards (relevant IEC standards listed).
• Functional equivalence to the legally marketed predicate device (Phoenix® version 3.35).
• Usability requirements verified through formative and summative usability validation.

It is not based on expert consensus for clinical diagnosis, pathology, or patient outcomes data, as no clinical studies were performed.

8. The Sample Size for the Training Set

This question is not applicable in the context of this device and submission. The Phoenix® Hemodialysis Delivery System is a hardware/software medical device that performs defined physiological functions, it is not an AI/Machine Learning algorithm that undergoes a "training phase" with a "training set" of data in the manner typically associated with such terms.

The software development would involve stages of coding, unit testing, integration testing, and system testing, which are forms of continuous verification and validation, but not "training" with a distinct "training set" of data for learning purposes.

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

As established in point 8, there is no "training set" in the context of this device. Therefore, the ground truth for a training set was not established.

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GamCath® High Flow Dolphin® catheters are indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. GamCath® High Flow Dolphin® Catheter is not intended for use in pediatric patients.

The GamCath® High Flow Dolphin® Catheters are single use medical devices for short term use to obtain vascular access in patients with acute or chronic renal failure. The GamCath® High Flow Dolphin® Catheter combines the GamCath® High Flow Catheter with an additional coating based on a block copolymer. The polymer layer results in a surface structure that locks in barium sulfate particles. The coated catheter is free of heparin, therefore the use of the catheter is not contraindicated in patients with HIT syndrome. Catheters made of Polyurethane are equipped with small rotatable Polypropylene suture rings, still allowing rotation of catheter when sutured to skin. Polyurethane Extension lines, present on each lumen, are equipped with PVC luer-lock connectors according to ISO 594-1 with Polyethylene protection caps and are provided with clamps which may be color coded to indicate the venous (blue), arterial (red). Clamp inserts bear easily legible and permanently fixed imprints indicating usable catheter length and outer diameter of catheter shaft (in French calibration) as well as priming volumes. The Catheter is available in 13 French and 11.5 French straight and curved extension line configuration. An inner dilator made of FEP is provided in the venous lumen for insertion. The insertion length is available in range from 150 mm (5.906") up to 250 mm (9.843"). The Dolphin coating is a co-polymer film which is applied over the catheter surface to form a continuous surface that has a smoother surface morphology than an untreated catheter. The copolymer film is formed by providing a hydrophobic polymer block, such as polydimethylsiloxan (PDMS) with functional -OH end groups.

The GamCath® High Flow Dolphin® Catheter is a short-term hemodialysis catheter. The study provided does not describe a clinical trial with human subjects or a comparison to human performance or AI. Instead, the "study" is a series of non-clinical, benchtop tests designed to demonstrate substantial equivalence to predicate devices and ensure the device meets recognized safety and performance standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the sample sizes for each non-clinical test.
• Data Provenance: Not applicable. These were non-clinical, benchtop tests conducted to verify compliance with standards, not a clinical study involving human patients or real-world data.

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

• Not applicable. The ground truth for these non-clinical tests is based on established engineering and biocompatibility standards (e.g., ISO 10993-1, ISO 11135-1, ISO 10555-1) and the successful execution of validated test protocols by qualified personnel in a laboratory setting. There is no mention of expert consensus for interpreting test results in the way it would be established for clinical image analysis or diagnostics.

4. Adjudication Method for the Test Set

• Not applicable. As these are non-clinical, objective tests against established standards, an adjudication method for a "test set" (in the sense of a clinical or image-based evaluation) is not required. Test results are compared directly to the specified criteria.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing of a medical device, not an AI or diagnostic tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests is a combination of recognized industry standards (e.g., ISO 10993-1, ISO 11135-1, ISO 10555-1) and predefined engineering specifications for the device's performance characteristics (e.g., specific tensile strength values, acceptable pressure ranges, absence of leakage).

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI context, so there is no "training set."

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

• Not applicable. As there is no training set for an AI model, the method of establishing its ground truth is irrelevant here.

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The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System.

The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.

The Gambro Cartridge® Blood Set Low Weight – Low Volume is single use sterile tubing set employed in the Gambro hemodialysis equipments extracorporeal circulation. It conveys the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line) and it is commonly referred to as bloodline. A Gambro Cartridge® Blood Set Low Weight - Low Volume can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

The provided document describes a 510(k) submission for the Gambro Cartridge® Blood Set Low Weight - Low Volume. This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than clinical performance data or AI/ML model performance.

Therefore, many of the requested criteria related to AI/ML device testing (such as ground truth establishment, expert adjudication, MRMC studies, training set details) are not applicable to this submission.

Here's the information that can be extracted or deduced from the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific numerical thresholds for each test. Instead, it describes a series of non-clinical performance tests designed to establish the safety and effectiveness of the device as performing "as well as or better than the legally marketed predicate device." The "acceptance" for these tests would be successful completion, indicating the device performs as intended and is comparable to the predicate.

Study Information

1. Sample size used for the test set and the data provenance:

   • The document describes non-clinical performance testing (bench testing). It does not refer to "test sets" in the context of patient data for a clinical or AI/ML study.
   • No information about specific sample sizes (e.g., number of devices tested for each bench test) or data provenance (country of origin, retrospective/prospective) is provided.

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

   • Not applicable as this is a non-clinical bench testing study, not a study requiring expert ground truth for clinical outcomes or diagnostic accuracy.

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

   • Not applicable for a non-clinical bench testing study. The results of the bench tests (e.g., pressure leak, flow rate, tensile strength) would be objectively measured against engineering specifications, not adjudicated by experts.

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:

   • No MRMC study was done. This document describes a traditional medical device (blood set) and its non-clinical testing, not an AI-powered device.

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

   • Not applicable. This is not an AI/ML algorithm.

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

   • For the non-clinical tests, the "ground truth" would be established by engineering specifications, material properties, and accepted industry standards for medical device performance and safety (e.g., ISO standards for blood contacting devices, internal Gambro specifications).

7. The sample size for the training set:

   • Not applicable. There is no AI/ML model for which a training set would be required.

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

   • Not applicable as there is no AI/ML model or training set.

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The Gambro WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.

The WRO 300 can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

The Gambro WRO 300 H Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.

The WRO 300 H can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

The Gambro WRO 300 and WRO 300 H Water Purification Units are dialysis accessories that produce water through reverse osmosis for one hemodialysis equipment.

They are both designed to maintain the low microbiological level in their flow path by the use of regular disinfection as a regular maintenance. Both WRO 300 and WRO 300 H Water Purification Units are designed with chemical disinfection capability. The WRO 300 H Water Purification Unit is also designed with heat disinfection capability.

WRO 300 or WRO 300 H Water Purification Unit is intended for use in conjunction with one dialysis machine, provided that the input flow and pressure demands correspond to the output of the WRO 300 or WRO 300 H Water Purification Unit.

WRO 300 and WRO 300 H Water Purification Units utilize the Reverse Osmosis Principle. A high pressure pump forces the water through the RO membrane. The product water is further distributed to the dialysis machine.

Reverse osmosis (RO) is a membrane process that is the most widely used technique for purification of water for dialysis. When the feed water is in contact with the semipermeable membrane (the most vital part of the system) and a high pressure is applied, water will flow through the membrane to the product water side. Most of the other constituents (dissolved salts, particles, bacteria and pyrogens) will remain on the feed water side of the membrane and be flushed to drain as reject water. The membrane material used for the WRO 300 and WRO 300 H Water Purification Units are Polyamide Thin-Film Composite.

An acceptable quality of the feed water is required. The feed water is usually pretreated with such as active carbon filters, softener, and particle filters before it is supplied to the WRO 300 or WRO 300 H Water Purification Unit. Depending on the local water quality and regulations different pretreament equipment may be required.

Gambro WRO 300 and WRO 300 H Water Purification units contain the same software package (version P4.2) which is intended for controlling water production and disinfection / clanning of the flow path of the WRO.

The software also supports Heat Disinfection in the WRO 300 H Water Purification Unit.

The provided text describes the WRO 300 and WRO 300 H Water Purification Units by Gambro Renal Products, Inc. and their substantial equivalence to a predicate device for use in hemodialysis.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are derived from the performance specifications compared to the predicate device and relevant standards. The reported device performance indicates that both the WRO 300 and WRO 300 H meet these criteria.

Study Information:

The provided text describes a non-clinical performance data assessment to establish substantial equivalence with a predicate device (Gambro WRO 300 Water Purification System, K042797). It explicitly states that clinical performance data is "Not applicable for this submission." This indicates that no human trials or studies were conducted for this submission.

1. 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 sample sizes for the non-clinical tests. It refers to "testing results of the R.O. Membrane," implying a physical testing of the device and its components.
   • Data provenance: The testing was performed internally by the manufacturer (Gambro Renal Products, Inc.) and by "external independent personnel." The country of origin for the testing data is not explicitly stated, but the submitter's address is in Lakewood, Colorado, USA. The nature of the testing (verification and validation of software, and functional/performance/safety requirements) suggests prospective testing conducted specifically for this submission, rather than retrospective data analysis from previous use.

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

   • The document states that the assessment was performed by "internal and external independent personnel with the appropriate skills." It does not specify the number of experts or their specific qualifications (e.g., years of experience, specific certifications).

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

   • The document does not describe an adjudication method as it pertains to expert reviews of interpretations for a test set. The nature of the evaluation involves technical testing against established standards and specifications, not subjective interpretation requiring adjudication.

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:

   • No MRMC comparative effectiveness study was done. This device is a water purification unit, not an imaging or diagnostic AI device that would involve human readers or AI assistance in interpretation. The submission explicitly states "Assessment of clinical performance data: Not applicable for this submission."

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

   • This question is not applicable in the context of a water purification unit. The device itself performs the function (water purification) autonomously once set up. The "software package (version P4.2)" controls water production and disinfection/cleaning. The software's performance was verified and validated, which could be considered a form of standalone testing of the algorithm's functional correctness for its intended purpose. However, it's not "algorithm only" in the sense of a diagnostic AI without human input to the diagnostic process.

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

   • The "ground truth" for this device's performance is established by technical specifications, functional requirements, and compliance with international standards. For example, for water quality, the ground truth is defined by specific rejection rates (e.g., >96% for total dissolved salts, >99% for bacteria and endotoxin) and physical parameters (e.g., output flow, pressure, temperature). For safety, the ground truth is compliance with electrical safety and EMC standards. For the heat disinfection on the WRO 300 H, the ground truth includes a minimum temperature of 80°C and a 5 log reduction for all positions.

7. The sample size for the training set:

   • This document describes a non-clinical assessment for a physical device, not an AI/ML model for which a "training set" in the traditional sense would apply. Therefore, no training set sample size is mentioned or relevant.

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

   • As there is no training set mentioned, this question is not applicable. The ground truth for the device's performance is established through adherence to engineering specifications, performance tests, and compliance with recognized industry standards.

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