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The Aquadex FlexFlow™ System is indicated for:
• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
• Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

The provided document is a 510(k) summary for the Aquadex FlexFlow™ System, specifically addressing the addition of a new blood circuit (UF250). This document is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than outlining a clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML-based medical devices or devices undergoing extensive efficacy trials.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML device or a device requiring new clinical efficacy data. Instead, the acceptance is based on demonstrating safety and effectiveness through regression testing and bench tests for the software change and the new blood circuit.

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

The document does not mention "test sets" in the context of clinical data or AI/ML model evaluation. The "data" referred to is from regression testing and bench tests. Therefore, no information on sample size (e.g., number of patients or cases) or data provenance (country of origin, retrospective/prospective) is provided, as these types of studies were not conducted for this submission.

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

This information is not applicable to the provided document. The evaluation was based on engineering testing (regression and bench tests) of a medical device's components and software changes, not on expert-adjudicated ground truth from medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

Not applicable, as there was no test set requiring expert adjudication.

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 an ultrafiltration system, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.

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

Not applicable. This is not an AI/ML algorithm. The "standalone" performance here refers to the device's functional operation in a controlled bench test environment.

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

The "ground truth" here is the expected functional performance and safety parameters of the device and its components, established through engineering specifications, regulatory standards, and comparison to the predicate device. This is determined through regression testing for software and bench testing for hardware (the UF 250 Blood Circuit). It is not based on expert consensus, pathology, or outcomes data in the traditional clinical trial sense for this submission.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable.

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The Aquadex FlexFlow™ System is indicated for:
• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
• Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

The provided document does not contain detailed acceptance criteria for the Aquadex FlexFlow™ System's performance, nor does it describe a specific study that proves the device meets such criteria in terms of quantitative performance metrics.

Instead, the document primarily focuses on the 510(k) submission for a software change to the Aquadex FlexFlow™ System and a labeling change incorporating a catheter compatibility chart. The "Safety & Performance" section states:

"Regression testing was performed to verify and validate the software change and to generate data in support of the labeling change which incorporates a catheter compatibility chart using the principles of ISO 14971:2000 "Medical devices - Application of risk management to medical devices. Data generated demonstrated the Aquadex FlexFlow System continues to be safe and effective."

This statement indicates that a study (regression testing) was performed, but it doesn't provide specific acceptance criteria or quantitative performance results relevant to the device's functional operation (e.g., fluid removal rate accuracy, filter efficiency).

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Based on the available text:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in quantitative terms. The general criterion appears to be "continues to be safe and effective" after software and labeling changes.
   • Reported Device Performance: "Data generated demonstrated the Aquadex FlexFlow System continues to be safe and effective." No specific performance metrics or values are provided.

2. Sample size used for the test set and the data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external ground truth establishment is described for performance evaluation. The "data generated" would likely pertain to internal testing.

4. Adjudication method for the test set: Not applicable.

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 an ultrafiltration system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software change" was validated, but the overall system's operation always involves human interaction and monitoring.

7. The type of ground truth used: For the regression testing, the "ground truth" would likely be the expected function and output of the device following the software and labeling changes, verified against design specifications and established safety/effectiveness parameters of the predicate device. This is internal testing, not external ground truth from patient data or experts.

8. The sample size for the training set: Not applicable. This is not a machine learning model requiring a training set in the typical sense. The "training" here refers to the device's internal software development and testing, not a dataset for model training.

9. How the ground truth for the training set was established: Not applicable.

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The Aquadex FlexFlowTM System is indicated for:
• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
• Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

This document describes regulatory information for the Aquadex FlexFlow System, specifically related to a software update (Rev. K). It is a 510(k) summary and an FDA clearance letter. It does not contain information about specific acceptance criteria, device performance, or a study proving that acceptance criteria were met.

The "Safety & Performance" section states:
"Regression testing was performed to verify and validate the software change and to generate data in support of the labeling change which incorporates a catheter compatibility chart using the principles of ISO 14971:2000 'Medical devices - Application of risk management to medical devices. Data generated demonstrated the Aquadex FlexFlow System continues to be safe and effective."

This statement indicates that testing was done to ensure the software update maintained safety and effectiveness, but it provides no further details regarding:

1. A table of acceptance criteria and the reported device performance: No specific criteria or performance metrics are listed.
2. Sample sized used for the test set and the data provenance: No sample size or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a ground truth for a test set in this context.
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 device is an ultrafiltration system, not an imaging device requiring human reader interpretation in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical system with software, not a standalone algorithm in the typical sense for performance evaluation (e.g., image analysis). Regression testing of the software was done.
7. The type of ground truth used: Not explicitly stated, but for a physical device software update, "ground truth" would likely relate to system functionality, safety parameters, and output accuracy, confirmed through engineering tests and potentially clinical data if new features warranted it. The document mentions a "catheter compatibility chart" implying performance related to different catheters.
8. The sample size for the training set: Not applicable, as this is a software update for an existing physical device, not an AI model requiring a training set in the typical machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document confirms the FDA clearance of a software update for an existing device based on regression testing, but it does not provide the detailed study information requested.

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The Aquadex FlexFlow™ System is indicated for:
• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
• Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins. This 510(k) is to add an alternate blood pump circuit which has a standard male and female luer adapter just before the filter on the withdrawal line to allow the optional use of a blood chamber cuvette to interface with a stand alone Hct monitor.

Here's a breakdown of the acceptance criteria and study information for the Aquadex FlexFlow™ System, based on the provided 510(k) summary:

This submission is for an alteration to an existing device (K050609), specifically to add an alternate blood pump circuit. Therefore, the focus of the testing is on validating this change, not re-proving the core functionality of the entire system from scratch.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for flow rates, pressure, or other performance metrics). Instead, it states that "The data demonstrated the Aquadex FlexFlow System continues to be safe and effective."

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

• Sample Size: Not specified. The summary only mentions "Bench tests were performed." It does not provide the number of units tested or the number of test runs.
• Data Provenance: Not specified, but by nature of "bench tests," this would be laboratory-generated data, not from human subjects. It would be prospective in the sense that the tests were conducted specifically for this 510(k) submission, but it's not clinical data.

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

• This question is not applicable to this specific 510(k) submission. The validation was based on "bench tests" for engineering performance, not on clinical interpretation or subjective assessment requiring expert review to establish ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. Bench tests typically involve objective measurements against engineering specifications or established performance characteristics, and thus do not usually require a consensus or adjudication process like clinical studies with subjective endpoints.

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

• No, an MRMC comparative effectiveness study was not done. This 510(k) is for a minor modification to an existing device validated through bench testing, not a new diagnostic or therapeutic device requiring a clinical comparison of human reader performance.

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

• Not applicable. This device is a medical system (hardware and software for ultrafiltration) and not an algorithm or AI system subject to "standalone performance" testing in the AI context. While it has proprietary software, the testing described is on the mechanical and functional integration of a new blood circuit.

7. The Type of Ground Truth Used:

• For the bench testing, the "ground truth" would be engineering specifications, established performance parameters of the original device, and objective measurements of the modified system (e.g., flow rates, pressure integrity, absence of leaks, compatibility with the Hct monitor). It's not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "proprietary software" is mentioned, but no changes were made to it, and its development would have preceded this specific 510(k).

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

• Not applicable. As this is not an AI/machine learning device with a training set, the question of how ground truth was established for it is irrelevant in this context.

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The Aquadex System is indicated for:
Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.

The Aquadex FlexFlow™ System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

The Aquadex™ FlexFlow™ System, manufactured by CHF Solutions, Inc., is a high permeability dialysis system designed to remove excess fluid from patients with fluid overload who have failed diuretic therapy. The device received 510(k) clearance (K050609) from the FDA on November 9, 2005.

Here's an analysis of the acceptance criteria and the study used to demonstrate the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the safety and performance evaluation for the Aquadex™ System, particularly in support of an expanded indication for use to include extended ultrafiltration treatment (longer than 8 hours). However, explicit, quantifiable acceptance criteria with specific thresholds for parameters like effectiveness or safety outcomes are not explicitly stated in the provided 510(k) summary. Instead, the summary concludes that the device "continues to be safe and effective" based on the data.

Therefore, the table below reflects what can be inferred as the general performance goal based on the clinical study's outcome rather than pre-defined numerical acceptance criteria.

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

• Sample Size: A subset of 60 patients with 89 extended use (>8 hours) UF500 circuits.
• Data Provenance: This was a post-market on-label prospective study. The country of origin is not explicitly stated, but the manufacturer is based in Brooklyn Park, MN, USA, and the FDA review is for the US market, suggesting the study was likely conducted in the US.

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

The provided document does not specify the number of experts used or their qualifications to establish ground truth for this study. Given that it's a post-market clinical study evaluating safety and effectiveness, the "ground truth" would likely be based on clinical outcomes assessed by treating physicians and medical staff, rather than a panel of independent reviewers establishing a "ground truth" for diagnostic accuracy.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the clinical study data. Clinical studies typically rely on predefined endpoints and statistical analysis to evaluate outcomes, rather than an adjudication method in the context described for diagnostic accuracy.

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. This type of study is primarily relevant for diagnostic imaging devices where the performance of an AI algorithm is compared against human readers, with or without AI assistance. The Aquadex™ FlexFlow™ System is a therapeutic device (dialysis system), and its evaluation focuses on its direct physiological effects.

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

No, a standalone (algorithm only) performance study was not done. The Aquadex™ FlexFlow™ System is a medical device that involves hardware, software, and human clinician interaction for its operation and effectiveness. Its performance is inherently tied to its function in a clinical setting with human oversight. The evaluation focused on the device's overall safety and effectiveness during extended use.

7. The Type of Ground Truth Used

The "ground truth" for this study would be derived from clinical outcomes data related to patient safety and the device's effectiveness in performing ultrafiltration. This would include measurements of fluid removal, patient vital signs, adverse events, and other clinical indicators relevant to the treatment of fluid overload.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of an algorithm or AI. This is because the device is a medical apparatus with a software component, but information provided does not suggest it employs machine learning or AI algorithms requiring a separate training set for model development. The "software changes" mentioned relate to functional enhancements rather than AI model training.

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

As no training set (for an AI algorithm) is mentioned, the method for establishing its ground truth is not applicable here.

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The 5.2F dELC catheter is a peripheral venous access catheter, inserted preferably in the basilic vein (arm) and antecubital region respectively and specifically for use with the Aquadex™ System 100 when the blood flow rate is set at ≤20ml/minute.

The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

The Aquadex System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

The 5.2F dELC is a 16 gauge, polyurethane, dual lumen extended-length catheter. It is intended to provide short-term peripheral venous access to facilitate blood removal and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is fused to a single lumen tube for the distal portion. The catheter shaft construction includes a 304 stainless steel coil to minimize kinking from bending. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal dual lumen section of the catheter shaft. The catheter will connect directly to the UF circuit of the Aquadex System 100 to conduct blood to and from the patient for the purposes of ultrafiltration. The 5.2F dELC is compatible with the Aquadex System 100 which utilizes software allowing blood flow rate adjustment as this catheters' optimal blood flow rate is at ≤20ml/minute.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided document does not specify a separate "test set" in the context of clinical trials or data for performance evaluation beyond bench testing. The assessment relies on "bench tests" to demonstrate compatibility and similar characteristics to predicate devices. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a distinct test set are not available.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not applicable, as the evaluation was based on bench testing of physical properties and compatibility, not a clinical study requiring expert consensus on a test set.

4. Adjudication Method (Test Set)

Not applicable for the reasons stated above.

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

No. This document describes the premarket notification for a medical device (a catheter), not an AI algorithm or a diagnostic tool that would typically undergo an MRMC study. The evaluation focuses on the safety and effectiveness of the physical device through comparison with predicate devices and bench testing, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. This document is for a physical medical device (catheter), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on bench testing results and comparison to the established characteristics and performance of predicate devices. This includes verifying material similarity, packaging, sterilization, sterility, nonpyrogenicity, and functional compatibility with the Aquadex System 100 at specified flow rates.

8. Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set" in this context.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

The Aquadex System 100 removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.

Here's an analysis of the provided text regarding the Aquadex System 100, focusing on acceptance criteria and the supporting study:

Aquadex System 100 Adjustable Blood Flow Rate - K04-0489

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study related to "adjustable blood flow rate" for the Aquadex System 100.

However, based on the Safety & Performance and Conclusion sections, the implicit acceptance criteria are that the device remains safe and effective for its intended use, specifically with the software change to allow for adjustable blood flow rate and compatibility with various catheters.

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

The document states that "Bench testing was performed". This typically means testing conducted in a laboratory environment, not on human subjects.

• Sample Size for Test Set: Not specified. Bench testing usually involves multiple iterations or units, but a specific number is not provided.
• Data Provenance: The data is generated from bench testing. This implies a controlled laboratory setting. It is not patient or clinical data, and thus, provenance in terms of country of origin or retrospective/prospective is not applicable in the human-clinical sense.

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

This information is not provided in the document. Bench testing typically relies on engineering specifications and validated test methods rather than expert consensus on a "ground truth" derived from human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers interpret data (e.g., medical images) and their agreements/disagreements need to be resolved to establish ground truth. Bench testing does not involve such human interpretation for its primary results.

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

No, an MRMC comparative effectiveness study was not done. The study described is bench testing, not a clinical study involving human readers or cases. Therefore, no effect size for human readers improving with AI vs. without AI assistance can be reported.

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

The device is a medical system (Aquadex System 100) with proprietary software, not an AI algorithm in the typical sense of standalone performance analysis. The "software change" was validated through bench testing, which evaluates the system's (including its software's) operational performance directly. Therefore, while the software's function was tested, it's not a "standalone performance" study of a diagnostic AI algorithm in the way that term is usually applied.

7. Type of Ground Truth Used

The ground truth for the bench testing would be based on engineering specifications, established physical principles, and measurement standards. For example, if testing blood flow rate, the ground truth would be the accurately measured flow rate using calibrated equipment, compared to the device's reported flow rate under various conditions. For catheter compatibility, the "truth" would be successful and safe operation with different catheters as defined by design specifications. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable/not provided. The "software change" was validated through bench testing. This typically involves software verification and validation activities against requirements, rather than an AI model "training set."

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

This information is not applicable/not provided for the same reasons as point 8. The concept of a "training set" and establishing ground truth for it is relevant to machine learning/AI models, which is not the nature of the described software validation.

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The Dual Lumen ELC catheters are peripheral venous access catheters, inserted preferably in the basilic vein (arm) and antecubital region respectively, and specifically for use with the System 100. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs. The System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

The dELC is a 6 French, polyurethane, dual lumen extended-length catheter. It is intended to provide short-term peripheral venous access to facilitate blood removal and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is bonded to a single lumen tube for the distal portion. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal section of the catheter shaft. The catheter will connect directly to the UF circuit of the System 100 to conduct blood to and from the patient for the purposes of ultrafiltration.

The provided text is a 510(k) summary for a medical device called the "Dual-Lumen Extended Length Catheter (dELC)". It describes the device, its intended use, and states that bench tests demonstrate its compatibility with the System 100. However, it does not include information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trials or performance studies. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, packaging, sterilization, and limited bench testing.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what cannot:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

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

   • Not provided. The document only mentions "bench tests," which are typically laboratory-based and do not involve human patient data in the context of this 510(k) summary. No details on the number of samples or data provenance are given.

2. 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/Not provided. Since "bench tests" are mentioned for compatibility, there's no indication of a test set requiring expert-established ground truth in the traditional sense of diagnostic or clinical performance studies.

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

   • Not applicable/Not provided. As stated above, this type of adjudication is typically for clinical or diagnostic performance studies, which are not described here.

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. This device is a physical medical catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not conducted.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • Not applicable/Not provided. For the "bench tests" mentioned, the "ground truth" would likely be the physical properties and functional performance of the catheter according to engineering specifications and compatibility with the System 100. This is not explicitly detailed.

7. The sample size for the training set:

   • Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • Not applicable/Not provided. There is no training set for this type of device.

Summary of Device and Evidence Presented in 510(k):

The 510(k) submission for the Dual-Lumen Extended Length Cathether (dELC) demonstrates its substantial equivalence to predicate devices (B. Braun Accuguide®, CHF Solutions System 100, and medComp® VASCU-PICC™ and Duo-Flow™) by:

• Being similar in materials of construction.
• Being identical for packaging and sterilization.
• Being provided sterile and nonpyrogenic.
• Having "bench tests" that demonstrate compatibility with the System 100.

The document uses these points to conclude that the device is "safe and effective for its intended use" for temporary peripheral venous access for ultrafiltration treatments for patients with fluid overload, and is therefore "substantially equivalent" to legally marketed predicate devices. The evidence presented focuses on design, materials, manufacturing processes, and general functional compatibility rather than detailed quantitative performance metrics from a formal "study" with set acceptance criteria in the clinical sense.

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1. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
2. The dual lumen ultrafiltration catheter [A1537] is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100.
3. The catheter extension [A1513] mav also be used to connect commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.
4. The System 100 S-100 console [A1100] may be used when either peripheral or central venous access is employed.
5. The UF 500 circuit [A1500 and A1550] may be used when either peripheral or central venous access is employed.

The System 100 Ultrafiltration Catheters are part of the fluid pathway and intended for blood withdrawal and infusion when repeat venous access over a period of ≤ 30 days is medically desired. Common medical practice is to exchange the catheter every seven days to minimize infection. The CVC catheter is percutaneously introduced into the subclavian vein or the internal jugular vein with the distal tip ending in the mid to lower superior vena cava. The proximal end with the proprietary connectors resides outside the body connecting to the withdrawal and infusion blood lines of the UF500 blood circuits which engages the System 100 pump console for ultrafiltration in patients with fluid overloaded. The catheter extension (A1513) may also be used to connect other commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.

The provided text describes the System 100 Ultrafiltration Catheter and System 100 device. However, it is a 510(k) summary for a medical device and not a study report on device performance or an AI/software device. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI or software product.

Based on the provided document, I can only extract limited information about "acceptance criteria" and "device performance" as it pertains to substantial equivalence for a physical medical device (catheter and ultrafiltration system). The document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria with detailed study data.

Here's an attempt to answer your request based only on the provided text, highlighting where information is missing due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document mentions "Bench tests," but does not provide details on the number of samples or tests performed.
• Data Provenance: Not specified. It's likely laboratory bench testing.

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

• Number of Experts: Not applicable. This document describes bench testing for a physical device, not an AI or software device that would require expert-established ground truth for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This document describes bench testing for a physical device, not an AI or software device that would require an adjudication method for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No. This document describes a 510(k) submission for a physical medical device (catheter and ultrafiltration system), not an AI or software device. Therefore, an MRMC comparative effectiveness study is not relevant or mentioned.

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

• Standalone Performance: Not applicable. This document is for a physical medical device. There is no "algorithm only" performance component to evaluate.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "bench tests," the ground truth would be established by the physical measurements and specifications of the device and its compatibility with the System 100. This is based on engineering and manufacturing standards, not expert consensus, pathology, or outcomes data in the context of an AI study.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI or software device, so there is no training set.

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

• Ground Truth for Training Set: Not applicable. This is not an AI or software device, so there is no training set or associated ground truth.

Summary of Device Safety and Performance from the Document:

The safety and performance of the System 100 Ultrafiltration Catheter are primarily established through substantial equivalence to its predicate device (System 100, K013733, K023224, K024124) and other commercially available catheters. The document states:

• The UF catheter and primary predicate device are similar in materials of construction and identical for packaging and sterilization.
• The UF catheter is provided sterile and nonpyrogenic.
• Bench tests demonstrate the UF catheter is compatible with the System 100.
• The use of CVCs (Central Venous Catheters) is expected to be performed in hospital environments where CVC use is common, implying standard medical practice and known risks.

The conclusion is that "Based on the similar intended use, patient population, technology characteristics including well understood CVC medical risks, and performance as access with bench testing the catheter has been shown to be safe and effective for its intended use." This indicates that simple bench testing for compatibility and adherence to material/sterilization similarities to predicate devices were sufficient for demonstrating substantial equivalence for this type of physical medical device.

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For use with the System 100. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

The UF500 blood circuit with needleless access port allows for aspiration, injection, or gravity flow of fluids using a male luer fitting.

The modified/alternate UF500 circuit incorporates an in-line needleless valve on the circuit withdrawal, infusion or both tubing lines. The in-line needless valve is independently commercially available medical device cleared for commercial distribution since May 15, 1996 (K955585) known as the ULTRASITE® valve. This is a luer activated valve manufactured and distributed by B. Braun Medical. CHF Solutions, Inc. is placing this valve at the end of a short piece of tubing (extension arm) that is permanently joined to the A1500 circuit of the System 100 (K013733) with a tee connector. A sliding clamp is also included on the extension arm and is blue on the withdrawal side and white on the infusion side. The in-line needleless access port allows the health care provided access to the circuit/vasculature without disconnecting the catheter connections or catheter extension (when used) for aspiration, injection, or gravity flow of fluids.

The provided text describes a 510(k) summary for a medical device called "System 100 Modified/Alternate UF500 With In-line Needleless Access Port." However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in a quantitative sense as typically seen in AI/software medical device submissions.

This submission is for a modification of an existing device (UF500 circuit) by adding a commercially available, already cleared, in-line needleless access port. The "study" here is primarily a demonstration of substantial equivalence through bench testing, rather than a clinical trial or performance study with defined statistically-derived acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of submission described.

Here's an analysis of what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the acceptance criteria are met if the modified device remains compatible with the System 100, is sterile, nonpyrogenic, and satisfies the intended use without introducing new safety concerns compared to the predicate devices. The phrase "Bench tests demonstrate the modified/alternative UF500 is remains compatible with the System 100" serves as the primary "acceptance."

Reported Device Performance:

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

• Sample Size: Not specified. The study involved "bench tests," which are typically laboratory tests of the device itself rather than tests on human subjects or clinical data. The quantity of devices tested is not mentioned.
• Data Provenance: The "bench tests" are presumably conducted by the manufacturer, CHF Solutions, Inc., in the United States. They are retrospective in the sense that they were conducted on the modified device before submission.

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

• Not applicable. This is a hardware modification submission, not an AI/software device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This type of submission does not involve adjudication of clinical data or expert opinions. The evaluation is based on engineering and performance specifications.

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

• No. This is not an AI or software device, and no MRMC study was performed.

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

• Not applicable. This is a physical medical device (circuit with a port), not an algorithm.

7. The Type of Ground Truth Used

• Not applicable in the typical sense for AI/software devices. The "ground truth" here is adherence to engineering specifications for compatibility, sterility, non-pyrogenicity, and mechanical integrity, as demonstrated through bench testing and comparison to predicate device characteristics.

8. The Sample Size for the Training Set

• Not applicable. No training set is mentioned or relevant for this type of device modification.

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

• Not applicable. No training set is mentioned or relevant for this type of device modification.

Summary of the Study (as described in the document):

The study was a series of bench tests conducted by CHF Solutions, Inc. to demonstrate the safety and effectiveness of the modified UF500 circuit. The core of the study aimed to show that integrating an existing, cleared needleless access port into the UF500 circuit did not negatively impact the performance, safety, and compatibility with the System 100. Key aspects verified were:

• Materials, Packaging, and Sterilization: These were confirmed to be identical to the predicate System 100 circuit, leveraging the existing clearance for these aspects.
• Sterility and Nonpyrogenicity: The final modified product was confirmed to be sterile and nonpyrogenic.
• Compatibility: Bench tests specifically demonstrated that the modified/alternative UF500 circuit remains compatible with the System 100, which is crucial as the needleless port is an add-on.

The overall conclusion was that, based on these bench tests and the technological characteristics, the modified device is "safe and effective for its intended use" and "substantially equivalent" to the predicate devices.

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