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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 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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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 a blood detoxification device comprised of dialyzers, adsorption columns, tubing connectors and a control unit. It is designed for the combined removal of water-soluble 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.

This document does not contain the information required to populate all sections of the requested table and study description. The provided text is a 510(k) summary for the MARS® system, which focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a clinical study demonstrating performance against specific acceptance criteria.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary asserts substantial equivalence without detailing specific acceptance criteria or the MARS® system's performance against them in a quantitative manner (e.g., sensitivity, specificity, accuracy, or specific clinical outcomes data).

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

This information is not provided. As this is a 510(k) summary relying on substantial equivalence, no new clinical study data with test sets, sample sizes, or data provenance is detailed.

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

This information is not provided. This type of detail would be relevant for a clinical study comparing the device to a ground truth, which is not described.

4. Adjudication method for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The MARS® system is described as a "blood detoxification device" and not an AI-assisted diagnostic or interpretative system that would involve human readers.

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

This information is not provided. The MARS® is a physical medical device, not an algorithm.

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

This information is not provided. No specific ground truth is referenced as part of the substantial equivalence claim.

8. The sample size for the training set

This information is not provided. The document does not describe a machine learning algorithm or a training set.

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

This information is not provided.

Summary of available information from the provided text:

• Device Name: Molecular Adsorbent Recirculating System (MARS®)
• Indication: Treatment of drug overdose and poisonings (where the drug/chemical is dialyzable and bound by charcoal and/or ion exchange resins).
• Contraindication: Not indicated for chronic liver conditions or as a bridge to liver transplant.
• Device Description: Blood detoxification device comprised of dialyzers, adsorption columns, tubing connectors, and a control unit. Designed for the combined removal of water-soluble low and middle molecular weight substances and albumin bound molecules. Based on dialysis of blood against an albumin-containing dialysate solution.
• Regulatory Claim: Substantial Equivalence to predicate devices.
• Regulatory Class: III
• Product Code: FLD

The document explicitly states that "Safety and efficacy has not been demonstrated for these indications in controlled, randomized clinical trials" for chronic liver conditions or bridge to liver transplant, indicating that such trials were not performed for those specific uses when the 510(k) was submitted. For its approved indication, the 510(k) process typically relies on comparison to existing, legally marketed predicate devices rather than new, extensive clinical trials with detailed performance metrics and ground truth establishment for the new device.

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1. Acute Hepatic Encephalopathy: The BioLogic-DT System is indicatd for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure.
2. Drug Overdose and Poisonings: The BioLogic-DT System 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, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides.

Not Found

This document is a 510(k) clearance letter for the BioLogic-DT® System, which means it's a device that has been deemed substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on demonstrating equivalence rather than extensive clinical studies that would establish acceptance criteria and performance against those criteria in the same way a Premarket Approval (PMA) would.

Therefore, the provided document does not contain the detailed information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert qualifications as it pertains to a direct performance study of the BioLogic-DT® System itself. The letter focuses on regulatory clearance based on substantial equivalence.

Here's an analysis based on the information provided and what is missing for each point:

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

• Information in document: Not present. The 510(k) clearance letter doesn't include performance data or acceptance criteria for the BioLogic-DT® System. It simply states that the device is "substantially equivalent" to predicate devices. The "Indications for Use" describe what the device is intended for, but not specific performance metrics or thresholds.
• Missing: Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, removal rates for toxins, etc.) and the predefined acceptance criteria for these metrics.

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

• Information in document: Not present. The document does not describe any specific clinical test set, its size, or its provenance.
• Missing: Details on a test set, including its size, whether it was retrospective or prospective, and its geographic origin.

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)

• Information in document: Not present. Since no test set is described, there's no mention of experts establishing ground truth.
• Missing: Information about experts, their number, and their qualifications.

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

• Information in document: Not present. No test set is described.
• Missing: Description of any adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Information in document: Not present. This document does not describe any MRMC studies, nor does it refer to an AI component for the device. The BioLogic-DT System appears to be a medical device for treatment (acute hepatic encephalopathy, drug overdose/poisonings), not an diagnostic AI tool.
• Missing: Any information related to MRMC studies or AI assistance.

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

• Information in document: Not present. The device is a treatment system, not an algorithm, so this concept is not applicable here.
• Missing: Not applicable for this type of device.

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

• Information in document: Not present. No study or ground truth is described.
• Missing: Information about ground truth.

8. The sample size for the training set

• Information in document: Not present. No training set is described.
• Missing: Sample size for a training set.

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

• Information in document: Not present. No training set or ground truth described.
• Missing: Method for establishing ground truth for a training set.

Summary:

The provided document is a 510(k) clearance letter, which signifies that the BioLogic-DT® System has been found "substantially equivalent" to a legally marketed predicate device. This regulatory pathway primarily focuses on demonstrating that a new device is as safe and effective as an already cleared device, without requiring extensive de novo clinical trials to prove device performance against specific, novel acceptance criteria.

Therefore, the detailed information requested about acceptance criteria, study design, sample sizes, ground truth establishment, and expert qualifications is typically found in design validation documentation, clinical study reports, or a Premarket Approval (PMA) submission, none of which are present in this 510(k) clearance letter. The letter confirms the device's clearance for marketing based on equivalence, not necessarily on a detailed performance study as would be required for innovative, high-risk devices.

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1. Acute Hepatic Encephalopathy: The BioLogic-DT System is indicated for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure.
2. Drug Overdose and Poisonings: The BioLogic-DT System 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, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides.

The BioLogic-DT System is a sorbent regenerated detoxification system consisting of the BioLogic-DT Machine and the single use BioLogic-DT-1000-TK (Treatment Kit). In many ways, it is similar to a standard hemodialysis machine in that blood is removed from the body, passed through a cellulosic dialyzer, and returned to the body. Within the dialyzer, diffusion causes many chemicals and toxins to pass from the dialysate surrounding the membranes. Depending on the binding characteristics of the sorbents in suspension in the dialysate, some chemicals remain at low concentration in the dialysate, and are therefore efficiently removed from the blood, while others reach concentrations similar to blood, and are therefore not removed from the blood. Like existing single-access dialysis systems, the BioLogic-DT System alternately withdraws and returns blood through a single-lumen catheter. Unlike standard dialysis machines, which use roller pumps to pass blood through the membranes, the DT applies an alternating pressure/ vacuum cycle to the sorbent suspension causing the alternating expansion and compression of the dialyzer's parallel plate cellulosic membranes. This expansion and compression of the membranes is used to pump blood through the system.

An improvement in software of the DT-1000 System mixes the sorbents before prime, obviating the need for the operator to shake the bag.

This document (K984546) describes a 510(k) submission for the BioLogic-DT System, an improved version of a sorbent-based blood treatment system. The improvements primarily concern a software change to automatically mix the sorbent suspension during device setup. The study focuses on this specific change and its impact on the device's performance.

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: 7 repetitions of the DT System setup with automatic mixing.
• Data Provenance: Retrospective, internally generated by HemoCleanse Inc. The study described is non-clinical performance data.

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

• Not applicable for this type of non-clinical, performance-based study. The ground truth (clogging or free flow) was an observable physical outcome.

4. Adjudication Method for the Test Set

• Not applicable. The outcome was a direct observation of the device's physical performance (clogging vs. free flow).

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

• No, a MRMC comparative effectiveness study was not done. The study was a non-clinical evaluation of a device function.

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

• Yes, this was a standalone performance evaluation of the device's new automatic mixing function. The "algorithm" here refers to the software change that automated the mixing process. The study directly assessed the device's ability to mix the sorbent and prevent clogging without human intervention during the mixing step.

7. The Type of Ground Truth Used

• Direct Observational Outcome: The ground truth was the direct observation of "sorbent flow freely through the dialyzer" or "sorbent clogging."

8. The Sample Size for the Training Set

• The document does not explicitly mention a training set. The "software change" was implemented, and then its performance was tested with 7 repetitions. It's implied that any development and internal testing prior to this documented study would have involved some form of iterative development, but a formal "training set" in the machine learning sense is not described.

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

• As a formal "training set" is not explicitly mentioned, there's no information on how its ground truth would have been established. The development of the software change likely involved engineering and design principles, with internal validation steps rather than a distinct "training set" with ground truth in the context of supervised learning. The previous method's 1 out of 4 (25%) clogging rate served as a baseline or justification for the need for improvement.

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Blood detoxification and drug removal/retention

AHCS Hemoperfusion System

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (AHCS Hemoperfusion System with heparin/hydrogel coated charcoal). This document focuses on regulatory approval and substantial equivalence to a predicate device.

It does not contain information on the acceptance criteria, study details, or performance metrics of the device itself. The letter confirms the device can be marketed based on its substantial equivalence to previously approved devices, subject to general controls and good manufacturing practices.

Therefore, I cannot extract the requested information like:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide performance data or specific acceptance criteria for a validation study.
2. Sample sized used for the test set and the data provenance: Not available in this regulatory letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided.
4. Adjudication method: Not applicable or provided.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone performance study: Not mentioned.
7. Type of ground truth used: Not applicable or provided for this type of regulatory submission.
8. Sample size for the training set: Not applicable or provided.
9. How the ground truth for the training set was established: Not applicable or provided.

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