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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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