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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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