(596 days)
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.
§ 876.5870 Sorbent hemoperfusion system.
(a)
Identification. A sorbent hemoperfusion system is a prescription device that consists of an extracorporeal blood system similar to that identified in the hemodialysis system and accessories (§ 876.5820) and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated-carbon or resins which may be coated or immobilized to prevent fine particles entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. The device is used in the treatment of poisoning, drug overdose, hepatic coma, or metabolic disturbances.(b)
Classification. (1) Class II (special controls) when the device is intended for the treatment of poisoning and drug overdose. The special controls for this device are:(i) The device must be demonstrated to be biocompatible;
(ii) Performance data must demonstrate the mechanical integrity of the device (e.g., tensile, flexural, and structural strength), including testing for the possibility of leaks, ruptures, release of particles, and/or disconnections under anticipated conditions of use;
(iii) Performance data must demonstrate device sterility and shelf life;
(iv) Bench performance testing must demonstrate device functionality in terms of substances, toxins, and drugs removed by the device, and the extent that these are removed when the device is used according to its labeling, and to validate the device's safeguards;
(v) A summary of clinical experience with the device that discusses and analyzes device safety and performance, including a list of adverse events observed during the testing, must be provided;
(vi) Labeling must include the following:
(A) A detailed summary of the device-related and procedure-related complications pertinent to the use of the device;
(B) A summary of the performance data provided for the device, including a list of the drugs and/or poisons the device has been demonstrated to remove, and the extent for removal/depletion; and
(vii) For those devices that incorporate electrical components, appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.
(2) Class III (premarket approval) when the device is intended for the treatment of hepatic coma and metabolic disturbances.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA by April 17, 2014, for any sorbent hemoperfusion system indicated for treatment of hepatic coma or metabolic disturbances that was in commercial distribution before May 28, 1976, or that has, by April 17, 2014, been found to be substantially equivalent to any sorbent hemoperfusion device indicated for treatment of hepatic coma or metabolic disturbances that was in commercial distribution before May 28, 1976. Any other sorbent hemoperfusion system device indicated for treatment of hepatic coma or metabolic disturbances shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.