Search Results

The intended use of the ThermoChem-HT System is to raise the core temperature of the peritoneum to the desired targeted temperature by continuously lavaging the peritoneum with circulating warmed Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.

The principal components, features and functions of the ThermoChem-HT System include an internal water heater/cooler, roller-type fluid pump, inputs for monitoring temperature, touch screen to direct the user through set-up and use, computer record storage, and disposable circuit that includes an integrated heat exchanger, fluid reservoir, and tubing connectors. The user provides and places commercially available introduction and drainage catheters into the patient's peritoneal cavity. One catheter acts as an Inlet and the other as an Outlet. The user also provides the Lactated Ringer's Solution. U.S.P., or another physiologically compatible sterile solution that is circulated into and out of the peritoneal cavity.

The system heats Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution, and circulates it into and out of the peritoneal cavity. Flow from the patient Outlet Catheter gravity drains into a fluid reservoir, then through to a roller Pump and then to an inline, disposable Heat Exchanger. The Heat Exchanger is interfaced with heated water from a heater/cooler that provides regulated temperature control to the Heat Exchanger. The heated solution then passes to the peritoneal cavity through the Inlet Catheter. The inline reservoir also aids in priming the disposable circuit and maintaining adequate fluid volumes. The system monitors the temperature of the circulating Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.

The provided text describes a 510(k) summary for the "ThermoChem-HT System", a Thermal Infusion Fluid Warmer. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets them in the way modern regulatory submissions might.

Based on the provided text, the acceptance criteria and study information are largely conceptual and focus on the safety and performance already established for components used in predicate devices. There is no explicit table of acceptance criteria with corresponding performance metrics from a dedicated study of the ThermoChem-HT System itself. Instead, the document relies on the prior approvals of its constituent parts and general principles.

Here's an attempt to extract and synthesize the requested information, noting where specific details are not provided in the text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a specific "test set" for the ThermoChem-HT System in the context of performance metrics from a new study. Instead, it relies on:

• The established performance and safety of its components through prior 510(k) submissions.
• "Published clinical studies involving intra-peritoneal perfusion hyperthermia" which are mentioned as demonstrating safety, but no details on their sample size or provenance are given for these external studies.
• Internal "laboratory/clinical tests" by HemoCleanse, Inc. for biocompatibility, electrical safety, EMC, and software, but the sample sizes for these are not specified.

Therefore, specific sample sizes for a dedicated "test set" for the ThermoChem-HT system are not provided. The data provenance relies on prior regulatory approvals and external publications.

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

This information is not provided. The submission relies on pre-existing data and regulatory approvals, not on a new test set requiring expert ground truth establishment for novel device performance.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set in the context of expert review.

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 is not applicable. The ThermoChem-HT System is a medical device for warming fluids, not an AI-powered diagnostic or decision-support tool that would involve human "readers" or AI assistance in this context.

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

This is not applicable. The ThermoChem-HT System describes a physical device with an electromechanical function, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the ThermoChem-HT System largely comes from:

• Established engineering and safety standards: For electrical safety, EMC, and software verification/validation.
• Prior regulatory approvals: For the performance and biocompatibility of the system's major components, which are used in other legally marketed devices (cardiopulmonary bypass, peritoneal dialysis).
• Published clinical literature: For the safety of intra-peritoneal perfusion hyperthermia, which supports the intended use's safety claims.

There is no mention of pathology or outcomes data specifically generated for the ThermoChem-HT System itself in this summary to establish ground truth in a clinical trial sense.

8. The Sample Size for the Training Set

This is not applicable. The device does not employ machine learning or AI that would require a "training set" in this context.

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

This is not applicable as there is no training set for an AI/ML algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device