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The intended use of the ThermoChem™ HT-2000 System is to raise the core temperature of the peritoneum to a desired target temperature by continuously lavaging the peritoneum with circulating and warmed Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.

The ThermoChem HT-2000 System is a next-generation design of the currently marketed ThermoChem HT-1000 System and consists of the ThermoChem unit, a touchscreen monitor and an Intraperitoneal Hyperthermia (IPH) Procedure Kit, or "Disposable." The ThermoChem unit houses an internal heating unit that warms distilled or sterile water to a desired temperature. This water is circulated around a single-use heat exchanger (included in the IPH Procedure Kit) where it warms Lactated Ringer's (or another physiologically compatible sterile solution) for infusion into the patient's peritoneal cavity. The IPH Procedure Kit contains two temperature probes, two suction guards, and a pressure sensor as well as a Perfusion Kit consisting of a heat exchanger, a fluid reservoir, and tubing set. The warmed Lactated Ringer's (or other physiologically compatible sterile solution) is pumped through the tubing to the patient and then returns to the fluid reservoir. The IPH Procedure Kit is a convenience kit of previously 510(k)-cleared devices that are repackaged / relabeled by ThermaSolutions, Inc. The ThermoChem HT-2000 unit has been redesigned to physically reduce the size of the unit and to allow use of components that are more commercially available. The software and touchscreen monitor user interface have been redesigned to make the device easier to use. The redesigned ThermoChem unit will continue to use the currently-marketed IPH Procedure Kit for use with the ThermoChem HT-1000 System.

The ThermoChem™ HT-2000 System underwent formal verification testing to demonstrate its performance and substantial equivalence to its predicate device, the ThermoChem HT-1000 System.

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes categories of performance testing that were conducted and that the device "met acceptance criteria." However, it does not explicitly state the specific numerical acceptance criteria for each test, nor does it provide the detailed quantitative results ("reported device performance") beyond the general statement that criteria were met.

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

The document does not specify the sample size used for any of the performance tests. The data provenance is described as "bench testing," meaning the tests were conducted in a laboratory setting, not with human patient data.

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

This information is not applicable. The performance testing described (bench testing, software validation, usability validation) does not involve establishing ground truth from expert consensus on clinical data. The tests focus on the device's functional and operational performance.

4. Adjudication Method for the Test Set

Not applicable, as the tests described are technical performance evaluations rather than clinical assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, an MRMC comparative effectiveness study was not done. The submission is for a Traditional 510(k) for a medical device (a heat exchanger system), not an AI/imaging diagnostic device that typically undergoes MRMC studies. The focus is on demonstrating that the new device (HT-2000) is substantially equivalent to a previously cleared device (HT-1000) based on functional and design changes.

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

The device is a medical system with hardware and software, not a standalone algorithm in the typical sense of AI/diagnostic software. The performance testing focuses on the integrated system's functionality. Therefore, a "standalone (algorithm only)" performance study as defined for AI models is not applicable in this context.

7. The Type of Ground Truth Used

For the functional and performance tests, the "ground truth" would be the engineering specifications and design requirements of the device. For example, for pump settings, the ground truth would be the target pressure and flow rate values as designed. For water bath temperatures, the ground truth would be the specified temperature range. No expert consensus, pathology, or outcomes data were used as ground truth for these tests.

8. The Sample Size for the Training Set

Not applicable. The ThermoChem™ HT-2000 System is a physical medical device with integrated software, not an AI model that undergoes machine learning training with a "training set" of data in the common understanding of that term. While software development involves testing and iteration, the concept of a "training set" for an AI algorithm does not apply here.

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

Not applicable, as there is no "training set" in the context of an AI model for this device.

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