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The ThermaSolutions HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site.

ThermaSolutions' HurriChem Device Kit consists of the HurriChem Irrigation Wand and braided poly tubing. The HurriChem Device Kit is intended for use to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures. It is designed to lavage blood and tissue debris from the surgical site. The kit is to be used in conjunction with standard injection pumps. The kit is to be used only by physicians trained in the use of this device. The device is packaged and sterilized for single use only, and should be discarded after use according to the policy of the facility.

The HurriChem Device Kit consists of a stainless-steel wand and a length of braided poly tubing. The one end of the tubing attaches to the stainless-steel wand, and the other end of the tubing is intended to attach to a standard injection pump (not part of the device). The sterile fluid is delivered from the injection pump through the poly tubing and into the stainless-steel wand. The wand has internal mechanics that deliver the fluid as microscopic droplets in a fine mist. The irrigation using fluid droplets allows for maximum lavage of the area with a minimal amount of fluid.

The provided text describes the ThermaSolutions HurriChem Device Kit, a laparoscopic irrigation device, and its substantial equivalence to a predicate device. However, the document does not contain details about specific acceptance criteria, reported device performance (beyond general statements of meeting requirements), sample sizes, ground truth establishment, or clinical study design elements that your request asks for.

The document explicitly states: "No clinical trials were performed on the HurriChem Device Kit." Instead, the submission relies on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence.

Therefore, many of your requested items cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance

• Cannot be fully provided. The document states: "All the tests demonstrate that the device meets the requirements of its pre-defined acceptance criteria and intended use." However, it does not list these pre-defined acceptance criteria or provide specific numerical performance results against them. It only mentions categories of tests performed (Biocompatibility, sterilization validation, packaging validation, shelf life, transportation testing, fit, function, performance).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The text does not disclose sample sizes for any of the non-clinical tests or the provenance of the data.

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)

• Not applicable / Not provided. Since no clinical trials or studies requiring expert ground truth establishment for a test set were conducted, this information is not present. The "ground truth" in this context would likely refer to engineering specifications and performance evaluations rather than clinical diagnoses. The document mentions "ThermaSolutions Engineering and Product Development teams evaluated fit, function, performance," implying internal company experts, but no specific number or qualifications are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. As no clinical studies with a test set requiring adjudication were conducted, this information is absent.

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

• Not applicable. No MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical laparoscopic irrigation kit; there is no algorithm or AI component involved in its function as described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Implied engineering standards/specifications. For the non-clinical tests, the "ground truth" would be established engineering requirements, test standards, and successful demonstration of function. No clinical ground truth (like pathology or outcomes data) was used because no clinical trials were performed.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" in the context of this device's non-clinical evaluation.

9. How the ground truth for the training set was established

• Not applicable / Not provided. See above.

Summary of available information:

The K222575 submission for the HurriChem Device Kit relies on non-clinical testing and comparison to a legally marketed predicate device (DANNIK Laparoscopic Suction Irrigation System, K192643) to demonstrate substantial equivalence, rather than clinical trials. The non-clinical tests covered:

• Biocompatibility
• Sterilization validation
• Packaging validation
• Shelf life
• Transportation testing
• Fit, function, and performance evaluation by ThermaSolutions Engineering and Product Development teams.

The conclusion is that the device "meets the requirements of its pre-defined acceptance criteria and intended use" and is "as safe and effective as the predicate device" based on these non-clinical evaluations. However, the specific details of these acceptance criteria, test results against them, and quantitative data (like sample sizes) are not present in the provided FDA letter and 510(k) summary.

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