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Circon Corporation's Tsunami™ Battery-Powered Irrigation Pump is intended to be used in conjunction with Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage.

The Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is comprised of a Tsunami™ Battery-Powered Pump that may be attached to a source of irrigation tubing connected to a Surgiflex WAVE suction-irrigation handpiece, and a length of suction tubing connected between the handpiece and a vacuum source (usually a suction canister that is connected to a wall suction outlet). Irrigation solution is introduced to the surgical site and fluids, debris and smoke are evacuated from the site via a disposable suction-irrigation probe. All components of the system are supplied sterile, disposable in a sealed plastic tray for single patient use.

This 510(k) summary (K992126) for the Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System does not contain specific acceptance criteria or the details of a study proving the device meets acceptance criteria in the way typically expected for performance claims of AI/ML-enabled devices.

This document is for a traditional medical device (a battery-powered irrigation pump) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing numerical performance metrics against predefined acceptance criteria for a new clinical function or AI algorithm.

Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluations, which is not applicable here.

Here's an explanation based on the provided text, highlighting why certain information is absent and what is available:

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

• Not Applicable/Not Provided: This document does not present acceptance criteria in a quantitative, measurable format (e.g., sensitivity, specificity, accuracy thresholds) for a specific clinical outcome or an algorithm's performance. The "performance" assessment here is focused on demonstrating that the device functions similarly to legally marketed predicate devices for its intended use, without raising new questions of safety or effectiveness. The comparison is primarily around design, operating principles, materials, sterility, and method of delivery/evacuation.

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

• Not Applicable/Not Provided: There is no "test set" in the context of an AI/ML device evaluation. This device is a hardware component. Any testing conducted would likely involve engineering verification and validation (e.g., flow rate, pressure, battery life, material compatibility, sterility) rather than a clinical study with a patient data test set.

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 there's no test set requiring ground truth labeling (e.g., image annotation, diagnosis), there's no mention of experts for ground truth establishment.

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

• Not Applicable/Not Provided: No test set, no ground truth 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

• Not Applicable/Not Provided: This is not an AI-assisted device, so an MRMC study is irrelevant.

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

• Not Applicable/Not Provided: This is a hardware device; there is no standalone algorithm.

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

• Not Applicable/Not Provided: No ground truth in the AI/ML sense is mentioned. Any "ground truth" equivalent for this device would be established through engineering specifications, standards, and possibly bench testing against known values (e.g., measuring actual fluid flow against specified flow rates).

8. The sample size for the training set

• Not Applicable/Not Provided: There is no AI/ML model, hence no training set.

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

• Not Applicable/Not Provided: No training set, no ground truth for it.

Summary of what is described in the document relevant to device acceptance (though not in the requested AI/ML format):

The primary "acceptance criteria" and "study" for this device are framed around substantial equivalence to predicate devices already on the market.

• Intended Use: The device is intended to "provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage." This intended use is compared directly to predicate devices.
• Technological Characteristics Comparison: The document states that "Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is substantially equivalent to Cabot's Surgiflex® Suction-Irrigation Probes, Davol's Hydro-Surgi Laparoscopic Irrigator and Stryker's Laparoscopic Suction Irrigator."
  • Basis for Substantial Equivalence: "All of these devices employ substantially equivalent design considerations and operating principles, and their materials of construction are safe for the intended uses. All of these devices are supplied sterile for single-use only, and none actively delivers any form of electrical energy to the patient."
  • Conclusion: "Any differences between the various devices do not raise new questions regarding safety or effectiveness."

In essence, the "study" is a comparison with predicate devices, showing that the new device shares fundamental technological characteristics and intended use with already cleared devices, and any differences do not negatively impact safety or effectiveness. This comparison is the method for demonstrating that the device meets the (implied) regulatory acceptance criteria for market clearance via the 510(k) pathway.

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