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The Hydro-Surg Irrigator is designed to be used in conjunction with a laparoscopic probe handle and tip to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.

The Hydro-Surg Irrigator uses a mechanical pumping system to generate fluid output. It is powered with four (4) standard AA alkaline batteries with an output amperage of approximately 1.0 amperes, with a voltage of 6 volts, direct current (dc). The batteries power a motor which activates movement of an impeller pump which drives the irrigation fluid to a preattached trumpet valve irrigation probe for delivery to the operative site. The proposed Hydro-Surg Irrigator system is designed for single patient use and allows for activation up to approximately 10 minutes. The flow rate of fluid delivered by the system is controlled by the surgeon with minimum flow rates of approximately 1200 cc/minute dependent on the surgeon's tip selection. Following completion of the procedure, the batteries, which power the Hydro-Surg Irrigator, may be removed for proper disposal by pushing in the tabs located on each side of the battery casing and pulling the battery casing apart.

This is a 510(k) premarket notification for a medical device (Hydro-Surg Laparoscopic Irrigator), not a study evaluating AI performance. Therefore, most of the requested information (such as sample sizes for test/training sets, expert qualifications, MRMC studies, and ground truth establishment) is not applicable or cannot be extracted from this document.

However, I can extract information related to the device's performance criteria and the testing conducted to demonstrate its equivalence to predicate devices, which can be interpreted as fulfilling "acceptance criteria" in the context of a 510(k) submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for Hydro-Surg Laparoscopic Irrigator

Based on the 510(k) submission, the "acceptance criteria" can be inferred from the comparison made against predicate devices, focusing on key performance characteristics relevant to safety and effectiveness. The study performed was a laboratory bench testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria: Laboratory Bench Testing

The study conducted was laboratory bench testing.

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as "sample size" in the context of clinical studies. The testing involved comparing the Hydro-Surg Irrigator against the predicate devices (Endo-Flo Irrigator and Stryker StrykeFlow) in a laboratory setting. The number of units tested for each device is not specified.
   • Data Provenance: The testing was conducted in a laboratory setting by Davol Inc. (the manufacturer). This is prospective in the sense that tests were specifically performed for this submission, but not in the context of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For laboratory bench testing of physical device performance (flow rate, longevity), "ground truth" is established by direct measurement using calibrated equipment, not by expert consensus or clinical evaluation of, for example, images.

3. Adjudication method for the test set:

   • Not Applicable. As per point 2, adjudication is not relevant for this type of objective performance measurement.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This was a laboratory bench test comparing physical device characteristics, not a clinical study involving human readers or AI algorithms.

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

   • Not Applicable. This document describes a physical medical device, not an AI algorithm.

6. The type of ground truth used:

   • For fluid flow rates and product longevity, the "ground truth" was established through objective physical measurements using laboratory equipment.
   • For biocompatibility, the "ground truth" was established through standardized biological testing in accordance with ISO-10993, Part 1.

7. The sample size for the training set:

   • Not Applicable. This document describes a physical medical device and its bench testing, not an AI development process requiring a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

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