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The Disposable Suction Irrigation Tubing Set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation normal saline to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site to aid visualization.

The Disposable Suction Irrigation Tubing Set consists of a grip body equipped with two trumpet style valves, a probe, and connecting lines of tubing; one set designed to attach a supply of irrigation normal saline, and the other designed to attach to suction equipment (aspiration pump). The valves allow for control of irrigation and aspiration during a surgical procedure. The handpiece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. The device is packaged as sterile with a shelf life of 3 years and is for single use only.

The provided text describes a 510(k) premarket notification for a medical device called "Suction Irrigation Tubing Set." This type of submission is for medical devices, not AI/machine learning (ML) enabled devices. The document does not contain any information about acceptance criteria or studies involving AI/ML performance, human readers, ground truth establishment for AI/ML, or training/test sets for AI/ML models.

Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets those criteria in the context of AI/ML, as the provided document pertains to a traditional medical device (Suction Irrigation Tubing Set) and its physical properties and functionality.

The document discusses:

• Device Name: Suction Irrigation Tubing Set
• Regulation Number & Name: 21 CFR 876.1500, Endoscope And Accessories
• Product Code: GCJ
• Indications for Use: Used in laparoscopic surgical procedures to deliver sterile irrigation and evacuate fluids/debris/smoke.
• Device Description: Consists of a grip body with valves, a probe, and connecting tubing for irrigation and suction.
• Predicate Device: K141592, Unimicro Suction Irrigation Tubing Set
• Non-clinical Tests Performed: Air tightness, smooth test, tensile strength, tubing collapse, irrigation/aspiration fluid flow test. These are typical physical and performance tests for medical tubing, not AI/ML performance metrics.
• Conclusion: The device is substantially equivalent to the predicate device, raising no new questions of safety or effectiveness based on technological comparison and nonclinical testing.

None of this information relates to the typical acceptance criteria or study methodologies used for AI/ML medical devices (sensitivity, specificity, AUROC, MRMC studies, expert adjudication for image interpretation, etc.).

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The Epix® Suction Irrigation System is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, and laparoscopic and open urologic surgery. This device delivers sterile irrigant solution and serves as a conduit for suction.

The Epix Irrigation Pump (model C7000) is reusable and operates outside of the sterile field. The Epix Suction Irrigation Tubing Set (model C7100) is a sterile, single use device, used in conjunction with the Epix Irrigation Pump and the house vacuum to deliver sterile irrigation fluids and to evacuate blood, tissue debris, and smoke from the surgical site.

Here's a breakdown of the acceptance criteria and study information for the Epix® Suction Irrigation System, based on the provided 510(k) summary:

This device is a suction irrigator, not an AI/ML powered device. As such, many of the typical categories for AI/ML device studies (such as MRMC studies, training set details, or ground truth establishment for a diagnostic algorithm) are not applicable. The study predominantly focuses on benchtop performance testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't explicitly state quantitative acceptance criteria with numerical targets for each test. Instead, the "acceptance criteria" are implied to be that the subject device performs comparably to the predicate device in the specified functional tests, demonstrating substantial equivalence. The reported device performance is that these tests confirmed substantial equivalence.

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

The summary describes "bench top tests" where "the devices were tested side-by-side." It does not specify a numerical sample size (e.g., number of devices tested, number of trials). The data provenance is a laboratory setting from Applied Medical Resources Corporation. This is a prospective test, as the protocol was created specifically to confirm substantial equivalence.

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

Not applicable. This is a functional performance test for a physical device, not an AI/ML diagnostic device requiring expert ground truth for classification or interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is a functional performance test for a physical device.

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. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device. The "standalone" test refers to the device's functional performance in a laboratory setting, as described in the benchtop tests.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is the expected physical and functional performance according to engineering and safety standards (e.g., IEC 60601-1, ISO 10993, ISO 10079-3) and by comparison to the established performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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