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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 Bladeless Trocar, Bladed Trocar, and Hasson Trocar have application in a variety of laparoscopic procedures to provide a port of entry for laparoscopic instruments.

The Disposable Surgical Trocar is composed of two parts, one obturator and one guide tube (cannula). The obturator of the Bladeless Trocar is plastic allowing the surgeon to dilate between tissues. The obturator of Bladed Trocar is made of PC and a small blade made of stainless steel, which is released when the surgeon presses the trocar to help with cutting. The Disposable Surgical Trocar Kit, bladed or bladeless, has one obturator and two cannulas or two obturators and four cannulas. The device is for single use only. This device is sterilized with ethylene oxide and has a shelf life of 3 years.

This is an FDA 510(k) summary for a medical device called "Bladeless Trocar; Bladed Trocar; Hasson Trocar." The document describes the device, its intended use, and compares it to a legally marketed predicate device (K141594).

However, your request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically in the context of an AI/ML medical device submission. The provided document is for a mechanical surgical instrument (trocar) and does not involve AI/ML. Therefore, the requested information categories concerning AI/ML performance (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

The document states:

"The subject device trocar models (Bladeless Trocar, Hasson Trocar) are manufactured by the same company that manufactures those of the predicate device (Unimicro) and are identical to those cleared under K141594. As such, performance testing is not required."

This statement indicates that the regulatory acceptance is based on the substantial equivalence to a predicate device, specifically because the new device is identical and manufactured by the same company as the predicate. Therefore, no new performance studies were conducted or required to demonstrate that the device meets acceptance criteria.

To specifically address the prompts given the available information:

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

   • Acceptance Criteria: Substantial Equivalence to predicate device K141594. The key criteria are identical design, materials, manufacturing process, and intended use to a previously cleared device.
   • Reported Device Performance: Not applicable, as performance testing was explicitly stated as "not required" due to the identical nature to the predicate device. The performance is assumed to be equivalent to the predicate device.

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 as no performance study was conducted.

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 as no performance study was conducted.

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

   • Not applicable as no performance study was conducted.

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 a non-AI device.

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

   • Not applicable. This is a non-AI device.

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

   • Not applicable as no performance study was conducted. Regulatory acceptance is based on substantial equivalence to the predicate device.

8. The sample size for the training set

   • Not applicable. This is a non-AI device.

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

   • Not applicable. This is a non-AI device.

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