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The SurgiSteer™ line of of electrocautery laparoscopic instruments are sterile, single-use devices intended for use in a variety of minimally invasive surgical procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

The SurgiSteer™ line of electrocautery laparoscopic instruments are sterile, single-use disposable instruments intended for use through appropriately sized surgical trocars and consist of a proximal handle and a flexible distal end segment interconnected with a rigid 5.0 mm outer tube, all safely insulated for monoplolar electrocautery use. Distal to the distal end segment of the shaft is one of the end effectors (scissors, dissector/grasper, or hook) rotationally mounted independent of the outer tube and flexible end segment . Proximal to the end of the rigid shaft is an ergonomically shaped handle which contains: 1) a rotation knob that causes the end effector to rotate freely in both CW and CCW directions, 2) a bend wheel that causes the flexible end segment to bend >90 degrees in both left and right directions, and, 3) the actuating trigger that causes the articulating components of the end effector, if any, to open and close with sufficient force to either dissect or transect tissue. Each instrument has a monopolar energy supply cable that extends from the bottom of the handle and that can be plugged into the "the universal monopolar receptacle for footswitch-activated accessories on any commercially available generator.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SurgiSteer™ electrocautery laparoscopic instruments:

Acceptance Criteria and Device Performance

Study Information:

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

   • The document states "Pre-clinical testing was used to evaluate performance." However, it does not specify the sample size for any part of the testing.
   • The data provenance is not explicitly mentioned (e.g., country of origin). Since it's a 510(k) submission, it's presumed to be relevant to U.S. regulatory standards, but the physical location of the testing is not stated. The study is prospective in nature, as it evaluates the performance of the new device.

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

   • The document does not specify the number of experts or their qualifications used to establish ground truth or evaluate ergonomics/performance.

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

   • The document does not mention any adjudication method for the test set. The nature of the "pre-clinical testing" suggests a series of engineering and functional tests rather than clinical evaluations requiring expert consensus adjudication in the typical sense.

4. 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:

   • No MRMC study was done. This device is a surgical instrument, not an AI-assisted diagnostic or interpretive tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

   • Not applicable. This is a physical surgical instrument, not an algorithm. Performance testing would inherently involve the device's interaction with simulated or actual tissues, likely operated by a human or automation replicating human action for testing purposes.

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

   • For this type of device, ground truth would be based on engineering specifications and established performance standards for electrosurgical instruments (e.g., specific force measurements, electrical safety standards, insulation integrity tests, and comparisons to the predicate device's known performance characteristics). The document generally states "acceptable reliability and design performance relative to the predicate device," implying a comparative engineering standard as the ground truth.

7. The sample size for the training set:

   • There is no mention of a "training set" in the context of this device. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

   • As there is no training set mentioned, this question is not applicable.

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