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The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are intended to be used in general laparoscopic surgical procedures requiring the use of Monpolar electrosurgical cutting and/or coagulation.

The LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes are sterile packaged single use stainless-steel electrodes coated with a non-stick material (PTFE), which is used to cut and coagulate soft tissue. The PTFE Coating reduced the buildup of eschar on the electrode during use; thus, eliminates the need to clean or "scrape" the electrode on an abrasive surface to remove the eschar buildup. These devices have a 5mm diameter with working lengths up to 44cm and includes various tip geometries (L-hook, Spatula, etc.). Additionally, devices are provided in either foot-activated (via a standard 4mm female monopolar connector) or hand-activated (via a standard electrosurgical pencil) versions.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the standard information related to AI/ML device studies, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable here.

This document describes the LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes, a device for electrosurgical cutting and coagulation in laparoscopic procedures. The acceptance criteria and study information provided in this document are focused on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative table format alongside the reported performance for each criterion, as would be common for AI/ML performance metrics. Instead, it describes various non-clinical tests conducted to demonstrate that the device meets design specifications and is substantially equivalent to the predicate device. The general acceptance criterion for all the tests described is that the subject device's performance is equivalent to, or within acceptable limits compared to, the predicate device or established standards.

• 25W: Fatty (1.21 ±0.08 mm/s), Lean (1.34 ±0.14 mm/s), Extra Lean (1.65 ±0.24 mm/s)
• 50W: Fatty (1.60 ±0.26 mm/s), Lean (2.34 ±0.30 mm/s), Extra Lean (2.40 ±0.24 mm/s)
• 90W: Fatty (3.87 ±1.65 mm/s), Lean (5.15 ±4.82 mm/s), Extra Lean (5.57 ±7.59 mm/s) |

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

The document does not specify exact sample sizes for each non-clinical test beyond stating "various performance studies" and "testing on three different tissue types." The provenance is not explicitly mentioned but these are typically laboratory tests conducted by the manufacturer or contract research organizations. These are not human data, so terms like "retrospective/prospective" or "country of origin of data" are not directly applicable in the same way they would be for clinical trials or imaging datasets.

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)

This is not applicable to this type of device submission. Ground truth, in the context of this device, refers to the established scientific and engineering principles, accepted standards (e.g., ISO, IEC), and the performance characteristics of the predicate device. Expert human review for "ground truth" as it relates to diagnostic accuracy is not relevant here.

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

Not applicable. Adjudication methods are typically associated with resolving discrepancies in human expert interpretations, which is not part of this non-clinical device testing.

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 device is an electrosurgical probe, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is a surgical instrument and does not involve algorithms or AI.

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

For non-clinical testing of a surgical instrument, the "ground truth" is established by:

• International and national standards: Such as ISO 10993 (biocompatibility), ISO 11135 (sterilization), IEC 60601-1 and IEC 60601-2-2 (electrical safety).
• Scientific principles: Underlying the device's function (e.g., electrosurgical effects on tissue).
• Comparison to predicate device: The performance characteristics of the legally marketed predicate device (Xodus Medical, Inc. PTFE Coated Electrode Tips - K081647) serve as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

Not applicable.

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