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The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories.

The System is not intended for use in cardiac procedures.

The AB1 Instrument, when used with the Creo Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.

The AB1 Instrument is not intended for use in cardiac procedures.

The Creo Medical (Creo) Electrosurgical System with AB1 Accessory includes the following:

• . AB1 Instrument
• . Electrosurqical Generator
• . Footswitch
• . Interface Cable with Sterile Sheaths

The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating (ablating) tissue. Only the microwave output is used to power the AB1 Instrument. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cutting; the other pedal activates the MW energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.

The single-use Interface Cable connects compatible Creo electrosurgical instruments to the Electrosurgical Generator and is supplied with a sterile sheath that is fitted over its distal end during use to minimize the potential for contamination of the sterile field.

The sterile, single-use AB1 soft tissue ablation accessory (Instrument) consists of a flexible, movable handle and a 0.95 m long x 4.3 mm diameter shaft that terminates in a 38 mm long x 1.9 mm diameter distal antenna with conical tip. Two metallic washers separated by dielectric materials couple microwave energy to target tissue when AB1 is only compatible for use with the Creo Electrosurgical System, and the Creo Electrosurgical System is only intended for use with compatible Creo instruments and accessories.

The provided text describes the Creo Electrosurgical System with AB1 Accessory, which is intended for soft tissue coagulation (ablation) using microwave energy. The 510(k) summary (K200298) primarily focuses on demonstrating substantial equivalence to a predicate device (K163105 Emprint Ablation System) through various performance data, rather than outlining specific clinical acceptance criteria for diagnostic performance.

Therefore, the requested information categories related to diagnostic performance (e.g., effect size of human readers with AI, standalone performance, MRMC study, expert qualifications for ground truth) are not applicable to this submission, as it is for an electrosurgical device and not an AI/diagnostic software.

However, the document does contain information about performance testing and acceptance criteria related to its operational safety and effectiveness as a medical device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (as implied by testing) and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated for each test type (e.g., "simulated use studies in ex-vivo tissue"). However, the text refers to "simulated use studies conducted in ex-vivo muscle, liver, lung and kidney tissue" and "ex vivo bovine tissue."
• Data Provenance: Ex-vivo tissue (not specified if animal or human for all tests, but bovine tissue is explicitly mentioned). Given the nature of these tests, it's lab-based simulated use. No country of origin for the ex-vivo tissue is provided. These are prospective tests performed by the manufacturer to demonstrate device performance.

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

• This question is not applicable as the ground truth for an electrosurgical device's performance relates to its physical, electrical, and ablative characteristics, not diagnostic interpretations requiring expert consensus. The "ground truth" here is the measured physical and biological effects of the device.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations of data, typically in diagnostic studies. For engineering and performance testing, objective measurements and established standards are used.

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 tool, not an AI-assisted diagnostic imaging or interpretation system.

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

• Not applicable. This device is a physical instrument for surgery, not an algorithm.

7. The type of ground truth used:

• For sterilization: Conformance to ISO 11135 and AAMI TIR28 standards.
• For biocompatibility: Conformance to ISO 10993-1 and FDA guidance, with specific toxicological and biological tests.
• For electrical/microwave safety and EMC: Conformance to IEC 60601 series standards.
• For mechanical/ablation performance: Direct physical measurements (e.g., diameter, force, thermal profiles, ablation zone size/shape) and comparison against design specifications and equivalence to the predicate device's measured performance in ex-vivo tissue models. This is effectively physical measurement and comparison to established engineering specifications and predicate device performance.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. As above, no training set for an algorithm is involved.

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