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The AB1 Instrument, when used with the Creo Medical 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 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 Creo Medical (Creo) AB1 soft tissue microwave ablation instrument (electrosurgical instrument, accessory or instrument, also referred to as AB1) is designed for use with the Creo electrosurgical system, previously cleared under K200298. No changes have been made to the Creo generator, footswitch, or interface cable with sterile sheaths that comprise the electrosurgical system, nor are any changes proposed to the AB1 instrument in this 510k.

AB1 is provided as a sterile, single-use instrument that is 0.95 m long with a 4.3 mm diameter shaft that terminates in a distal antenna that is 38 mm long and less than 2.00 mm in diameter (nominally, 1.9 mm) with a conical tip. The AB1 instrument is provided with a flexible, removable (distal) handle. The outer sheath of the flexible shaft may be removed.

This 510k provides instructions to the end user on how to remove the outer extrusion and distal handle to create a configuration that has an outer diameter less than 2.00 mm. The instrument may be used to access target tissue directly, e.q. in open surgical procedures, or, with the handle and outer sheath removed, through a compatible trocar in minimally invasive procedures. The antenna couples microwave energy to target tissue when AB1 is powered by the Creo Electrosurqical System. 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 is a 510(k) summary for a medical device (Creo Electrosurgical System with AB1 Instrument). It describes a change to the Indications For Use (IFU) of an already cleared device, specifically allowing the removal of an outer sheath and distal handle to enable use with a compatible trocar in minimally invasive procedures.

This document does not describe an AI/ML-based device or a study involving human readers and AI assistance for diagnostic purposes. Therefore, most of the requested information (such as acceptance criteria for AI performance, sample size for AI test sets, expert ground truth establishment, MRMC studies, standalone AI performance, etc.) is not applicable to this submission.

The document focuses on demonstrating the safety and effectiveness of a modified configuration of an electrosurgical instrument for soft tissue ablation, predominantly through bench testing and preclinical evaluation, ensuring it is equivalent to the predicate device.

However, I can extract the information related to the device performance data based on the context of the document, even though it's not an AI/ML study.

Here's a breakdown of the available information:

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

The document lists performance tests conducted to address the change in labeling. It doesn't present a formal table of acceptance criteria with corresponding performance data, but rather a list of tests and a general conclusion.

Overall Conclusion on Performance: "The results of the tests conducted and leveraged demonstrate that the AB1 instrument in the proposed configuration with outer sheath and distal handle removed meets all design specifications and applicable medical device standard requirements, and that it is substantially equivalent to the predicate AB1 instrument with the handle and outer sheath in place."

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

• Sample Size: Not specified for individual bench or preclinical tests. The document generically refers to "tests conducted". For the "Preclinical evaluation of safety and performance in a pig model", the sample size (number of pigs) is not provided.
• Data Provenance: Not explicitly stated for each test. The sponsor, Creo Medical Ltd., is based in the United Kingdom, so some testing might have occurred there. The preclinical study type would be prospective.

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. This summary is for an electrosurgical instrument, not an AI/ML-based diagnostic device where expert ground truth for interpretation would be established. The "ground truth" for this device's performance would be engineering specifications, material properties, and biological effects (ablation size/shape, safety in animal models).

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

• Not applicable. This refers to a process typically used in AI/ML performance evaluation where multiple human readers contribute to a consensus ground truth. The tests performed here are primarily objective engineering and preclinical evaluations.

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

• No. An MRMC study is not relevant to an electrosurgical cutting and coagulation device. This document is not describing an AI-assisted diagnostic or therapeutic system.

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

• No. This is not an algorithm-based device. The "performance" being evaluated is the physical and functional characteristics of the electrosurgical instrument itself.

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

• For the performance tests, the "ground truth" would be:
  • Engineering Specifications: For mechanical tests (tensile, bending, insertion/retraction), and electrical tests (VNA, electrical safety).
  • Defined Ablation Characteristics: For ex-vivo tissue comparisons (ablation dimensions).
  • Physiological/Histopathological Observation: For the preclinical pig model, assessing safety (e.g., lack of unintended damage) and efficacy (e.g., successful ablation).
  • Usability Standards: For usability engineering validation.

8. The sample size for the training set

• Not applicable. This device is an electrosurgical instrument, not an AI/ML model. There is no training set in the AI/ML sense.

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

• Not applicable. As above, there is no AI/ML training set.

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