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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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The NP1 MicroBlate Fine Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.

The NP1 MicroBlate Fine Instrument is not intended for use in cardiac procedures.

The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for coagulation (ablation) of soft tissue.

The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical HS1 SlypSeal Instrument, intended for coagulation (hemostasis and cauterization) of soft tissue.

The Electrosurgical Generator provides microwave (MW) and radiofrequency (RF) energy to the compatible Creo Medical RS2 Speedboat Instrument, intended for coagulation (hemostasis and cauterization) and cutting soft tissue.

The Electrosurgical System is not intended for use in cardiac procedures.

The Creo Medical Electrosurgical System with NP1 Instrument includes the following:

• . NP1 Instrument
• . Electrosurgical 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 tissue. Only the microwave output is used to power the NP1 Instrument. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cutting (not active for use of NP1); the other pedal activates the MW enerqy output for coaqulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.

The single-use Interface Cable provides a conductive pathway between compatible Creo electrosurgical instruments and the output of the Electrosurgical Generator and is supplied with a sterile sheath that is fitted over the cable's distal end during use to minimize the potential for contamination of the sterile field.

The sterile, single-use NP1 soft tissue ablation instrument consists of a handle, 1.6 m long x 2.7 mm diameter flexible shaft, active nitinol antenna and pointed ceramic tip. Bipolar electrodes separated by dielectric materials couple microwave energy to target tissue when NP1 is activated. NP1 is only compatible for use with the Creo Medical Electrosurgical System, and the System is only intended for use with compatible Creo instruments and accessories.

The provided document does not contain acceptance criteria or a study demonstrating device performance against such criteria in the context of typical AI/ML device evaluations. This document is a 510(k) premarket notification for a medical device (electrosurgical system) and focuses on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and the removal of a specific contraindication for transluminal use.

Therefore, I cannot provide the requested information for an AI/ML context because the document does not discuss an AI/ML device, its performance metrics, or related studies like sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

The "Performance Data" section explicitly states: "No bench or clinical data were required to demonstrate substantial equivalence with the predicate device or to justify the elimination of the contraindication for transluminal use from the NP1 instrument IFU." It does mention a preclinical study in a porcine model to demonstrate transluminal navigation and ablation, but this is not presented as meeting specific, measurable acceptance criteria in the format requested for AI/ML performance.

In summary, the information you requested is not present in the provided document as it pertains to a different type of device clearance rather than an AI/ML device performance evaluation.

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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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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 NP1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.

The NP1 Instrument is not intended for use in cardiac procedures.

The Creo Medical Electrosurgical System with NP1 Accessory includes the following:

• . NP1 Instrument
• . Electrosurgical 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 tissue. Only the microwave output is used to power the NP1 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 Medical 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 NP1 soft tissue ablation accessory (Instrument) consists of a handle, 1.4 m long x 2.7 mm diameter shaft, active nitinol antenna and pointed ceramic tip. Stainless-steel bipolar electrodes separated by dielectric materials couple microwave energy to target tissue when NP1 is in use. NP1 is only compatible for use with the Creo Medical Electrosurgical System, and the System is only intended for use with compatible Creo instruments and accessories.

I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for the Creo Medical Electrosurgical System with NP1 Accessory does not contain the specific information required to answer your request.

The document is a notification of substantial equivalence for a medical device, and while it mentions performance testing, it does not include:

1. A table of acceptance criteria and reported device performance related to a specific study. It broadly states, "The system meets all design specifications, risk mitigation requirements, and applicable medical device standard requirements." and references "Results of mechanical and ablation performance tests, including bench tests and simulated use studies conducted in ex-vivo tissue, demonstrate that the NP1 Electrosurgical System meets design specifications and performs as intended." but no specifics.
2. Sample sizes used for a test set or data provenance for specific performance studies. It mentions "simulated use studies conducted in ex-vivo muscle, liver, and kidney tissue" but does not give sample sizes or specific data provenance beyond being ex-vivo tissue.
3. Number of experts used or their qualifications for establishing ground truth. This information is entirely absent for any performance claims.
4. Adjudication method for a test set. Not mentioned.
5. Details about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size. This type of study is not described or referenced.
6. Details about a standalone (algorithm only) performance study. The device is an electrosurgical system, not an AI algorithm, so this concept does not apply in the typical sense of AI/ML software. Its performance is tied to its physical operation and effect on tissue.
7. The type of ground truth used (e.g., pathology, outcomes data). For the ablation studies, it implies the "ablation volumes created" as a measure of performance, but it doesn't describe who established this ground truth or how precisely it was measured in terms of a clinical "ground truth."
8. The sample size for a training set. As this is a hardware device with embedded software for control, not a machine learning model, the concept of a "training set" for an AI algorithm is not applicable here. The software verification and validation are mentioned but not in the context of a machine learning training set.
9. How the ground truth for the training set was established. Not applicable for the reasons above.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of technological characteristics.
• Compliance with electrical safety, EMC, and biocompatibility standards.
• Software verification and validation (for control software, not AI/ML).
• Bench testing and simulated use testing to show the system meets design specifications and performs as intended.

Therefore, I cannot extract the requested information from the provided text.

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The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories.

The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:

• · Peptic Ulcers
• · Dieulafoy Lesions
• · Mallory-Weiss Tears
• · Bleeding Polyp Stalks
• · Arteriovenous Malformations (AVMs)
• · Angiomata

The HS1 also has irrigation capability. Any other use is not recommended.

The Creo Medical Electrosurgical System with HS1 hemostasis accessory comprises of the following:

• . HS1 hemostasis surgical accessory
• . Electrosurgical Generator
• Footswitch
• Interface Cable

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

The Interface Cable connects electrosurgical instruments to the Electrosurgical Generator and is for single-use and is supplied with a sterile sheath that is fitted over its distal end during connection to the surgical accessory.

HS1 is an electrosurgical hemostasis accessory for use with the Creo Medical Electrosurgical Generator only. HS1 is for endoscopic use and provides coagulation and injection of fluids incorporated in a single device. HS1 is for single-use only and provided sterile.

This submission describes the Creo Electrosurgical System with HS1 Hemostasis Accessory. The device is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, primarily for endoscopic electrohemostasis in the gastrointestinal tract.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail format typical for AI/ML device submissions. Instead, it details performance testing to demonstrate substantial equivalence to predicate devices. The performance aspects tested are related to the device's functional characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for each type of bench, ex-vivo, or in-vivo test.

• Data Provenance: The studies include "bench testing," "ex-vivo," and "in-vivo" tests. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though in-vivo studies are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a electrosurgical device, "ground truth" might refer to histological analysis of tissue effects or clinical outcomes. The document does not mention the use of experts for establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method, such as 2+1 or 3+1, which is typically relevant for studies involving human interpretation or subjective assessments. For objective performance metrics like thermal spread or mechanical durability, such methods are not usually applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is an electrosurgical system, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers. Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device incorporates "proprietary software developed by Creo Medical for generating and controlling the two energies delivered," the submission focuses on the performance of the integrated electrosurgical system (hardware + software). There is no mention of a standalone algorithm performance study independent of the physical device or a human operator. The system itself is the "standalone" entity whose performance is being evaluated.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for evaluation involved:

• Physical Measurements/Observations: For bench testing of coagulation (penetration and spread of thermal effects), injection flowrate, durability, sharpness, and tensile strength.
• Standard Compliance: Adherence to electrical safety (IEC 60601), EMC (IEC 60601), biocompatibility (ISO 10993), and sterility (ISO 11135) standards.
• Clinical/Biological Equivalence: Demonstrated through ex-vivo and in-vivo tests (though specific metrics for "ground truth" here are not detailed, they would likely involve histological analysis or observable clinical effects in tissue).

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of this device submission. This is a medical device (electrosurgical system), not an AI/ML diagnostic or predictive algorithm that typically undergoes a training phase with a distinct training set of data. The "proprietary software" controls energy delivery but isn't described as a machine learning model trained on a dataset.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a specific "training set" for an AI/ML algorithm in this submission, this information is not applicable. The "ground truth" for the device's design and engineering would have been established through established physics, electrical engineering principles, surgical practice, and regulatory standards.

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