(48 days)
Intended for use in the cutting of soft tissue using radiofrequency current, the coagulation (hemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
The Creo Medical Electrosurgical System comprises: Speedboat RS2 surgical instrument (7-RS2-001), Electrosurgical Generator (7-EMR-050), Footswitch (2-EMR-032), Interface Cable (7-RS2-210). The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave 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 microwave 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. Speedboat RS2 is an electrosurgical instrument for use with the Creo Medical Electrosurgical Generator only. Speedboat RS2 is for endoscopic use and provides cutting, coagulation and injection of fluids incorporated in a single device. Speedboat RS2 is for single-use only and provided sterile.
This document describes the premarket notification (510(k)) for the Creo Medical Electrosurgical System, including the Speedboat RS2 surgical accessory. This device is intended for electrosurgical procedures within the gastrointestinal tract, specifically for cutting soft tissue using radiofrequency (RF) current, coagulating soft tissue using microwave energy, and delivering/injecting solutions.
Based on the provided text, the submission relies heavily on bench testing and compliance with existing medical device standards rather than clinical studies with human participants or a detailed AI model evaluation. Therefore, many of the requested elements for an AI-based device acceptance criteria and study cannot be fully addressed.
Here's the information that can be extracted or inferred:
Acceptance Criteria and Device Performance
The document states that the system "meets all design specifications, design-risk analysis, and medical device standards." When discussing differences between the subject device and predicate devices, the "Performance Testing" column serves as an implicit acceptance criterion, with the reported device performance being "substantial equivalence with the predicate device" in relevant areas.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Cutting Performance (Energy) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Cutting Performance (Distal Tip Design) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Coagulation Performance (Energy) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Coagulation Performance (Distal Tip Design) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Biocompatibility | "Meets all relevant requirements of ISO10993." (Performance data also states, "The mechanical, cut, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices.") |
| Electrical Safety and EMC | "Meets... medical device standards for electrical safety and EMC (IEC 60601)." |
| Sterility | "Meets... medical device standards for... sterility (ISO 11135)." |
| Mechanical, Cut, Coagulation and Injection Performance (Overall) | "The mechanical, cut, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices." (This appears to be an overarching summary of the performance.) The statement also notes: "The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered." |
Study Details for Acceptance Criteria Proof
Based on the provided document, the "study" demonstrating the device meets acceptance criteria is primarily a series of bench tests and compliance checks against established standards. The information provided does not indicate a clinical study with human patients for AI performance evaluation.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "bench testing" explicitly. It refers to "gastrointestinal tissue" for thermal effects comparisons. It also mentions "ex-vivo and in-vivo" testing, but no specific numbers for samples or cases are provided.
- Data Provenance: The bench testing and "ex-vivo and in-vivo" tests were conducted by Creo Medical Ltd. The country of origin of the data is not explicitly stated beyond Creo Medical's location in the United Kingdom. It is considered prospective for the purpose of this submission, as it was conducted to support the 510(k).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The assessment relies on measurements of physical effects (penetration, thermal spread) and compliance with standards, rather than expert interpretation of images or other subjective data. If experts were involved in interpreting histological samples from the ex-vivo/in-vivo tests, their number and qualifications are not disclosed.
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Adjudication method for the test set:
- This information is not provided. Given the nature of bench testing and comparing physical effects, a formal adjudication method (like 2+1, 3+1 for expert review) is not typically applicable in the same way it would be for diagnostic AI.
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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 conducted. This device is an electrosurgical system, not a diagnostic AI system intended to assist human readers in interpreting medical images or data. The "AI" mentioned is proprietary software controlling energy delivery, not an AI for diagnostic assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "performance" described refers to the physical effects of the electrosurgical device as controlled by its internal software. In essence, the "algorithm only" performance (referring to the control software) is what was tested through the bench and ex-vivo/in-vivo studies to ensure it produced the desired energy outputs and tissue effects. There is no separate "standalone" performance in the context of an AI diagnostic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" seems to be physical measurements of parameters like penetration depth and spread of thermal effects in tissue, likely compared against established safe and effective ranges or the performance of predicate devices. For biocompatibility, electrical safety, and sterility, the ground truth is adherence to specified international standards (ISO 10993, IEC 60601, ISO 11135).
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The sample size for the training set:
- The document mentions that the Electrosurgical Generator incorporates "proprietary software developed by Creo Medical for generating and controlling the two energies delivered." This is control software, not explicitly described as a machine learning/AI model that undergoes "training" in the conventional sense. Therefore, a "training set" for such a system would not be applicable or described in this type of submission.
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How the ground truth for the training set was established:
- As there is no described training set for an AI model, this question is not applicable. The control software functionality would have been developed and validated through traditional software engineering and testing processes, likely using design specifications as the "ground truth" for its correct operation.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).