(266 days)
The SpydrBlade Flex Instrument is indicated for use in the cutting (incision, dissection, avulsion) of soft tissue using radiofrequency energy and the coagulation (hemostasis, cauterization, arrest of bleeding) of soft tissue using microwave energy in the gastrointestinal tract as required or encountered in endoscopic procedures.
The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.
The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
The Creo Medical electrosurgical system comprises of the CROMA electrosurgical generator, an interface cable accessory and a footswitch accessory, and a compatible electrosurgical instrument.
The CROMA electrosurgical generator comprises two distinct energy sources for the independent generation of bipolar radiofrequency (RF) current at 400 kHz and microwave (MW) current at 5.8 GHz.
Both energy sources are delivered through the same output coaxial connector. These generator outputs are controlled in terms of voltage, power, current, duty cycle, and duration by means of widely used and long-established design and engineering techniques. Via these controls and system design, only one energy source can be delivered to the output coaxial connector at any one time.
The compatible electrosurgical instrument that is subject of this submission is SpydrBlade Flex. The subject and predicate devices use the same electrosurgical generator, footswitch, and interface cable.
SpydrBlade Flex is a single-use, sterile endoscopic electrosurgical instrument used for procedures in the gastrointestinal (GI) tract. The product is sterilized using Ethylene Oxide.
SpydrBlade Flex is intended for use in endoscopes with a minimum working channel of 3.2 mm and maximum working length of 1.35 m.
SpydrBlade Flex incorporates a distal tip, a shaft, and a handle. The distal tip includes a jaws assembly that consists of two gold-plated ceramic bipolar antennas, each soldered to a stainless-steel base. The stainless-steel bases are joined in a manner to provide a mechanical opening and closing function. The bipolar antennas deliver RF energy for cutting and MW energy for coagulation, in the same manner as the predicate Speedboat SB1. The cutting and coagulation functions are performed regardless of the jaw mechanism and can be provided with the jaws open or closed. The jaw mechanism provides a grasping function for easier tissue manipulation between and during energy applications.
The subject and predicate devices are composed of the same technological components with the same principles of operation related to the energy function:
- Cutting of mucosa, sub-mucosa, muscle using bipolar RF energy,
- Thermal coagulation of mucosa and/or sub-mucosa, muscle, vascular and arterial structures using MW energy.
The provided FDA 510(k) clearance letter pertains to the SpydrBlade Flex Instrument (PRD-RG1-001), an endoscopic electrosurgical unit and accessories. However, the document does not contain information related to software-based AI performance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth by expert consensus for diagnostic purposes.
The information requested in the prompt, such as acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets, number and qualifications of experts for ground truth, adjudication methods, and training set details, are typically associated with the clearance of AI-powered diagnostic devices.
The SpydrBlade Flex Instrument, as described in this 510(k) summary, is a surgical instrument that uses RF and MW energy for cutting and coagulation of soft tissue. The "Software Verification and Validation" section likely refers to the embedded software controlling the electrosurgical generator and instrument functions, ensuring its proper operation and safety, rather than an AI analyzing medical images or data for diagnostic purposes.
Therefore, I cannot provide a table of acceptance criteria and reported device performance for AI, nor can I elaborate on sample sizes, ground truth establishment, or human-in-the-loop performance studies, as this information is not present in the provided document for this specific device.
The document primarily focuses on:
- Substantial Equivalence: Comparing the SpydrBlade Flex Instrument to a predicate device (Speedboat Flush SB1 Instrument) based on indications for use, technological characteristics (design, materials, principles of operation), and safety/performance testing.
- Non-Clinical Testing: Sterilization, biocompatibility, electrical safety, microwave safety, electromagnetic compatibility, and software verification/validation.
- Bench Tests: Confirming that the device meets design verification and validation criteria and performs equivalently to the predicate device.
Key takeaway for your request: This document describes the clearance of a medical device (an electrosurgical instrument) that does not appear to involve AI for diagnostic purposes, hence the absence of the detailed AI-related study information you are seeking.
§ 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).