(106 days)
The ArthroCare Monopolar Loop is indicated in patients requiring endoscopic soft tissue ablation and resection in general urological surgical procedures.
The ArthroCare Urologic Monopolar Electrosurgery Loop is a high frequency electrosurgical device intended for use in general urological surgery to resect soft tissue and provide hemostasis.
Acceptance Criteria and Study for ArthroCare Urologic Monopolar Electrosurgery Loop
This document describes the acceptance criteria and the supporting information for the ArthroCare Urologic Monopolar Electrosurgery Loop (K970526).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not specify quantitative acceptance criteria or detailed performance metrics from a formal study for the ArthroCare Urologic Monopolar Electrosurgery Loop. Instead, the device's clearance is based on its substantial equivalence to predicate devices already on the market. The implied acceptance criteria revolve around exhibiting similar functionality and safety profiles to these existing devices.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functionality | Resect soft tissue | "intended for use in general urological surgery to resect soft tissue" |
| Provide hemostasis | "provide hemostasis" | |
| Safety | Utilize safe materials | "materials used...are virtually identical to those used in the ArthroCare Arthroscopic Electrosurgery System (K943450)" |
| Materials comparable to predicate devices | "Predicate devices use either stainless, tungsten or titanium for the wire material of their electrosurgical electrodes" | |
| Equivalence | Substantially equivalent to existing devices | "By virtue of design, materials and function, the ArthroCare Urologic Monopolar Electrosurgery Loop is substantially equivalent to the predicate devices currently marketed in the United States." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific test set or a formal study with a defined sample size for the ArthroCare Urologic Monopolar Electrosurgery Loop. The clearance is based on substantial equivalence to existing predicate devices. Therefore, there is no direct information on sample size for a test set or data provenance (country of origin, retrospective/prospective) for a study of this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there was no specific test set described for this device, there is no information provided on the number or qualifications of experts used to establish ground truth. The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices based on their prior marketing and regulatory clearances.
4. Adjudication Method for the Test Set
Since no specific test set or study is described, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed, or at least not reported in the provided documents. The clearance is based on substantial equivalence, not a comparative effectiveness study against other devices or human performance.
6. Standalone (Algorithm Only) Performance Study
As this is a physical electrosurgical device and not an AI/algorithm-based product, a standalone (algorithm only) performance study was not applicable and therefore not performed/reported.
7. Type of Ground Truth Used
The "ground truth" for the clearance of this device is based on the established safety and effectiveness of predicate electrosurgical devices that have been marketed since the 1950s. This includes historical clinical use and regulatory clearances of devices manufactured by companies like Circon ACMI and Karl Storz, as well as more recent 510(k) clearances for monopolar loops and rollerball/barrel electrodes from manufacturers like ProSurge and Karl Storz-America, Inc.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI/machine learning model, the concept of a "training set" with a sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
Similarly, as there is no "training set," the concept of establishing ground truth for it is not applicable. The device's safety and effectiveness are established through demonstrating substantial equivalence to predicate devices, which gained their market clearance based on their own safety and effectiveness data (likely clinical experience and performance testing) at the time of their regulatory review.
§ 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).