(267 days)
This device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.
The subject device consists of a handle section, a sheath section. The snare head section. The snare head section is inserted into the sheath section and is extended and retracted by operating the three-ring handle section.
The sheath section and the snare head section are inserted in the gastrointestinal tract through an endoscope. The snare head is extended from the sheath to resect target polyps. This resection is performed with high-frequency current.
This document is a 510(k) premarket notification for the AcuSnare Polypectomy Snare. It's not a study report that includes typical acceptance criteria and performance data for AI/ML devices. Instead, it demonstrates substantial equivalence to predicate devices for a conventional medical device. Therefore, I cannot extract the information requested as it is not present in the provided text.
Here is why your specific information requests cannot be fulfilled:
- A table of acceptance criteria and the reported device performance: This document doesn't define acceptance criteria in terms of a study's statistical endpoints (e.g., sensitivity, specificity, AUC) or report quantitative performance metrics like a standalone AI/ML study would. The acceptance criteria for this device are implicitly tied to demonstrating that it performs as intended and is as safe and effective as the predicate devices through non-clinical testing.
- Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this type of device. The testing described is non-clinical (e.g., tensile strength, shelf life).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review is mentioned, as this is not an AI/ML diagnostic or prognostic device.
- Adjudication method: Not applicable for the reasons above.
- 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 is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. This is not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
Instead, the document focuses on comparing the AcuSnare Polypectomy Snare to existing predicate devices based on:
- Intended Use: The device is used endoscopically for the removal and cauterization of sessile and pedunculated polyps from the gastrointestinal tract. This is compared to the predicate devices' stated uses.
- Technological Characteristics: Comparison of physical attributes like configuration, snare material, sheath material, handle material, length, FR size, sterility, sterilization method, reusability, and compatibility with electrosurgical units.
- Non-Clinical Testing: A list of tests performed to demonstrate the device's performance and safety, including:
- Shelf Life Testing
- Package Integrity Testing
- Tensile tests (snare to catheter, catheter to handle, snare head to drive cable joint, snare wire to cannula joint, handle/cannula/drive cable joint, pin to handle joint)
- IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18 standards compliance (related to electrical safety for electrosurgical equipment)
- Biocompatibility testing (ISO 10993-1)
The "study" that proves the device meets acceptance criteria, in this context, refers to the non-clinical testing summarized in {5} and the comparison to predicate devices in {4}. The acceptance criteria are implicitly met if these tests show performance equivalent to or better than the predicate devices, and that the device is safe and effective for its stated intended use. The document concludes that the modifications to the subject device have been adequately addressed through Design Control Processes and do not affect the safety or effectiveness.
§ 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).