(29 days)
The Polypectomy Snares are used endoscopically in the removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.
This document focuses on the Boston Scientific Polypectomy Snares and describes the in-vitro testing performed to demonstrate substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria related to a specific clinical outcome or a multi-reader multi-case study with human readers and AI. The performance data presented is limited to technical specifications of the device itself.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Loop Extension Functionality | Met required specifications during in-vitro testing. |
| Loop Retraction Functionality | Met required specifications during in-vitro testing. |
| Cable to Handle Tensile | Met required specifications during in-vitro testing. |
| Active Cord Compatibility | Met required specifications during in-vitro testing. |
| Active Cord Attachment | Met required specifications during in-vitro testing. |
| Loop Width | Met required specifications during in-vitro testing. |
| Electrical Resistance | Met required specifications during in-vitro testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for individual tests. The document states "all components, subassemblies, and/or full devices met the required specifications," implying that an appropriate number of samples were tested for each characteristic, but the exact count is not given.
- Data Provenance: The testing was "in-vitro," meaning it was conducted in a laboratory setting, not on human subjects. There is no information about country of origin, retrospective or prospective nature as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Not applicable. This device's performance was evaluated through engineering and functional testing (in-vitro), not requiring expert-established ground truth related to medical diagnoses or interpretations.
4. Adjudication Method
- Not applicable. As noted above, this was a technical performance study, not a clinical trial requiring adjudication of patient cases.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes in-vitro engineering tests for device functionality, not a clinical study involving human readers or AI assistance.
6. Standalone Performance Study (Algorithm Only)
- No, a standalone study (algorithm only without human-in-the-loop performance) was not done. This device is a physical medical instrument (polypectomy snare), not an AI algorithm.
7. Type of Ground Truth Used
- The "ground truth" for the in-vitro performance tests was based on established engineering specifications and requirements for mechanical, electrical, and functional performance of the polypectomy snare.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment method.
§ 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).