Search Results
Found 1 results
510(k) Data Aggregation
(29 days)
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
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.
Ask a specific question about this device
Page 1 of 1