(23 days)
The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
The Rotatable Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a three-ring handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is Polyglide™ coated to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.
This document is a 510(k) premarket notification for a medical device called "Rotatable Snares" from Boston Scientific Corporation. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and effectiveness via clinical studies with acceptance criteria in the same way one would for a novel device or a PMA.
Therefore, the specific information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test sets (in the context of clinical data), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not typically found or required in a 510(k) submission for a device like this, especially when the changes are related to ergonomic improvements and not a fundamental change in the intended use or technology.
However, I can extract the information provided regarding performance data from the document:
1. A table of acceptance criteria and the reported device performance
The document states that "In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." It then lists the tests performed. While specific numerical acceptance criteria and reported values are not provided in the summary, the conclusion is that the device met all specifications.
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Working Length | Met required specifications |
| Tortuous Path Functionality | Met required specifications |
| Rotation Capability | Met required specifications |
| Handle to Core Wire Tensile Strength | Met required specifications |
| Electrical Resistance | Met required specifications |
| Electrical Safety | Met required specifications |
| Snare Actuation | Met required specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes in-vitro testing, not clinical studies with patients. Therefore, the concept of sample size for a "test set" in the context of clinical data, country of origin, or retrospective/prospective data is not applicable here. The testing was performed on components, subassemblies, and/or full devices in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The tests performed are engineering/performance specification tests (e.g., electrical safety, tensile strength), not diagnostic or interpretative tasks requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements against predefined engineering specifications.
5. 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 for an endoscopic snare, not an imaging or AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for an endoscopic snare, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in-vitro testing, the "ground truth" would be the defined engineering specifications or performance standards for each test category (e.g., a specific tensile strength value, acceptable electrical resistance range, proper actuation of the snare).
8. The sample size for the training set
Not applicable. This document refers to in-vitro testing for an existing device with an ergonomic modification, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not a machine learning context.
§ 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).