(175 days)
The Polypectomy 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 Polypectomy 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 threering 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 PTFE 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.
The document provides a 510(k) summary for the "Rotatable Snares, Non-Rotatable Snares" device (Polypectomy Snare). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independent clinical performance studies. Therefore, much of the requested information regarding AI device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies is not applicable to this submission type and the provided documentation.
However, the document does contain information about performance testing to ensure the device meets specified criteria.
Here's a summary of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." A summary of the tests performed is provided, implying that the device successfully met the acceptance criteria for these tests. The specific quantitative acceptance criteria for each test are not detailed in this summary document, but the device is reported to have met them.
| 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 |
| EO residual and ECH residual (after sterilization) | Met criteria defined in ISO 11135 and ISO 10993-7 |
| Shelf-life (3 years) | Validated in accelerated testing (ASTM F1980-16) |
| Packaging | Met requirements of ISO 11607-1 and ISO 11607-2 |
| Biocompatibility (cytotoxicity, sensitization, intracutaneous irritation, system toxicity pyrogen, endotoxin) | Demonstrated biocompatibility (in accordance with ISO 10993-1) |
| Electromagnetic Compatibility and Electrical Safety | Performed in accordance to AAMI/ANSI ES 60601-1 and AAMI/ANSI/IEC 60601-2-2 |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the sample sizes used for each of the in-vitro performance tests. It only states that "all components, subassemblies, and/or full devices" underwent testing.
- Data Provenance: The tests are in-vitro, meaning they were performed in a lab setting. The country of origin of the data is not explicitly stated for each test, but the manufacturer is based in Hangzhou, Zhejiang, China. The data is retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable. The performance testing described is in-vitro engineering and biocompatibility testing, not clinical studies requiring expert ground truth for diagnostic or prognostic purposes.
4. Adjudication method for the test set
- This information is not applicable. The tests performed are objective measurements against predefined specifications, not subjective assessments requiring adjudication.
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
- This information is not applicable. The device is an endoscopic accessory (polypectomy snare), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable. The device is a physical medical instrument, not an algorithm, and therefore there is no standalone algorithm performance to evaluate.
7. The type of ground truth used
- The "ground truth" for the performance tests outlined (e.g., working length, tensile strength, electrical resistance, biocompatibility, sterilization residuals) is defined by established engineering specifications, international standards (ISO, ASTM, AAMI/ANSI), and regulatory guidance, rather than expert consensus, pathology, or outcomes data. For example, ISO 11135 defines acceptable EO residual levels.
8. The sample size for the training set
- This information is not applicable. The device is a physical medical instrument, not an AI model, and therefore there is no training set.
9. How the ground truth for the training set was established
- This information is not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.
§ 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).