(204 days)
The Articulating Snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope.
The Ethicon Endo Surgery Articulating Snare consists of a flexible wire cable and loop, which can be extended, rotated, articulated, and retracted from the flexible outer shaft using a three-finger actuator. It is passed through endoscopes having a 3.2 mm or larger working channels. When activated, the snare delivers a monopolar electrical current to cut and cauterize tissue within the loop. The device is supplied sterile for single-patient use.
The provided 510(k) summary for the Ethicon Endo Surgery Articulating Snare describes bench testing as the performance data used to demonstrate that the device performs as intended. It does not include information about clinical studies with human subjects, AI algorithms, or ground truth establishment relevant to those types of studies.
Therefore, many of the requested categories are not applicable to the information contained in the document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| AAMI HF 18, 2001: Electrosurgical Devices | Device was tested to demonstrate compliance and performs as intended. |
| IEC/EN 60601-2-2, 2000: Particular Requirements for the Safety of Endoscopic Equipment | Device was tested to demonstrate compliance and performs as intended. |
| IEC/EN 60601-2-18, 1996: Particular Requirements for the Safety of High Frequency of Surgical Equipment | Device was tested to demonstrate compliance and performs as intended. |
| ISO 10993-1 (Biocompatibility) | Device materials have been evaluated for biocompatibility and comply. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The performance data is based on bench testing of the device itself, not a test set of data from human subjects.
- Data Provenance: Not applicable, as this refers to bench testing of the device, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for a test set is not relevant for bench testing of device compliance with standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are not relevant for bench testing of device compliance with standards.
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
- No. This is a medical device (snare) and not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (snare) and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the bench testing was compliance with established industry standards (AAMI HF 18, IEC/EN 60601-2-2, IEC/EN 60601-2-18, and ISO 10993-1).
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This document describes a physical medical device.
§ 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).