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510(k) Data Aggregation
(304 days)
Well Care (Wuhan) Medical Technology Co., Ltd
WellCare Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.
WellCare Anoscope is composed of Anoscope, Introducer and Sleeve.The anoscopes are divided into the following models according to the way the components are configured and the differences in size : WellCare-ANO-Light Sterile . WellCare-ANO-Truncated Sterile.This is a single use, disposable device(s), provided sterile.
The provided text describes the regulatory clearance of the WellCare Anoscope by the FDA, primarily relying on non-clinical (bench) testing. There is no information about any study that proves the device meets specific performance criteria related to AI or human-in-the-loop performance. The device described is a physical medical instrument, an anoscope, not a software or AI-driven diagnostic tool. Therefore, many of the requested details, such as those pertaining to AI assistance, ground truth establishment, expert qualifications, adjudication methods, and training/test set sizes for AI, are not applicable to this submission.
Here's the relevant information based on the provided text, focusing on the acceptance criteria and the non-clinical study conducted for the WellCare Anoscope:
1. A table of acceptance criteria and the reported device performance
| ID# | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1 | Appearance | Smooth surface of all parts, no sharp edges, no burrs. | Pass |
| 2.1 | Compatibility | The anal expander and the guide mirror opened and closed easily with the scope, without swing and jam. The end of the anal expander should be smooth and anastomosed with the endoscope, and the maximum gap should not be greater than 0.6mm. | Pass |
| 2.2 | Material strength | Any of the components (excluding the light source) should be able to withstand a 4 kg suspension without significant deformation. | Pass |
| 3.1 | Reducing substances (oxide prone) | The difference in the volume of potassium permanganate solution [ c(1/5KMnO4) = 0.01 mol/L ] consumed by the test solution and the blank control solution should not exceed 2.0 mL. | 0.4ml |
| 3.2 | pH | The difference between the pH of the test solution and that of the blank control solution should not exceed 1.5. | 1.01 |
| 3.3 | EO/ECH residues | Average daily dose to patient: EO |
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