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510(k) Data Aggregation
(304 days)
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 < 4 mg, ECH < 9mg. | Pass |
| 3.4 | Sterile | WellCare Anoscope should be sterile. | Pass |
| 4.1 | In Vitro Cytotoxicity | Non-cytotoxic. | Pass |
| 4.2 | Skin Sensitization Test | Non-sensitizer. | Pass |
| 4.3 | Acute Systemic Toxicity Test | No systemic toxicity. | Pass |
| 4.4 | Pyrogen Test | Non-pyrogen. | Pass |
| 4.5 | Irritation Test | Non-Irritation. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The text states "Take 1 set of samples" for compatibility and material strength testing. Specific numbers for other tests (Appearance, Chemical Testing, Biocompatibility) are not explicitly provided, but these are typically batch-based tests on representative samples.
- Data Provenance: Not specified, but generally, these are laboratory bench tests conducted by the manufacturer (Well Care (Wuhan) Medical Technology Co., Ltd. in Wuhan, Hubei, China). These are prospective tests during device development and verification.
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 performance testing described is for physical, chemical, and biological characteristics of a medical device, not for diagnostic accuracy requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require 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
Not applicable. This device is a physical anoscope, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on established engineering standards, material science properties, chemical analysis, and biological safety testing protocols. For example:
- Physical tests: Engineering specifications (e.g., gap tolerance, deformation under load).
- Chemical tests: Analytical chemistry principles (e.g., KMnO4 titration, pH measurement).
- Biocompatibility tests: Recognized international standards (ISO 10993 series) for evaluating biological responses to medical devices.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning product and does not involve training data.
9. How the ground truth for the training set was established
Not applicable.
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