(179 days)
This device is used to dilate strictures in the pancreatobiliary systems and to dilate openings via the transgastric or transduodenal wall. This device is indicated for adult use only.
The Tornus ES is a rotary-operated dilator designed for use in bile duct/pancreatic duct strictures and via transgastric/transduodenal dilation of openings. The Tornus ES is comprised of stainless-steel coils and polymeric materials. The Dilation and Shaft segments are composed of coils materials that are welded together. The Tornus ES is available for prescription use only.
The provided text describes the performance data for the Tornus ES device, specifically focusing on non-clinical testing and biocompatibility assessments. It does not detail a study involving human subjects or AI assistance, which would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader performance metrics. Therefore, several points of your request cannot be fulfilled as they are not applicable to the information provided.
Based on the provided text, primarily pages 8 and 9, here's the information regarding the device's acceptance criteria and the study that proves it meets those criteria:
1. A table of acceptance criteria and the reported device performance
The document provides acceptance criteria specifically for biocompatibility testing, and a general "Pass" for non-clinical performance tests.
Table 1: Non-Clinical Testing Performance
| Test Item | Reported Device Performance |
|---|---|
| Appearance | Pass |
| Tensile strength | Pass |
| Guidewire pass-through ability | Pass |
| Dilation ability | Pass |
| Slide durability | Pass |
| Radio-detectability | Pass |
| Corrosion resistance | Pass |
| Polyurethane strength | Pass |
| Guide wire trackability | Pass |
| Kink resistance | Pass |
| Dimension measurement | Pass |
| Simulated use and (torsional strength) | Pass |
Table 2: Biocompatibility Testing Acceptance Criteria and Results
| Test Method | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity MEM Elution Test | ISO 10993-5 (No deviations) | The test system is considered suitable if no signs of cellular reactivity (Grade 0) are noted for both the negative control article and the medium control. | Non-cytotoxic |
| Sensitization KLIGMAN Maximization Test | ISO 10993-10 (No deviations) | The extracts should show no evidence of causing delayed dermal contact sensitization in the guinea pig. | Non-Sensitizing |
| Irritation Intracutaneous Injection Test | ISO 10993-10 (No deviations) | The test extract and the negative control must exhibit similar edema and erythema scores. | Non-Irritant |
| Systemic Toxicity Acute System Toxicity Test | ISO 10993-11 (No deviations) | The test article must not show significantly greater biological activity than the control. | Non-toxic |
| Systemic Toxicity Rabbit Pyrogen Test (material mediated) | ISO 10993-11 (No deviations) | The test article should not increase the rectal temperature of any of the animals by more than 0.5 degrees Celsius. | Non-pyrogenic |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Non clinical laboratory testing" and "in vitro bench tests". This indicates that the testing was performed on units of the device itself and not on patient data. No specific sample sizes for these tests are provided, nor is the country of origin of the data or whether it was retrospective or prospective, as these terms are generally applicable to clinical trials or studies involving patient data, which is not the case here.
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 testing was non-clinical and benchtop, not requiring human expert interpretation or ground truth establishment in the context of imaging or clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication of ground truth in clinical data, not bench testing.
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 document describes a medical device (a catheter) and its non-clinical performance and biocompatibility. It does not involve AI or human image readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards established for the device. For biocompatibility, the ground truth is established by the methods and criteria defined in the ISO 10993 series of standards.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.