(149 days)
This device is intended for endoscopic placement of a preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. This device is supplied sterile and intended for single use only.
The Marathon Stent with Fusion Technology is designed to place its preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. A soft sock is attached to the proximal end of a traditional biliary stent that reduces duodenal content reflux without compromising antegrade flow. The stent is 10 Fr and will be offered in variable lengths of 5, 7, 9 and 12 cm between the flaps.
Here's a breakdown of the acceptance criteria and the study details for the Marathon Stent with Fusion Technology, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria with specific threshold values for the performance of the Marathon Stent. Instead, the "Performance Data" section describes categories of non-clinical testing performed and the overall finding of a clinical study. The acceptance criteria appear to be implicit in demonstrating equivalence to predicate devices and verifying safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-Clinical Performance: | |
| - Equivalence to predicate devices | Non-clinical testing was carried out to determine the equivalence of the Marathon Stent with Fusion Technology to the predicate devices. |
| - Safety and effectiveness verification | Non-clinical testing was carried out to verify the safety and effectiveness of the stent. |
| - Endoscope and wire guide compatibility | Verification carried out. |
| - Stent deployment validation | Validation carried out. |
| - Sock to stent security | Testing carried out. |
| - Antegrade flow (with simulated bile) | Testing carried out. |
| - Retrograde flow | Testing carried out. |
| Clinical Performance: | |
| - Effectiveness compared to standard plastic stent | A prospective, randomized clinical study showed that the Marathon Stent with Fusion Technology was as effective as a standard plastic stent. |
| - Safety (no new or increased risks vs. similar devices) | The clinical study indicated no new or increased risks related to safety and effectiveness were likely to be raised when compared to risks experienced with similar marketed devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document simply states "Clinical data in support of the claim of substantial equivalence... has been collected and presented within this submission." It does not specify the exact sample size for the clinical study.
- Data Provenance: The clinical study was described as prospective and randomized. The country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not mention using experts to establish ground truth for the test set. The clinical study likely relied on standard clinical endpoints and assessments for effectiveness and safety, rather than expert interpretation of images or other data requiring "ground truth" establishment in the context of AI/diagnostic device evaluation.
4. Adjudication Method for the Test Set
As there's no mention of experts establishing ground truth or needing consensus on diagnoses, no adjudication method (like 2+1 or 3+1) is described or appears to have been used in the context of an AI/diagnostic device. The clinical study was a prospective, randomized comparison to a standard plastic stent, suggesting direct clinical outcomes were assessed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted. The study described is a clinical trial comparing the new stent to a standard plastic stent, not an evaluation of human readers with or without AI assistance. Therefore, there is no mention of the effect size of how much human readers improve with AI vs. without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a physical medical device (a stent), not a software algorithm or diagnostic tool. Therefore, the concept of "standalone performance" for an algorithm does not apply to this submission. The performance assessment relates to the physical and biological function of the stent itself.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" for assessing effectiveness and safety would have been derived from clinical outcomes data (e.g., successful drainage of obstructed biliary ducts, reduction of duodenal content reflux, incidence of adverse events, patency rates, etc.) collected as part of the prospective clinical trial.
8. The Sample Size for the Training Set
This submission is for a physical medical device. The concept of a "training set" is relevant for AI or machine learning models. Since this is not an AI/ML device, there is no training set in the traditional sense. The development of the stent would have involved engineering and design efforts, followed by non-clinical and clinical testing.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model for this device, this question is 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.