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510(k) Data Aggregation
(171 days)
This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
This flexible, self-expanding stent is constructed of nitinol wire. The total length of the stent is indicated by radiopaque markers on the inner catheter, indicating the actual length of the stent at nominal stent diameter. The stent has flanges at both stent ends. The stent is provided with a body diameter of 25mm and flange diameters of 30mm and is provided in three lengths 6cm, 8cm and 10cm. The stent is mounted on an inner catheter, which accepts a 0.035 inch wire guide and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or recapture. The introducer system diameter is 10 Fr and working length is 230cm.
The provided text describes the Cook Ireland Evolution® Colonic Stent System and its performance testing. However, it does not explicitly define acceptance criteria in a quantifiable manner, nor does it present the study results in a way that directly maps to specific performance metrics with clear pass/fail thresholds. The information provided is more descriptive of the types of tests conducted and the general outcomes.
Therefore, I will extract relevant information that implies acceptance criteria and describe the study in the best way possible given the available text.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Bench Testing: | |
| Deployment Functionality | "deployment testing was successfully completed." "Results of the testing provide reasonable assurance that the Evolution® Colonic Stent System will function as intended." |
| Expansion Force | "expansion force testing was successfully completed." |
| Compression Force | "compression force testing was successfully completed." |
| Dimensional Accuracy | "dimensional testing was successfully completed." |
| Corrosion Resistance | "corrosion testing was successfully completed." |
| Tensile Strength | "tensile strength testing was successfully completed." |
| MRI Compatibility | "MRI testing was successfully completed." |
| Biocompatibility | "Biocompatibility testing in compliance with ISO 10993-1 and FDA's Guidance... supports the safety of the Evolution® Colonic Stent." |
| Clinical Performance: | |
| Technical Success | "The data demonstrate acceptable technical success... were achieved." |
| Clinical Success | "The data demonstrate acceptable... clinical success... were achieved." |
| Acute Procedural Success | "The data demonstrate acceptable... acute procedural success were achieved." |
| Symptom Relief | "The data demonstrate acceptable... symptom relief." |
| Absence of Device Malfunction Related Adverse Events | "Importantly, no adverse events were associated with device malfunction." |
| Absence of Device Complication Related Deaths | "no deaths were considered to be caused by a device complication." |
Important Note: The document states that the bench testing was "successfully completed" and provided "reasonable assurance" and that clinical data demonstrated "acceptable" levels of success. This suggests that certain pre-defined thresholds were met, but the specific numerical acceptance criteria (e.g., a specific percentage for technical success or a specific force measurement range) are not explicitly stated in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 80 patients
- Data Provenance: The study was a "registry study," implying real-world data collection, but no specific country of origin is mentioned beyond "Cook Ireland Ltd" being the manufacturer. It's prospective in the sense that data was collected during the use of the device in these patients with follow-up, suggesting it's not purely retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given text.
4. Adjudication Method for the Test Set:
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:
This information is not applicable as the device is a physical medical stent, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable as the device is a physical medical stent, not an AI algorithm.
7. The Type of Ground Truth Used:
For the clinical study, the "ground truth" was established by clinical observation and assessment of patient outcomes. This included:
- Technical success of the stent placement.
- Clinical success in achieving palliation or relief of obstruction.
- Acute procedural success.
- Symptom relief.
- Reporting and assessment of adverse events (perforation, migration, obstruction, and their association with device malfunction or complication).
8. The Sample Size for the Training Set:
This concept is not applicable to this type of device and study. The "training set" is generally used for machine learning models, which is not what is being described here. The clinical study involved 80 patients who received the device, and their outcomes informed its effectiveness.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no "training set" in the context of an AI/algorithm. For the clinical study, the "ground truth" (i.e., the actual clinical outcomes and adverse events) was established through direct patient follow-up and medical assessment.
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