(237 days)
The AXIOS™ Stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, and symptomatic Walled Off Necrosis ≥ 6 cm in size, that are adherent to the gastric or bowel wall. Once placed, the AXIOS™ Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The Stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled-Off Necrosis resolution.
The AXIOS™ Stent is a flexible, MR conditional, fully-covered, self-expanding braided nitinol stent, which comes preloaded into a delivery system. The AXIOS™ stent is designed with two flanges on each end to prevent migration and to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance.
The AXIOS™ Electrocautery-Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS™ Stent. The AXIOS™ Electrocautery-Enhanced Delivery System is designed to be used in the gastrointestinal tract with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially available 0.035-inch insulated endoscopic guidewires.
The Electrocautery-Enhanced Delivery System connects with an off-the-shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2.
The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is provided sterile, disposable and intended for single use.
The provided text is a 510(k) summary for a medical device (AXIOS™ Stent and Electrocautery-Enhanced Delivery System), establishing its substantial equivalence to a predicate device. It details the device's description, indications for use, and performance data from a clinical trial.
However, the request asks for information typically found in an AI/ML medical device submission, specifically concerning "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance. The document describes a medical device (a stent and delivery system), not an AI/ML algorithm. Therefore, many of the requested fields are not applicable to the content provided (e.g., number of experts to establish ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training/test set sample sizes for an algorithm, etc.).
The "Performance Data" section in the document refers to a clinical trial evaluating the safety and effectiveness of the stent, not an AI/ML algorithm's performance.
Given this discrepancy, I will extract the relevant "performance data" provided for the stent and explain why other AI/ML-specific questions are not applicable to this document.
Acceptance Criteria and Study Proving Device Meets Criteria (Based on Provided Document)
This document describes the regulatory submission for a medical device: the AXIOS™ Stent and Electrocautery-Enhanced Delivery System. It is not an AI/ML-driven device, so the typical AI/ML-specific acceptance criteria and study design (like MRMC studies, ground truth establishment by experts for an algorithm, training/test sets for an algorithm, etc.) are not applicable here.
The "acceptance criteria" in this context would implicitly refer to demonstrating safety and effectiveness for its intended use, sufficient for FDA 510(k) clearance based on substantial equivalence to predicate devices, and in support of an expanded indication. The "study that proves the device meets the acceptance criteria" is the described clinical trial.
Here's the information extracted and contextualized based on the provided document:
1. Table of "Acceptance Criteria" (Clinical Endpoints) and Reported Device Performance
Note: These are not acceptance criteria for an AI/ML algorithm's performance but rather for the clinical efficacy and safety of a medical device (stent).
| Clinical Endpoint (Analogous to Acceptance Criteria) | Reported Device Performance (N=40 subjects) |
|---|---|
| Primary Effectiveness Endpoint: | |
| Resolution of WON to ≤ 3 cm (assessed radiographically by CT scan or MRI within 60 days from AXIOS™ stent placement) | 97.5% (39/40) |
| [86.8%, 99.9% CI] | |
| Primary Safety Endpoint: | |
| AXIOS™ stent related or WON drainage procedure related serious adverse events | 7.5% (3/40) |
| [1.6%, 20.4% CI] | |
| Additional Endpoints: | |
| Technical success (AXIOS™ stent placement) | 100.0% (40/40) |
| Technical success (AXIOS™ stent removal) | 100.0% (40/40) |
| Resolution of WON by 6-month post-stent removal | 100.0% (40/40) |
| Recurrence of WON from initial resolution to 6 months post-AXIOS™ stent removal | 0.0% (0/34) |
| Visual confirmation of AXIOS™ stent lumen patency (after stent placement) | 100.0% (40/40) |
| Visual confirmation of AXIOS™ stent lumen patency (before stent removal) | 97.5% (39/40) |
| Incidence of new organ failure | 2.6% (1/39) |
2. Sample Size and Data Provenance
- Sample Size (Clinical Trial): 40 patients (with 45 AXIOS™ stents implanted, as some subjects had multiple WON).
- Data Provenance: The document states "a prospective, single arm, multi-center trial." It does not specify the country of origin but implies a formal clinical investigation under an approved Investigational Device Exemption (IDE) per GCP and 21 CFR Parts 50, 56, and 812, which are U.S. regulations. Thus, it's a prospective, clinical trial data.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable (N/A): This is a clinical trial of a medical device (stent and delivery system), not an AI/ML algorithm requiring expert ground truth for image interpretation or similar AI-specific tasks. The "ground truth" here is the clinical outcome (WON resolution, adverse events), determined by medical professionals treating the patients and clinical assessments (radiographic imaging, physical exams) as part of the trial protocol.
4. Adjudication Method for the Test Set
- N/A: As this is a clinical trial, not an AI/ML algorithm's test set requiring human reader adjudication for performance metrics. Clinical endpoints are typically evaluated by blinded assessment where possible, and adverse events are adjudicated by a clinical events committee, but the specific details of that adjudication are not provided beyond the general statement of a "prospective, single arm, multi-center trial conducted per GCP."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No (N/A): An MRMC study is relevant for evaluating the impact of an AI/ML algorithm on human reader performance (e.g., radiologists interpreting images). This document describes a clinical trial of a physical medical device (stent), not an AI/ML algorithm.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- N/A: This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Clinical Outcomes and Radiographic Assessment: For the primary effectiveness endpoint, the "ground truth" was the "radiographic decrease of WON size to
§ 876.5015 Pancreatic drainage stent and delivery system.
(a)
Identification. A pancreatic drainage stent is a prescription device that consists of a self-expanding, covered, metallic stent, intended for placement to facilitate transmural endoscopic drainage of pancreatic pseudocysts. This stent is intended to be removed upon confirmation of pseudocyst resolution. This device may also include a delivery system.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device and elements of the delivery device that may contact the patient must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of patient-contacting components of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life.
(4) Non-clinical testing data must demonstrate that the stent and delivery system perform as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing of the stent and delivery system must be conducted under simulated use conditions.
(ii) Removal force testing must be conducted. The removal force testing must demonstrate that the stent can be safely removed, and that the stent will remain in place when subjected to forces encountered during use.
(iii) Expansion force testing must be conducted. The expansion force must demonstrate that the forces exerted by the stent will not damage the tissue surrounding the stent.
(iv) Compression force testing must be conducted. The compression force must demonstrate that the stent will withstand the forces encountered during use.
(v) Dimensional verification testing must be conducted.
(vi) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(vii) Fatigue testing must be conducted. Material strength must demonstrate that the stent will withstand forces encountered during use.
(viii) Corrosion testing must be conducted. Corrosion resistance must demonstrate that the stent will withstand conditions encountered during use.
(5) Non-clinical testing must evaluate the compatibility of the stent in a magnetic resonance (MR) environment.
(6) Well-documented clinical experience must demonstrate safe and effective use, and capture any adverse events observed during clinical use.
(7) Labeling must include the following:
(i) Appropriate instructions, warnings, cautions, limitations, and information related to the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device.
(ii) A warning that the safety and patency of the stent has not been established beyond the duration of the documented clinical experience.
(iii) Specific instructions and the qualifications and clinical training needed for the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device.
(iv) Information on the patient population for which the device has been demonstrated to be effective.
(v) A detailed summary of the clinical experience pertinent to use of the device.
(vi) A detailed summary of the device technical parameters.
(vii) A detailed summary of the device- and procedure-related complications pertinent to use of the device.
(viii) An expiration date/shelf life.