(26 days)
The AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, 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 the 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 Sten. 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 contains information about the AXIOS Stent and Electrocautery-Enhanced Delivery System, specifically an FDA 510(k) summary for a new version of the device (K192043). However, it does not describe a clinical study that proves the device meets specific acceptance criteria based on human or expert evaluation. Instead, it describes bench testing against predefined product specifications to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be answered from the provided document as it does not detail a clinical performance study with human readers or AI.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "pre-defined product specifications" for bench tests as the acceptance criteria. The device is reported to have met these criteria.
| Acceptance Criteria (Pre-defined Product Specifications) | Reported Device Performance (Results) |
|---|---|
| Deployed Stent Saddle Length | Pass |
| Deployed Stent Saddle Outer Diameter | Pass |
| Deployed Stent Flange Width | Pass |
| Stent Pull-out Force (tensile) | Pass |
| Stent (Saddle) Radial Strength - in compression & expansion | Pass |
| Deployment Force | Pass |
| Implant Anchor Function- Retention (tensile) | Pass |
| Magnetic Resonance Testing | Pass |
Regarding the other requested information:
- 2. Sample size used for the test set and the data provenance: This information is not provided in the document. The tests performed were bench tests on the device itself, not clinical tests on a patient population.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the bench tests would be the established product specifications for physical properties, not expert-derived medical diagnoses.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for clinical studies involving interpretation of medical images or patient outcomes, not for bench testing of device specifications.
- 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: No MRMC study was mentioned. The device is a medical stent and delivery system, not an AI diagnostic tool that assists human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical medical device, not a standalone AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the ground truth was the pre-defined product specifications for mechanical and physical properties of the device (e.g., specific dimensions, force resistance, MR compatibility).
- 8. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI model that requires a training set.
- 9. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI model.
Summary from the document:
The provided text focuses on the technical characteristics and bench testing of a medical device (AXIOS Stent and Electrocautery-Enhanced Delivery System) to demonstrate substantial equivalence to a previously cleared predicate device. The "acceptance criteria" here refer to predefined product specifications for the physical device, and the "study" is a series of bench tests. No clinical studies involving human readers, AI, or patient outcomes for the purpose of establishing device performance against clinical acceptance criteria are described in this document.
§ 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.