(150 days)
ProdiGI Traction Wire: The Medtronic ProdiGI Traction Wire is indicated to grasp tissue within the esophagus, stomach, and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.
ProdiGI Traction Magnet: The Medtronic ProdiGI Traction Magnet is indicated to grasp tissue within the stomach and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.
The ProdiGI Traction System includes the Traction Wire and Traction Magnet devices. The Traction Wire and Traction Magnet are not intended to be used together. Both devices are used in adults only and are used to provide improved visualization of the submucosal space during an endoscopic submucosal dissection (ESD) procedure.
ProdiGI Traction Wire Device: The Traction Wire consists of two graspers: a primary tissue grasper with traction wire attached (ERD-TW20 and ERD-TW35), and a secondary tissue grasper (ERD-TWSG) without a wire. The secondary tissue grasper is used to secure the distal end of the traction wire. The traction wire is a nitinol shape-memory loop (2.0 cm or 3.5 cm in length) that provides tension to the attached tissue after deployment. The nitinol wire is attached to the grasper with a stainless-steel crimp.
ProdiGI Traction Magnet Device: The traction magnet (ERD-TMST and ERD-TMLG) consists of two identical tissue graspers with a permanent neodymium magnet attached to the grasper via a suture. The sutured magnet provides tension to the attached tissue after deployment.
Here's an analysis of the provided text to describe the acceptance criteria and the study proving the device meets them, based on your requested format:
Acceptance Criteria and Device Performance for ProdiGI
The ProdiGI device underwent non-clinical/bench studies and usability testing to demonstrate its safety and effectiveness. Importantly, no clinical data was provided. The primary studies proving the device meets acceptance criteria are summarized in the "Performance Testing - Bench", "Usability Testing", and "Performance Testing - Animal" sections of the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document presents acceptance criteria and reported performance in a narrative and tabular format for both bench and usability testing. I will consolidate the key performance criteria for each device type into a single table. Note that specific numerical results (e.g., 'b)(4)') were often redacted in the original text, so I will indicate where this occurs.
Table 1: Consolidated Acceptance Criteria and Reported Device Performance (Bench and Usability)
| Test Category | Specific Test / Needs ID | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | General | Conformance to ISO 10993-1:2003 for cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, and acute systemic toxicity. | PASS: "The results supported the biocompatibility of the ProdiGI device." (Tests performed on final finished devices.) |
| Shelf Life/Sterility | Sterilization | Conformance to ANSI/AAMI/ISO 11135:2014, ensuring a sterility assurance level of 10^-6. | PASS: "Sterilization was evaluated for conformance..." (Implied successful validation as no issues reported and device granted.) |
| Accelerated Aging | Support 1.5-year shelf life per ASTM F1980-16, demonstrating packaging integrity (gross leak, pouch seal strength). | PASS: "Accelerated aging to support a 1.5-year shelf life was performed... The shelf life was verified by demonstrating packaging integrity..." (Implied successful validation.) | |
| Bench/Mechanical (Traction Wire) | Tensile Test (Grasper to Wire) | Grasper to wire tensile force should be above (b)(4) lbf. | PASS: "The device passed all the tests in Tables 1 and 2." (Table 1 states "The grasper to wire tensile force should be above (b)(4)" for both, implying the criteria was met.) |
| Tensile Test (Crimp to Wire) | Crimp to wire tensile test must be above (b)(4). lbf. | PASS: "The device passed all the tests in Tables 1 and 2." (Table 1 states "The crimp to wire tensile test must be above (b)(4)" for both, implying the criteria was met.) | |
| Torque Test | Torque to rotate device (b)(4) lbf; 2nd grasper > (b)(4) lbf; 2nd grasper arms not come out of capsule; force to remove 2nd graspers from tissue (b)(4) lbf and = (b)(4) lbf; force to remove magnet from suture >= (b)(4) lbf; force to separate crimp from suture >= (b)(4) lbf; force to remove magnet from grasper body (b)(4) lbf; arms not come out of capsule during detachment; force to remove grasper from tissue = (b)(4) prior and after being opened/closed (b)(4). | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Deployment Force | Force to deploy by squeezing handle: > (b)(4) lbf and (b)(4) lbf (lower); = (b)(4). | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Usability (Traction Wire) | N1.1 (Visualization) | Average visualization score (dissection with traction wire) >= average visualization score (without traction wire). (3-point scale: 1=unacceptable, 2=acceptable, 3=exceeds expectations) | PASS: Test: 15/24, Control: (b)(4) (Specific average values are redacted, but "PASS" indicates the criterion was met. This implies the average score with the device was at least as good as without.) |
| N1.2 (Procedure Time) | Average procedure time (with traction device) = average visualization score (without traction magnet). (5-point scale: 1=unacceptable, 2=poor, 3=clinically acceptable, 4=good, 5=exceeds expectations) | PASS: (Specific score values redacted, but "PASS" indicates the criterion was met. This implies the average score with the device was at least as good as without.) | |
| NL2 (Procedure Time) | Average procedure time (with traction device) 5 years of experience and three or more ESD cases per month. |
* For the **Traction Wire**, "skilled by moderate and provice physicians participated."
* For the **Traction Magnet**, "two skilled, two moderate and two novice physicians participated."
* The observations and ratings from these physicians formed the basis of the usability ground truth.
- Animal Testing: Bleeding, perforation, mucosal laceration, visualization, ease of removal, and ease of procedure were assessed by "study physicians intraoperatively via endoscopic visualization." No specific number of physicians is given for the animal studies, but they are implied to be experts in therapeutic endoscopy and ESD.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the usability or animal studies. It appears that the expert physicians directly provided the ratings and assessments which were then used to calculate means and comparisons. For perforation in the animal study, it notes a singular assessment that was then reviewed for causality ("unrelated to the device use or design or the control procedure").
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
While not explicitly termed an "MRMC study," the usability testing and animal (in vivo) testing were designed as comparative effectiveness studies where human readers (physicians/experts) performed procedures with and without AI (device) assistance. The "AI" here refers to the device itself as providing assistance, not an AI algorithm in the traditional sense of image analysis.
- Effect Size of Human Readers (with device vs. without):
- Visualization: For both Traction Wire and Traction Magnet, the device showed PASS for visualization, meaning the average visualization score with the device was equal to or better than without. This indicates a positive effect on visualization compared to unassisted procedures. For the animal study, Visualization (Start, Mid, End) was consistently rated as Traction better than Control for both devices.
- Procedure Time: For the Traction Wire, procedure time was PASS (device time
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