(225 days)
The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.
The esolution® Esophageal Retractor is a catheter-based device designed to displace the esophagus away from the source of ablation energy during percutaneous cardiac catheter ablation procedures and to reduce the risk of ablation energy-induced esophageal injury. The esolution® Esophageal Retractor uses both mechanical force and vacuum suction to grasp the esophagus and deflect it away from the posterior wall of the left atrium in both left and right directions. The device comprises three components: (1) outer sheath, (2) inner mechanical displacement plates, and (3) handle and control knob. The distal end of the outer sheath features two eyelets for attaching a temperature probe (a temperature probe is not required for use of the esolution® Esophageal Retractor).
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for esolution® Esophageal Retractor
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance | Study/Section Proving Compliance |
|---|---|---|---|
| Clinical Performance | Reduce incidence of esophageal injury during cardiac ablation procedures. | 5.7% (esolution) vs. 35.4% (Control) incidence of ablation lesions (p 4 mm) were seen in the device group. Benign suction marks were more likely in the intervention group. No device-related adverse events. | EASY AF Clinical Study (Adverse Events, Endoscopy Findings) |
| Animal Performance | Adequately deviate the esophagus, including its trailing edge, away from the ablation energy source. | Successfully deviated the esophagus in right and left directions. 93% of deviations were not associated with any detectable trailing edge. | Performance Testing - Animal (Ease and Safety of Insertion and Positioning, Effect of Suction upon Esophageal Deviation, Bilateral and Controlled Degrees of Deviation) |
| No esophageal injury from device use. | Deviation successfully deviated the esophagus without injury. Mild changes with 60min and 150min suction were seen without disruption of the epithelium and were considered clinically insignificant. No injury to the esophagus despite prolonged suction and multiple bilateral deviations. | Performance Testing - Animal (Bilateral and Controlled Degrees of Deviation, Effect of Suction Upon Esophageal Cellular Architecture) | |
| Non-Clinical Performance (Bench) | Mechanical integrity testing using clinically relevant forces. | All test results met acceptance criteria for Visual Inspection, Dimensional Verification, Intubation fit, Immobilization, Device Insertion and Withdrawal, Deflection (with/without weights), Vacuum Leak/Decay Test, Torque Test, and Tensile Test. | Summary of Nonclinical/Bench Studies (Performance Testing - Bench) |
| Compatibility testing with accessory devices. | Did not interfere with accurate luminal esophageal temperature measurement. Did not alter the normal function of electroanatomic mapping systems. | Performance Testing - Animal (Impact of ProtectE Upon Accurate Measurement of Luminal Esophageal Temperature, Impact of esolution® Esophageal Retractor upon Electroanatomic Mapping Systems) | |
| Sterility | Device components intended to be sterile are sterile. | The device is a sterile, single-use device. Supported by shelf-life testing. | Shelf Life/Sterility |
| Biocompatibility | Patient-contacting components are biocompatible. | Found non-cytotoxic, non-sensitizing, and non-irritating. | Biocompatibility/Materials |
| Shelf Life | Package integrity and device functionality over identified shelf life. | Acceptable package integrity and functional performance over its 1-year shelf life. | Shelf Life/Sterility |
2. Sample Size Used for the Test Set and Data Provenance
The primary clinical effectiveness study (EASY AF Study) enrolled 120 randomized subjects who received study treatment and were followed up. Of these, 118 subjects (65 Control and 53 esolution) underwent endoscopy.
The study was a prospective, randomized, controlled, single-blinded multicenter study. The text mentions a "small pilot OUS clinical trial" and "12 medical centers" for the pivotal IDE trial, indicating multi-country (outside US) and US data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
An Endoscopy Adjudication Committee (EAC) was used to review endoscopy images and establish the ground truth for ablation lesions and other findings.
The specific number of experts on the EAC and their detailed qualifications (e.g., number of years of experience) are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set
The text states: "Images reviewed by EAC." It also says, "The Clinical Events Committee, who blindly adjudicated each adverse event." This implies a blinded independent adjudication process for both endoscopy findings and adverse events. The specific format (e.g., 2+1, 3+1) is not specified, but the involvement of an EAC and blinding suggests a robust consensus process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described in the provided text. The study compares the device's performance against a control group (standard therapy without the device), not specifically how human readers improve with AI assistance. The esolution® Esophageal Retractor is a mechanical device, not an AI-assisted diagnostic tool for image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The esolution® Esophageal Retractor is a mechanical medical device, not an algorithm or software. Therefore, standalone algorithm performance is not relevant to this submission.
7. Type of Ground Truth Used
For the clinical study, the primary ground truth was ablation-related esophageal lesions noted on post-ablation esophageal endoscopy, characterized using the Kansas City Classification. This was adjudicated by an EAC.
For animal studies, ground truth involved gross and microscopic architecture of the esophagus.
8. Sample Size for the Training Set
Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a training set. The clinical study investigated the direct effect of the device on patient outcomes rather than training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this mechanical device.
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