(371 days)
The Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. The device is not for use as a sole diagnostic screening tool.
The Mucosal Integrity Conductivity (MI) Test System provides real-time measurements of alterations in esophageal evithelial integrity. The device is intended to aid in the evaluation of esophageal epithelial integrity by means of a balloon probe with direct electrical contact with the mucosal epithelium of the esophagus along with associated signal conditioning, hardware, and software for measuring and displaying information.
The provided text describes the "Mucosal Integrity Conductivity (MI) Test System," an esophageal tissue characterization system. However, the document does not contain information about a study that assesses the device's performance against specific acceptance criteria using a test set of patient data or
human readers in a comparative effectiveness study. The "Performance Testing - Bench" section details benchtop tests of the device's physical properties and electrical measurement capabilities, but this is distinct from a clinical performance study using patient data.
The "Summary of Clinical Information" section briefly mentions two prospective clinical studies where the device was used in patients, noting its ability to measure esophageal mucosal impedance and the occurrence of few adverse events. However, these descriptions do not provide specific acceptance criteria, performance metrics (like sensitivity, specificity, accuracy), or details on how ground truth was established for diagnosis or classification of esophageal conditions based on the impedance measurements, which would typically be part of a study proving the device meets clinical acceptance criteria for its intended use as an aid in evaluation.
Therefore,Based on the provided text, I cannot answer all parts of your request as it does not detail a study that proves the clinical performance of the device against specific acceptance criteria for diagnostic accuracy or human-in-the-loop improvement for clinical decision making. The information focuses on bench testing, safety, and general functionality.
However, I can extract the acceptance criteria and performance for the benchtop performance tests.
Acceptance Criteria and Reported Device Performance (Benchtop Testing)
Here's a table summarizing the acceptance criteria and reported "Pass" results for the benchtop performance testing:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Functionality Testing | ||
| Double Wall Thickness | .00045" +/- .00025" | Pass |
| Compliance Diameter @ 0.5atm | 20 mm +/- .65 mm | Pass |
| Burst Pressure | 2.04 atm minimum | Pass |
| Dimensional Design Verification Testing | ||
| Probe Overall Length | 55.25" +/- 2.0" | Pass |
| Probe, Balloon Diameter when Inflated | 2.0 cm +/- 0.1 cm | Pass |
| Probe Weight | 2.8 oz. +/- 0.5 oz. | Pass |
| Bond between Sensors and Balloon Testing | ||
| Adhesive Strength after Exposure to Saline | ≥ adhesive strength without saline exposure | |
| 2.267 lbf | Pass | |
| Tensile Strength, Distal Tip to Catheter of MI Probe | ||
| Tensile Strength Distal Tip Joint MI Probe (Initial) | ≥ 3.0 lbf based on independent study | Pass |
| Tensile Strength Distal Tip Joint MI Probe (Added to Submission) | ≥ 4.5 lbf from EN 1617 (20 Newtons) | Pass |
| Impedance Measurements of MI Probe Sensors | ||
| Impedance Measurement Accuracy | 174+/- 100 Ohms | Pass |
| Impedance Signal Noise |
§ 876.1450 Esophageal tissue characterization system.
(a)
Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.(b)
Classification. Class II (special controls). The special controls for this device are:(1) All patient contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.
(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.
(6) Performance data must validate the reprocessing instructions for any reusable components of the device.
(7) Labeling must include:
(i) Specific instructions regarding the proper placement and use of the device;
(ii) Instructions for reprocessing of any reusable components; and
(iii) An expiration date for single use components.