(60 days)
The TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.
The subject device, TruDi™ NAV Wire, is a single-use electromagnetically (EM) navigated, flexible guidewire, which is compatible for use with the TruDi™ Navigation System to provide access and confirmation of placement in patient anatomy during intranasal and paranasal surgeries. The TruDi™ NAV Wire is intended to provide real-time tracking at the distal tip of the guidewire in the nasal anatomy and is intended to be used during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy. The subject device, TruDi™ NAV Wire, may be used with compatible non-ferromagnetic instruments that have a lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire onto the instrument.
The provided text describes the "TruDi™ NAV Wire," an electromagnetically navigable guidewire. Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with numerical targets and the device's reported performance against those targets in a readily digestible format for certain tests. Instead, it states that "Bench testing has been performed and met all acceptance criteria for attributes..." and then lists the attributes. For sterility, it mentions a specific level.
Here's a table based on the provided text, outlining the tests performed and the general statement of performance:
| Test/Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use Testing | Met acceptance criteria | "met all acceptance criteria" |
| Dimensional Specs | Met acceptance criteria | "met all acceptance criteria" |
| Insertion Durability | Met acceptance criteria | "met all acceptance criteria" |
| Rotational Durability | Met acceptance criteria | "met all acceptance criteria" |
| Suction Durability | Met acceptance criteria | "met all acceptance criteria" |
| Joint Separation Force | Met acceptance criteria | "met all acceptance criteria" |
| Stiffness | Met acceptance criteria | "met all acceptance criteria" |
| Swivel Functional Perf. | Met acceptance criteria | "met all acceptance criteria" |
| Frictional Force | Met acceptance criteria | "met all acceptance criteria" |
| Location Accuracy (Sensor Sensitivity) | Met acceptance criteria | "met all acceptance criteria" |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 (per ISO 11135:2014) | "demonstrated a sterility assurance level of 10-6" |
| Ethylene Oxide Residuals | Meet ISO 10993-7:2008 requirements | "meet ISO 10993-7:2008 requirements" |
| Biocompatibility | Biocompatible per ISO 10993-1 | "successfully completed to determine...is biocompatible" |
| Packaging Shelf Life | Meet ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-11 requirements for 3 months | "confirmed to meet a shelf life of three months" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the bench tests (simulated use, durability, etc.).
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin. Since these are bench tests, they are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies described are bench tests on the device's physical and functional properties, not clinical studies requiring expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are bench tests and do not involve human interpretation or adjudication in the way clinical studies with ground truth establishment would. The tests would likely have pre-defined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary for the TruDi™ NAV Wire." The studies described are non-clinical bench tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not directly applicable as the TruDi™ NAV Wire is a physical medical device, not an algorithm, and its performance relies on interaction with a navigation system. The "Location Accuracy (Sensor Sensitivity)" test implicitly assesses the standalone performance of the guidewire's electromagnetic tracking capability, but it's not an algorithm in the typical sense of AI.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" would be established by engineering specifications, industry standards (e.g., ISO, ASTM), and design requirements. For example, a specified durability threshold or a precise dimensional measurement.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical guidewire and the studies described are bench tests, not machine learning studies that require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a machine learning model.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).