(126 days)
The Acclarent® NavWire Sinus Navigation Guidewire is intended for use as a navigable guidewire to provide access to nasal and sinus spaces, and confirmation of placement in the accessed anatomy. The Acclarent® NavWire Sinus Navigation Guidewire is designed for use during procedures where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, can be identified relative to a CT-based model of the anatomy.
The Acclarent® NavWire Sinus Navigation Guidewire an electromagnetically (EM) trackable guidewire that provides surgeons a means to access the intranasal and paranasal sinus spaces in endoscopic and image guided sinus surgeries. It is compatible with the CARTO® ENT System to track the NavWire within an electromagnetic field, which displays the magnetic sensor position relative to a patient's pre-operative CT scan.
The provided text describes the Acclarent NavWire Sinus Navigation Guidewire. However, it does not include detailed acceptance criteria or the specific study results proving the device meets those criteria in a format that allows direct extraction of a table of acceptance criteria and reported performance with numerical values and statistical analyses.
The document is a 510(k) summary, which typically provides a high-level overview of testing rather than granular study details.
Here's what can be extracted and what is missing based on the prompt's requirements:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (General): The document states "The Acclarent NavWire passed all intended criteria in accordance with appropriate test criteria and standards." This implies that specific, pre-defined acceptance criteria were met for each test listed. However, the specific numerical criteria for "accuracy and precision," "functionality," "accelerated aging," "simulated use," and "sterilization" are not provided.
- Reported Device Performance: Similarly, the specific results (e.g., "accuracy was X mm," "precision was Y mm," "device remained functional for Z cycles") are not provided. The text only confirms that the device "passed all intended criteria."
Therefore, I cannot construct a table with specific criteria and performance values as requested due to the lack of this detailed information in the provided text.
2. Sample Size for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "Bench testing" and "Nonclinical accuracy testing," "Nonclinical performance testing," "Simulated use testing," but does not specify the number of samples, trials, or units tested for any of these.
- Data Provenance (Country of Origin, Retrospective/Prospective): Implied as bench testing, which is laboratory-based, often conducted in the manufacturer's facilities. The country of origin of the data is not specified a part of the test description itself. As it's bench testing, the terms "retrospective" or "prospective" don't directly apply in the clinical sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This question is highly relevant for studies involving human interpretation or expert review of clinical data. For bench testing of a guidewire's mechanical and navigational performance, the "ground truth" is typically established by engineering measurements against known physical standards, rather than expert consensus on medical images or diagnoses.
- Therefore, this information is not applicable and not provided in the context of the described bench and non-clinical tests.
4. Adjudication Method for the Test Set:
- Similar to point 3, adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies among human experts in interpreting clinical data. Since the tests described are bench and non-clinical, involving physical measurements and performance verification, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. The document describes bench and non-clinical testing of the device itself (accuracy, precision, functionality, sterilization) and its compatibility with a navigation system. It does not describe a study involving human readers or a comparison of human performance with and without AI assistance. The device is a physical guidewire, not an AI software for interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, a standalone study of the device performance was done. The described "Bench testing" and "Nonclinical accuracy testing," "Nonclinical performance testing," "Functionality... after accelerated aging," and "Simulated use testing" all represent evaluations of the device's inherent capabilities (accuracy, precision, durability, etc.) independent of a human operator's skill in a clinical setting. It's a standalone performance evaluation of the physical medical device.
7. Type of Ground Truth Used:
- For "Bench testing" and "Nonclinical accuracy/performance testing," the ground truth would be established through engineering measurement standards, calibrated instruments, and physical test fixtures. For example, an "accuracy" test would compare the device's reported position to a known, precisely measured physical location. For "sterilization verification," the ground truth is the absence of viable microorganisms as per specified sterility assurance levels (SAL).
8. Sample Size for the Training Set:
- This device is a physical medical guidewire, not an AI algorithm that requires a "training set" in the machine learning sense. Therefore, this concept is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established:
- As the device is not an AI algorithm requiring a training set, this information is not applicable and not provided.
In summary, the provided document focuses on the regulatory submission for a physical medical device (a guidewire) and outlines the types of non-clinical, bench tests performed to demonstrate its safety and effectiveness. It does not contain the detailed numerical acceptance criteria or performance results that would be needed to complete the requested table, nor does it describe studies involving AI, human readers, or clinical image interpretation, as many of the prompt's questions imply.
§ 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).