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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.

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SinuSys Vent-Os® Sinus Dilation family is intended to provide a means to access the sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.

• The Vent-Os Maxillary Dilation System is indicated for dilation of Maxillary sinus and associated spaces.
• · The Vent-Os Frontal Dilation System is indicated for dilation of the Frontal recess and associated spaces.
• · The Vent-Os Sphenoid Dilation System is indicated for dilation of Sphenoid sinus and associated spaces.

The Vent-Os® Sinus Dilation family comprises a family of osmotically driven devices that access and dilate the sinus ostia and spaces associated with the paranasal sinus cavities. Each member of the Vent-Os® Sinus Dilation family is a system that includes a Dilation Device preloaded on a Placement Instrument. The Placement Instrument accesses the target site through the nasal passageway and delivers the Dilation Device. The Vent-Os® Sinus Dilation Device then expands and remodels the target tissues and then is removed.

Here's an analysis of the acceptance criteria and study detailed in the provided text.

Based on the provided text, the device in question is the "Vent-Os® Sinus Dilation Family."

Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for outcomes like "patent" rates for the clinical trial. Instead, it compares the device's performance to a literature control to demonstrate "substantial equivalence." The "acceptance criteria" can be inferred as achieving comparable safety and effectiveness to the predicate device and the literature control.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Clinical Trial Test Set: 30 patients.
   • Data Provenance: The study was a "multi-center, prospective, single arm, non-randomized trial conducted at three (3) clinical sites." The country of origin is not explicitly stated, but given the FDA submission, it's typically understood to be within or recognized by the US regulatory framework.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document states "three (3) investigators" for the clinical trial. It implies these investigators were physicians involved in treating patients with chronic rhinosinusitis and evaluating the outcomes. Specific qualifications (e.g., years of experience, specific specialization beyond "physician users") are not detailed.
   • For cadaver testing, "multiple physician users" were involved in validating usability.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • The document does not describe any specific adjudication method for the clinical outcomes. It implies the "investigators" assessed the success of the treatment, but details on how agreement was reached for indeterminate cases or divergences in assessment are not provided.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done. This device is a surgical instrument, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is not applicable as the Vent-Os® Sinus Dilation Family is a surgical instrument and not an algorithm or AI system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the clinical trial, the outcomes (patent, non-patent, indeterminate) appear to be based on clinical assessment by the physician investigators (outcomes data) at the 3-month follow-up. This type of assessment often relies on endoscopic evaluation and investigator judgment.
   • For cadaver testing, the ground truth was expert observation/confirmation of successful delivery and placement by "multiple physician users."

7. The sample size for the training set:

   • As this is a surgical device and not an AI or machine learning model, there is no "training set" in the conventional sense. The development of the device would involve engineering, material science, and iterative testing, but not data-driven training of an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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