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The RhinAer® Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

The RhinAer Stylus is functionally unchanged from the predicate in design and intended use to generate and deliver bipolar RF energy to treat tissue in ENT procedures. The design of the Stylus shaft has been changed to improve physician visualization and access during the procedure. The Stylus shaft diameter has been reduced and is more malleable. The treatment tip shape has been re-designed to change its position relative to the shaft to facilitate tissue apposition. The subject and predicate devices have the same material composition. The device and packaging system has been tested and validated with shelf-life studies out to 6 months. The optional custom treatment parameters (power, temperature, time) have been removed.

The provided text describes a 510(k) summary for a medical device called the RhinAer® Stylus (FG1393). This summary focuses on demonstrating substantial equivalence to a predicate device (RHIN1 Stylus, K192471) rather than presenting a study where specific acceptance criteria are defined for a performance outcome and then proven.

In the context of this 510(k) submission, "acceptance criteria" are generally related to demonstrating that the modified device maintains the safety and effectiveness of its predicate, and that changes to the device (shaft diameter, malleability, treatment tip design) do not introduce new safety or effectiveness concerns. The "study" here refers to the non-clinical tests performed to support this claim.

Given the information, here's how we can address your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for a "device performance" in the sense of a clinical outcome, but rather for engineering and safety aspects to demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document only references "non-clinical tests" and "bench functional testing" and "usability testing." It does not provide specific sample sizes for these tests beyond implying a sufficient number were performed to meet test objectives.

• Sample Size (Test Set): Not specified beyond general statements about "bench functional testing," "usability testing," and "aging and transit testing."
• Data Provenance: Not explicitly stated, but as these are non-clinical (bench and usability) tests conducted for a medical device submission, they would typically be performed in a controlled laboratory or simulated clinical environment. There is no indication of country of origin of patient data, as no clinical studies were performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This section is not applicable (N/A) because the reported "studies" are non-clinical engineering and usability tests, not studies requiring expert-adjudicated ground truth for a clinical outcome (e.g., image interpretation or disease diagnosis).
• Usability testing likely involved healthcare professionals or trained users, but their role was to evaluate the device interface and identify potential use errors, not to establish a clinical "ground truth."

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving interpretation (e.g., radiology reads). The non-clinical tests described (functional, usability, shelf-life) do not involve such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

• N/A. This device is an electrosurgical cutting and coagulation device, not an AI or imaging diagnostic device. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• N/A. This device is a physical medical instrument, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used

• N/A for clinical ground truth. For the non-clinical tests, the "ground truth" was established by engineering specifications, safety standards, and validated test methods (e.g., force load measurements, thermocouple calibration, sterility validations, package integrity standards).

8. The Sample Size for the Training Set

• N/A. Training sets are relevant for machine learning algorithms. This device is a physical medical instrument and does not involve a training set as understood in AI/ML contexts.

9. How the Ground Truth for the Training Set Was Established

• N/A. This question is not applicable for the reasons mentioned in point 8.

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