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The Reach Needle is used for in injecting local anesthetics into a patient to provide regional anesthesia.

The Reach Needle is a sterile, single use, 4-inch-long needle used for administering anesthetic solutions for regional anesthesia. The Reach Needle is 27-qauge needle that is reinforced to reduce needle flex during administration of anesthesia solutions. The needle tip is a short bevel quincke style tip that extends approximately 2mm past the reinforcing shaft, providing a distal stop for consistent injection depth. The distal end of the needle has a slight bend to help access difficult to reach areas such as nasal anatomy. The needle hub is compatible with luer lock connectors. The Reach Needle is intended for use in adults (≥ 22 years).

The provided text is a U.S. FDA 510(k) summary for the "Reach Needle," an anesthesia conduction needle. It outlines the device's characteristics, intended use, and comparison to a predicate device.

Crucially, the document explicitly states under the section "Summary of clinical test": "Clinical testing was not necessary for this device."

This means that the device's acceptance was based on non-clinical testing (e.g., in vitro or bench testing) and a demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical study involving human patients or complex AI algorithms requiring extensive ground truth establishment and expert adjudication.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as the nature of the device (a medical needle, not an AI or imaging device) and the regulatory pathway chosen (510(k) based on substantial equivalence and non-clinical data) did not involve such a study.

The questions you asked are highly relevant for AI/ML-enabled medical devices or devices where performance needs to be validated against complex human assessment or outcomes, but they do not apply to this specific medical needle as per the provided FDA documentation.

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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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The VivAer® Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, including cartilage in the internal nasal valve area.

The VivAer® Stylus is a disposable, handheld device capable of delivering bipolar radiofrequency energy to tissue. The stylus consists of an array of bipolar electrodes positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature during treatment. The product's intended users are physicians including otolaryngologists, maxillofacial surgeons and other physicians specialized in nasal procedures.

The VivAer® Stylus improves nasal breathing by modifying the soft tissues of the nasal airway through the use of low doses of radiofrequency energy. The low-power radiofrequency generates heat within the submucosal tissue, creating a coagulation lesion. As the lesion heals, the tissue retracts and stiffens. This decreases the nasal airflow resistance thereby improving inflow of air through the nose.

Here's a breakdown of the acceptance criteria and study information for the VivAer Stylus based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for a "test set" in the context of an AI/algorithm-based device. The testing described is primarily non-clinical performance testing of a physical medical device (VivAer Stylus) and its packaging.

• Sample Size: Not specified in terms of numerical units for each test, but implied to be sufficient for demonstrating compliance with acceptance criteria.
• Data Provenance: The studies were conducted internally by Aerin Medical Inc. in Sunnyvale, California, as part of their 510(k) submission. These are prospective tests performed on the manufactured device.

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

This information is not applicable as the described testing is for a surgical device focused on its physical and functional performance, not for an AI/algorithm that requires expert-established ground truth for image interpretation or diagnosis. The ground truth for these tests is based on engineering specifications, regulatory standards, and objective measurements (e.g., temperature readings, force measurements, sterility verification).

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a human-in-the-loop diagnostic or interpretive task that would require adjudication. The testing involves engineering and performance validations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic or screening devices to assess the impact of AI on human reader performance. The VivAer Stylus is a surgical device, not a diagnostic AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical electrosurgical tool and does not employ an AI algorithm in the manner described. The "algorithm" here refers to the pre-programmed treatment parameters of the device (power, temperature, time), which were verified for correct programming.

7. The Type of Ground Truth Used

The ground truth used for the described non-clinical tests is based on:

• Engineering Specifications: E.g., for thermocouple accuracy, shaft strength, power output.
• Regulatory Standards: E.g., for sterilization (SAL of 10-6), biocompatibility.
• Objective Measurements: E.g., confirmed energy delivery to tissue samples, verification of programmed parameters.

8. The Sample Size for the Training Set

This is not applicable. The device is a surgical instrument, not an AI/machine learning model that requires a training set of data.

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

This is not applicable for the same reason as #8.

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The RHIN I Stylus is indicated for use in otothing of the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

The RHIN1 Stylus is a handheld bipolar radiofrequency (RF) probe designed for use in otorhinolaryngology (ENT) surgery. The Stylus comprises a handle, shaft, and treatment tip. The treatment tip consists of an array of bipolar electric es and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. The shaft is malleable to allow the user to bend the shaft in order to more easily access the desired treatment area(s). The Stylus is designed for use with the Aerin Console. It includes features to allow compatibility with and authentication by the Aerin Console. The Stylus connects to the Aerin Console via a flexible cable.

The RHIN1 Stylus is used to treat patients experiencing chronic rhinitis. During a treatment procedure, the clinician inserts the shaft of the RHIN1 Stylus into a patient's nostril to position the treatment tip and deliver low power RF energy to the target tissue of the nasal airway. The low-power radiofrequency energy generates heat within the tissue, causing destruction of the unwanted soft tissue. The shaft of the RHIN1 Stylus is then removed from the nostril.

The provided text describes the 510(k) premarket notification for the RHIN1 Stylus, a radiofrequency probe for treating chronic rhinitis. While the document details the device's technical characteristics, regulatory classification, and a summary of non-clinical and clinical tests, it does not include information about an AI/algorithm-based device. Instead, the study outlined is a clinical trial assessing the effectiveness and safety of the RHIN1 Stylus itself in human subjects for a medical procedure.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/algorithm-based device cannot be extracted from this document. The document pertains to a physical medical device and its performance in a clinical setting.

To answer your request, I would need a document describing an AI/algorithm-based medical device.

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