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The Aerin Console is an electrosurgical system intended to generate radiofrequency electrical current for the use of an Aerin Medical Stylus. The Aerin Console is indicated for use in small clinic, office or hospital environments.

The Aerin Console is a radio-frequency (RF) generator designed to be used with an Aerin Medical Stylus (RhinAer Stylus, K221907 and VivAer, K200300) to deliver bipolar RF energy to tissue. The Aerin Console consists of an RF generator, a power cord, and a foot switch. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.

The provided text is a 510(k) summary for a medical device called the "Aerin Console." A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and performance studies like those typically seen for novel AI/ML devices or those requiring clinical studies.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI/ML or diagnostic accuracy. The device is an electrosurgical system (RF generator), not an AI-powered diagnostic tool. The document states:

• "Clinical testing was not necessary for this device."
• The comparison focuses on technological characteristics (design, energy type, temperature, power, stylus compatibility) to a predicate device.
• The non-clinical tests listed are for electrical safety, EMC, software validation (IEC 62304), and device security (IEC 81001-5-1). These are related to the hardware and software's safe operation, not its performance in a diagnostic or AI-assisted task.

Therefore, most of the requested information (points 1-9) which pertain to the performance evaluation of a diagnostic device, especially one involving AI/ML and human interpretative performance, cannot be extracted from this document.

However, I can extract the relevant information from the document as it applies to the device described:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implicitly based on comparison to predicate and safety standards):
     • Compliance with electrical safety, EMC, software validation, and device security standards.
     • Performance characteristics (design, energy type, temperature range, output power, stylus compatibility) substantially equivalent to the predicate device.
   • Reported Device Performance (from "Summary of non-clinical test"):
     • Complies with:
       • ISO 60601-1 (Electrical Safety)
       • ISO 60601-1-2 (EMC)
       • IEC 60601-4-2 (EMC)
       • 47 CFR Part 15 Subpart B (FCC, unintentional radiators)
       • 47 CFR Part 27 (FCC, wireless (likely related to EMC, but could imply wireless comms are part of device))
       • IEC 62304 (Software validation)
       • IEC 81001-5-1 (Device Security)

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML diagnostic device, and no test set in the context of diagnostic performance (e.g., images for classification) is mentioned. The "tests" refer to compliance with engineering standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not established for this device.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, explicitly stated "Clinical testing was not necessary for this device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device with controlling software, not a standalone algorithm for diagnostic interpretation.

7. The type of ground truth used: Not applicable for diagnostic performance. Ground truth for engineering tests (e.g., electrical safety) is defined by the standards themselves.

8. The sample size for the training set: Not applicable. This device does not use a training set for machine learning.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for an electrosurgical generator, focusing on demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards for hardware and control software. It does not contain the kind of information typically associated with the performance evaluation of AI/ML diagnostic devices.

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The Vivaer ARC 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, in the internal nasal valve area.

The Vivaer ARC 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 electrodes and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. 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.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The studies collectively support the safety and efficacy of the Vivaer ARC Stylus for its intended use and its substantial equivalence to the predicate device.

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

• Clinical Study (Test Set):

  • Sample Size: 50 subjects
  • Data Provenance: Prospective, multi-center, non-randomized, non-significant risk clinical study conducted in the United States.

• In Vivo Study (Non-Clinical Test Set):

  • Sample Size: Canines (specific number not provided, but refers to "canines" implying multiple animals).
  • Data Provenance: In vivo testing.

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

• Clinical Study: Not explicitly stated that experts established the primary ground truth for the test set by independently reviewing images or data for the NOSE score. The NOSE score is a patient-reported outcome.
  • However, for physical and endoscopic nasal assessment, the assessments would have been performed by clinicians/physicians at the 8 study sites, who are presumed to be qualified in ENT surgery, given the context of the study. Specific expert qualifications (e.g., years of experience, board certification) are not detailed in the provided text.
• In Vivo Study:
  • Expert: A veterinary pathologist was used to evaluate the treated tissue histologically.
  • Qualifications: "veterinary pathologist" is mentioned. Specific years of experience or other detailed qualifications are not provided.

4. Adjudication Method for the Test Set

• The text does not explicitly mention an adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in either the clinical or in vivo studies.
• For the clinical study, the primary efficacy endpoint (NOSE score) is a patient-reported outcome, not typically subject to expert adjudication of results, though it would be collected and managed by clinical study staff. The physical/endoscopic assessments would be performed by individual clinicians, and any discrepancies across sites or with baseline would likely be managed through standard clinical trial protocols (e.g., central review if severe discrepancies arose, but not detailed here).
• For the in vivo study, the veterinary pathologist evaluated histology. This implies a single expert assessment for the histological ground truth, with no multi-reader adjudication method specified.

5. 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 mentioned or performed. This device is a surgical tool (radiofrequency probe), not an AI-powered diagnostic or assistive tool for human readers/interpreters of medical images. Therefore, the concept of human readers improving with AI assistance does not apply to this device.

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

• This is not applicable. The Vivaer ARC Stylus is a medical device, a handheld radiofrequency probe used for surgical procedures, it is not an algorithm or AI system. Its performance is directly tied to the physical action of the device and the clinician's use of it, not independent algorithmic performance.

7. The Type of Ground Truth Used

• Clinical Study:
  • Efficacy: Patient-reported outcome (Nasal Obstruction Symptom Evaluation - NOSE score) from subjects treated in a prospective study.
  • Safety: Characterization of adverse events reported by subjects and clinicians, physical/endoscopic nasal assessments performed by clinicians, and patient satisfaction surveys.
• In Vivo Study (Non-Clinical):
  • Safety/Healing: Histological evaluation by a veterinary pathologist, endoscopic evaluation, and observation of healing and long-term effects in canines.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical surgical instrument and does not involve AI or machine learning algorithms that require a "training set" in the conventional sense. The "training" for the device's development would be through engineering design, material science, and iterative testing, not data-driven machine learning.

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

• Not applicable. As stated above, there is no "training set" for an AI/ML algorithm associated with this device. Device development relies on established engineering principles, biocompatibility standards, electrical safety standards, and pre-clinical and clinical testing to validate its design and performance against its intended use.

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InSeca ARC Stylus: The InSeca ARC 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.

Aerin Console: The Aerin Console is an electrosurgical system intended to generate radiofrequency electrical current for the use of an ARC Stylus (e.g., InSeca ARC Stylus). The Aerin Console is indicated for use in small clinic, office or hospital environments.

InSeca ARC Stylus: The InSeca ARC 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 electrodes and a temperature sensor that allows for monitoring of tissue temperature during RF energy delivery. 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 InSeca ARC Stylus is used to treat patients experiencing chronic nasal airway obstruction. During a treatment procedure, the clinician inserts the tip of the InSeca ARC Stylus into a patient's nostril to deliver low power RF energy to the target tissue of the nasal airway. Radiofrequency treatment of tissue creates a coagulative lesion which fibroses and retracts as it heals, thereby shrinking the tissue to lessen the degree of obstruction.

Aerin Console: The Aerin Console is an RF generator designed to be used with the InSeca ARC Stylus to deliver bipolar RF energy to tissue. The Aerin Console consists of an RF generator, a power cord, and a foot switch. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cableconnected electrosurgical hand piece and electrode.

The provided document discusses a 510(k) premarket notification for the InSeca ARC Stylus and Aerin Console. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial or a performance study for a novel device would.

Based on the provided text, here's a breakdown of the information requested, with "N/A" where the information is not provided because the submission is for substantial equivalence rather than a full performance study with specific acceptance criteria in the traditional sense:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance testing. The "acceptance criteria" are implied by the statement "The subject devices met all the performance testing requirements." Specific quantitative acceptance criteria for each test are not explicitly listed in a table, but the areas of testing are detailed.

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

The document describes non-clinical bench testing. Specific sample sizes for each test (e.g., number of styluses tested for force load, number of tissue samples for heating time) are not specified. The data provenance is generally "bench testing" and "tissue heating time testing performed using tissues representative of the submucosal tissues of the nasal airway." There is no mention of country of origin for bench testing, and it is entirely retrospective in the sense that it's laboratory testing, not a prospective human clinical trial.

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

Not applicable. The ground truth for bench and functional testing is based on engineering specifications, regulatory standards, and objective measurements (e.g., temperature, force, voltage, thermal lesion volume). There is no mention of human experts establishing "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

Not applicable. As the testing described is non-clinical bench and laboratory testing against established specifications and regulatory standards, an adjudication method for a "test set" in the context of expert review or consensus is not relevant or described.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study typically involves human readers (e.g., radiologists, clinicians) evaluating cases (e.g., images) to determine the effectiveness of an intervention (like an AI algorithm). This type of study is not mentioned in the document as it pertains to a physical electrosurgical device rather than an AI or image-based diagnostic system. Therefore, no effect size of human readers improving with AI assistance is provided.

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

Not applicable. The InSeca ARC Stylus and Aerin Console are electrosurgical devices used by a clinician during a procedure; they are not an AI algorithm designed to operate in a standalone diagnostic or predictive capacity. While the Aerin Console incorporates "user interface software to control, monitor and regulate RF power delivery," its performance is intrinsically linked to its use by a human operator with the stylus. No "algorithm only" performance is discussed.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests described in the document is based on:

• Engineering specifications and design requirements: For mechanical integrity, electrical safety, and software functionality.
• Regulatory standards: Such as AAMI/ANSI/ISO 10993-1 for biocompatibility, ANSI/AAMI/ISO 11135 and ISO 10993-7 for sterilization, IEC 60601-1/60601-2-2 for electrical safety, and IEC 60601-1-2 for EMC.
• Physical measurements and objective comparisons: For thermocouple accuracy, tissue heating time, and thermal lesion volumes (compared to the predicate device).

8. The Sample Size for the Training Set

Not applicable. This document describes a 510(k) submission for a medical device based on substantial equivalence, with non-clinical performance and safety testing. It does not involve machine learning or AI models with "training sets."

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

Not applicable. As there is no "training set" referenced for a machine learning model, the establishment of its ground truth is not relevant to this document.

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The Aerin Medical 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.

The Aerin Medical 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 electrodes and a temperature sensor that allows for monitoring of tissue temperature during radiofrequency energy delivery. The stylus is connected, via a flexible cable, to a commercially-available RF generator (the ORA-50 S, cleared under K993854) meeting the following requirements: RF operating frequency of 460 kHz (± 5 kHz); bipolar low power (3 watts to 5 watts) RF energy delivery; and sensitive temperature control with low overshoot (50°C to 70°C).

This document describes a 510(k) premarket notification for the Aerin Medical Stylus, a radiofrequency wand intended for use in otorhinolaryngology (ENT) surgery to coagulate soft tissue in the nasal airway to treat nasal airway obstruction. The submission asserts substantial equivalence to the predicate device, Aerin Medical Wand (K150637).

Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of specific quantitative acceptance criteria for device performance. Instead, it describes general performance testing conducted and states that the device "met all performance testing requirements." The relevant performance aspects mentioned are:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Cadaver Study (for usability): The document mentions a "cadaver study" but does not specify the number of cadavers or individual tests performed.
  • Tissue Heating Time: The number of tissue samples or tests is not specified.
  • Other tests (Biocompatibility, Sterilization, Electrical Safety, EMC, Packaging): These tests typically involve a defined number of device units or samples according to the relevant standards, but specific numbers are not provided in this summary.
• Data Provenance: Not specified in the provided text. The submission is from Aerin Medical, Inc. based in Sunnyvale, CA, USA, so it is likely that the testing was conducted in the USA or by facilities adhering to relevant international standards. The document does not indicate whether data was retrospective or prospective for any of the non-clinical tests.

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

Not applicable for this device. The testing described is primarily non-clinical engineering and performance testing. "Ground truth" in the traditional sense of expert consensus on diagnostic images or clinical outcomes is not relevant here. Decisions on usability would likely have been made by engineers or clinical specialists involved in the cadaver study, but their qualifications and numbers are not specified.

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

Not applicable. As noted above, this summary focuses on non-clinical performance and safety testing, not clinical studies requiring adjudication of outcomes or diagnoses.

5. 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

Not applicable. The Aerin Medical Stylus is a surgical device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant here.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. For the non-clinical studies described:

• Biocompatibility and Sterilization were validated against established ISO/AAMI standards.
• Electrical Safety and EMC were validated against IEC standards.
• Usability was evaluated in a cadaver study (presumably by observing ease of use, visualizing the treatment, etc.).
• Thermocouple accuracy and response time were measured against known temperatures in a water bath.
• Tissue heating time was measured directly in representative tissues.

The "ground truth" for these tests are the objective measurements against predefined engineering specifications and regulatory standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

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The Aerin Medical Wand 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.

The Aerin Medical Wand is a handheld bipolar radiofrequency (RF) probe designed for use in otorhinolaryngology (ENT) surgery. The Wand comprises a handle, shaft and treatment tip. The treatment tip consists of an array of bipolar electrodes and a temperature sensor that allows for monitoring of tissue temperature during radiofrequency energy delivery. The Wand is connected, via a flexible cable, to a commercially-available RF generator (the ORA-50 S, cleared under K993854) meeting the following requirements: RF operating frequency of 460 kHz (± 5 kHz); bipolar low power (3 watts to 5 watts) RF energy delivery; and sensitive temperature control with low overshoot (50°C to 70°C).

All patient-contacting materials of the Aerin Medical Wand are polymers or stainless steel that have been shown to be biocompatible for short-term contact (less than 24 hours) with breached or compromised surfaces. The Wand is individually packaged and supplied radiation-sterilized for single use.

The Aerin Medical Wand is used in the treatment of patients experiencing chronic nasal airway obstruction. During a treatment procedure, the clinician inserts the tip of the Aerin Medical Wand into a patient's nostril to deliver low power RF energy to the target tissue of the nasal airway. Radiofrequency treatment of tissue creates a coagulative lesion which fibroses and retracts as it heals, thereby shrinking the tissue to lessen the degree of obstruction.

Here's an analysis of the provided text regarding the Aerin Medical Wand (Model FG011) and its acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria for device performance. However, it implicitly defines successful performance by meeting the following:

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

• Clinical Study (Test Set):

  • Sample Size: 33 subjects were enrolled.
  • Treatments: 47 nostrils were treated in the index procedures. 10 subjects had repeat treatments (12 nostrils), for a total of 59 nostril treatments.
  • Data Provenance: Prospective, multi-center, non-randomized study conducted in the United States.

• Pre-Clinical Testing (Animal Study - also a form of test set):

  • Sample Size: Not explicitly stated how many animals were used, but "Several combinations of energy delivery durations and target temperatures were used" in in vivo testing.
  • Data Provenance: This was an in vivo animal study. Location not specified, but typically conducted in a controlled lab/research environment.

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

• Clinical Study:
  • The document implies that physicians performed "physician evaluation of the tissue healing progression" and assessed "endoscopic intranasal assessments." Specific number of physicians or detailed qualifications are not provided, but they would be medical professionals (likely ENT specialists) involved in the study.
• Pre-Clinical Testing:
  • A veterinary pathologist evaluated the treated tissue histologically after 8 weeks of healing. The number of pathologists and their specific experience level are not stated.

4. Adjudication Method (for the test set)

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical study's outcomes. Clinical outcomes like SAE reporting and NOSE score improvements are generally direct measures or subject self-assessments complemented by physician review.

5. 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, an MRMC comparative effectiveness study involving AI assistance was not done. This device is an electrosurgical wand, not an AI-powered diagnostic or assistive tool. The study focused on the device's safety and effectiveness in treating nasal obstruction, comparing its outcomes to medical literature on a predicate device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This report is for a physical medical device (electrosurgical wand), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

• For the Clinical Study (human subjects):

  • Outcomes Data: Primarily based on the patient's subjective "Nasal Obstruction Symptom Evaluation (NOSE) score" (a validated patient-reported outcome measure).
  • Physician Evaluation: Physician assessment of tissue healing progression via endoscopic intranasal assessments.
  • Safety Data: Freedom from SAEs, reporting of adverse events, and external photographic assessments.

• For the Pre-Clinical Testing (animal study):

  • Pathology: Histological evaluation of treated tissue by a veterinary pathologist.

8. The Sample Size for the Training Set

• Not applicable. This document describes a medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. All samples discussed (clinical subjects, animal models) are generally considered test sets for assessing the final device's performance.

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

• Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm.

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