Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Smith & Nephew ElectroThermal® 20S Spine System is intended to create lesions in nervous tissue, and to coagulate and decompress disc material when used in combination with Smith & Nephew thermal/coagulating probes. The generator and accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The proposed Smith & Nephew ElectroThermal® 20S Spine generator is a 20-watt electrothermal generator. It is intended to be used to create lesions in nervous tissue and to coagulate and decompress material when used in combination with Smith & Nephew thermal/coagulating probes. The generator provides temperature and impedance monitoring of energy to maintain effective tissue heating during temperature controlled applications. Smith & Nephew ElectroThermal® 20S Spine generator is designed to be used in conjunction with Smith and Nephew Spine products. These products include the Smith & Nephew SpineCATH® Intradiscal Catheter, the Smith & Nephew Decompression Catheter and the Smith & Nephew RF Denervation Probe and Smith & Nephew RF Probe.

The provided document is a 510(k) summary for the Smith & Nephew ElectroThermal® 20S Spine Generator, which details its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the manner of a clinical trial for diagnostic performance.

Therefore, the detailed information requested regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in this document, as it pertains to performance studies typically conducted for devices with diagnostic or AI components. This submission is for an electrosurgical generator, and the "performance data" referred to is about its functional equivalence to other similar generators.

Here's an interpretation of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence based on technological characteristics and functional performance compared to predicate devices. The "reported device performance" is the demonstration of this substantial equivalence.

2. Sample size used for the test set and the data provenance

• Not Applicable. This document describes a 510(k) submission for an electrosurgical generator, focusing on its substantial equivalence to predicate devices based on technological characteristics and functional performance rather than diagnostic accuracy or clinical outcomes tested on a "test set" of patient data. Performance testing would typically involve engineering and bench testing to confirm the generator's output parameters match those of the predicate, not a "test set" of patient data in the context of diagnostic AI.

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

• Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant here as this is an electrosurgical device. The "ground truth" for its functional performance would be established by engineering specifications and measurements.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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. This device is an electrosurgical generator, not an AI-powered diagnostic tool. MRMC studies are for diagnostic accuracy, typically involving human readers interpreting images with or without AI assistance.

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

• Not Applicable. This is not an algorithm but an electrosurgical device. Its performance is evaluated through engineering and functional tests.

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

• Implied Ground Truth: For this type of device, the "ground truth" for its performance would be established through engineering specifications, bench testing, and functional measurements to ensure that the device generates the correct RF energy, monitors temperature and impedance accurately, and performs its intended electrosurgical functions within established parameters that are comparable to the predicate devices. This is not derived from clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an electrosurgical generator. This terminology applies to machine learning algorithms.

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

• Not Applicable. See point 8.

Ask a specific question about this device