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The Stylus is intended to assist in the placement of Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button by providing temporary feeding tube stability during insertion through patient stoma tract.

The Stylus (may also be referred as Stylet, Introducer, Obturator or Stiffener) is an Introducer for the Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button (LPGFT/B - K122030) originally cleared in July 2012 which was developed at Degania Silicone Ltd. The Stylus is made of Polycarbonate (Macrolon®) and has various ranges of lengths, colors and weights. The Stylus is inserted all the way into the Feeding Port of the LPGFT/B port of the cleared gastrostomy device. The use of the Stylus is optional, it provides stiffness to the LPGFT/B shaft to guide the LPGFT/B through the stoma. The Stylus should not exceed the buttons distal tip. The Stylus is being sterilized by Ethylene Oxide (EtO) along with a compatible Low Profile Gastrostomy Feeding Tube/ Gastrostomy Button kit, rather than a standalone device.

The provided text describes the "Stylus" device, which assists in placing gastrostomy feeding tubes. The 510(k) summary (K233591) details its regulatory information and a brief overview of testing. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and study specifics.

Based on the available text, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Bench Performance Testing" that included:

• Tensile strength testing
• Stylus stiffness testing
• Dimensional testing
• Gastrostomy compatibility testing

The reported performance conclusion is: "The results show that the device is at least as [effective as] a legally marketed predicate device."

However, the specific numerical acceptance criteria or the quantitative results for these tests are not provided in the given text. A table cannot be generated without these details.

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

The document states, "Bench Performance Testing included tensile strength testing, styls stiffness testing dimensional testing, and gastrostomy corpatibilitytesting." However, no details about the sample size used for these tests or the data provenance (e.g., country of origin, retrospective/prospective) are provided.

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

This information is not mentioned in the provided text. The testing described appears to be bench testing, not involving human interpretation or ground truth established by experts.

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

This information is not mentioned in the provided text. Adjudication methods are typically relevant for studies involving human assessment or interpretation, which is not described for this bench testing.

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

An MRMC study is not mentioned in the provided text. The device described, the Stylus, is a physical introducer for feeding tubes, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable as the Stylus is a physical medical device, not an algorithm or software. The testing mentioned is device performance testing, not algorithm performance testing.

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

For the bench performance tests mentioned (tensile strength, stiffness, dimensions, compatibility), the "ground truth" would be the engineering specifications and established physical measurement standards relevant to the device's function and comparison to the predicate. The document doesn't explicitly state "ground truth" in this context but implies a comparison to predicate device performance.

8. The sample size for the training set

The Stylus is a physical device and not an AI/ML model, so there is no training set in the context of machine learning. The testing described is physical performance testing.

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

As there is no training set for this type of device, this question is not applicable.

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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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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

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The Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy
• Lumbar Stenosis Decompression
• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar Interbody Fusion (ALIF)
• Direct Lateral Interbody Fusion (DLIF)

The Electric Drill System consists of an electric Integrated Power Console, Electric Foot Control unit with Y-Splitter, Connection Cables, Irrigation/Cooling Sets including a remote Irrigation Control Unit, and various Electric Handpieces and/or electric motors and Attachments to drive various Surgical Dissecting Tools. The Integrated Power Console device of the Electric Drill System can also function as an endoscope lens cleaning system.

Thank you for providing the detailed documentation for the Medtronic Powered Surgical Solutions. However, after careful review, I must inform you that the provided information does not contain the specific details required to complete your request for acceptance criteria and a study proving a device meets those criteria.

The document is a 510(k) premarket notification for an Electric Drill System. While it discusses the device's indications for use and compares it to predicate devices, it primarily focuses on demonstrating substantial equivalence to previously cleared devices.

Here's why the requested information is not available in the provided text:

• Acceptance Criteria for Device Performance: The document does not explicitly state quantitative or qualitative "acceptance criteria" for the device's performance that would typically be associated with a new or significantly modified device needing to demonstrate its capabilities against specific benchmarks. The focus is on demonstrating that the device performs similarly to previously cleared devices for its expanded indications.
• Study Proving Device Meets Acceptance Criteria: Consequently, there is no detailed study described that proves the device meets such acceptance criteria. The performance testing sections (9.12) describe a "Clinical Literature Review" and "Cadaveric Testing."
  • The Clinical Literature Review supports the use of the system for expanded indications, but doesn't quantify device performance against specific targets.
  • The Cadaveric Testing states that "The Medtronic Electric Drill System is acceptable for its intended use in various surgical procedures," which is a qualitative conclusion rather than a demonstration against defined acceptance metrics. There are no details about what was measured, how it was measured, or what values would be considered acceptable.

Therefore, I cannot provide the requested table or detailed information regarding sample sizes, data provenance, ground truth establishment, or specific performance metrics from the provided document.

The document's purpose is to establish substantial equivalence based on comparable performance and indications for use, rather than to present a de novo study with explicit acceptance criteria for a new device's performance.

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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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SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures

SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus and Twist applicators contain the identical adhesive formula and incorporate a plastic ampoule, which houses the adhesive, contained within the double longer plastic sleeves with an attached applicator tip. When SURGISEAL is applied to the skin with these applicators, it polymerizes in minutes.

The provided document is a 510(k) premarket notification for topical skin adhesives (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or performance study.

Therefore, the information required to populate most of the sections of your request (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document. This document is related to a medical device approval and not a software or AI algorithm approval.

However, I can provide information on acceptance criteria that are implicitly or explicitly mentioned for the biocompatibility and sterilization aspects of the device, which are part of its overall safety and effectiveness.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not provided in the document):

2. Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI/ML algorithm evaluation; for biocompatibility, sample sizes for in vitro or in vivo tests are part of the ISO standards but not detailed here. The studies were previously conducted on predicate devices. Data provenance would be related to the lab conducting the biocompatibility tests.
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 biocompatibility and sterilization is based on established scientific methods and standards.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used:
   • For Biocompatibility: The "ground truth" is defined by the biological response of cells/tissues to the material, as assessed by standardized tests (e.g., cytotoxicity, irritation, sensitization assays) according to ISO-10993.
   • For Sterilization: The "ground truth" is the sterility assurance level (SAL) achieved, verified by validated sterilization cycles and appropriate microbiological testing, according to ISO 11137 and ISO 11135.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The document describes a 510(k) submission for new topical skin adhesive products (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). The "study" or rather, the evidence presented to ensure safety and effectiveness and demonstrate substantial equivalence, relies primarily on:

• Identity of Technological Characteristics: The device's formulation (monomeric 2-octyl cyanoacrylate) and mode of action are identical to previously cleared predicate devices.
• Biocompatibility Testing: Prior biocompatibility testing conducted on the predicate devices (SURGISEAL Teardrop (K082993), SURGISEAL Stylus (K130474), and SURGISEAL Twist (K130474)) in accordance with ISO-10993 was leveraged. This testing confirmed the materials were non-toxic, non-irritating, non-sensitizing, and biocompatible. No new biocompatibility testing was required because the subject devices are identical to the predicates in terms of materials.
• Sterilization Validation: Validation of sterilization methods (electron beam and gamma irradiation for Surgiseal, and gamma followed by ethylene oxide for Stylus and Twist) was conducted according to international standards (ISO 11137-2:2006, ISO 11135-1:2008, ISO 11135-2:2008). This ensures the devices are supplied sterile.
• Shelf-Life Determination: A 2-year shelf life was established, implying stability testing was performed, though details of this testing are not provided in this specific document snippet.
• Microbial Barrier Properties (In vitro): In vitro studies showed SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. However, the document explicitly states that clinical studies were not conducted to demonstrate microbial barrier properties, and a correlation between microbial barrier properties and a reduction in infection has not been established.

In essence, the "study" for this 510(k) submission is a demonstration that the new devices are substantially equivalent to already approved predicate devices regarding their materials, design, intended use, and performance characteristics, supported by prior testing data and adherence to recognized standards for biocompatibility and sterilization.

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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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SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.

SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.

SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus applicator incorporates the identical adhesive formula but incorporates the Stylus applicator that consists of a plastic ampoule, which houses the adhesive, contained with the longer plastic sleeve within a longer plastic sleeve with an attached applicator tip. When SURGISEAL is applied to the skin with either Applicator, it polymerizes in minutes.

In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.

The provided document describes a 510(k) submission for SURGISEAL® Topical Skin Adhesive and SURGISEAL Stylus™ Topical Skin Adhesive. The submission is for a labeling change to include a "Microbial Barrier description." The document explicitly states: "In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established." Furthermore, it clarifies that the 510(k) submission is for a labeling change to characterize the ease, safety, or effective use of the product based on extensive bench performance testing, which has demonstrated to be safe & efficacious.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical studies, ground truth, sample sizes, and expert adjudication cannot be extracted accurately for the microbial barrier claim, as no clinical studies were performed. The "Performance Testing" section mentions "Microbial Barrier Tests and Film Thickness determinations for each of the two applicators" as bench tests.

However, based on the information provided about the bench performance testing for the microbial barrier property, here's what can be inferred and stated:

1. Table of acceptance criteria and the reported device performance:

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

• Sample size: Not specified in the provided text for the in vitro microbial barrier studies.
• Data provenance: "In vitro studies," meaning laboratory-based studies. The location/country of the lab is not specified, but it's a retrospective assessment of prior in vitro work.

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

• Not applicable. The ground truth for in vitro microbial barrier studies would typically be established through standardized microbiological testing protocols, not human expert consensus.

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

• Not applicable as it was an in vitro laboratory test, not a subjective assessment requiring human adjudication.

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 was not done. The submission is for a topical skin adhesive, not an AI-assisted diagnostic or interpretive device.

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

• No, not applicable. This is for a medical device (topical skin adhesive), not an algorithm.

7. The type of ground truth used:

• For the microbial barrier claim: The ground truth was based on the results of in vitro microbiological testing demonstrating the physical barrier property.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or algorithm-based device requiring a training set in that context. The "training" here refers to the development and testing of the physical adhesive product.

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

• Not applicable in the context of a "training set" for an algorithm. The development of the adhesive product was likely based on various bench tests and physicochemical characterizations to achieve desired properties, which would serve as "ground truth" for product development.

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