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The Introducer Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.

The Introducer Sheath is intended for establishing a percutaneous access that facilitates the introduction of intravascular devices. The Introducer Sheath is composed of the Guiding Sheath and the Dilator. The Introducer Sheath is available in multiple effective lengths and curve shape configurations.

This document is an FDA 510(k) premarket notification letter for an "Introducer Sheath" device, which is a Class II medical device. The letter determines substantial equivalence to a legally marketed predicate device.

The provided document does NOT describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-powered device or a study involving human readers. Instead, it details the non-clinical bench performance testing for a physical catheter introducer sheath.

Therefore, many of the requested information points, such as AI-specific acceptance criteria, human reader studies, or ground truth establishment for a training set, are not applicable to this document.

However, I can extract the information that is relevant to the physical device performance testing.

Here's an analysis of the provided information:

This document describes the regulatory approval of a physical medical device (an Introducer Sheath), not an AI/Software as a Medical Device (SaMD) or a study involving diagnostic image analysis.

As such, the information requested regarding AI acceptance criteria, human reader studies (MRMC), standalone algorithm performance, ground truth for AI, and training/test set sample sizes for AI is not present in this document. The document focuses on the mechanical, material, and sterility performance of a physical device.

Information relevant to the physical device's performance testing:

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

The document states: "Performance tests were conducted to ensure that the Introducer Sheath met the applicable design and performance requirements throughout its shelf life." and "The tests results indicate that the Introducer Sheath passed all the tests and it conforms to 150 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires."

Explicit Acceptance Criteria (implied by passing tests and conformity to standards):

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

The document refers to "Performance tests" and "tests results" but does not specify the sample sizes (e.g., number of units tested for each physical property) or the provenance (country of origin, retrospective/prospective) of the data. This is typically detailed in the full test reports that support the 510(k) submission, but not in the summary letter itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is for a physical device, not an AI diagnostic tool or an imaging study requiring expert ground truth for interpretation.

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

Not applicable. This is for a physical device, not an AI diagnostic tool or an imaging study requiring expert 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. This is for a physical device. Clinical studies (including MRMC) were explicitly not included: "No clinical study is included in this submission."

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

Not applicable. This is for a physical device.

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

For a physical device, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 11070:2014, ISO 10993 series for biocompatibility) and internal design specifications. There isn't "ground truth" in the diagnostic sense (like pathology for AI).

8. The sample size for the training set

Not applicable. This is for a physical device, not an AI model.

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

Not applicable. This is for a physical device, not an AI model.

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The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

The Super Sheath Introducer Sheath (hereinafter referred to as the "Subject Device") is used to introduce diagnostic or interventional devices into a blood vessel. The Subject Device is available in two products: one consisting of a Sheath and Dilator (Super Sheath Introducer Sheath without Guidewire), and the other consisting of a Sheath, Dilator, and Guidewire (Super Sheath Introducer Sheath with Guidewire), similar to the Predicate Device K121504. These devices are provided sterile and intended for single use, and the shelf-life is three years.

The main component of the Sheath consists of a Sheath hub, a Sheath shaft connected to the Sheath hub, and a three-way stopcock valve connected to the hub with a side port tube. The Sheath shaft is 3.3 French size and available in 5cm and 7cm lengths. The Sheath hub contains a hemostatic valve and has a suture wing. The shape and dimensions of the three-way stopcock luer connector are modified to comply with the new applicable standard ISO 80369-7:2021.

The Dilator has an open, tapered plastic tube for Guidewire insertion. The Dilator tube is press-fit into the inner hub with a bushing. The length of the Dilator tube corresponds to the length of the Sheath shaft, which is longer and available in 10.5 cm and 12.5 cm.

The 0.018" Guidewire is the smallest size Guidewire and a 40 cm long, thin, flexible wire with a inserter attached to the tip. This Guidewire is a legally marketed product which is cleared by the Food and Drug Administration (K021990).

The upper cap and suture wing of the Sheath hub, and the Dilator hub are colored purple. The Dilator tube and the inserter are colored blue. And the unvented cap of the three-way stopcock is pink.

This document is a 510(k) premarket notification for a medical device called the "Super Sheath Introducer Sheath". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or performance data like an AI/ML diagnostic device would.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study to prove a device meets those criteria for an AI/ML-based device. The original request is formulated for a performance study of a diagnostic device (likely AI-powered), which requires metrics like sensitivity, specificity, or AUC, and details on clinical validation with ground truth.

The document describes a physical medical device (an introducer sheath), and its substantial equivalence is proven through:

• Bench Testing: Mechanical and physical properties (tensile strength, kink resistance, connection strength, pressure tests, lubricity, radiopacity, corrosion resistance).
• Biocompatibility Testing: Cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, hemocompatibility, pyrogen test, LAL test.
• Comparison of Technological Characteristics: To a predicate device (K121504) across features like French sizes, indications for use, regulation numbers, components, sterilizations, and dimensional comparisons.

In summary, the provided document does not allow for a response to the specific questions regarding acceptance criteria and performance study details for an AI/ML device.

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The Morph DNA Steerable Introducer Sheath is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

The Morph DNA Steerable Introducer Sheath is sterile, single-use bidirectional deflectable catheter with an ergonomic handle that has an integrated swiveling hemostasis valve. When the handle is fully actuated, the distal tip deflects to a nominal angle in either of two directions based on the diameter and the working length of the catheter. The catheter tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock. Devices are packaged with a compatible dilator on a plastic backing card within a sealed Tyvek pouch, all of which are contained in a product box.

The provided text describes the 510(k) premarket notification for the BioCardia Morph DNA Steerable Introducer Sheath (K242169). This document does not include information about acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML-driven medical device, as the product is a physical medical instrument (a steerable introducer sheath), not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for a machine learning model, as this content is not present in the provided document.

The document details the device's technical specifications, comparison to predicate devices, and various benchtop and simulated use tests conducted to demonstrate that modifications did not affect product specification requirements. These tests are focused on the physical and functional performance of the catheter, not on an AI's diagnostic or predictive capabilities.

Here's a breakdown of what the document does provide in relation to performance testing, which is different from an AI/ML performance study:

Device Performance Testing (Not AI/ML Study)

The document lists performance tests conducted to confirm the device meets product specifications due to modifications from predicate/reference devices.

1. Acceptance Criteria and Reported Device Performance: This section is presented as a list of tests conducted, implying that successful completion of these tests (meeting internal product specifications for each test) is the "acceptance criteria" for this type of physical device. The specific quantitative acceptance criteria values or detailed reported performance values for each test are not explicitly stated in the provided text. Instead, it indicates that the tests were conducted "to confirm that the modifications... did not affect the ability to meet all product specification requirements."

2. Sample Size Used for the Test Set and Data Provenance: Not applicable for a physical device. Testing would involve a number of manufactured units, but this is not typically referred to as a "test set" in the context of data for AI. No information on data provenance (country, retrospective/prospective) is provided as there's no data being collected for an AI model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. The "ground truth" for a physical device like this is its physical and functional performance according to engineering specifications and simulated use scenarios, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set: Not applicable for this type of device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, an MRMC study is relevant for AI/ML diagnostic or prognostic tools that assist human readers. This is a physical medical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no AI algorithm.

7. The Type of Ground Truth Used: For this physical device, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993, ASTM standards) and internal product specifications for attributes like tip deflection, catheter diameter, material properties, and functional performance in simulated use models.

8. The Sample Size for the Training Set: Not applicable, as there is no training set for an AI model.

9. How the Ground Truth for the Training Set Was Established: Not applicable.

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Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.

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I'm sorry, but this document does not contain the information requested regarding acceptance criteria and device performance for an AI/ML-based medical device study.

The provided text is a 510(k) clearance letter from the FDA for an "Introducer Sheath Kit" (product code DYB). This is a physical medical device (a catheter introducer), not an AI/ML-based software device.

Therefore, I cannot extract details about:

1. A table of acceptance criteria and reported device performance for an AI model.
2. Sample size, data provenance, expert qualifications, or adjudication methods for an AI test set.
3. MRMC studies or standalone AI performance.
4. Ground truth types or training set details for an AI model.

The letter focuses on the substantial equivalence of the "Introducer Sheath Kit" to legally marketed predicate devices, and discusses general regulatory requirements for medical devices.

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The Intri24 Introducer Sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

The Intri24 Introducer Sheath is a single-use over-the-wire system intended for use in vessels > 9 mm and is a conduit for the insertion of diagnostic or endovascular devices into the peripheral vasculature. The Intri24 Introducer Sheath consists of a Sheath and Dilator. The Sheath is comprised of a single lumen catheter with a hydrophilic coating, a proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid with fluoroscopic visualization. The Dilator is 0.035" guidewire compatible and attaches to the hemostasis valve on the Sheath. The Dilator has a tapered edge to aid in the dilation of the target vessel for insertion and positioning of the Sheath.

The provided text describes a medical device, the Intri24 Introducer Sheath, and its regulatory clearance. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The tests described are primarily related to mechanical performance, biocompatibility, and sterilization of a physical medical device, not the performance of an AI algorithm or model.

Therefore, I cannot provide the information requested in your prompt based on the given text.

Specifically:

1. Table of acceptance criteria and reported device performance: This information is not present for AI/ML performance. The document lists non-clinical performance tests for the physical introducer sheath (e.g., visual inspection, dimensional inspection, tensile testing, fluid leak tests), but these are not related to an AI/ML device's performance.
2. Sample size for test set and data provenance: Not applicable, as there's no AI/ML test set discussed.
3. Number of experts used to establish ground truth and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document discusses "design verification testing" and lists various mechanical and functional tests for the introducer sheath, but these are for a traditional hardware device, not an AI/ML-powered one.

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ARMADA Ureteral Dilator Set: Used for step by step dilatation of the intramural and ureter and / or for stone manipulation.
ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter.
ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal.
ARMADA Renal Dilator: Used for dilatation of Renal Tract.
Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract.
Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire.
Introducer Sheath: Used for introducing safety wire during nephrostomy.
Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy tract.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Allwin Dilator & Sets", which specifies the device's indications for use and regulatory information. However, it does not describe any acceptance criteria or a study that proves the device meets specific performance criteria through a rigorous testing process involving AI or human reader performance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm only) performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval letter for a medical device (dilators and sets), not a technical report or study detailing the validation or performance of an AI/ML diagnostic tool.

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Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.

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The provided document is an FDA 510(k) clearance letter for an "Introducer Sheath Kits." This type of document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical imaging device utilizing AI.

The letter focuses on the regulatory clearance process, establishing substantial equivalence to a predicate device, and outlining general controls and regulations that the manufacturer must adhere to. It concerns a physical medical device (introducer sheath kits) used for facilitating the introduction of guidewires and catheters.

Therefore, I cannot provide the requested information based on the given text.

To answer your questions about acceptance criteria and device performance studies, you would typically need a clinical study report or a data summary from a premarket submission (e.g., PMA or 510(k) summary for an AI/ML medical device), which would detail:

1. Acceptance criteria and reported performance: Specific metrics (e.g., sensitivity, specificity, AUC) and predefined thresholds.
2. Sample size and data provenance: Details of the dataset used for validation.
3. Experts for ground truth: Number and qualifications of readers/experts.
4. Adjudication method: How disagreements were resolved.
5. MRMC study information: If applicable, details on human reader performance with and without AI.
6. Stand-alone performance: Algorithm-only performance metrics.
7. Type of ground truth: How the "truth" was established for the test data.
8. Training set size: Number of cases used for model training.
9. Training set ground truth: How ground truth was established for the training data.

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The EXTesia Introducer Sheath Set is intended to be inserted percutaneously into a vessel to facilitate placing the interventional or diagnostic devices into a vein or artery.

The EXTesia Introducer Sheath Set is used to facilitate placing a catheter through the skin into a vein or artery. The set consists of an introducer (a sheath and a dilator) packaged together with an entry needle, guide wire, flushing syringe, and scalpel. The sheath and dilator contain a radiopaque material which makes these devices visible under fluoroscopy. In addition, the sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

EXTesia Introducer Sheath Set is packaged in a Tyvek 1073B pouch, sealed, labelled and EtO sterilized. It is for single use only. The EXTesia Introducer Sheath Set is designed for 3 years shelf life.

This document is a 510(k) summary for the EXTesia Introducer Sheath Set, not a study report that details specific acceptance criteria and device performance in a clinical study with human data. Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for training sets cannot be extracted from this document.

However, based on the provided text, I can infer some information relevant to performance testing and the lack of clinical studies.

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

The document broadly states that the device "meets the requirements for product specifications" but does not provide specific quantitative acceptance criteria or detailed performance results for each test.

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

• This document does not specify sample sizes for mechanical, functionality, biocompatibility, sterilization, or simulated usability tests.
• Data Provenance: Not specified, but these are typically in-house laboratory and engineering tests, not clinical studies with human data from specific countries. The testing would be prospective (designed and executed for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable for performance testing described. The "ground truth" for mechanical and functional tests is typically based on engineering specifications and validated test methods, not expert human assessment in the way clinical studies would require. Simulated usability implies expert observation or evaluation but details on the number or qualifications of "experts" are not provided.

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

• Not applicable for performance testing described. Adjudication methods like 2+1 or 3+1 are used in clinical studies where there's a need to resolve discrepancies in human expert interpretations of ground truth. The performance testing outlined here (biocompatibility, sterilization, mechanical, functionality, simulated usability) would follow pre-defined test protocols with objective pass/fail criteria, not consensus-based 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 MRMC comparative effectiveness study was done. The document explicitly states: "No Clinical Testing was required for this product." This makes it clear that there was no study involving human readers/users in a comparative effectiveness setting as described for AI assistance.

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

• Not applicable. The EXTesia Introducer Sheath Set is a physical medical device (catheter introducer), not a software algorithm or AI-powered device. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The performance testing focused on the physical characteristics and function of the device itself.

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

• For the performance testing mentioned (biocompatibility, sterilization, mechanical integrity, functionality, product specifications, simulated usability), the "ground truth" would be established by engineering specifications, international standards, and established laboratory test methods. For example, biomechanical tests would have defined load limits, and sterility tests would have defined microbial reduction rates. Outcomes data, pathology, or expert consensus (in a clinical sense) are not relevant to these types of bench and simulated tests.

8. The sample size for the training set:

• Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, no training set was used.

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The Clarus Peel-Away Introducer Sheath is intended to be used in indications requiring access through the brain into the ventricular system.

The Clarus Peel-Away Introducer Sheath is a thin-walled, cylindrical device that is placed in position so that it provides a communicating passageway through brain tissue. This is accomplished by fitting the sheath securely over an obturator, advancing both devices through the tissue together as a unit. A hole through the distal tip of the obturator aids in placement by allowing pressurized cerebrospinal fluid to egress once the ventricular system is reached. The proximal hub on the obturator is rotated, unlocking it from the sheath, and the obturator is removed from the sheath, leaving the sheath alone in the desired position acting to hold the penetrated site in an open condition. The peel away sheath is capable of being pulled apart lengthwise to allow varying insertion depths into brain tissue. The proximal end of the sheath has tab handles that are provided to facilitate grasping and tearing. At this point, a regulatorily cleared device can be inserted through the sheath for patient procedures.

The provided text describes the Clarus Peel-Away Introducer Sheath and its substantial equivalence determination. Here's a breakdown of the acceptance criteria and study details based on the provided FDA 510(k) summary:

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

The acceptance criteria for the Clarus Peel-Away Introducer Sheath were based on demonstrating substantial equivalence to predicate and reference devices, primarily through biocompatibility and mechanical testing. The reported device performance indicates that the device passed all tests and had comparable results to the predicate/reference devices.

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

The document does not explicitly state the sample sizes used for the biocompatibility or mechanical testing. It mentions "Components of the Clarus Peel-Away Introducer Sheath and predicate devices were tested," implying that multiple units were tested, but no specific numbers are provided.

The data provenance is not specified regarding country of origin or whether studies were retrospective or prospective. Given this is a 510(k) submission for a medical device, the testing would generally be prospective to generate data for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of device and testing described. The acceptance criteria for this device are based on objective performance characteristics (biocompatibility, mechanical properties) rather than interpretation requiring expert consensus. There were no "ground truth" labels established by experts in the context of image interpretation or diagnostic accuracy studies.

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

Not applicable. As noted above, this device's evaluation relies on objective physical and material property tests rather than diagnostic interpretation requiring 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

Not applicable. This device is a physical introducer sheath, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.

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)

For biocompatibility testing, the "ground truth" is adherence to established international standards (ISO 10993-1) and the successful completion of specific biological tests, with "acceptable" results serving as the ground truth for safety.

For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to the performance of predicate devices that are already deemed safe and effective. "Pass" results and "comparable results" to predicates served as the ground truth for performance.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not based on machine learning or AI models that require training data.

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

Not applicable, as there is no training set for this type of device.

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The EasyPath RF Introducer Sheath is a single-use device intended to be used with flexible bronchoscopes as a working channel through which endoscopic tools may be introduced to target tissue. It is indicated for electrosurgical procedures involving cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree.

The EasyPath RF Introducer Sheath is a sterile, single-use, monopolar endoscopic device intended to be inserted through the working channel of a flexible bronchoscope, with an inner diameter (ID) of 2.8 mm or greater, which provides an extended working channel through which endoscopic tools, such as needles, biopsy forceps, or other endoscopic devices may be introduced to target sites. Similar to Empower RF Catheter, the EasyPath incorporates a distal electrode for delivering RF energy for cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree. The monopolar electrode at the distal tip facilitates cutting the target tissue using controlled monopolar radiofrequency (RF) energy.

The EasyPath has a flexible shaft with a 2.65 mm OD with braid reinforced tubing and a stylet, to resist kinking during device advancement and articulation. The stylet is used to provide an atraumatic tip and to provide rigidity (i.e., pushability). Removal of the stylet allows for standard 2.0 mm working channel bronchoscopic accessories to be inserted through the lumen of the sheath. The electrode tip of the sheath is visible, as well as the marker bands to provide the user with an indication of movement relative to the bronchoscope. Radiopaque markers are at the distal end of the sheath to aid visualization of the sheath under fluoroscopy, if utilized.

The provided document is a 510(k) Pre-Market Notification for the Broncus Medical EasyPath RF Introducer Sheath. It describes the device, its intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner as typically seen for AI/software devices. Instead, it lists the types of testing performed to demonstrate that the device meets product specifications and is "safe and effective for its intended clinical use." The "reported device performance" is essentially that the device met the specifications for each test, thereby supporting substantial equivalence.

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

The document describes various engineering and biological tests, not a clinical study with a "test set" of patient data in the context of AI performance.

• Sample Sizes: Not specified for individual bench or in vivo tests. However, typical regulatory submissions for devices like this involve a sufficient number of samples to ensure statistical significance for each test.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of this device type. The tests are laboratory-based (bench, in vitro, in vivo animal model) and conducted by the manufacturer or contracted labs as part of the design verification process. The in vivo testing was conducted on porcine lungs.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this device type. There is no "ground truth" to be established by human experts in a diagnostic sense for this electrosurgical introducer sheath. The "ground truth" for its performance is determined by meeting engineering specifications and safety standards through the described testing.

4. Adjudication Method for the Test Set

Not applicable. There is no concept of a "test set" requiring adjudication by human readers for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI device or a diagnostic device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device (introducer sheath) with an electrosurgical function, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

• Engineering Specifications: The device's physical dimensions, material properties, electrical characteristics, and functional performance must meet predefined design specifications.
• Regulatory Standards: Compliance with recognized international and national standards (e.g., ISO, IEC, ASTM) for biocompatibility, sterilization, electrical safety, and packaging.
• Bench Test Results: Direct measurement and observation of device performance under controlled laboratory conditions.
• In-vivo Animal Model Data: Functional and thermal effects demonstrated in living biological tissue (porcine lung).

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for this type of medical device submission.

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

Not applicable, as there is no "training set."

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