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The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

The GORE® ACUSEAL Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the GORE® ACUSEAL Vascular Graft. This type of document establishes substantial equivalence to a predicate device and does not contain the detailed study information typically found in a clinical trial report or an academic paper describing device performance against explicit acceptance criteria.

Specifically, the document states:

• "One in vitro study was conducted to demonstrate substantial equivalence to the predicate device."
• "The GORE® ACUSEAL Vascular Graft is substantially equivalent to the predicate device. The change to the end-of-shelf-life Heparin Surface Activity specification does not raise new types of safety or effectiveness questions, and the testing provided in this application supports a determination of substantial equivalence."

Therefore, the document does not provide the information requested regarding acceptance criteria and the detailed study that proves the device meets them because it's a 510(k) clearance based on substantial equivalence, not a performance study against predefined criteria.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria or conducting extensive clinical trials, especially for Class II devices like this vascular graft.

As a result, I cannot fill in the requested table and details about the study because that information is not present in the provided FDA clearance letter.

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GORE® BIO-A® Tissue Reinforcement is intended for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery.

Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include:

-Hernia repair as suture line reinforcement

-Muscle flap reinforcement

-General tissue reconstructions

The subject GORE® BIO-A® Tissue Reinforcement is a bioabsorbable web structure that functions as a surgical mesh for soft tissue reinforcement while providing a scaffold for tissue ingrowth. It is used to reinforce soft tissue during the phases of wound healing by filling soft tissue deficits. The device elicits a physiologic tissue response which fills the deficit with native tissue and gradually absorbs the device. The implanted GORE® BIO-A® Tissue Reinforcement is a textured porous fibrous web surface on both surfaces composed solely of synthetic bioabsorbable poly (glycolide:trimethylene carbonate) copolymer (PGA:TMC). In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months. The GORE® BIO-A® Tissue Reinforcement is available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The device is sterilized by gamma irradiation validated to an SAL of 10°. It is for single use only.

I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain the information needed to answer your request about acceptance criteria and the study that proves the device meets those criteria.

The 510(k) submission for the GORE BIO-A Tissue Reinforcement, K191773, explicitly states:

• "No bench, animal, or clinical studies were required to support the labeling modification." (Page 4, under "Summary of Performance Testing")
• The entire submission is focused on a "labeling change that is not related to any safety or effectiveness issue" and clarifies that there are "no differences in technological characteristics between the subject and predicate device." (Page 4, under "Differences in Technological Characteristics")

Therefore, the document does not discuss:

1. A table of acceptance criteria or reported device performance from a new study.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Types of ground truth used.
8. Sample size for training sets.
9. How ground truth for training sets was established.

This is a regulatory clearance for a labeling change only, implying that the device itself was previously cleared or is substantially equivalent to a cleared predicate, and no new performance data was submitted or required for this specific 510(k) application.

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The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.

The GORE® Tri-Lumen Catheter (TLC) is a 140cm long multi-lumen accessory catheter designed to assist with multiple wire introduction and control during endovascular procedures. The central lumen can accommodate one 0.035" guidewire or two 0.018" guidewires while the two auxiliary lumens can each accommodate one 0.014" quidewire. The trailing end of the device has two distinct extension tubes to assist in the introduction of the guidewires into the auxiliary lumens. The leading end of the device is radiopaque to assist in visibility under fluoroscopy. The GORE® Tri-Lumen Catheter is designed to minimize entanglement of multiple quidewires and facilitate through and through access during cardiovascular procedures with fewer snaring maneuvers.

The provided text describes the 510(k) premarket notification for the GORE Tri-Lumen Catheter (TLC), primarily focusing on its substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and the performance data gathered. However, the document does not present "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format typically used for AI/ML device evaluations, which would involve metrics like sensitivity, specificity, or AUC against a ground truth.

Instead, the performance data section (page 8) focuses on engineering and biocompatibility testing for a medical catheter, confirming its functionality and safety characteristics by comparing it to established standards (BS EN ISO 10555-1:2013) and a predicate device. The information provided is for a physical medical device, not an AI/ML algorithm.

Therefore, many of the specific questions regarding acceptance criteria for AI models, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable or cannot be answered from the provided text for an AI/ML device.

Here's an attempt to extract relevant information and note the absence of others based on your request, understanding that the device is a physical catheter, not an AI solution:

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

Since this is a physical medical device (catheter) and not an AI/ML algorithm, the "acceptance criteria" are based on engineering performance tests and biocompatibility, demonstrating that the device meets general requirements for intravascular catheters and is substantially equivalent to a predicate. The document doesn't provide specific quantitative acceptance criteria or reported performance values in a table format that are directly comparable, but lists the types of tests performed.

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: The clinical "test set" (referred to as an Early Feasibility Study) involved 13 patients.
• Data Provenance: The study was an "Early Feasibility Study to evaluate the initial safety of an investigational aortic stent graft," which used the GORE Tri-Lumen Catheter as an accessory device. The document does not specify the country of origin of the data, but W.L. Gore & Associates, Inc. is a U.S.-based company, suggesting the study likely took place in the US or a region with similar regulatory standards. The study appears to be prospective as it involved treating patients with an investigational device.

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 a physical catheter, "ground truth" as understood in AI/ML is not relevant. The assessment of the catheter's performance in the clinical study would have been conducted by the medical professionals involved in the procedures. The document states the "intended user" includes "Physicians trained in and/or familiar with endovascular procedures and similar devices," which may include "vascular surgeons, interventional radiologists, and interventional cardiologists." No specific number or qualifications for establishing ground truth are provided, as clinical observation and reporting of events served as the outcome assessment.

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

Not applicable. As this is not an AI/ML device requiring interpretative output to be adjudicated against a ground truth, no such adjudication method is mentioned or relevant. The clinical study assessed the catheter's safe and effective performance.

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 is not an AI/ML device, so no MRMC comparative effectiveness study was performed, and thus no effect size related to AI assistance can be reported.

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 the clinical performance, the "ground truth" was based on outcomes data and observational reports during the Early Feasibility Study. Specifically, it states, "The GORE® Tri-Lumen Catheter performed this task safely and effectively with no procedural or device related events reported as a result of using the catheter." This indicates safety and efficacy were assessed through direct observation of procedural success and lack of adverse events.

8. The sample size for the training set

Not applicable for a physical medical device. There is no concept of a "training set" for AI/ML in this context. The device's design and manufacturing are based on engineering principles and validated through the performance tests mentioned.

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

Not applicable, as there is no training set for an AI/ML model for this device.

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GORE® ENFORM Biomaterial is indicated for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® ENFORM Biomaterial may be used include hernia repair as suture line reinforcement, muscle flap reinforcement, and general tissue reconstructions.

As packaged, GORE® ENFORM Biomaterial is a porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure that functions to reinforce soft tissue during the phases of wound healing by filling softtissue deficits. The bioabsorbable, porous scaffold structure of the ENFORM device elicits a physiological response which fills the deficit with native tissue and gradually absorbs the device. There are two configurations of the GORE® ENFORM Biomaterial. One configuration will possess an added PGA:TMC film layer on one side of the device to provide visceral protection in soft tissue reinforcement applications requiring intraperitoneal contact with the viscera. Both ENFORM configurations are available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The GORE® ENFORM Biomaterial is supplied sterile for single use only.

The provided text describes a medical device, the GORE® ENFORM Biomaterial, and its FDA 510(k) premarket notification. However, it does not include acceptance criteria, specific device performance data in a table format, or details about a study that proves the device meets specific acceptance criteria in the way typically found for an AI/ML powered device.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a traditional medical product (surgical mesh).

Here's an attempt to answer your questions based solely on the provided text, highlighting what is and isn't available:

Since this document describes a traditional medical device (surgical mesh), not an AI/ML powered device, most of the requested information (like sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not provided in this type of submission.

Therefore, the table of acceptance criteria and reported device performance from an AI/ML perspective cannot be created as the data is not present. The "performance criteria established for the indicated uses of the device" are mentioned as having been met, but the specific criteria and results are not detailed.

Here's what can be extracted based on your desired headings:

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

• Acceptance Criteria: The document states: "Results demonstrated that both configurations of the GORE® ENFORM Biomaterial met the performance criteria established for the indicated uses of the device." However, the specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum stiffness, specific biological response thresholds) are not detailed in this document.
• Reported Device Performance: Similarly, the specific quantitative performance results are not detailed. The document broadly states that the device "met the performance criteria" and "demonstrated substantial equivalence" to predicate devices.

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

• Test Set Sample Size: Not specified. The document mentions "Bench study" and "Animal study" but does not provide sample sizes for these studies.
• Data Provenance: Not specified. Animal studies are mentioned, but details on the species, number of animals, or study design (e.g., retrospective/prospective) are absent.

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 / Not Provided. For a surgical biomaterial, "ground truth" would typically be established through histological analysis, physical testing, and clinical observations in animal models. The experts involved in evaluating these results (e.g., pathologists, surgeons, material scientists) are not specified.

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

• Not Applicable / Not Provided. This concept is more relevant to AI model evaluation where multiple human readers assess cases. For a traditional device, testing focuses on physical properties, biocompatibility, and physiological response, which are typically measured objectively or evaluated by specialists without a "reader adjudication" process.

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. Not Applicable. This device is a biomaterial, not an AI/ML product designed to assist human readers.

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

• No. Not Applicable. This device is a biomaterial, not an algorithm.

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

• For the Animal Study, the "ground truth" would implicitly be derived from observed physiological responses, tissue ingrowth, and visceral protection evaluations (likely through gross observation, histology/pathology, and potentially biomechanical assessments in the animals).
• For Bench Testing, the "ground truth" would be the measured physical properties against established material specifications or predicate device performance.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is not an AI/ML product developed using training data.

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

• Not Applicable / Not Provided. This device is not an AI/ML product.

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The GORE® VIABIL® Short Wire Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.

The GORE® VIABIL® Short Wire Biliary Endoprosthesis is a flexible endoprosthesis (stent) that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the GORE® VIABIL® Short Wire Biliary Endoprosthesis at the target site in the biliary tract. The subject of this 510(k) pre-market notification is a modification to the catheter component of the endoscopic (GI) delivery system to include a guidewire exit port located near the distal end of the catheter which will allow use of a shorter length (minimum 260cm) guidewire enabling single user control of the guidewire during use. No changes have been made to the implanted endoprosthesis of the predicate GORE® VIABIL® Biliary Endoprosthesis device.

This document is a 510(k) premarket notification from the FDA, discussing the substantial equivalence of a new medical device, the GORE® VIABIL® Short Wire Biliary Endoprosthesis, to a previously marketed predicate device. As such, it focuses on demonstrating substantial equivalence rather than proving a device meets specific clinical performance acceptance criteria through a full-scale clinical study with human patients and outcomes data.

Therefore, the provided text does not contain the information requested for a detailed "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance or AI/human reader studies.

Specifically, the document states:

• "No animal studies were required to support this submission." (Page 7)
• "No clinical evaluations were required to support this submission." (Page 7)

The "Summary of Performance Testing" section (Page 6-7) refers to non-clinical testing primarily related to the device modification (a change to the catheter component for guidewire use). This testing aims to show that the modified device performs similarly to the predicate device in terms of engineering and material properties, rather than clinical efficacy.

Here's what can be extracted based on the provided text, and what is missing:

Information Present in the Document:

The document describes non-clinical performance testing conducted to ensure the modified device (GORE® VIABIL® Short Wire Biliary Endoprosthesis) is substantially equivalent to its predicate (GORE® VIABIL® Biliary Endoprosthesis K081184). The focus is on the catheter component modification to allow for a shorter guidewire.

Acceptance Criteria and Reported Device Performance (Non-Clinical):

Information NOT Present in the Document (and explicitly stated as not required):

The document explicitly states that no animal or clinical evaluations were required. Therefore, none of the following information, which would typically be found in a clinical study report for proving device efficacy or effectiveness, is available:

1. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used. The non-clinical tests were conducted on "representative sterile, aged samples."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as there was no clinical study.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 endoprosthesis, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" would be engineering specifications and predicate device performance.
7. The sample size for the training set: Not applicable. No machine learning/AI model was developed or trained.
8. How the ground truth for the training set was established: Not applicable.

Conclusion:

This 510(k) submission relies on a demonstration of substantial equivalence through non-clinical performance testing of a modified device component, rather than a clinical study proving new efficacy or safety. The acceptance criteria and performance data provided relate only to engineering, materials, and functional aspects of the device in a non-clinical setting, ensuring the modified device functions comparably to its predicate.

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The GORE® DrySeal Flex Introducer Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

The GORE® DrySeal Flex Introducer Sheath consists of an introducer sheath with the GORE® DrySeal Valve attached, a twist style locking dilator, and a syringe. The introducer sheath is a composite tube which consists of a flat stainless steel wire reinforced hydrophilic coated Pebax® outer tube and PTFE liner with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath is attached to the GORE® DrySeal Valve.

The GORE® DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5 mL of saline into the space, using the provided syringe, during procedural preparation of the device.

The dilator has a tapered leading end and provides dilatation of the access vessel while providing a smooth transition from the guidewire to the introducer sheath leading tip. The dilator is 0.035" guidewire compatible and has a locking mechanism which mates with, and secures to, the DrySeal Valve. The sheath hub is embossed with its French size and a visual marker on the trailing end of the dilator shaft that ensures correct combination of the dilator within the sheath.

The provided text describes a medical device, the GORE® DrySeal Flex Introducer Sheath, and its FDA 510(k) premarket notification. However, it does not contain a typical "study" proving the device meets specific acceptance criteria in the format usually seen for AI/ML or diagnostic device performance claims (e.g., sensitivity, specificity, AUC, human reader performance).

Instead, the document details a bench study used to demonstrate the device's substantial equivalence to predicate devices, focusing on engineering and material characteristics rather than diagnostic or human performance.

Therefore, many of the requested fields cannot be directly answered from the provided text, as the focus is on a hardware medical device rather than a software algorithm or a diagnostic tool requiring expert ground truth and comparative effectiveness studies.

Here's an attempt to extract and interpret the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Performance Data / Predicate Device Comparison" section, which lists the tests performed to demonstrate substantial equivalence. The "Reported Device Performance" is stated as "the subject device performed as intended and was substantially equivalent to the predicate devices." No specific numerical performance metrics (like percentage of tensile strength, level of lubricity) are reported in the document; only that the tests were performed and the device met the implied criteria for equivalence.

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

The document states a "bench study" was performed. It does not specify sample sizes for this bench study. The data provenance is internal testing by W.L. Gore & Associates, Inc. (the manufacturer). This is a retrospective evaluation of the device's physical properties.

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

This information is not applicable and not provided. The "ground truth" for this type of device (an introducer sheath) relates to its physical performance characteristics (e.g., dimensions, tensile strength, freedom from leakage), which are established through engineering specifications and objective measurements, not expert human interpretation like in diagnostic imaging.

4. Adjudication method for the test set

This information is not applicable and not provided. As the "ground truth" is based on objective physical measurements and engineering specifications, there is no need for expert adjudication in the traditional sense.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation tasks, which is not the function of an introducer sheath.

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

This information is not applicable. The device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used

The ground truth is based on engineering specifications, material science properties, and objective physical measurements (e.g., dimensions, force measurements, leakage tests, biocompatibility standards).

8. The sample size for the training set

This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms, not for the physical testing of an introducer sheath. The bench study evaluates the final manufactured device against predetermined performance standards.

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

This information is not applicable and not provided. As explained above, there is no "training set" in the context of this device's evaluation.

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The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

The GORE® ACUSEAL Vascular Graft is a multilayer graft design comprised of expanded polytetrafluoroethylene (ePTFE) separated by an elastomeric layer and may be available both with and without covalently bound bioactive heparin on the luminal surface of the device (commonly known as the Carmeda® BioActive Surface, or CBAS® heparin). The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

The GORE® ACUSEAL Vascular Graft is primarily intended for use as a vascular prosthesis in patients requiring vascular access. The device demonstrated substantial equivalence to predicate devices through in vitro, in vivo animal, and in vivo clinical testing.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: For in vitro tests (Wall Thickness, Internal Diameter, Suture Retention, Kink Radius, Punctured Burst, Punctured Leak, Burst Testing, Fibril Length, Water Entry Pressure (WEP), Tensile Strength, Pressurized Internal Diameter), the document states that results "demonstrate that the technological characteristics and performance criteria of the devices are comparable and equivalent" to predicate devices. Specific numerical acceptance criteria were not provided in the summary but were met.

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

• In-Vivo Animal Study:

  • Sample Size: Not explicitly stated, but the study was conducted in a "canine model" and tested "4 device attributes." Typically, these studies involve a small number of animals per test group.
  • Data Provenance: Prospective, animal model (canine).

• In-Vivo Clinical Trial:

  • Sample Size: 138 subjects.
  • Data Provenance: Multi-centered, prospective, single-arm clinical trial. The location (country of origin) is not explicitly stated, but as it's a 510(k) submission to the FDA, it's highly likely to include US-based centers. The "historical controls" data would have been derived from existing literature or internal company data from previously marketed devices.

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

• In-Vivo Animal Study: Not explicitly stated. For animal studies, the "ground truth" (e.g., histological response, patency) is typically established by veterinary pathologists, surgeons, and imaging specialists. Qualifications would generally be board certification or equivalent experience in their respective fields.
• In-Vivo Clinical Trial: The ground truth for endpoints such as cumulative patency, freedom from bleeding, and time to cannulation would have been established by the clinical investigators (physicians/surgeons) involved in the multi-centered trial, supported by objective measurements (e.g., hemodynamic evidence of blood flow, clinical documentation of bleeding events). Their qualifications would be as medical professionals (e.g., vascular surgeons, nephrologists) experienced in managing patients requiring vascular access for hemodialysis. The exact number of experts in each center or for overall data review is not specified.

4. Adjudication Method for the Test Set:

• In-Vivo Animal Study: Not explicitly stated.
• In-Vivo Clinical Trial: Not explicitly stated. For a multi-centered clinical trial, endpoints are typically defined in the study protocol, and data is collected according to these definitions. It is common for adverse events and efficacy endpoints to undergo an adjudication process by an independent clinical events committee (CEC) to ensure consistency and minimize bias, especially for subjective assessments. However, the document does not specify if such a method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• This is not applicable. The GORE® ACUSEAL Vascular Graft is a physical medical device (vascular prosthesis), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers was not performed. The "readers" in this context would be the clinicians assessing the patient outcomes directly.

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

• This is not applicable. As mentioned above, the GORE® ACUSEAL Vascular Graft is a physical medical device, not an algorithm or software. Its performance is evaluated based on its biological, mechanical, and clinical characteristics, not as a standalone AI system.

7. The Type of Ground Truth Used:

• In-Vivo Animal Study:

  • Intra-Operative Suture Line Bleeding: Direct observation by surgeons.
  • Post-Cannulation Time-to-Hemostasis: Direct observation and measurement.
  • Device Patency: Angiographic imaging (objective assessment of blood flow) and CT scans (objective assessment of kinking).
  • Histological Response: Pathological examination of tissue samples by trained pathologists.

• In-Vivo Clinical Trial:

  • Cumulative Patency: Hemodynamic evidence of blood flow (objective measurement), presumably through clinical assessment, Doppler ultrasound, or angiography as per study protocol.
  • Freedom from Bleeding: Clinical documentation and reporting of bleeding events (e.g., hematoma, incision site bleeding, gastrointestinal bleeding, rectal bleeding, hemoptysis).
  • Time to First Cannulation: Clinical records of when the graft was first accessed.
  • Time to Third Consecutive Hemodialysis: Clinical records of dialysis sessions.
  • Adverse Events/Deaths: Clinical reporting and monitoring.

8. The Sample Size for the Training Set:

• This is not applicable in the context of device approval for a physical medical implant. There is no "training set" in the machine learning sense. The clinical trial data for the GORE® ACUSEAL Vascular Graft serves as the evaluation set. The "training" for the device's design would come from engineering principles, pre-clinical testing, and experience with predicate devices.

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

• This is not applicable as there is no "training set" for an AI model. For the development of the device itself, the "ground truth" guiding its design and iterative improvements comes from:
  • Engineering specifications and material science: Based on known properties of ePTFE and elastomer.
  • Bench testing data: In vitro tests (e.g., tensile strength, burst pressure) establishing mechanical properties against engineering standards and comparability to predicate devices.
  • Pre-clinical animal data (prior to this specific study): Early phase animal studies to understand basic biocompatibility and performance characteristics, guiding design modifications.
  • Clinical experience with predicate devices: Understanding the performance and failure modes of existing vascular grafts (GORE® PROPATEN®, GORE-TEX® Stretch, Vascutek® SEALPTFE™) informed the design of the GORE® ACUSEAL graft.

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The GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.

The GORE® Embolic Filter system consists of a device, a delivery catheter, and a retrieval catheter, and is compatible with guiding catheters and sheaths having a minimum inner diameter of 0.066". The GORE® Embolic Filter is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm. This Special 510(k) provides for the use of CBAS® heparin coating on the device.

The provided text focuses on the GORE® Embolic Filter's 510(k) summary, which details its substantial equivalence to predicate devices. It describes the device, its intended use, and the performance data used to support its equivalence. However, it does not provide specific quantitative acceptance criteria or a detailed study proving the device meets those criteria in the way a clinical study report would.

The information primarily discusses types of testing performed rather than specific results or predefined acceptance thresholds.

Here's an attempt to answer based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format of a table with specific quantitative acceptance criteria and corresponding reported device performance values. The text describes types of tests performed to demonstrate substantial equivalence, but not the specific numerical targets or results of these tests against defined acceptance criteria.

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

Again, this information is not explicitly provided in the document. The text mentions "Animal: Animal studies were conducted to evaluate the performance of the CBAS® heparin coating," but does not specify the number of animals used or the design of these studies (e.g., retrospective or prospective).

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

This information is not applicable as the document describes non-clinical and animal studies, not a study involving human interpretation or expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above.

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

A MRMC comparative effectiveness study was not mentioned or indicated. The document focuses on demonstrating substantial equivalence through non-clinical and animal testing, not through human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable as the device is a physical medical device (embolic filter), not an AI algorithm. The performance evaluation is related to its mechanical and biological characteristics.

7. Type of Ground Truth Used

Based on the description of testing, the "ground truth" was established through:

• Biocompatibility testing: Standardized laboratory assays (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility, LAL endotoxin test).
• Non-Clinical System Tests: Evaluation of loading, deployment, and retrieval forces.
• Filter Component Tests: Evaluation of filter efficiency, heparin concentration, hydrophilicity, residuals, and elution.
• Animal Studies: In vivo evaluation of CBAS® heparin coating performance.

Essentially, the ground truth was established by direct measurement and observation in controlled laboratory and animal environments according to established protocols for medical device testing.

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical device and does not involve AI/machine learning, and therefore does not have a "training set" in that context.

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

This is not applicable for the same reason as above.

In summary, the provided text describes a 510(k) submission focused on demonstrating substantial equivalence for a physical medical device (GORE® Embolic Filter). The document outlines various types of performance testing (biocompatibility, mechanical, animal studies) but does not provide the quantitative details of acceptance criteria or the specific results of these studies against those criteria, nor does it describe studies involving human readers, AI, or specific statistical evaluations of diagnostic performance.

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The GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.

The GORE® Embolic Filter system consists of a device, a delivery catheter, and a retrieval catheter, and is compatible with guiding catheters and sheaths having a minimum inner diameter of 0.066". The GORE® Embolic Filter is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.

Acceptance Criteria and Study Details for GORE® Embolic Filter

This document describes the acceptance criteria and supporting study for the GORE® Embolic Filter, based on the provided 510(k) summary.

Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a full-scale clinical trial with specific performance goals for de novo approval. Therefore, the "acceptance criteria" here are framed around successful demonstration against a performance goal derived from existing carotid stent studies using embolic protection, rather than absolute, pre-defined numerical thresholds for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria" in this Context:
For a 510(k) submission, the "acceptance criteria" for clinical performance are typically relative to predicate devices or established performance goals. Here, the device aimed to demonstrate safety and efficacy that was non-inferior (or superior) to a performance goal established from a meta-analysis or pooled data of previously approved carotid stent studies that also used distal embolic protection. The specific numerical targets for safety and efficacy endpoints (e.g., stroke rates, major adverse cardiac and cerebrovascular events (MACCE)) that comprised this "performance goal" are not explicitly detailed in the summary but are implied to have been defined prior to the study.

2. Sample Size and Data Provenance

• Test Set Sample Size: 250 pivotal subjects.
• Data Provenance: Prospective, multicenter, nonrandomized, single-arm study conducted across Thirty five (35) US sites.

3. Number of Experts and Qualifications for Ground Truth

The provided summary does not explicitly state the number of experts used to establish ground truth for the test set from a diagnostic or image interpretation perspective. As this is an embolic filter, the "ground truth" would primarily be clinical outcomes (e.g., incidence of stroke, periprocedural complications) rather than a specific diagnostic interpretation. Therefore, the "experts" would be the clinical investigators and study personnel responsible for assessing patient outcomes. Their qualifications are implicitly assumed to be appropriate for conducting clinical trials involving carotid artery stenting procedures.

4. Adjudication Method for the Test Set

The summary does not explicitly detail an adjudication method (e.g., 2+1, 3+1). For clinical trials evaluating safety and efficacy, particularly for events like stroke or other adverse events, an independent Clinical Events Committee (CEC) is typically employed to adjudicate reported events according to pre-defined criteria. While not explicitly mentioned, this is a standard practice for trials of this nature.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI devices where human readers interpret images. The GORE® Embolic Filter is a medical device for embolic protection during a procedure, and its performance is assessed through clinical outcomes rather than diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not performed. This device is a physical medical device, not an AI algorithm. Its performance is intrinsically linked to its use by medical professionals in a clinical setting ("human-in-the-loop").

7. Type of Ground Truth Used

The ground truth used for the clinical study was primarily outcomes data. This includes:

• 30-day safety outcomes (e.g., stroke, death, myocardial infarction related to the procedure).
• 30-day efficacy outcomes (implied to be successful delivery and protection, potentially assessed by freedom from periprocedural stroke or TIA).

These outcomes are collected and assessed from the actual patients in the study.

8. Sample Size for the Training Set

This question is not applicable in the context of this device. The GORE® Embolic Filter is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The "training" for such devices typically refers to pre-clinical testing, design iterations, and eventually, the clinical trial (which acts as a validation/confirmation step rather than iterative training).

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

This question is not applicable for the reasons stated above. As there is no AI/ML training set, there is no corresponding method for establishing a ground truth for a training set. The "ground truth" during the development phase would relate to engineering specifications and performance in bench and animal testing. These were mentioned as "Non-Clinical" and "Animal" studies, respectively, covering aspects like loading, deployment, retrieval, quantification of particulate, filter efficiency, and vessel damage.

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The GORE DrySeal Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

The GORE DrySeal Sheath consists of an introducer sheath with GORE DrySeal Valve attached, a dilator, and a syringe. The introducer sheath is a polyethylene tube with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath has an insert molded hub on the trailing end, which is attached to the GORE DrySeal Valve. The GORE DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5mL of saline into the space, using the provided syringe, during procedural preparation of the device. The dilator has a tapered leading end and provides dilatation of the access vessel. A mark on the trailing end of the dilator ensures correct positioning of the dilator within the sheath.

Here's an analysis of the provided text regarding the GORE DrySeal Sheath, focusing on acceptance criteria and the supporting study information.

It's important to note that this document is a 510(k) Summary for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or effectiveness through extensive clinical trials. Therefore, the "study" referred to will be primarily bench testing (in-vitro performance and biocompatibility) rather than a clinical study in the traditional sense of comparing outcomes or measuring human reader performance.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" alongside specific numerical results. Instead, it states that "In-vitro design verification testing data demonstrate that the device is in compliance with ISO 11070 Sterile, single use intravascular catheter introducers and product labeling." and "The testing demonstrated acceptable results." for various tests.

Therefore, the acceptance criteria are implicitly defined as meeting the requirements of ISO 11070 and internal procedures for each test, and the reported device performance is simply that all tests yielded "acceptable results."

Here's the table based on the provided information:

Table 1: Acceptance Criteria and Reported Device Performance for GORE DrySeal Sheath

Study Details

Based on the provided text, here's a breakdown of the study information:

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

   • Sample Size: Design Verification testing was conducted on "the 12 Fr and 26 French Size sheaths." This indicates at least these two sizes were tested. The exact number of units/samples per size tested for each specific benchmark test (e.g., how many sheaths were subjected to "Force at Break" testing) is not specified in this summary.
   • Data Provenance: The tests are described as "in-vitro testing" and "Bench / Performance Data." This means the data was generated in a laboratory setting, not from human or animal subjects. The country of origin of the data is not specified, but the manufacturer (W. L. Gore & Associates, Inc.) is based in the USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate performance.

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

   • This question is not applicable to this type of submission and study. The "ground truth" for these tests (e.g., whether a sheath conforms to a specific length, or if a material is cytotoxic) is established by adherence to documented ISO standards and internal procedures, using calibrated laboratory equipment and trained technicians, not by expert consensus in interpretation.

3. Adjudication method for the test set:

   • This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or when interpreting subjective image data where expert consensus is needed to establish a definitive diagnosis or outcome. Here, the results are objective measurements against defined standards.

4. 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. This device is an introducer sheath, a physical medical device, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this product or its evaluation as described in this 510(k) summary.

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

   • No, a standalone algorithm performance study was not done. As mentioned, this is a physical medical device, not an algorithm or AI system.

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

   • The "ground truth" for the performance tests (e.g., sheath length, kink resistance) is defined by objective measurements and adherence to ISO standards (e.g., ISO 11070) and internal test protocols.
   • For biocompatibility tests, the ground truth is established by conformance to ISO 10993 standards, which involve specific laboratory assays (e.g., cell culture for cytotoxicity, animal models for sensitization/toxicity).

7. The sample size for the training set:

   • This is not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" in the context of its development and evaluation as described here.

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

   • This is not applicable, as there is no training set for this type of device.

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