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The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

The GORE® Tri-Lobe Balloon Catheter is a compliant, tri-lobed polyurethane balloon catheter. The lobed design of the balloon catheter is designed for inflation without complete blockage of aortic blood flow. The three polyurethane balloons are mounted on the leading end of a multi-lumen catheter shaft. Radiopaque markers indicate the balloon edges. Each of the three inflation lumens is in communication with one of the balloons. The inflation port is in communication with all of the inflation lumens and is affixed with a luer lock. The guidewire lumen allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the guidewire lumen is affixed with a flushing/guidewire port with a luer lock, used for flushing the guidewire lumen. A Tuohy-Borst valve is integrated into the trailing end of the guidewire lumen.

The GORE® Tri-Lobe Balloon Catheter is available in two sizes. The smaller balloon can be inflated to diameters of 16 mm to 32 mm and the larger balloon can be inflated to diameters of 26 mm to 48 mm.

The provided FDA 510(k) clearance letter and associated summary pertain to a medical device, the GORE® Tri-Lobe Balloon Catheter, not an AI/ML-driven software device. Therefore, the information typically requested for AI/ML device acceptance criteria and study design (such as confidence intervals for performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or ground truth establishment) is not applicable or present in this document.

The document describes the device's technical characteristics, indications for use, and summaries of performance testing and clinical data to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the relevant information provided, structured to highlight what is and isn't applicable to your request:

Acceptance Criteria and Device Performance (Not Applicable as per AI/ML context)

While the document details performance testing, it doesn't present a table of quantitative acceptance criteria and corresponding reported device performance values in the way one would for an AI/ML device (e.g., Sensitivity, Specificity thresholds). Instead, safety and effectiveness are demonstrated through various tests and clinical observations.

Table 1. Technological Characteristics (This is a comparison of intended balloon diameters and inflation volumes, not performance metrics like accuracy or sensitivity for an AI/ML device.)

Key observations for performance (qualitative as per the document):

• Clinical Outcomes (Day 0 Adverse Events): Among the 44 subjects with known GORE® Tri-Lobe Balloon Catheter use in the Aortic Arch substudy:
  • Zero (0) Adverse Events of Aortic Rupture, Aortic Dissection, Balloon Related Mortality, and Type III Endoleak.
  • One (1) reported Type I Endoleak at Day 0.
• Conclusion: The device is deemed "substantially equivalent" to its predicate based on bench, pre-clinical, and clinical testing. The changes did not raise new concerns related to safety or effectiveness.

Study Details (Interpreted for a medical device rather than AI/ML)

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

   • Test Set (Clinical Data): 77 total subjects were treated for lesions of the aortic arch in the GORE® TAG® Thoracic Branch Endoprosthesis Clinical Trial (G130120). Of these, 44 subjects (57.1%) had known use of the GORE® Tri-Lobe Balloon Catheter during the index procedure.
   • Data Provenance: The study was a "prospective, non-randomized, multicenter study." The country of origin is not explicitly stated but implied to be related to FDA clearance (likely US-based).
   • Retrospective/Prospective: Prospective.

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

   • This is not applicable as this is a medical device study, not an AI/ML performance evaluation requiring expert labeling for ground truth. Clinical outcomes and observations from medical professionals involved in the trial serve as the "ground truth" for device safety and performance here.

3. Adjudication Method for the Test Set:

   • Not applicable in the context of AI/ML ground truth adjudication. Clinical adverse events and outcomes were reported and presumably reviewed as part of the clinical trial protocol.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study is relevant for evaluating the impact of AI on human readers' diagnostic performance. This document describes the performance of a physical medical device.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

   • Not applicable as this is not an algorithm. The device's performance is inherently linked to its use by medical professionals in a clinical setting ("human-in-the-loop" in a very different sense).

6. The Type of Ground Truth Used:

   • Clinical Outcomes/Events: The "ground truth" for the device's safety and effectiveness was established through direct observation of clinical adverse events (e.g., Aortic Rupture, Aortic Dissection, Type I Endoleak) and the device's ability to facilitate dilatation of endoprostheses during the clinical trial. Bench and In Vivo Animal Testing also contributed to this "ground truth" indirectly by demonstrating physical properties and performance.

7. The Sample Size for the Training Set:

   • Not applicable. This is not an AI/ML device that requires a training set.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable.

In summary, the provided document is a 510(k) clearance letter for a physical medical device. As such, the standard criteria and study designs relevant to AI/ML device performance evaluation (e.g., sensitivity, specificity, expert adjudication, MRMC studies, training/test sets) are not found within this content.

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The GORE® PROPATEN® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering from occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE® PROPATEN® 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) premarket notification letter from the FDA for a vascular graft. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document only discusses substantial equivalence to a predicate device based on similar technology, manufacturing, coating, sterilization, and intended use, with a minor update to the end-of-shelf-life Heparin Surface Activity specification.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a training set from this document.

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GORE® PROPATEN® Vascular Graft is intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE® PROPATEN® 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 text describes a 510(k) premarket notification for the GORE® PROPATEN® Vascular Graft. This type of FDA submission is for medical devices and does not involve an AI/ML algorithm. Therefore, the device does not have acceptance criteria, a study proving it meets acceptance criteria, or any of the other AI/ML-specific information requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, or how training set ground truth was established).

The document details the device, its intended use, predicate devices, and a summary of performance testing conducted to demonstrate substantial equivalence to the predicate device. These tests are physical and material property tests related to the vascular graft's design and manufacturing, not AI/ML performance.

Therefore, I cannot provide the requested information as it is not applicable to the provided document.

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

GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access. The GORE® ACUSEAL Vascular Graft is a multi-layer vascular graft with a low bleed layer between the inner and outer layers of ePTFE (expanded polytetrafluoroethylene). The luminal surface of the inner graft component is coated with the CBAS® Heparin Surface.

This document is a 510(k) Summary for the GORE® ACUSEAL Vascular Graft. It describes a medical device and its regulatory review, not an AI/ML powered device. Therefore, the request to describe acceptance criteria and associated studies for an AI/ML powered device cannot be fulfilled.

The document states that the GORE® ACUSEAL Vascular Graft has the same clinical use, indications for use, fundamental technology, materials, sterilization, and intended use as its predicate device (K130215, GORE® ACUSEAL Vascular Graft). The only differences are an additional packaging configuration and additional device configurations with different diameters.

The performance testing summarized relates to the physical and material properties of the vascular graft itself, not to the performance of an AI/ML algorithm.

Therefore, since the input document does not pertain to an AI/ML powered device, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, ground truth establishment, or sample sizes for AI/ML models.

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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 soft-tissue 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 is a 510(k) premarket notification for a medical device called GORE® ENFORM Biomaterial. It describes the device, its indications for use, and a summary of performance testing. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device.

The document states:

• "No animal studies were required to support this change."
• "No clinical data was required to support this change."
• "Simulated use testing conducted as part of design verification demonstrated the GORE® ENFORM Biomaterial devices can be introduced via minimally invasive surgical procedures when used according to the instructions for use of the device."
• "Other bench testing was leveraged from the predicate GORE® ENFORM Biomaterial device."

This 510(k) pertains to a surgical mesh/biomaterial, not an AI or algorithm-based device. Therefore, the questions related to AI/algorithm performance (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, ground truth types) are not applicable to the information contained in this document.

Therefore, I cannot provide the requested information based on the given text because the device described is not an AI/algorithm-driven medical device, and the document does not include the type of performance data relevant to AI/algorithm acceptance criteria.

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GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. It can be used for reinforcement of staple lines during hysterectomy, lung resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. It is also intended to be used for remforcement of suture lines and staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The subject of this 510(k) pre-market notification is a modification to the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material Configured for Endoscopic Surgical Staplers (EBSG, also referred to as the predicate) to include altered bioabsorbable sheet geometries, tailored lattice stitching, and inner dimension geometry for both the cartridge and anvil devices. The cartridge and anvil devices were specifically designed to fit the geometry of the Intuitive SureForm 60™ mm staplers (K173721 cleared July 5, 2018) Black, Green and Blue cartridge reloads. GORE® SEAMGUARD® Reinforcement Bioabsorbable Staple Line Reinforcement Configured for Intuitive Surgical® Robotic Endoscopic Surgical Staplers (EBSG-R, also referred to as the modified device) possesses the same fundamental scientific technology as the predicate. No other physical modifications were made to the predicate device, and the implantable materials of the modified device and predicate are the same synthetic bioabsorbable poly (glycolide: trimethylene carbonate) copolymer (PGA:TMC).

The provided text describes a 510(k) premarket notification for a medical device, the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement. However, it does not contain information about a study that assesses the performance of an AI-powered device against specific acceptance criteria, nor does it detail and of the requirements listed in points 2-9 of your prompt.

The document is a regulatory submission for a physical medical device (a staple line reinforcement material), not a software or AI device. Therefore, it focuses on demonstrating substantial equivalence to a predicate device through pre-clinical bench testing, and explicitly states that "No clinical evaluations were required to support this submission."

As such, it is not possible to extract the requested information (acceptance criteria for an AI device, sample sizes, expert qualifications, MRMC study details, ground truth methods, training set details) from this document.

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GORE® SYNECOR PREPERITONEAL Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material.

GORE® SYNECOR Preperitoneal Biomaterial is a composite mesh intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material. The device incorporates two distinct functional layers comprised of 1) a polytetrafluoroethylene (PTFE) knit mesh, laminated between 2) two porous synthetic bioabsorbable web layers. The permanent PTFE knit layer functions to provide strength when bridging a hernia or soft tissue defect. The porous bioabsorbable web layers provide a scaffold for tissue ingrowth and vascularization. The GORE® SYNECOR Preperitoneal Biomaterial is for single use only and is designed for preperitoneal placement and should be placed between tissue layers where ingrowth is desired.

The provided document is a 510(k) summary for the GORE® SYNECOR Preperitoneal Biomaterial, a surgical mesh. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device.

Below is an analysis of the acceptance criteria and study information based on the provided text, formatted to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" for each performance test in a tabular format with corresponding "reported device performance." Instead, it states that the device "met the intended functional acceptance criteria necessary for providing strength when bridging a hernia or soft tissue defect for up to the stated shelf life" and that "Performance data includes acceptable results for mesh thickness, density, suture retention, burst strength, and pore size relative to the predicate device."

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

• Bench Studies: The document does not specify the exact sample sizes (N-numbers) for each bench test conducted (mesh thickness, density, suture retention, burst strength, pore size). It states "Testing demonstrated..." and "Performance data includes acceptable results..."
• Biocompatibility Studies: The studies were conducted "according to ISO 10993 standards," which typically involve specific sample sizes for each test (e.g., animal numbers for in vivo tests, replicates for in vitro tests), but these are not explicitly detailed here.
• Animal Studies:
  • 30-day subcutaneous implant rabbit model: Sample size not explicitly stated for the subject device.
  • 90-day rat subchronic toxicity study: "multiple device implants" - specific number not stated.
  • 180-day subcutaneous implant study in rabbits: Sample size not explicitly stated.
• Data Provenance: All studies mentioned are pre-clinical (bench and animal studies). The country of origin for the studies is not specified, but the applicant is W. L. Gore & Associates, Inc. with a US address. The studies are prospective in nature, as they involve testing the device under controlled conditions.

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

This information is not applicable as the studies described are pre-clinical (bench and animal studies) and do not involve human diagnostic performance or expert-derived ground truth in the way medical imaging or clinical studies would. The "ground truth" here is objective physical measurements, histopathological findings (for animal studies), and standardized biocompatibility assessments.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Animal study histopathology and biocompatibility assessments would typically involve qualified pathologists and toxicologists, but no "adjudication method" in the context of resolving disagreements among multiple human readers for a test set is described or implied.

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 device is a surgical mesh; it is not an AI-based diagnostic tool that would involve human readers or AI assistance in interpretation.

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. The device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

• Bench Studies: Objective physical measurements (e.g., mesh thickness, density, suture retention force, burst strength, pore size). The "ground truth" for comparison was the predicate device's performance.
• Biocompatibility Studies: Results of standardized in vitro assays and in vivo animal tests (e.g., presence/absence of cytotoxicity, inflammatory response, systemic toxicity).
• Animal Studies: Histopathological examination of tissue response (e.g., tissue ingrowth, vascularization, inflammatory cell types and extent) and observation for systemic toxicity.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical surgical mesh, not an algorithmic model that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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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. It 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 porous, fibrous flat sheet web structure composed solely of synthetic bioabsorbable polyglycolide / trimethylene carbonate copolymer. In vivo studies indicate the bioabsorption process should be complete by six to seven months. The device 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 10-6. It is for single use only.

The provided document is a 510(k) premarket notification for a medical device called "GORE BIO-A Tissue Reinforcement," which is a surgical mesh. This document does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it discusses the substantial equivalence of a bioabsorbable surgical mesh to previously marketed predicate devices.

Therefore, I cannot extract the information required to populate the fields related to an AI/Machine Learning device study, such as

• A table of acceptance criteria and the reported device performance (for an AI/ML device)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance (algorithm only)
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document explicitly states: "No bench or clinical testing was used to support this 510(k) premarket notification. The animal study presented in this submission demonstrated equivalent performance when comparing Gore's synthetic PGA:TMC scaffold to a Cook's SIS collagen-based scaffold structure."

This indicates that the device's substantial equivalence was demonstrated through comparison to predicates and an animal study, not through a performance study against acceptance criteria for an AI/ML algorithm.

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GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

The modified GORE® SEAMGUARD® Reinforcement possesses the same indications for use and fundamental scientific technology as the predicate GORE® SEAMGUARD® Reinforcement. The implantable device and loading carriers of the predicate GORE® SEAMGUARD® Reinforcement are being modified to permit the reinforcement material to be loaded onto the stapler and attach via adhesive-coated tabs that wrap around the side/back of the cartridge/anvil jaws of a surgical stapling device, in lieu of attaching a fully-coated device surface to the top surfaces of the cartridge/anvil jaws, to minimize the impact of the surface topography of surgical staplers in establishing compatible device fit. The implantable materials of the modified GORE® SEAMGUARD® Reinforcement and predicate GORE® SEAMGUARD® Reinforcement are the same bioabsorbable PGA:TMC. Both utilize the same bioabsorbable PLA:TMC adhesive to secure the device onto the jaws of a surgical stapler.

This document is a 510(k) premarket notification for a medical device (GORE® SEAMGUARD® Reinforcement), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details (sample sizes, ground truth, expert opinions, MRMC studies, standalone performance, training sets), and adjudication methods for an AI/ML device is not applicable here.

The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria using AI/ML methodology.

Here's what can be extracted from the document regarding the device's evaluation, framed in the context of the prompt's request, but clearly indicating the differences:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a list of specific, quantifiable acceptance criteria with corresponding numerical performance metrics as would be expected for an AI/ML device. Instead, the "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to a predicate device through various tests.

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

• Test Set Sample Size: Not explicitly stated with a numerical value. The document mentions "deployment reliability testing under simulated use conditions," which implies testing on a sample of devices, but the number of devices or trials is not provided.
• Data Provenance: The "Pre-Clinical: Bench study" implies testing performed in a laboratory setting, likely within the manufacturer's facilities. It is a prospective test specifically conducted for this submission.

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

• Not Applicable. This type of information is typically relevant for studies involving human interpretation (e.g., radiology images). The testing described here is a bench study evaluating mechanical/functional performance, which does not involve "ground truth" established by experts in the context of a diagnostic interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a bench test for mechanical/functional performance (deployment reliability), no adjudication method (like 2+1 or 3+1 for expert discrepancies) is described or relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is for evaluating human reader performance, often with AI assistance (e.g., radiologists interpreting images). This device is a surgical reinforcement material, and its evaluation did not involve human readers interpreting cases.

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. Therefore, "standalone algorithm performance" is not relevant. The "bench study" is analogous to a standalone functional test for the physical device.

7. The Type of Ground Truth Used:

• For the "deployment reliability testing," the "ground truth" would be the successful or unsuccessful deployment of the device as per pre-defined functional specifications, measured by objective metrics in a simulated environment. It is based on engineering specifications and direct observation of device function rather than expert consensus, pathology, or outcomes data in a diagnostic sense.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not Applicable. There is no training set for this device.

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The GORE® BIO-A® Wound Matrix is intended for use in the management of wounds.

Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mob's surgery, post laser surgery, podiatic, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds.

GORE® BIO-A® Wound Matrix device is a tailorable, porous, bioabsorbable material matrix that provides a scaffold for cellular infiltration and vascularization. The device permits the ingress of cells and soft tissue formation into the defect space/wound bed. GORE® BIO-A® Wound Matrix is a porous fibrous structure composed solely of a synthetic copolymer comprised of polyglycolic acid and trimethylene carbonate (PGA:TMC).

This document is a 510(k) Summary for the GORE® BIO-A® Wound Matrix. It does not describe an AI medical device or provide acceptance criteria and study data in the typical format for such a device.

Therefore, I cannot fulfill your request for an acceptance criteria table and study details as they pertain to an AI device. The document describes a traditional medical device (wound matrix) and its substantial equivalence to predicate devices based on pre-clinical (bench and animal) testing, not on AI algorithm performance.

Here's why the provided information doesn't fit the requested structure:

• No AI Device: The device described is a biocompatible wound matrix, not an AI algorithm.
• No "Acceptance Criteria" for AI Performance: The document discusses meeting "intended product specifications" and similarity to predicate devices, which are not the same as performance metrics like sensitivity, specificity, or AUC typically used for AI.
• No "Study that Proves the Device Meets Acceptance Criteria" for AI: The "Performance Data" section details bench and animal studies (biocompatibility, wound closure, histological assessment) for the physical wound matrix, not studies evaluating an AI algorithm's diagnostic or predictive capabilities.
• No "Test Set," "Training Set," "Ground Truth," "Experts," "MRMC Study," or "Standalone Performance" related to AI: These concepts are specific to AI/machine learning model evaluation and are not applicable to the GORE® BIO-A® Wound Matrix.

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