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The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines as patients who:
• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC) with delivery stylet, (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft with a guideline and beading near the custom titanium alloy connector to provide kink resistance. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The HeRO Graft Accessory Component Kit is intended to aid in the implantation of the HeRO Graft and contains instruments including, introducers, dilators, hemostasis valve with stopcock, disposable clamp, and hemostasis plug.
The HeRO Graft is a fully subcutaneous surgical implant single-use device provided sterile via ethylene oxide for long-term (>30 day) use.

The document provided does not contain information related to an AI/ML powered device, so there is no data to extract for device performance, ground truth, or expert review. The device described, the HeRO Graft, is a vascular graft prosthesis, which is a physical implant used in hemodialysis patients.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device, as the provided text pertains to a traditional medical device.

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The HeRO® Graft is intended use in maintaining long term vascular access for chronic hemodialysis patients who have exhausted venous access sites suitable for fistulas or grafts.

The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines¹ as patients who:
• Have become catheter-dependent or who are approaching catheter dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC), (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft with a guideline and beading near the custom titanium alloy connector to provide kink resistance. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The ACK (a convenience kit) contains instruments that aid in the implantation of the HeRO Graft including, introducers, dilators, delivery stylet, hemostasis valve with stopcock, disposable clamp, and hemostasis plug. The HeRO Graft is a fully subcutaneous surgical implant single-use device provided sterile via ethylene oxide for long-term (>30 day) use.

This document describes the premarket notification (510(k)) for the Merit HeRO Graft, a vascular graft prosthesis. The provided text details the device description, indications for use, and a comparison to a predicate device, as well as a list of performance and design validation tests, and an animal study. However, it does not contain the specific acceptance criteria and detailed device performance results in a table format that would directly fulfill all aspects of your request. It rather lists the types of tests conducted and states that the device met the requirements.

Based on the provided text, I can infer and organize the available information to best answer your request, highlighting where direct numerical acceptance criteria or performance values are not explicitly stated in this FDA submission summary.

Here's a breakdown of the information that can be extracted and inferred, structured to align with your questions:

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

The document states that a "battery of tests was performed based upon the risk analysis and the requirements of the following internationally recognized standards and guidance documents pertaining to the device performance, as well as biocompatibility, sterilization, and labeling standards and guidance. Conformity to these standards demonstrates that the proposed HeRO Graft meets the acceptance criteria established by the standards as they apply to device safety and efficacy."

While specific numerical acceptance criteria and precise performance values are not given in a table, the document broadly describes the types of tests and the overall outcome.

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

• Animal Study Test Set Sample Size: 18 sheep.
• Data Provenance: The document does not specify the country of origin of the animal study data or if the performance/design validation tests were conducted externally. The animal study was generally described as "chronic study" with set time points (30-day, 90-day, 180-day), indicating a prospective setup for that specific component. The other performance and design validation tests are typical of pre-market, laboratory-based testing.

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)

• The document describes a device (vascular graft), not an AI/diagnostic software. Therefore, the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not applicable here. The ground truth for device performance is established through physical and biological testing against established standards and controls (e.g., precise measurements, chemical analyses, histological assessments in the animal study).

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

• This concept applies to human interpretation of data, typically in diagnostic studies. As this is a medical device (vascular graft) and not a diagnostic AI, adjudication methods for expert interpretation are not relevant or described. Device performance testing relies on objective measurements and verified protocols.

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 study was not done. This type of study is specific to evaluating the clinical performance of diagnostic AI systems in conjunction with human readers. The Merit HeRO Graft is a physical implantable device, not an AI software.

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

• This question is also not applicable. The device is a physical vascular graft, not an algorithm. Performance tests are inherently "standalone" in the sense that they evaluate the device's physical and biological properties.

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

• For Biocompatibility Testing: Ground truth is established by standardized laboratory assays and results against accepted biological safety limits (e.g., no cytotoxicity, no irritation, no genotoxicity).
• For Performance and Design Validation Testing: Ground truth is established by engineering specifications, physical measurements, and conformity to recognized international standards (e.g., ISO 7198, ASTM F756).
• For the Animal Study: Ground truth was established by direct observation, angiographic evaluation, and histopathologic evaluations (pathology) of the implanted grafts and non-target organs. Patency, stenosis, thrombogenicity, and cellular/tissue response were assessed and compared to control articles.

8. The sample size for the training set

• This question is for AI models. As this is a physical medical device, there is no "training set" in the AI sense. Device development involves design, prototyping, and testing, not machine learning model training.

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

• Not applicable, as there is no AI training set.

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The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines[1] as patients who:

· Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).

• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.

• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).

· Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.

• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.

• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.[2]

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC), (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft attached to a custom titanium alloy connector. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The ACK (a convenience kit) contains instruments that aid in the implantation of the HeRO Graft including, introducers, dilators, delivery stylet, hemostasis valve with stopcock, vascular clamp and hemostasis plug.

The HeRO Graft is a fully subcutaneous surgical implant single-use

The provided text describes a 510(k) premarket notification for the Merit HeRO Graft, a vascular graft prosthesis. The document details the device's indications for use, comparison to a predicate device, and the performance data submitted to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text:

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

The document lists various performance tests and states that the device "met the acceptance criteria applicable to the safety and efficacy of the device" for these tests. However, it does not explicitly state the quantitative acceptance criteria for each test. Instead, it broadly indicates conformity to recognized standards and guidance documents.

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a series of performance tests conducted based on established FDA guidance documents and recognized performance standards. These standards include:

• FDA Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions, Nov 1, 2000
• FDA guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process"
• FDA Guidance Document: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Dec 11, 2014
• ISO 10555-1, Sterile, Single-Use Intravascular Catheters, Part 1: General Requirements
• ISO 7198, Cardiovascular implants and extracorporeal systems - Performance Vascular prostheses - Tubular vascular grafts and vascular Data patches.
• ISO 11135, Sterilization of health care products -Ethylene oxide - Requirements for the development, validation and routing control of a sterilization process for medical devices
• ISO 10993 series (Parts 1, 3, 4, 5, 6, 10, 11) for Biological Evaluation of Medical Devices
• ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials
• ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
• ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants during Magnetic Resonance Imaging
• ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• United States Pharmacopeia, National Formulary 30, General Chapter ``, Pyrogen Test.

The document states: "Conformity to these standards demonstrates that the proposed HeRO Graft meets the acceptance criteria established by the standards as they apply to device safety and efficacy."

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 lists "Performance Data" and "Biocompatibility testing" as being provided. These are laboratory/benchtop test results, not clinical study data with human patients. Therefore, the concepts of "sample size for the test set," "country of origin of the data," and "retrospective or prospective" are not applicable in the context of this 510(k) submission for mechanical/material and biocompatibility testing. The data provenance is from laboratory tests conducted by the manufacturer, Merit Medical Systems, Inc.

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 question is not applicable. The "ground truth" for these types of engineering and biocompatibility tests is based on the specifications defined by the recognized international and national standards (e.g., ISO, ASTM, USP) and FDA guidance documents. There is no mention of human experts establishing ground truth for these specific tests.

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

This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for human reader interpretation of medical images or outcomes. This section of the document describes laboratory performance testing, not human reader studies.

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. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and biocompatibility. The device is a physical vascular graft, not an AI or imaging diagnostic tool that would involve human reader 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 vascular graft, not a software algorithm.

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

The "ground truth" for the performance tests and biocompatibility evaluation is derived from the quantitative specifications and methodologies outlined in the referenced national and international standards (ISO, ASTM) and FDA guidance documents. For instance, a tensile strength test would have a specified minimum allowed force, or a leakage test would have a maximum allowed leakage rate. Biocompatibility relies on adherence to the testing requirements and acceptable response limits defined in the ISO 10993 series.

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The 510(k) describes a physical medical device.

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

This question is not applicable, as there is no "training set."

Ask a specific question about this device

The HeRO Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines as patients who:

• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.e. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: Arterial Graft Component, Venous Outflow Component and Accessory Component Kit. The Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the Venous Outflow Component is sized to fit the patient by cutting it to the proper length and sliding it over the barbs of the connector on the Arterial Graft Component. The Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. An alternate to the Arterial Graft Component is The Adapter which allows the physician to choose and connect a 6mm ID vascular graft from the list of qualified grafts. The Accessory Component Kit (a convenience kit) contains instruments that assist in the implantation of the HeRO Graft.

The provided text describes the HeRO® Graft, a vascular graft prosthesis, and its 510(k) clearance (K124039). The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (design verification testing). There is no information provided regarding a study conducted to prove the device meets specific acceptance criteria based on clinical outcomes or a comparison against a defined performance target. Instead, the submission states that "Additional clinical performance data was not required to support the modification of the device." and relies on "design verification testing" and comparison to a predicate device.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be answered directly from the provided text.

Here's an analysis based on the available information:

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

The document provides a table of "Test Parameter" and "Results" which essentially act as acceptance criteria and their successful fulfillment.

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

The document refers to "design verification testing." However, it does not specify the sample sizes used for each of the non-clinical tests. For example, it says "None of the connections tested leaked," but not how many connections were tested. It also does not mention data provenance (country of origin) as these are non-clinical, in-vitro tests, nor does it specify if any clinical data was retrospective or prospective (as "additional clinical performance data was not required").

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)

For the "Human Factors/ Usability engineering" tests, it states "All doctors rated..." However, the number of doctors (experts) is not specified, nor are their specific qualifications (e.g., years of experience, specialty). For the other non-clinical tests, the "ground truth" would be established by engineering standards and measurements, not medical experts.

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

There is no mention of an adjudication method for any of the tests. For the human factors portion, it simply states "All doctors rated," implying either unanimous agreement or that individual ratings were sufficient without a formal 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 MRMC comparative effectiveness study was done as this device is a vascular graft prosthesis, not an imaging AI diagnostic device. The application is for a physical medical device, not a software or AI-assisted diagnostic tool.

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

This question is not applicable as the device is a physical vascular graft, not an algorithm.

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

For the non-clinical performance data, the "ground truth" is based on engineering specifications, standardized test methods, and direct physical measurements of the device's components and connections. For the "Human Factors/Usability engineering" tests, the ground truth is based on subjective ratings by "doctors."

8. The sample size for the training set

This device is a physical product, not an algorithm that requires a training set. Therefore, this question is not applicable.

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

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

Ask a specific question about this device

The HeRO® Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines' as patients who:

• . Have become catheter-dependent or who are approaching catheter-dependency (i.e.. have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as . determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure . or venography (e.g. fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined . by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as . determined by history or previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• . Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.2

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: Arterial Graft Component, Venous Outflow Component and Accessory Component Kit. The Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the Venous Outflow Component is sized to fit the patient by cutting it to the proper length and sliding it over the barbs of the connector on the Arterial Graft Component. The Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The Accessory Component Kit (a convenience kit) contains instruments that assist in the implantation of the HeRO Graft.

This 510(k) premarket notification for the HeRO® Graft vascular prosthesis does not describe a study to establish acceptance criteria or demonstrate device performance against such criteria in the way a diagnostic AI/ML device submission would.

Instead, this submission is for a physical medical device (a vascular graft) and relies on demonstrating substantial equivalence to a previously cleared predicate device.

Therefore, many of the requested elements for a typical AI/ML device study's acceptance criteria and performance study are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, or a table of reported device performance against such criteria. For a physical device like a vascular graft, "performance" is typically assessed through aspects like graft patency, infection rates, blood flow, durability, and biocompatibility, often in clinical trials or through post-market surveillance. This 510(k) summary explicitly states:

• "No changes were made to the previously cleared packaging verification and sterilization validation. Additional clinical performance data was not required to support the modification of the device."

This indicates that the focus of this particular submission was on demonstrating that the modified device (HeRO® Graft) is as safe and effective as the predicate device (HeRO™ Vascular Access Device) without requiring new clinical performance studies for this specific clearance.

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

Not applicable. There is no "test set" in the context of an AI/ML diagnostic study described here. The submission is for a physical device.

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

Not applicable. There is no "test set" or "ground truth" establishment in the context of an AI/ML diagnostic study described here.

4. Adjudication method for the test set

Not applicable. No "test set" or adjudication method is described.

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 diagnostic device, and no MRMC study is described. The device is a physical vascular graft.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. There is no ground truth described in the context of AI/ML performance. For a physical device, "ground truth" would relate to the actual clinical outcomes in patients, which is not detailed as a new study in this 510(k). The submission relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set mentioned.

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

Not applicable. This is not an AI/ML device.

Summary based on the document:

The core of this 510(k) submission is to demonstrate substantial equivalence of the HeRO® Graft to its predicate device (K071778, K091491, K120006).

• Acceptance Criteria for Substantial Equivalence: The primary "acceptance criteria" here relate to demonstrating that the modified device "raises no new questions of safety or effectiveness compared to the predicate device." This is achieved through:

  • Design Verification Testing: "Results of design verification testing demonstrate that the device system as modified is as safe as the predicate device."
  • Risk Assessment: "The risk assessment results... confirm that the HeRO Graft, as modified, raises no new questions of safety or effectiveness..."
  • Lack of Required New Clinical Data: "Additional clinical performance data was not required to support the modification of the device." This implies that existing data for the predicate and the "minor modification" were deemed sufficient to maintain equivalence in safety and effectiveness.

• "Study" Proving Acceptance: The "study" in this context is the design verification testing and risk assessment conducted by the manufacturer, which concluded that the changes (mainly branding and slight component-level modifications described in the Device Description) did not alter the fundamental safety or effectiveness profile of the device compared to the predicate. No new clinical trials or performance studies, as would be expected for a novel AI/ML device or a more significant device change, were conducted or required for this particular submission.

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The HeRO® Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

The HeRO® Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQ! guidelines' as patients who:

• ♥ Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as . determined by a history of previous access failures or venography.
• t Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography(e.g. fistula/graft salvage).
• . Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as . • determined by history or previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low KIV) via cathefers. KDOQI guidelines recommend a minimum Kt/V of 1.4.2

The HeRO® Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: HeRO® Arterial Graft Component, HeRO® Venous Outflow Component and HeRO® Accessory Component Kit. The HeRO® Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the outflow component is sized to fit the patient by cutting it to the proper length and sliding it over the barbs of the connector on the graft component. The HeRO® Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The HeRO® Accessory Component Kit (a convenience kit) contains tools that assist in the implantation of the HeRO® Graft.

This 510(k) summary explicitly states that "Additional clinical performance data was not required to support the modification of the device." Therefore, there is no information in the provided text regarding a clinical study that proves the device meets specific acceptance criteria based on its performance in patients.

The document states: "Results of design verification and validation testing demonstrate that the device system as modified is as safe as the predicate device. The risk assessment results, together with the results of design verification and validation testing presented in this submission, confirm that the HeRO® Graft, as modified, raises no new questions of safety or effectiveness compared to the predicate device."

This indicates that the acceptance criteria and proof of meeting them are based on non-clinical design verification and validation testing, which typically involves laboratory or bench testing, and comparisons to a predicate device, rather than a clinical study with human subjects.

Given this, I cannot extract the requested information (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) that would be present in a report of a clinical efficacy study.

The provided text does not contain the information needed to fill out the requested table and details because a clinical performance study was explicitly not required for this 510(k) submission.

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