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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 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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The HeRO™ Vascular Access Device is intended for use in maintaining long-term hemodialysis access in patients who have exhausted peripheral vascular access sites suitable for fistulas or grafts.

The HeRO™ Vascular Access Device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheterdependent patients are readily identified using the K/DOQI 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.
• 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. K/DOQI guidelines recommend a minimum Kt/V of 1.4.

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

The provided text is a 510(k) summary for the HeRO™ Vascular Access Device. It describes the device, its intended use, and indications for use, and states that it has been found substantially equivalent to a predicate device. However, it does not contain the detailed information necessary to complete the requested table and study description.

Specifically, the document states:
"Results of design verification and validation demonstrated that the HeRO™ Vascular Access Device met its acceptance criteria." and "Additional clinical performance data was not required to support the modification of the device."

This indicates that the submission relies on design verification and validation, likely non-clinical (bench testing, biocompatibility, sterilization, and packaging verification), rather than a clinical study with human subjects, to demonstrate the device meets acceptance criteria.

Therefore, many sections of your request cannot be fulfilled based on the provided text, as the detailed acceptance criteria and a study proving those criteria were met by clinical performance data are not present.

Here's a breakdown of what can and cannot be answered:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not explicitly stated in terms of specific metrics against acceptance criteria. The document only generally states, "demonstrated that the HeRO™ Vascular Access Device met its acceptance criteria."

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

• Not applicable as no clinical test set/study is described to support the modification for this 510(k). The document specifically states, "Additional clinical performance data was not required to support the modification of the 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 as no clinical test set/study is described.

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

• Not applicable as no clinical test set/study 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

• No MRMC study was done. This is a vascular access device, not an AI-assisted diagnostic tool. No AI is mentioned.

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

• Not applicable. This is a medical device, not an algorithm, and no AI is mentioned.

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

• Not applicable as no clinical test set/study is described. The "ground truth" for design verification would be established through engineering specifications, material standards, and validated testing protocols.

8. The sample size for the training set

• Not applicable as no clinical study or AI algorithm is described. "Training set" is not relevant here in the context of device approval for this 510(k).

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

• Not applicable as no clinical study or AI algorithm is described.

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