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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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