HEMASHIELD VANTAGE (VASCULAR GRAFT by MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

The provided text describes a medical device, the HEMASHIELD VANTAGE™ Vascular Graft, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML or diagnostic device.

The document details product testing for physical and material properties of the graft (e.g., Burst Strength, Tensile Strength, Integral Water Permeability) to demonstrate equivalence to predicate devices. It also mentions biocompatibility testing. However, these are engineering and material science tests, not performance studies for an AI/ML diagnostic system or a study with a test set, ground truth, or expert readers.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as the provided text pertains to a different type of medical device assessment.

Here's a breakdown of why the requested information cannot be extracted from the given text:

No AI/ML or Diagnostic Device: The HEMASHIELD VANTAGE™ Vascular Graft is a physical vascular graft for surgical replacement, not a diagnostic tool or an AI/ML system.
No Acceptance Criteria for Diagnostic Performance: The "acceptance criteria" discussed in the text are implicitly related to the physical and chemical properties of the graft meeting established standards for similar devices, not to diagnostic performance metrics like sensitivity, specificity, or AUC.
No "Study" in the Requested Sense: The "testing" mentioned (Burst Strength, Tensile Strength, etc.) are laboratory characterizations of a physical product, not clinical or reader studies involving patient data, ground truth, or human expert interpretation.
No Test Set, Ground Truth, or Expert Readers: These concepts are entirely absent because the device is not a diagnostic or AI system.
No MRMC or Standalone Performance: These are metrics specific to AI/ML diagnostic device evaluation.
No Training Set: As it's a physical product, there's no training set in the context of machine learning.

Summary

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JAN 22 1997

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Meadox Medicals, Inc. Owner: 112 Bauer Drive Oakland, NJ 07436 (201) 337-6126 Fax# (201) 337-5797 Carolyn Tauber Contact Person: Senior Regulatory Affairs Specialist May 9, 1996 Submission Date: HEMASHIELD VANTAGE™ Vascular Grafts Device Name: Predicate Devices: HEMASHIELD® CARDIOVASCULAR GRAFTS: HEMASHIELD® MICROVEL® Double Velour Knitted Vascular Grafts HEMASHIELD® Woven Double Velour Vascular Grafts [510(k) #K954848, determined substantially equivalent Feb. 1, 1996) The HEMASHIELD VANTAGE™ Vascular Graft is a woven Description of Device: polyester graft, impregnated with bovine collagen. For use in systemic vascular reconstructions, e.g., replacement in the Intended Uses: case of aneurysmal or occlusive disease, in the peripheral region. The indications are substantially equivalent to the predicate devices, except for the specification of the region of application (peripheral region) of the devices.

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The HEMASHIELD VANTAGE™ Vascular Graft is substantially Substantial Equivalence: equivalent in design, components, materials, intended use and labeling to the currently marketed predicate devices. The modifications in this device compared to the predicate devices are:

It combines a smooth inner surface and veloured outer . surface in the same graft; predicate Meadox grafts have the same inner and outer surface: both surfaces are either smooth or velour.
Like its predicate devices, it is intended for use in . vascular replacement in the case of aneurysmal or occlusive disease; with the exception that this device is intended for application in the peripheral region.
The labeling is distinct from that for the predicate devices . to reflect the above described modifications in this device compared to the predicate devices.

Testing has been performed which demonstrates that in spite of these modifications in the proposed device, the proposed devices are substantially equivalent in safety and performance to the currently marketed predicate devices.

The following testing has been conducted on HEMASHIELD Product Testing: VANTAGE™ Vascular Grafts to demonstrate the equivalency in safety and efficacy of these devices to their currently marketed predicate devices.

· Burst Strength
· Tensile Strength
· Suture Pull Out
· Wall Thickness
· Needle Penetration
· Crush Resistance
· Flexural Rigidity
· Integral Water Permeability
· Integral Water Permeability under load
· Strength of Collagen Bonding
· Shrinkage Temperature
· Glycerol Content
· Collagen Content
· Hydrolytic Stability Testing
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product
equivalent to marketed product

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CONFIDENTIAL

Testing performed in accordance with ISO 9000 Standards Biocompatibility Testing: indicates that the HEMASHIELD VANTAGE™ Vascular Grafts fabricated from polyester textile materials and with the same collagen composition and method of manufacture as its predicate devices are safe for their intended use and substantially equivalent in biocompatibility to the currently marketed predicate devices.

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”