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The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary, carotid, iliac or renal vasculature.

The SilverHawk™ Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk™ Peripheral Catheter and SilverHawk™ Cutter Driver.

The SilverHawk™ Peripheral Plaque Excision System will be provided sterile for singleuse. The catheter will be sterilized by Ethylene Oxide (ANSVAAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 106, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.

The SilverHawk™ Peripheral Plaque Excision System with the additional clinical contraindication statement is identical in material of construction, overall design, intended use, and safety and efficacy to the predicate device.

The provided text is a 510(k) summary for the SilverHawk™ Peripheral Plaque Excision System. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study demonstrating the device meets such criteria.

The document states: "The SilverHawk™ Peripheral Plaque Excision System with the additional clinical contraindication statement is identical in material of construction, overall design, intended use, and safety and efficacy to the predicate device." This indicates that the new device's safety and efficacy are established by its similarity to the already-approved predicate device (K053460), rather than a new standalone study with specific acceptance criteria.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them because this information is not present in the provided text. The submission relies on substantial equivalence to a predicate device, which typically means a new clinical study to establish acceptance criteria for the new device is not required or presented in the 510(k) summary.

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Indications for Use: The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectorny of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System is provided sterile for single-use.

The provided text is related to a 510(k) submission for a medical device called the "SilverHawk™ Peripheral Plaque Excision System." It describes the classification, predicate device, and confirms its substantial equivalence for marketing. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a summary of the 510(k) notification and the FDA's clearance letter, which focuses on regulatory aspects such as substantial equivalence to a predicate device and adherence to general controls. It does not detail the technical studies, performance metrics, or clinical trial data that would typically be included in a full submission to demonstrate safety and efficacy.

Therefore, I cannot provide the requested information based on the input text.

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