(53 days)
The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature and 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 will be provided sterile for single-use.
The SilverHawk Peripheral Plaque Excision System is a medical device intended for atherectomy of the peripheral vasculature. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth for a de novo study is not directly available in this summary.
However, based on the provided text, here's what can be inferred and stated:
1. Table of Acceptance Criteria and Reported Device Performance
Strict acceptance criteria and detailed performance metrics are not explicitly stated in this 510(k) summary, as the submission is based on demonstrating substantial equivalence to a predicate device rather than a de novo approval requiring a set of performance benchmarks. The "performance" reported is primarily in the context of being substantially equivalent to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (ReFORM Peripheral Catheter System (K024243)) in material, design, intended use, safety, and efficacy. | The SilverHawk Peripheral Plaque Excision System was shown to have "substantially equivalent performance" when compared to the predicate device. The FDA concurred with this determination. |
| Biocompatibility | The device is biocompatible per ISO-10993-1. |
| Sterility Assurance Level (SAL) for catheter | Validated to a SAL of 10-6 for Ethylene Oxide sterilization. |
| Sterility Assurance Level (SAL) for cutter driver | Validated to a minimum SAL of 10-6 by Gamma Sterilization Cycle (VDmax method, minimum dose of 25kGy). |
| Ethylene Oxide residuals | Limits for Ethylene Oxide residuals were met during sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not detail a specific clinical test set for the SilverHawk Peripheral Plaque Excision System. The "performance" is assessed based on comparison to the predicate device, which would involve engineering, bench, and potentially animal testing data, but the specific sample sizes for these tests are not provided. The data provenance is not mentioned as this is a regulatory submission rather than a clinical study report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is a 510(k) submission based on substantial equivalence, the "ground truth" for device performance is largely established through comparison to the predicate device's known performance characteristics and regulatory clearances, not through expert consensus on a new clinical test set for the SilverHawk device itself in this document.
4. Adjudication Method for the Test Set
Not applicable. There is no described "test set" in the context of a prospective clinical trial requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe a MRMC comparative effectiveness study involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an AI algorithm. It is a physical medical device (atherectomy catheter system). Therefore, the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness profile of the predicate device (ReFORM Peripheral Catheter System, K024243), as determined by its previous FDA clearance and market performance. The goal of this 510(k) is to demonstrate that the SilverHawk system is "substantially equivalent" to this established ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI algorithm.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).