(107 days)
The Revolution Peripheral Atherectomy System is intended for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries with occlusive atherosclerotic disease.
The Revolution Peripheral Atherectomy System is sterile, single-use device designed for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.
The Revolution device incorporates a flexible drive shaft designed to track over the Revolution guidewire. Attached to the distal end of the drive shaft is a diamond coated spheroid shaped burr which rotates at high speed to ablate occlusive material and restore luminal patency. Power is derived from a mains source and converted using the reusable power supply. During treatment, the rotating burr ablates material into fine particles. This particulate is conveyed proximally by a mechanical means through the catheter and handle into a collection receptacle that resides outside the patient. The device is available in 145cm and 60cm lengths with burr diameters of 1.33mm, 1.66mm, and 2.00mm.
The Revolution Peripheral Atherectomy System consists of the following components:
- Single-use Revolution Device (provided sterile)
- Single-use Revolution .014" Guidewire (provided sterile)
- Single-use infusion assembly (provided sterile)
- Single-use collection receptacle (provided sterile)
- Single-use guidewire clip (provided sterile)
- Reusable power supply (provided non-sterile)
This document describes the Revolution™ Peripheral Atherectomy System, a medical device. The information provided outlines the acceptance criteria and the study conducted to prove the device meets these criteria.
Here's the breakdown as requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides primary safety and effectiveness endpoints with predefined success criteria, which can be interpreted as acceptance criteria.
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance |
|---|---|
| Safety: Freedom from 30-day Major Adverse Events (MAE) | 97.3% (110/113) freedom from MAE |
| (MAE defined as composite of all-cause mortality, clinically-driven TLR, major target limb amputation, target vessel perforation requiring endovascular or surgical repair, and clinically significant distal embolization in the target limb) | |
| Effectiveness: Technical success (≤50% diameter residual stenosis after atherectomy, prior to adjunctive therapy) | 90.2% (111/123) technical success |
Comment: The document explicitly states, "Both primary endpoints met the predefined IDE study success criteria."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- Total Patients Enrolled: 121
- Evaluated for 30-day Primary Safety Endpoint (ITT population): 113 patients
- Evaluated for Primary Effectiveness Endpoint (PP population): 123 lesions (from 121 enrolled subjects)
- Data Provenance:
- Country of Origin: U.S. (17 U.S. centers)
- Study Design: Prospective, multi-center, non-randomized, single-arm study (REVEAL clinical study).
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)
The document mentions two independent groups involved in establishing ground truth for the clinical study:
- Independent Clinical Events Committee (CEC): Adjudicated the primary safety endpoint (MAE). The number of experts is not specified, nor are their exact qualifications, but they are identified as an "independent" committee.
- Independent Angiographic Core Laboratory: Evaluated residual stenosis for the primary effectiveness endpoint. The number of experts is not specified, nor are their exact qualifications, but they are identified as an "independent" core lab.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Safety Endpoint: "adjudicated by the independent Clinical Events Committee (CEC)." The specific voting mechanism (e.g., 2+1) is not provided.
- Effectiveness Endpoint: "evaluated by an independent Angiographic Core Laboratory." This implies a systematic evaluation, but the specific adjudication method (e.g., multiple readers, consensus) is not detailed.
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
There is no indication that an MRMC comparative effectiveness study involving human readers with and without AI assistance was conducted or reported in this document. This study is for a medical device (atherectomy system), not an AI algorithm for diagnostic reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical atherectomy system used in a procedure, not a diagnostic algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The performance evaluated is the device's ability to achieve clinical outcomes (safety and effectiveness) when used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical study was established through a combination of:
- Adjudicated Clinical Outcomes Data: For the safety endpoint (MAE), adjudicated by an independent Clinical Events Committee.
- Core Lab Measurements/Expert Interpretation of Imaging: For the effectiveness endpoint (residual stenosis), evaluated by an independent Angiographic Core Laboratory based on angiographic measurements.
8. The sample size for the training set
The document describes a clinical study to evaluate safety and effectiveness. It does not mention a training set in the context of machine learning or AI. This is a clinical trial for a physical medical device.
9. How the ground truth for the training set was established
As there is no mention of a training set or AI model in the provided text, this question is not applicable.
§ 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).