(25 days)
The RX ACCUNET Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the site of filter basket placement should be between 3.25 mm and 7.0 mm.
The RX ACCUNET Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System, the RX ACCUNET Recovery Catheter, Shapeable Tip Design and the RX ACCUNET 2 Recovery Catheter, Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside.one of the provided Recovery Catheters. Recovery Catheter selection is based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy. The change being made is to the formulation of an adhesive that is used to adhere two core subassemblies.
The provided text describes a 510(k) premarket notification for the RX ACCUNET Embolic Protection System and focuses on a change in adhesive formulation rather than a comprehensive study for initial device efficacy. Therefore, much of the requested information regarding clinical study design, ground truth, and reader studies is not present in this document.
However, based on the provided information, I can extract details about the acceptance criteria for the specific modification to this device and the study conducted to demonstrate that the device meets these criteria.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Hypotube adhesion pull test met acceptance criteria | The testing demonstrated that the RX ACCUNET Embolic Protection System met the acceptance criteria and performed comparable to the predicate devices. |
| No new safety or effectiveness issues raised | "No new safety or effectiveness issues were raised during the testing" and "There were no new safety or effectiveness issues raised during the testing program." |
| Biocompatibility in accordance with ISO 10993-1 | Biocompatibility testing included cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogen, hemolysis, coagulation and complement activation. The results confirm that the device with the modified adhesive formulation remains appropriate for its intended use. |
| Performed comparably to predicate devices | "performed comparable to the predicate devices" and "show that it performed similarly to the predicate devices." |
Since this 510(k) is for a modification to an already cleared device, the study described here is focused on demonstrating that the modification (adhesive reformulation) does not adversely affect the device's performance compared to its predicate and that it remains safe. It is not a study to establish initial clinical efficacy or standalone performance against a clinical ground truth.
Here's what can be extracted and what information is not available:
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A table of acceptance criteria and the reported device performance: (See table above)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The testing described is in vitro bench testing. Typically, in vitro tests don't involve "patients" or "data provenance" in the same way clinical studies do. The samples would be device units or components.
- Data Provenance: Not applicable in the context of in vitro bench testing of device components.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/not provided because the described studies are in vitro bench tests (e.g., hypotube adhesion pull test), not clinical studies involving expert interpretation of medical data or images. The "ground truth" for a pull test is the physical outcome of the test (e.g., force at failure).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/not provided as it pertains to expert consensus in clinical evaluations, which is not described here.
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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:
- This information is not applicable/not provided. The device is an Embolic Protection System, not an AI-powered diagnostic tool requiring human reader studies.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable/not provided. The device is a physical medical device (an Embolic Protection System), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the in vitro bench testing, the "ground truth" would be the physical measurements and observations from the specific tests conducted (e.g., force measured in the hypotube adhesion pull test, laboratory results from biocompatibility assays). There is no clinical "ground truth" in this context.
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The sample size for the training set:
- This information is not applicable/not provided. This document describes the testing of a physical medical device modification, not the development or training of an AI algorithm.
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How the ground truth for the training set was established:
- This information is not applicable/not provided for the same reasons as point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).