(30 days)
The EZ Plus Retrieval Sheath is indicated for use with the Boston Scientific FilterWire EZ™ Embolic Protection System as an alternative method for retrieval and/or redeployment of a deployed FilterWire EZ device. Reference the FilterWire EZ Embolic Protection System Instructions for Use for indications, warnings and precautions for the system.
The Boston Scientific EZ Plus Retrieval Sheath, a separately packaged, accessory component of the Boston Scientific FilterWire EZ Embolic Protection System, is an easy exchange sheath with a retractable tip at the distal end. The retractable tip facilitates its ability to cross a deployed stent as well as to negotiate tortuous anatomy when retrieving the FilterWire EZ protection wire. The radiopaque retractable tip and marker band at the distal end of the EZ Plus Retrieval Sheath provide visualization of the device under fluoroscopic imaging. At the completion of the procedure, the EZ Plus Retrieval Sheath is advanced up the FilterWire to just proximal the deployed filter loop. The filter is resheathed into the distal end of the EZ Plus Retrieval Sheath and the entire system is then removed from the patient.
The provided text refers to a Special 510(k) submission for a device modification, specifically the "EZ Plus Retrieval Sheath" which is an accessory to the "FilterWire EZ Embolic Protection System." This document outlines regulatory information and device description, but it does not contain the typical information about clinical studies, acceptance criteria for device performance, or details regarding ground truth establishment that would be found in a comprehensive clinical study report.
The section titled "5.6 Non-Clinical Test Summary" explicitly states: "Where appropriate, testing conformed to the requirements of 21 CFR Part 58 [Good Laboratory Practices (GLP)]. Specifically, non-clinical tests conducted for the EZ Plus Retrieval Sheath showed the device met its design-input criteria, and is safe and effective for its intended use."
This indicates that the device's performance was evaluated through non-clinical testing (e.g., bench testing, mechanical testing) rather than human clinical trials or AI performance evaluations. Therefore, I cannot provide details for most of the requested categories.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document states that "non-clinical tests conducted for the EZ Plus Retrieval Sheath showed the device met its design-input criteria, and is safe and effective for its intended use." However, specific acceptance criteria and their corresponding reported performance values are not detailed in this document. It's a high-level summary indicating successful completion of relevant non-clinical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Met design-input criteria; safe and effective for intended use (based on non-clinical testing) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes non-clinical (laboratory/bench) testing, not a clinical study involving human patients or data sets.
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)
This is not applicable as there is no mention of a test set requiring expert-established ground truth. The evaluation was based on non-clinical engineering and performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no mention of a test set with human assessments requiring adjudication.
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 mention of an MRMC comparative effectiveness study, AI assistance, or human readers in this document. This device is a physical medical device (retrieval sheath), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical retrieval sheath, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable as the document describes non-clinical testing, which would rely on engineering specifications, material properties, and functional performance benchmarks rather than clinical ground truth types.
8. The sample size for the training set
This is not applicable as this describes a physical medical device and not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as this describes a physical medical device and not an AI algorithm that requires a training set with ground truth.
§ 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).