(101 days)
The Emboshield® Embolic Protection System is indicated for use as a guidewire 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 artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
The Emboshield NAV6 Embolic Protection System is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: Bare Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
The provided text describes a 510(k) premarket notification for the Emboshield NAV6 Embolic Protection System. It outlines the device's intended use and design, and summarizes the substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria or provide a detailed study report proving the device meets specific performance criteria beyond general statements of safety and performance.
Thus, a direct answer to the request to populate the table with "acceptance criteria" and "reported device performance" is not possible from the provided text, as these specific metrics are not present. Similarly, details for most of the other questions are either not provided or only vaguely mentioned.
Here's an analysis of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Information Not Provided in the Text. The document states:
- "Results of testing have demonstrated that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
- "In vitro and in vivo testing was conducted."
- "The PROTECT Study was conducted enrolling a total of two hundred and twenty (220) patients at 34 sites."
- "In summary, the results of the testing and clinical study support the safety and performance of the Emboshield NAV6 device and its components for the intended indication when used in accordance with the Instructions for Use."
These are general conclusions, not specific quantitative acceptance criteria or reported performance metrics.
2. Sample size used for the test set and the data provenance
- Sample size for the test set: 220 patients (from the PROTECT Study).
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective outside of "clinical study"), but given it's a 510(k) submission to the US FDA, it likely includes US data, potentially multi-national given "34 sites". The study was "conducted," implying prospective collection for the clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Information Not Provided in the Text.
4. Adjudication method for the test set
Information Not Provided in the Text.
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
The device is an Embolic Protection System (a physical medical device, not an AI or imaging diagnostic tool). Therefore, an MRMC comparative effectiveness study involving human readers (typically associated with AI/imaging for diagnosis/detection) is not applicable to this type of device. The "PROTECT Study" seems to be a clinical trial for the device's safety and performance in patients, not an AI efficacy study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the PROTECT Study (clinical trial): It can be inferred that outcomes data (related to safety and efficacy in removing embolic material during carotid procedures) would be the primary ground truth. Specific details on how "embolic material" removal or "protection" was quantified and verified are not provided.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set for a physical device.
§ 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).