(8 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 2.8 mm and 6.2 mm.
The Emboshield® 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: RX BareWire™, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
The provided text describes a 510(k) premarket notification for the "Emboshield® Embolic Protection System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving device performance against specific acceptance criteria. While a clinical study (SECuRITY Registry Trial) is mentioned, details about acceptance criteria, specific performance metrics, and study methodologies for those criteria are largely absent from this document.
However, based on the information provided, here's an attempt to answer the questions, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "device must achieve X accuracy with Y confidence"). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The general "acceptance criteria" are implied to be that the device is as safe and effective as the predicate device.
The reported device performance is broadly summarized as:
- "results of the testing and clinical study support the safety and performance of the Emboshield device and its components for the intended indication."
Missing Information: Specific quantitative acceptance criteria (e.g., % reduction in embolic events, % successful deployment, filtration efficiency) and the corresponding achieved performance values are not detailed in this document.
2. Sample size used for the test set and the data provenance
- Sample Size: The "SECuRITY Registry Trial" enrolled 399 patients.
- Data Provenance: The document does not explicitly state the country of origin. It mentions 30 sites, suggesting a multi-center study, but location is not specified. The trial name "Registry Trial" implies it's a prospective observational study, gathering data on standard clinical practice rather than a randomized controlled trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: The document does not provide any information about the use of experts to establish a "ground truth" for the test set outcomes. Clinical trials typically rely on clinical endpoints (e.g., stroke rates, neurological deficits), which are evaluated by treating physicians and potentially adjudicated by independent clinical events committees, but the specifics are not mentioned here.
4. Adjudication method for the test set
Missing Information: The document does not describe any specific adjudication method for the test set outcomes.
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
Not Applicable: This device is an embolic protection system (a physical medical device), not an imaging or diagnostic AI device that would involve human readers interpreting cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable: This is a physical device, not an algorithm or AI system. Its performance is evaluated through its mechanical function and clinical outcomes, not through "standalone algorithm performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for evaluating the device's safety and performance would be clinical outcomes data from the SECuRITY Registry Trial, likely pertaining to embolic events, device-related complications, and successful protection during procedures.
Missing Information: Specific details on how these clinical outcomes were defined and assessed (e.g., what constituted an embolic event, how it was diagnosed, etc.) are not provided.
8. The sample size for the training set
Not Applicable/Missing Information: This is a physical medical device. The concept of a "training set" is generally applicable to machine learning algorithms. While the device undergoes extensive R&D and engineering testing (which could conceptually be seen as "training" its design), there isn't a "training set" in the machine learning sense for its clinical application. If the question implies prior data used to inform the device design or predicate device data synthesis, that detail isn't provided.
9. How the ground truth for the training set was established
Not Applicable/Missing Information: As mentioned above, the concept of a "training set" in the context of an algorithm's ground truth is not directly applicable to a physical device like this.
§ 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).