(143 days)
The SpideRX Embolic Protection Device 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 filter basket placement should be between 3.0mm and 7.0mm.
The SpideRX Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for device performance based on the clinical study. Instead, the study's conclusion is that the "differences observed between the primary endpoint event rates were not statistically significant," which "demonstrates the safety and performance of the SpideRX Device for its intended use." This implies that the acceptance criterion was likely non-inferiority to predicate devices or a pre-defined acceptable complication rate, which was met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-inferiority in safety and performance compared to predicate devices, or acceptable event rates. | "The differences observed between the primary endpoint event rates were not statistically significant," demonstrating safety and performance for intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The study is described as a "non-randomized multi-center registry study."
- Data Provenance: Not explicitly stated, but "multi-center registry study" suggests data from multiple clinical sites, likely within the country where the trial was conducted (presumably the US, given the FDA submission). It is a prospective clinical study, as it was performed to assess the safety and performance of the device when used with another system.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The clinical study assessed "safety and performance," which would involve clinical outcomes and event rates, but the method for establishing "ground truth" (e.g., assessing the nature of embolic material, or specific clinical outcomes via independent review) is not detailed.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a "non-randomized multi-center registry study" focused on the safety and performance of the SpideRX device, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This is not applicable as the SpideRX Embolic Protection Device is a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used:
The ground truth for the clinical study was based on clinical outcomes/events related to safety and performance (e.g., embolic events, complications, successful deployment/retrieval). The document doesn't specify how these events were formally adjudicated or categorized as "ground truth," but it would typically involve clinical assessments and potentially imaging. It does not mention pathology or outcomes data in the sense of long-term follow-up beyond the immediate procedural context being assessed.
8. Sample Size for the Training Set:
This is not applicable. The SpideRX Embolic Protection Device is a physical medical device; thus, there is no "training set" in the context of machine learning or AI. The term "training set" is generally used for algorithms that learn from data.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no "training set" for a physical medical 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).