(22 days)
The SpiderFXTM 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 SpiderFXTM Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 190/320 cm PTFE-coated 0.014" stainless steel guidewire and a dual-ended SpiderFX Catheter for delivery and recovery.
The provided text describes the SpiderFXTM Embolic Protection Device and its 510(k) summary (K063204). However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria with reported performance metrics, expert involvement, or statistical details.
The document states that:
- "Non-clinical verification and validation of the SpiderFX™ Embolic Protection Device consisted of in vitro bench testing, package integrity testing, and in vivo animal studies. Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use."
- The device is "substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K052659) in intended use, materials, technological characteristics and performance."
This indicates that the acceptance criteria and proof of performance were likely evaluated by demonstrating equivalence to the predicate device (SpideRX™ K052659) through these non-clinical tests. The K063204 document serves as the FDA's acceptance of this substantial equivalence, not as a detailed report of the underlying studies.
Therefore, for the specific questions asked, most of the information is not available in the provided text.
Here's a breakdown of what can and cannot be answered based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that "Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use," but it does not present specific quantitative acceptance criteria or corresponding device performance results (e.g., capture efficiency, deployment success rates, etc.).
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document mentions "in vitro bench testing" and "in vivo animal studies" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not available in the provided text. The verification and validation involved non-clinical studies (bench and animal), not human expert-read test sets in the context of diagnostic or interpretive devices.
4. Adjudication Method for the Test Set
Not applicable/Not available in the provided text. This usually applies to studies involving human interpretation or performance on images/data, which is not described here for the non-clinical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is an embolic protection device, not an AI-based diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to its evaluation.
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. Its performance is inherent to its mechanical design and function. While bench and animal tests evaluate its standalone physical performance, it's not "algorithm only" in the sense of AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not explicitly stated in detail. For "in vitro bench testing," the ground truth would be established by the test parameters themselves (e.g., known particle sizes for filtration, known forces for mechanical integrity). For "in vivo animal studies," the ground truth would typically refer to outcomes observed in the animal model (e.g., prevention of emboli, vessel patency, tissue damage).
8. The Sample Size for the Training Set
Not applicable/Not available in the provided text. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available in the provided text. This device is not an AI algorithm that requires a training set.
In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device through non-clinical testing (bench and animal studies), rather than detailing specific clinical trial data with acceptance criteria and performance metrics in the format requested for a typical AI/diagnostic device study.
§ 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).