(84 days)
The Aesculap AVM Microclips are intended for intracranial vascular occlusion (permanent or temporary) of small vessels.
The Aesculap AVM Microclip Applier is intended for holding and applying intracranial AVM Microclips.
The Aesculap AVM Microclips are designed for temporary or permanent occlusion of small vessels during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are available with either straight or curved blades. The AVM Microclip Applier is constructed from Titanium Alloy per ISO 5832/3 with Phynox jaws.
The provided text describes the 510(k) summary for the "Aesculap AVM Microclips and Applier." It states that the device received FDA clearance (K024349) in 2003.
However, the document does not contain the information requested in the prompt regarding a study that proves the device meets specific acceptance criteria.
The section titled "PERFORMANCE DATA" only states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Aesculap AVM Microclips were completed. Biomechanical testing results demonstrate the Aesculap AVM Microclips and Applier are substantially equivalent to other AVM Microclips and Appliers currently on the market."
This indicates that internal biomechanical testing was performed to demonstrate substantial equivalence to existing predicate devices, which is a regulatory pathway for clearance, but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results (effect size).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on regulatory compliance and substantial equivalence, not on a detailed clinical or performance study as might be expected for an AI-powered device or one with specific performance acceptance criteria measured in a clinical context.
Therefore, I cannot fulfill your request for items 1-9 based on the provided text. The device described (AVM Microclips) is a physical surgical instrument, not an AI/software device that would typically involve the types of studies mentioned in your prompt (e.g., MRMC, standalone algorithm performance, ground truth establishment with experts for image analysis).
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).