(90 days)
The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: a)very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovencus fistulae of the neuro vasculature.
The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.
The provided text describes a medical device (Guglielmi Detachable Coil - GDC) and its intended use, but it does not contain information regarding acceptance criteria, a specific study proving the device meets those criteria, or any details about AI/algorithm performance. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical trial results with specific performance metrics and acceptance criteria.
Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.
Here's what I can infer from the given document, which is limited to the device description and intended use:
1. A table of acceptance criteria and the reported device performance:
- Not applicable / Not provided in the text. The document does not describe specific acceptance criteria (e.g., success rates, complication rates, embolization effectiveness metrics) or report performance against such criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided in the text. No "test set" in the context of algorithm evaluation is mentioned. The document describes expanding indications for an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided in the text. No mention of ground truth establishment by experts for a test set. The document refers to "treating neurosurgical team" determining suitability for the GDC, but this is clinical decision-making, not ground truth for an AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / 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:
- Not applicable / Not provided in the text. No AI or algorithm is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided in the text. No AI or algorithm is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided in the text.
8. The sample size for the training set:
- Not applicable / Not provided in the text. No AI or algorithm training is mentioned.
9. How the ground truth for the training set was established:
- Not applicable / Not provided in the text. No AI or algorithm training is mentioned.
Summary of what the document does describe:
- Device Name: Guglielmi Detachable Coil (GDC)
- Device Description: Consists of a remote power supply and an occlusion coil attached to a delivery wire, detached electrolytically. Coils are platinum.
- Intended Use: Embolizing certain intracranial aneurysms (high risk or inoperable) and other vascular malformations (AVMs, AVFs) of the neuro vasculature.
- Expanded Indications: The document indicates an expansion of use to "other vascular lesions such as arteriovenous malformations (AVM) and arteriovenous fistulas (AVF)." This expansion is being sought based on substantial equivalence to predicate devices (other GDCs and Cook Occlusion Coils) already marketed for similar vascular lesions.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).