(29 days)
The Sapphire™ Detachable Coils are intended for the endovascular embolization of 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) be inoperable. The Sapphire™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
The Sapphire" NXT Detachable Coil is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary three-dimensional structure, which forms helical and spherical shapes. The coil is coated with parylene polymer material. The embolization coil is laser welded to the detachment element made of stainless steel. The detachment element is then laser welded to the delivery wire assembly, which consists of a stainless steel wire and a radiopaque positioning coil that is partially covered with Teflon. The positioning coil provides visual indication under fluoroscopy for positioning of the embolization coil.
In the case of fibered coils, nylon fiber bundles are secured into the primary coil at regular intervals on the coil length.
The tension safe coil is manufactured with an inner filament made of a Nickel-Titanium.
The coil is detached by the battery operated power supply (NDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire.
I am sorry, but I cannot provide a response to your request. The provided text describes a medical device, the Sapphire NXT Detachable Coil System, and its clearance process with the FDA. However, the text details bench testing results and a summary of substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria with human subjects or a detailed AI algorithm study.
The document does not contain the following information necessary to fulfill your request:
- A table of acceptance criteria and the reported device performance in a clinical setting. The provided table only lists bench testing results, which are not acceptance criteria in the context you're asking for (e.g., sensitivity, specificity, accuracy).
- Sample size used for the test set and data provenance. No information on human test sets or their origin is provided.
- Number of experts used to establish ground truth and their qualifications. Not applicable as no clinical study with ground truth establishment is described.
- Adjudication method. Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study. No such study is mentioned.
- Standalone (algorithm only) performance. The document describes a physical medical device, not an AI algorithm.
- Type of ground truth used. Not applicable.
- Sample size for the training set. Not applicable.
- How the ground truth for the training set was established. Not applicable.
Therefore, based solely on the provided text, I cannot generate the requested description of acceptance criteria and a study proving device performance in the manner you've outlined for AI/clinical study contexts. The document focuses on regulatory clearance based on substantial equivalence and bench testing for a physical medical device.
§ 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).