(43 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 VDS™ Tension Safe Coil is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary helical shape. The VDS Tension Safe has multiple coil segments with polymer "cap" at each segment ends, integrated into one coil system. The coil is welded to a positioning wire, which consist of ground stainless steel core wire with a stainless steel coil laser welded at the distal end and a Teflon outer jacket. The coil is detached by the battery operated power supply (SDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire.
Here's an analysis of the provided text regarding the Sapphire Detachable Coil System, VDS™ Tension Safe, focusing on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Bench Testing (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Coil Deformation | Meet established acceptance criteria |
| Ease of Delivery/Coil Frictional Characteristics | Meet established acceptance criteria |
| Reliability After Fatigue & Premature Detachment | Meet established acceptance criteria |
| Tensile Strength of Coil & Detachment Zone | Meet established acceptance criteria |
| Detachment Time | Meet established acceptance criteria |
| Particulate Generation | Meet established acceptance criteria |
| Physical Dimensions | Meet established acceptance criteria |
| Radiopacity | Meet established acceptance criteria |
| Aging and Shelf Life (6 months) | Meet established acceptance criteria (for 6 months) |
Note: The document explicitly states "Meet established acceptance criteria" for each test, implying that specific quantitative or qualitative thresholds were defined and met. However, the exact numerical values or detailed qualitative descriptions of these criteria are not provided in the given text.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set for any of the "Bench Testing" categories. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The tests appear to be conducted in a laboratory or bench setting rather than using patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and therefore, not provided. The acceptance criteria and performance are based on bench testing, not on clinical evaluation or expert interpretation of medical images.
4. Adjudication Method for the Test Set
This information is not applicable and therefore, not provided. The "tests" mentioned are bench tests of mechanical and physical properties, not clinical assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through bench testing of physical and mechanical properties. There's no mention of human reader performance or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and therefore, not provided. The "device" is a physical medical implant (an embolization coil system), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests would have been the defined engineering specifications, performance standards, and material properties that the device was designed to meet. For instance:
- Coil Deformation: A specific tolerance for deformation under a defined load.
- Tensile Strength: A minimum tensile strength requirement.
- Detachment Time: A specified range for detachment time.
- Physical Dimensions: Exact dimensional specifications.
However, the document does not explicitly detail these ground truths beyond stating that the device "Meet established acceptance criteria."
8. The Sample Size for the Training Set
This information is not applicable and therefore, not provided. As mentioned, the device is a physical medical implant, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore, not provided, for the same reason as point 8.
§ 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).