(8 days)
The Sapphire™ Detachable Coils are intended for the endovascular cmbolization 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 Tetris 3-D 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 a spherical cage of loops. The Tetris is manufactured with an inner filament made of a Nickel-Titanium. The Tetris 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.
The provided text describes the Micro Therapeutics, Inc. Sapphire Tetris 3-D Detachable Coil System.
Here's the analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Bench Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Coil Deformation | Established acceptance criteria | Meet established acceptance criteria |
| Ease of Delivery/Coil Frictional Characteristics | Established acceptance criteria | Meet established acceptance criteria |
| Reliability After Fatigue & Premature Detachment | Established acceptance criteria | Meet established acceptance criteria |
| Coil Knotting | Established acceptance criteria | Meet established acceptance criteria |
| Detachment Time | Established acceptance criteria | Meet established acceptance criteria |
| Physical Dimensions | Established acceptance criteria | Meet established acceptance criteria |
| Physician/Marketing Laboratory Evaluation (side-by-side comparison with Atlas) | Established acceptance criteria | Meet established acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The provided document describes bench testing for the device, not a human clinical study with a "test set" in the context of patient data. Therefore, information about sample size for a test set, data provenance (country of origin, retrospective/prospective), and ground truth establishment, as typically understood for clinical trials, is not applicable here. The tests were performed on the device itself.
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)
This information is not provided as the evaluation focuses on device bench performance, not human interpretability of medical data. The "Physician/Marketing Laboratory Evaluation" suggests input from physicians, but the number and qualifications are not detailed beyond their involvement in a "side-by-side comparison with Atlas" (the predicate device).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as there is no test set of patient data requiring adjudication.
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
An MRMC study was not performed. This submission is for a medical device (embolization coil), not an AI diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not performed in the context of an algorithm. The device itself (the embolization coil) is the "standalone" component being evaluated for its physical and functional performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench testing would be engineering specifications and performance standards. For example, the detachment time would be compared against a defined acceptable range, and physical dimensions against design specifications.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set mentioned or implied.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study that proves the Sapphire Tetris 3-D Detachable Coil System meets its acceptance criteria is a series of bench tests evaluating various physical and functional characteristics of the device. These tests were conducted according to established acceptance criteria, and the results consistently indicated that the device "Meet established acceptance criteria" across all assessed parameters, including:
- Coil Deformation
- Ease of Delivery/Coil Frictional Characteristics
- Reliability After Fatigue & Premature Detachment
- Coil Knotting
- Detachment Time
- Physical Dimensions
- Physician/Marketing Laboratory Evaluation (side-by-side comparison with the predicate device, Sapphire Atlas 3-D)
The purpose of these studies was to demonstrate substantial equivalence to the predicate device (Sapphire Atlas 3-D) by showing that the two devices share the same intended use, operating principle, basic design and material, and manufacturing/sterilization processes. The testing was focused on the device's inherent properties and performance, not on clinical outcomes or diagnostic accuracy involving human subjects.
§ 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).