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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

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.

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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 Detachable Coil (SDC) is manufactured from a platinum alloy attached to a positioning wire. The coil is detached by the Sapphire Detachment System (SDS) power supply, which dissolves a small detachment element between the emboliozation coil and the positioning wire. This occurs after desired placement of the coil in the anatomy. The Sapphire coils are manufactured from platinum/iridium alloy wire that is first wound into the primary coil, and then formed into a secondary (spherical or helical) shape. The Sapphire Detachment Coils are manufactured in different shapes and sizes. These coils are available in spherically shaped configurations, as well as, helically shaped configurations of various diameters and lengths.

The Sapphire Detachable Coil System underwent various tests to demonstrate its performance and substantial equivalence to the predicate device. The Acceptance Criteria and reported performance are summarized below, though specific numerical acceptance criteria were not provided in the document for all tests. The document states that "All performance characteristics met the acceptance criteria" and "All testing demonstrated compliance with the appropriate standard and/or met the acceptance criteria," indicating successful completion of the tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document describes "animal studies" for the Sapphire Detachable Coil series. However, the specific sample size (number of animals) used for these studies is not provided. The data provenance is described as prospective animal studies. The country of origin of the data is not specified.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not include information on the number of experts used to establish ground truth or their qualifications. The animal studies would rely on observations and measurements from the researchers and veterinarians involved.

4. Adjudication Method

The provided text does not include information on any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a medical implant and not an imaging or diagnostic AI device that would typically involve human readers. The studies focused on the physical and functional performance of the coil and its detachment system.

6. Standalone (Algorithm Only) Performance Study

While the Sapphire Detachment System (SDS) includes firmware, the "standalone" performance described is not in the context of an AI algorithm producing a standalone diagnostic output. Instead, it refers to the functional performance of the SDS, including electrical safety, emission, disturbance, ESD immunity, and firmware compliance with design specifications. The performance of the coil itself is also assessed in a standalone context in the sense that its physical properties are measured independently.

7. Type of Ground Truth Used

The ground truth used in the studies includes:

• Physical Measurements and Standards: For tests like coil strength, tensile strength, flexibility, radiopacity, particulate generation, and electrical properties, ground truth is established by objective measurements against predefined engineering specifications and relevant industry standards.
• In-vitro Performance Assessment: For aspects like ease of delivery, detachment time (in-vitro), and detachment reliability (in-vitro), the ground truth is based on the devices' performance in controlled laboratory settings and simulations.
• Animal Outcomes/Observations: For the animal studies, the ground truth relates to observed physiological responses and device function within a living system, such as fluoroscopic visibility, ability to position and pack the aneurysm sac, coil reposition-ability, ease of use of the detachment system, coil detachment reliability, and coil stability.

8. Sample Size for the Training Set

The concept of a "training set" is typically applicable to machine learning algorithms. Since the Sapphire Detachable Coil System is a physical medical device and not an AI algorithm in the context of its development as described, there is no mention of a training set in the provided information.

9. How the Ground Truth for the Training Set Was Established

As there is no training set discussed, information on how its ground truth was established is not applicable/provided.

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