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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 arteriovenous fistulae of the neurovasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The GDC system consists of GDC power supply, GDC occlusion coil attached to a delivery wire, set of GDC connecting cables, patient return electrode, two 9-volt batteries, each of which is sold separately. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape. Coils are attached to a delivery wire, which consists of a ground stainless-steel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC devices cleared variously under K991139, K001183 and K030475. The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm. Each time the power supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the .05 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting. The GDC Power Supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by: 1) sensing the amount of resistance to current flow through the GDC System, and 2) adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the GDC System and to recognize those changes which indicate detachment. Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.

Here's an analysis of the provided text regarding the Boston Scientific Neurovascular's GDC® 360° Coils, highlighting the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a Special 510(k) Notification, which implies substantial equivalence to predicate devices rather than a new device requiring extensive de novo clinical trials. Therefore, the "acceptance criteria" are primarily established by meeting the design and performance characteristics of the previously cleared predicate devices and showing that any changes do not adversely affect safety or effectiveness. The "reported device performance" is essentially a confirmation that the new device (GDC® 360° Coils) meets these established standards.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of clinical data for algorithmic performance. This is not a study of AI or a diagnostic device, but rather a Class III medical device (embolic coil) for which the primary "test set" would be engineering and bench testing relevant to the physical characteristics and performance of the coil and power supply.

• Sample Size: Not explicitly stated for specific tests, but implied to be sufficient for engineering validation.
• Data Provenance: Not applicable in the context of human data. The "provenance" is through engineering testing and comparison to existing predicate devices. The document does not mention any human clinical data or retrospective/prospective studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device submission. There is no mention of "ground truth" being established by experts in the context of human data for the GDC® 360° Coils. The ground truth for the device's physical performance is established through established engineering and quality control standards.

4. Adjudication Method for the Test Set:

This is not applicable as there is no indication of a clinical "test set" or read 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:

This is not applicable. This submission is for an embolic coil, a physical medical device, not an AI or diagnostic algorithm, and thus, no MRMC study or AI assistance is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable as this is not an algorithm or AI device.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the GDC® 360° Coils and power supply is based on:

• Engineering specifications and standards: Performance characteristics (tensile strength, friction, detachment time, etc.) are judged against predefined engineering requirements.
• Comparison to predicate devices: The crucial aspect of a 510(k) submission is showing substantial equivalence to legally marketed predicate devices. Therefore, the "ground truth" for acceptable performance is largely defined by the performance envelope of the predicate devices.

8. The Sample Size for the Training Set:

This is not applicable as this is not an AI or machine learning device submission. There is no "training set" in the context of data for an algorithm.

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

This is not applicable as there is no training set mentioned or implied.

Summary of the Study (as described in the document):

The document K042539 is a Special 510(k) Notification for Boston Scientific Neurovascular's GDC® 360° Coils. A Special 510(k) is used when a modification to an existing device is made, and the modification does not affect the device's indications for use or its fundamental scientific technology. The "study" described here is primarily a bench testing and comparison study to demonstrate substantial equivalence to previously cleared predicate devices (K991139, K001083, K030475).

The core of the "study" involves:

• Comparison of Technological Characteristics: Detail tables comparing coil dimensional attributes, materials, and power supply specifications to the predicate devices. The consistent finding is that the new devices are either "Same as predicate devices" or "within the range of sizes used across all current GDC coils."
• Verification Test Summary Table: A list of standard engineering tests performed on the GDC® 360° Coils. For several tests (Tensile Strength, Friction, Deployment/Retraction Force, Tip Ball Strength, Coil Stiffness, Heating Effect of MRI), the device "Meets acceptance criteria." For other tests (Detachment Time, Heating Effect of Electrolysis, Electrostatic Discharge, Electromagnetic Compatibility, Operating System Test), the statement is "No change made which would affect this test," implying that because no relevant change was made from the predicate, and the predicate met these criteria, the new device also meets them by extension.

In essence, the "study" is a demonstration through technical specifications and bench testing that the modified GDC® 360° Coils maintain the safety and effectiveness profile of their predicate devices, and that changes (like two new primary coil sizes and an expanded range of secondary coil sizes) do not introduce new questions of safety or effectiveness. This type of submission relies heavily on engineering verification rather than clinical data or algorithmic performance studies.

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