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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 indications for use for GDC-10 3D Shape and GDC-18 3D Shape are identical to those for the predicate GDC device cleared under K962503.

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 stainlesssteel 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 cleared under K962503.

The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:

• · Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
• · Voltage diplay and indicator Displays the DC output voltage.
• · Time display · Displays the elapsed time that the current has been flowing through the GDC system.
• Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
• · Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
• · Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.

This document describes the GDC-10 and GDC-18 3D Shape Guglielmi Detachable Coils, which are artificial embolization devices. The submission focuses on demonstrating substantial equivalence to a predicate device (K962503). As such, the acceptance criteria and study information provided are primarily focused on the technological characteristics comparison and verification testing to show that the new device performs as well as the predicate.

Here's the breakdown of the information requested, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the 3D Shape GDC are primarily established by demonstrating that its performance "Meets acceptance criteria established for predicate device" or shows "No change made which would influence" certain characteristics, or establishes "equivalency."

Note: The document only refers to "acceptance criteria established for predicate device" without providing specific numerical values for those criteria. It focuses on the comparison and equivalence rather than absolute performance metrics for the new device.

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

The provided document does not specify the sample sizes used for the test sets in the verification tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The tests described (e.g., friction, tensile strength, detachment time, heating effects) are typically conducted in a lab setting on device samples rather than with patient data.

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

This information is not provided in the document. The tests seem to be primarily engineering and bench-top evaluations of physical and functional characteristics of the device, rather than studies requiring expert medical interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (bench-top/engineering), an adjudication method as typically used in clinical studies with human readers would not be applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. This document describes a 510(k) submission for a medical device (embolization coil), which typically relies on demonstrating substantial equivalence through technological comparison and verification testing, rather than clinical efficacy studies involving human readers and interpretations of medical cases.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant (embolization coil) and does not involve an algorithm or AI component in the sense of image analysis or diagnostic support.

7. Type of Ground Truth Used

The "ground truth" for the verification tests is based on engineering specifications and established performance criteria for the predicate device. For tests like "Friction" or "Tensile Strength," the ground truth is a measurable physical property that must meet a predefined standard. For a test like "Coil Migration," the ground truth is the observation of "no movement" within the specified test conditions. These are objective engineering measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

This information is not applicable/not provided. As this is a physical medical device (embolization coil) and not an AI/algorithm-based product, there is no "training set" in the context of machine learning.

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

This information is not applicable/not provided for the same reasons as above.

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