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Target Detachable Coils are indicated for the endovascular embolization of:

• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature

Stryker Neurovascular's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Stryker Neurovascular's InZone™ Detachment System (sold separately).

Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils ≥ 2mm, the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.

Stryker Neurovascular's InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

The modifications described within this Special 510(k) have resulted in 70 new coil sizes to be added to the currently approved Target Coil product family. These 70 new UPNs use the same processes as the current Target Detachable Coil products with the only difference being the addition of a tapering process to taper the profile of a larger primary coil of 0.014 inches prior to assembly with the delivery wire for new coil sizes designated as Target XL Detachable Coils.

The provided 510(k) summary (K123377) describes the modifications made to the Target® Detachable Coils and assesses their substantial equivalence to predicate devices. This submission does not pertain to an AI/ML medical device, but rather to a physical medical device. Therefore, the questions related to AI/ML device performance metrics, such as sensitivity, specificity, F1-score, reader studies, training sets, and ground truth establishment methods for algorithms, are not applicable in this context.

Instead, the acceptance criteria and study focus on establishing the mechanical properties, biocompatibility, and intended use of the modified physical device compared to its predicate devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance (Focus on Substantial Equivalence):

The document does not present a formal table of quantitative acceptance criteria with corresponding performance values for the specific modifications. Instead, the approach is based on demonstrating substantial equivalence to legally marketed predicate devices by verifying that the modified device's characteristics remain within acceptable limits or are comparable to the predicates across various performance aspects.

The overall reported device performance is that the modified Target Detachable Coils were found to be substantially equivalent to the predicate Target Detachable Coils.

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

The document describes several types of testing: functional, MR compatibility, pre-clinical, packaging, shelf-life, and biocompatibility.

• Sample Size for Functional & Packaging Testing: Not explicitly stated with specific numbers (e.g., N=X coils tested for tensile strength). The descriptions indicate "testing to assess" or "verification testing," implying a sufficient number of units were tested to demonstrate compliance and equivalence.
• Sample Size for Biocompatibility Testing: Not explicitly stated by number of samples. This type of testing typically follows established standards (e.g., ISO 10993 series), which specify sample requirements.
• Data Provenance: All testing appears to be prospective as it's conducted to verify the safety and effectiveness of the new coil sizes or modified components before market introduction. The testing was conducted by Stryker Neurovascular as part of their 510(k) submission, likely at their facilities or certified labs. The country of origin of the data is not explicitly stated beyond "Stryker Neurovascular, Fremont, CA. 94538".

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

The concept of "ground truth" as it applies to AI/ML models (e.g., labeling data by experts) does not directly apply here. However, expert involvement is mentioned:

• Design Validation Testing (from K112385): "Design Validation testing in which a physician assessed the new introducer sheath and new retention clip for the ability of the new configuration to: a) protect the finished device, b) provide acceptable introducer sheath friction, c) provide for proper hydration of the finished device within the new introducer sheath, d) enable easy removal of the finished device from the dispenser coil. Physician evaluation also assessed whether the revised DFU was clear, legible and easy to read."
  • Number of Experts: "a physician" (singular).
  • Qualifications: "physician" – implying a medical professional with clinical experience relevant to using such devices. No specific years of experience or subspecialty (e.g., interventional neurologist/radiologist) are detailed.

4. Adjudication Method for the Test Set:

Not applicable in the context of this physical medical device submission. Adjudication methods like 2+1 or 3+1 are typically used in AI/ML studies to resolve discrepancies in expert annotations or diagnoses. Here, the "truth" is established through engineering and biocompatibility testing against predefined specifications and predicate device performance. The physician assessment mentioned above is a qualitative validation by a single expert, not an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is a submission for a physical medical device (detachable coils), not an AI/ML device. Therefore, no MRMC study involving human readers with or without AI assistance was conducted.

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

Not applicable. This is not an algorithm or software-only device. Performance is assessed through physical testing of the device components.

7. The Type of Ground Truth Used:

The "ground truth" (or basis for acceptance) for this physical medical device is established by:

• Compliance with established standards: Mention of ASTM (F2052, 2213, F2182, F2119, D6499-07) and ISO (EN ISO 10993-5:2009, 10993-10:2009, 10993-10:2010, 10993-11:2009, 10993-4:2009, 10993-18:2009) standards for testing.
• Comparison to predicate devices: Demonstrating that the modified device performs comparably to the legally marketed predicates across specified functional, mechanical, and biocompatibility criteria.
• Engineering specifications and design requirements: Functional testing against predetermined specifications (e.g., tensile strength, detachment time).
• Qualitative physician assessment: For aspects like ease of use and device hydration.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

Not applicable. As there's no training set for an AI/ML model, there's no ground truth to establish for it in this context.

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