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Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Target Detachable Coils are indicated for 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 Target Detachable Coils are comprised of the following coil types: Target 360 Nano, Target Helical Nano, Target 360 Ultra, Target Helical Ultra, Target 360 Soft, Target 3D, Target 360 Standard, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra (Subject Device). 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 the Stryker Neurovascular 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 Coils with the Tetrahedral shape, the distal end of the main coil is formed such that the diameter of the distal loop is approximately 75% that of the overall secondary outer diameter (OD) size.

The provided text describes a 510(k) premarket notification for the "Target Tetra Detachable Coils" (K222533), a neurovascular embolization device. The document focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing. It does not describe an AI/ML-based device or a study involving human readers or AI assistance. Therefore, information related to AI/ML acceptance criteria, ground truth establishment for AI, sample sizes for AI training/test sets, expert adjudication, or MRMC studies is not present in the provided document.

The document does provide information on the performance data collected to support the substantial equivalence claim for this medical device.

Here's an analysis of the provided text, extracting the relevant information within the scope of the original request, focusing on the device performance and acceptance criteria where applicable to the physical medical device described:

Acceptance Criteria and Device Performance

The document states that the "Target Tetra Detachable Coils" are substantially equivalent to their predicate devices. The performance data is primarily from bench testing and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML):

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

• Test Set Sample Size: The document does not specify the exact number of units tested for each bench test. It generally states that "performance bench testing has demonstrated" the results.
• Data Provenance: This is a physical medical device. The data comes from bench tests conducted by Stryker Neurovascular. The document does not specify the country of origin for the testing, but the company is based in Fremont, California, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission.

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

• Not Applicable. This is a physical medical device, not an AI/ML device requiring clinical expert ground truth for interpretation. Performance is measured against engineering specifications and physical properties.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not an AI/ML device; therefore, an MRMC study related to readers improving with AI assistance would not be applicable. The document explicitly states: "No clinical study was conducted because bench testing was determined sufficient to support substantial equivalence to the predicate device."

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

• Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

• For physical properties and mechanical performance: Engineering specifications, established test methods, and comparison data from predicate devices serve as the "ground truth" or reference for evaluating performance parameters.
• For biocompatibility: International standards (EN ISO 10993-1:2020) and FDA guidance documents serve as the ground truth.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The "training" or development of the device would involve engineering design and prototyping.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8. The "ground truth" for developing a physical medical device involves scientific principles, material properties, biomechanical considerations, and clinical needs, leading to design specifications.

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