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The Spartan SC 069TM is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The Spartan SC 069™ is a support catheter designed for the introduction of interventional devices into the peripheral and neuro vasculature. The SC 069™ is a single lumen, flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the device is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating to reduce the overall frictional force during intravascular use. The device is supplied sterile and intended for single use only.

The provided text describes the performance data for the Spartan SC 069™ support catheter. This device appears to be a medical device, and the information presented is from a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's diagnostic performance. Therefore, many of the requested fields regarding diagnostic acceptance criteria, multi-reader multi-case studies, and human-in-the-loop performance are not applicable.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document lists various non-clinical bench tests and biocompatibility tests, with each test summary implying a pass/fail acceptance criterion. The results consistently state that the Spartan SC 069™ "met the acceptance criteria" or showed "acceptable" performance, or similar to the predicate device.

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The Spartan Center Wire™ is indicated for general intravascular use in the peripheral vasculature. It can be deployed into the vessel to facilitate the selective placement of diagnostic or therapeutic catheters.

The device is not intended for use in the coronary or neuro vasculature.

The Spartan Center Wire™ is a stabilizing exchange wire designed for temporary assistance in catheter exchange. The device is comprised of a tubular mesh tip attached to a pusher wire of adequate length to accommodate the exchanging of catheters commonly used for access, stabilization, or aspiration. The pusher wire diameter is 0.015" (0.38 mm) with length 350 cm to allow for the exchange of therapeutic devices without the use of extension wires or other exchange devices. The distal end is a permanently attached self-expanding mesh that is deployed out of an introducer sheath and into the vessel where it conforms to the vessel wall. There are 3 distal radiopaque markers and 1 proximal radiopaque marker visible under fluoroscopy. The deployed and stable mesh ensures that the wire is not displaced from the desired position and can be advantageously utilized in multiple exchanges or re-positioning of catheters. The Spartan Center Wire™ is offered in 2 available sizes to accommodate common vascular sizing. There is a 4 mm diameter basket with 15 mm useable length and a 6 mm basket with 30 mm useable length. Both sizes are compatible with catheters that have a minimum I.D. of 0.027".

The provided text describes the performance data for the Spartan Center Wire™ medical device, primarily focusing on bench testing, biocompatibility, sterilization, pyrogenicity, shelf life, and animal studies. However, it does not contain information about acceptance criteria or studies related to an AI/ML-driven device's performance in a diagnostic context, MRMC studies, or multi-reader studies. The device in question is a physical catheter guidewire, not a medical AI software.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance of an AI/ML device from the provided text. The prompt asks for details that are not present in the document.

The document explicitly states: "No clinical testing was conducted." and "No torque device is needed or supplied with the Spartan Center Wire™." This reinforces that the evaluation is for a physical device, not an AI/ML software.

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The Spartan eCoil™ System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The System is also indicated for arterial and venous embolizations in the peripheral vasculature.

The Spartan eCoil™ System is a mechanically detachable embolic coil system that consists of an embolic coil (the Spartan eCoil™) attached to a delivery wire with a fluoroscopic marker band and the system is housed in an introducer sheath. The system is provided sterile and requires no additional equipment to be employed by the user.

The Spartan Micro, Inc. Spartan eCoil™ System is a neurovascular embolization device. The provided text from the 510(k) summary indicates that no clinical or animal testing was performed for this device to prove its acceptance criteria because it was deemed substantially equivalent to a predicate device (Micro Therapeutics Inc. Axium Prime Detachable Coil System - K162704). Therefore, the acceptance criteria are met through bench testing and assessments that confirm its performance is similar to or better than the predicate device, and through biocompatibility and sterilization testing.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since no specific numerical acceptance criteria are explicitly stated for each test (e.g., "tensile strength must be >X Newtons"), the performance is generally reported as "Pass" or "Equivalent" when compared to the predicate device or a minimum acceptable specification limit.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each bench test. For the animal study (implantation in rabbits, sub-acute/sub-chronic toxicity in mice), the sample sizes are not provided either.
The data provenance is not mentioned. Given it's a 510(k) submission to the FDA, it is expected that the studies adhered to relevant US regulations and standards, but the country of origin of the actual testing is not specified. All tests were non-clinical (bench and animal, where specified) and are essentially prospective studies conducted specifically for this submission.

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 section is not applicable as there was no clinical study involving human patients to establish a medical ground truth (e.g., disease presence). The "ground truth" for the performance and biocompatibility tests was based on established engineering specifications, ASTM standards, ISO standards (for biocompatibility), and comparison to the predicate device's known performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there were no subjective clinical assessments requiring adjudication. The tests conducted were objective physical, mechanical, and biological evaluations against defined standards or comparisons.

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. The Spartan eCoil™ System is a physical medical device (an embolization coil), not an AI/software device. There were no human readers or AI involved in evaluating its performance in the context of effectiveness against a disease or condition.

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

This is not applicable, as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the evaluation of this device was established based on:

• Engineering specifications and standards: Many bench tests refer to "minimum acceptable specification limit" or comparison to "accepted values."
• ASTM and ISO standards: For material properties, corrosion, MRI compatibility, and biocompatibility testing.
• Predicate device comparison: Performance parity or superiority to the legally marketed predicate device (Micro Therapeutics Inc. Axium Prime Detachable Coil System - K162704) was a primary "ground truth" for substantial equivalence.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning model that requires a training set.

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

This is not applicable as the device is not an AI/machine learning model.

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