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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.

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

The document relates to non-clinical bench testing and biocompatibility assessments of a medical device (catheter). It does not involve a "test set" in the context of diagnostic accuracy, human subjects, or data provenance like country of origin. The tests were performed in a laboratory setting for regulatory 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 information is not applicable as the study involves bench testing and biocompatibility of a medical device, not diagnostic performance requiring expert ground truth.

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

This information is not applicable as the study involves bench testing and biocompatibility of a medical device, not diagnostic performance 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 information is not applicable. This is a 510(k) submission for a physical medical device (catheter), not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

This information is not applicable. This is a 510(k) submission for a physical medical device (catheter), not an algorithm or AI.

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

The "ground truth" for these performance studies is established by the specifications and standards (e.g., ISO standards, internal design requirements) that the device must meet, as well as comparison to the predicate device. For biocompatibility, it's about not eliciting adverse biological responses.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning study.

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

This information is not applicable. There is no "training set" as this is not an AI/machine learning study.

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