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The NaviCross 0.018" is intended to guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The NaviCross 0.018" is a single use, ethylene oxide sterilized device that is intended to guide and support a guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

NaviCross 0.018" features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyamide and an inner layer of polytetrafluoroethylene. It has a distal tip that is comprised of a polyamide. It also has a hydrophilic coating over the distal 40 cm of the catheter.

The device is offered in effective lengths of 65, 90, 135 and 150 cm.

The provided text describes a 510(k) submission for the NaviCross 0.018" catheter. It details the device's technical specifications, comparison to predicate and reference devices, and non-clinical performance testing. However, it explicitly states that no clinical tests were performed or included in this 510(k) submission.

Therefore, I cannot provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text, as these typically pertain to clinical studies.

The document focuses on demonstrating substantial equivalence through non-clinical performance testing and biocompatibility testing.

Here's a breakdown of what is available in the document regarding non-clinical performance:

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

The document lists various performance tests conducted. While it states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life," the specific numerical acceptance criteria and the exact reported performance values for each test are not detailed in the provided text. The table (Table 5.4) only lists the Test Items.

2. Sample sized used for the test set and the data provenance:

• Sample Size: The document does not specify exact sample sizes for each non-clinical test. It states that tests were performed on "non-aged and accelerated aged samples."
• Data Provenance: The device manufacturer and sterilization facility are the Ashitaka Factory of Terumo Corporation in Japan (Fujinomiya, Shizuoka 418-0015, Japan). The testing was conducted as part of their 510(k) submission for the US market. The testing is pre-market, laboratory-based performance and biocompatibility testing, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the testing described is non-clinical performance and biocompatibility testing, not clinical data requiring expert ground truth or interpretation of images/patient outcomes.

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

Not applicable for non-clinical performance testing.

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:

Not applicable. No clinical studies, especially MRMC studies comparing human performance with and without AI assistance, were performed or referenced in this document.

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

Not applicable. This device is a medical catheter, not an AI algorithm.

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

For the non-clinical tests, the "ground truth" or reference for acceptance is established by predefined engineering and material science standards (e.g., ISO standards, internal specifications for dimensions, strength, leakage, etc.). It's based on physical and chemical measurements rather than clinical ground truth types.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. No training set for an algorithm is mentioned.

In summary, the provided document details non-clinical performance and biocompatibility testing for a medical device (catheter) to establish substantial equivalence. It explicitly states that no clinical tests were included in this 510(k) submission. Therefore, most of the questions relating to clinical study design, expert involvement, and AI performance are not applicable to the information given.

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