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Starlight Imaging Catheter with Hyper Vue Imaging System is intended for imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The Starlight Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The Starlight Imaging Catheter is a sterile, single-use, non-pyrogenic device and consists of two main assemblies: the catheter body and the internal rotating fiber optic imaging core. The catheter has an insertable length of 141 cm and a 2.5 Fr imaging window. It is a rapid exchange design with monorail tip, designed for compatibility with 0.014" (0.355mm) steerable guidewires used during coronary interventional procedures.

The Starlight Imaging Catheter connects to the HyperVue Imaging System through the HyperVue Controller (Controller), a reusable catheter connection allowing direct control of basic data acquisition. All fiber optic rotation and translational pullback is driven by the Controller and occurs inside the catheter.

The provided text is a 510(k) summary for the Starlight Imaging Catheter. It discusses the device's substantial equivalence to a predicate device and details performance testing. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The summary states that no clinical testing was provided in this pre-market notification (Section 7.9), and usability evaluation testing was not required for the modifications (Section 7.8). This indicates that the device's performance against specific clinical acceptance criteria, as evaluated through human-in-the-loop or standalone algorithm studies with detailed ground truth establishment, is not described in this document.

The performance testing described (Sections 7.1-7.7) includes:

• Bench testing: Optical performance, catheter deliverability, pullback performance, trackability, kink resistance, tensile strength. These tests were performed using "well-established methods used for the predicate devices."
• Biocompatibility testing: In accordance with ISO 10993-1.
• Animal testing: Performed in 3 porcine models (18 imaging passes) to evaluate vascular injury, thrombogenicity, device safety, and device performance.

Therefore, I cannot provide the requested table and details because the information is not present in the provided document.

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