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1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
   a. The System is intended for the detection of lipid-core-containing plaques of interest.
   b. The System is intended for the assessment of coronary artery lipid core burden.
   c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
2. The System is intended for ultrasound examination of coronary and peripheral intravascular pathology.
   a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.

The Makoto Intravascular Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.

The Makoto Intravascular Imaging System™ is composed of three main components: the Catheter, the Controller (Pullback and Rotation Device (PBR)), and the Console. These three interconnected components work together to produce dual images of NIRS and IVUS in a single scan of the vessel.

The provided document is a 510(k) premarket notification summary for the Makoto Intravascular Imaging System™. It details the device's characteristics and compares it to a predicate device, primarily justifying substantial equivalence based on minimal design changes and previous testing. However, it explicitly states: "No prospective clinical trials were conducted in support of this Traditional 510(k)." This means the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them through clinical performance.

Therefore, I cannot provide the requested table and study details. The document focuses on demonstrating substantial equivalence to a previously cleared device through bench and animal testing, and by asserting that the minor changes (like adding peripheral IVUS indication) do not significantly affect safety or effectiveness.

Based on the provided text, the device was NOT proven to meet acceptance criteria through a clinical study as described in your request. The submission relies on demonstrating equivalence to a predicate device, which implies that the predicate device previously met certain criteria, and the new device is sufficiently similar.

The document does mention:

• Performance Testing (Bench): There are no changes that significantly affect safety or effectiveness. Minor modifications were documented, reviewed, and tested according to verification and validation protocols (which are typically internal and not detailed here).
• Performance Testing (Animal): No new animal testing was conducted. The justification is that the predicate device's animal testing (K163345 on swine for coronary arteries) applies, and the proposed TVC-E195-42 peripheral catheter is identical in form, fit, and function, considering the animal studies as a worst-case (coronary) model for safety and performance.
• Performance Testing (Clinical): "No prospective clinical trials were conducted in support of this Traditional 510(k)."

In summary, the document does not contain the information required to answer your prompt because it did not involve a new clinical study to prove the device met acceptance criteria.

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