(107 days)
- 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. - The System is intended for ultrasound examination of coronary intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
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 provided text discusses the Makoto Intravascular Imaging System™ (Dualpro IVUS + NIRS Imaging Catheter™). It's a 510(k) summary for a re-branded device that is substantially equivalent to a previously cleared predicate device (K163345), with an expanded indication for use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: The device's substantial equivalence and the expanded indication are primarily supported by existing data from the predicate device and a single prospective, multi-center clinical study (the Lipid-Rich Plaque (LRP) Study). The study's focus was on the NIRS component of the device and its ability to identify lipid-core-containing plaques associated with adverse cardiac events, rather than AI-driven performance. Therefore, many standard AI/ML study components (like expert ground truth for training/testing, adjudication methods for ground truth, MRMC studies, or standalone algorithm performance) are not directly addressed or applicable in the provided context as the device itself is not an AI/ML product. The "acceptance criteria" here relate to the clinical performance of the NIRS technology for its new indication.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this submission are implicitly tied to demonstrating the clinical validity of the expanded indication for use, specifically "...the identification of patients and plaques at increased risk of major adverse cardiac events." The performance is measured by the study's ability to show a statistically significant association between NIRS-identified lipid cores and the occurrence of adverse cardiovascular events.
| Acceptance Criterion (Implicit for Expanded Indication) | Reported Device Performance (from LRP Study) |
|---|---|
| Demonstrate independent and statistically significant association between NIRS-identified coronary lipid cores and the occurrence of patient-level major adverse cardiovascular events. | "The results satisfied the primary and key secondary endpoints of the LRP Study, demonstrating an independent and statistically significant association between NIRS-identified coronary lipid cores and the occurrence of patient and plaque level major adverse cardiovascular events." |
| Demonstrate independent and statistically significant association between NIRS-identified coronary lipid cores and the occurrence of plaque-level major adverse cardiovascular events. | "The results satisfied the primary and key secondary endpoints of the LRP Study, demonstrating an independent and statistically significant association between NIRS-identified coronary lipid cores and the occurrence of patient and plaque level major adverse cardiovascular events." |
| No statistically significant differences in findings due to age, race, ethnicity, or sex. | "There were no statistically significant differences found due to age, race, ethnicity, or sex." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states the study was a "prospective, multi-center Lipid Rich Plaque (LRP) clinical study." However, the exact sample size (number of patients or plaques) for this study is not specified in the provided text.
- Data Provenance: The study was "prospective" and "multi-center," indicating real-world data collection. The geographic origin (e.g., country) of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable in the context of the provided text. The device itself (the Makoto Intravascular Imaging System) is an imaging system (NIRS + IVUS) that provides data and detects lipid cores. There is no mention of "AI" or "machine learning algorithm" within this summary that would require establishing ground truth via expert consensus for performance evaluation. The "ground truth" for the LRP study appears to be the occurrence of actual major adverse cardiovascular events in patients, not a subjective interpretation of images by experts.
4. Adjudication Method for the Test Set
Since the ground truth is based on the occurrence of clinical events, an "adjudication method" in the sense of resolving conflicting expert opinions on image interpretation is not applicable. Clinical events (e.g., major adverse cardiac events) are typically adjudicated by an independent clinical events committee in prospective trials, but the specifics of this adjudication are not detailed in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance. No MRMC comparative effectiveness study was mentioned or conducted as per the provided text because the device itself is not an AI/ML assistant to human readers. It's a diagnostic imaging tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is typically for AI/ML algorithms. The Makoto system is an imaging device that measures and displays information (NIRS chemogram). The "detection of lipid-core-containing plaques" is an output of the system's NIRS technology, not a result of a separate AI algorithm being evaluated for standalone performance. Therefore, a "standalone algorithm performance" evaluation as commonly understood for AI/ML is not applicable here. The LRP study assessed the clinical utility of the device's output (NIRS findings) in predicting events.
7. The Type of Ground Truth Used
The primary ground truth for the expanded indication based on the LRP study was outcomes data, specifically the "occurrence of patient and plaque level major adverse cardiovascular events." The NIRS detection of lipid-rich plaques served as the predictor, and the clinical events were the outcome used as ground truth to validate the prediction.
8. The Sample Size for the Training Set
This information is not applicable. The device's NIRS technology is based on spectroscopy and its physical principles, not a machine learning model that requires a "training set" in the conventional AI/ML sense. The LRP study focused on validating the clinical utility of the device's output, not on training an underlying algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of an AI/ML algorithm for this device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).