Search Results

The Spectra WAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

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

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

The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest.

The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden.

The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system.

The SpectraWAVE Imaging System consists of the following components:

• Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
• Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data.
• Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
• Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.

This document describes the SpectraWAVE Imaging System, an intravascular imaging device combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS). It aims to demonstrate substantial equivalence to predicate devices, K192019 Dragonfly OpStar™ Imaging Catheter and K183599 Makoto Intravascular Imaging System™.

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table detailing quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for NIRS detection of lipid-core plaques) and corresponding reported performance values for each criterion. Instead, it broadly states that "All testing passed the acceptance criteria" for bench testing and that the animal study met acceptance criteria for acute performance and safety.

The Indications for Use (page 3) serve as a high-level set of intended performance characteristics for the NIRS capability:

• Detection of lipid core containing plaques of interest.
• Assessment of coronary artery lipid core burden.
• Identification of patients and plaques at increased risk of major adverse cardiac events.

However, specific numerical acceptance criteria for these indications (e.g., a minimum sensitivity or specificity for lipid core detection) are not provided in this document. The Device Comparison Tables (Table 1 and Table 2, pages 5-6) compare various technical specifications (e.g., catheter diameter, image collection time, rotational rate) to predicate devices, indicating that the SpectraWAVE device's specifications are "Substantially equivalent," which implies they meet comparable functional performance as the predicates.

For instance, a comparison point that serves as an implicit performance and acceptance criterion for the OCT portion is the "SpectraWAVE Imaging System allows imaging of vessels up to 5.2mm in diameter, which covers the expected range of left main coronary arteries" as stated in the "Discussion of Equivalence & Differences" column (page 6) when comparing to the primary predicate which is limited to 3.5mm. This implies the SpectraWAVE device meets or exceeds the imaging range of its predicate for OCT.

Similarly, under "NIRS Verification & Validation summarizes the NIRS performance of the SpectraWAVE system, with the predicate device as a reference" in Table 2, it indicates that the NIRS performance was evaluated against the predicate, implying an acceptance criterion of comparable performance. However, the specific quantitative comparison is not detailed here.

Given the absence of a detailed quantitative table in the provided text, a summary is provided below based on the implicit and some explicit performance claims.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify exact sample sizes for test sets in a numerical sense (e.g., number of cases or images) for performance studies related to lipid core detection or OCT imaging metrics. It mentions "a series of bench tests" (page 17) and "a GLP animal study" (page 17).
• Data Provenance:
  • Bench Testing: In vitro, conducted internally by SpectraWAVE.
  • Animal Testing: In vivo, conducted in a porcine coronary artery model, GLP (Good Laboratory Practice) study (page 17).
  • Clinical Testing: "No clinical testing is provided in this pre-market notification." (page 17)

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. Since no clinical testing was performed and detailed performance metrics for NIRS/OCT interpretation by experts are not discussed, there's no mention of experts establishing ground truth for a test set. Ground truth for the animal study would typically be established through pathological examination by veterinary pathologists, but details are not provided.

4. Adjudication Method for the Test Set

This information is not provided in the document. Without details on expert review or ground truth establishment by multiple parties, an adjudication method cannot be inferred.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers' improvement with or without AI assistance was not explicitly described or provided in this pre-market notification. The document states, "No clinical testing is provided in this pre-market notification." (page 17).

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

The document broadly mentions "Software verification and validation were conducted to FDA regulations, standards, and guidance document requirements. The results of this testing conclude the software has met these requirements." (page 16). While this confirms the software's functional correctness and validation, it does not specifically describe a standalone performance study of the algorithm's diagnostic capabilities (e.g., NIRS lipid core detection accuracy) without human intervention. The NIRS capability is intended for detection and assessment, implying an algorithmic component, but its standalone performance against a ground truth is not detailed in terms of metrics.

7. The Type of Ground Truth Used

• Bench Testing: Ground truth would be derived from known physical properties and measurements of phantoms or test objects.
• Animal Testing: Ground truth for acute performance and safety in the porcine model would typically involve direct observation, physiological measurements, and subsequent histopathological analysis of the vessel tissue. The document refers to "vascular injury" assessment, which implies pathological ground truth (page 17).
• NIRS Performance (implicit): The NIRS capabilities are compared against a predicate device, suggesting the predicate's established performance serves as a comparative reference, rather than explicitly an independent "ground truth" like pathology for novel claims. However, the predicate device (Makoto Intravascular Imaging System) itself utilizes NIRS for lipid core detection, which would have been validated against pathology in its original submission.

8. The Sample Size for the Training Set

This information is not provided. The document does not describe the development or training of any AI/ML models that would typically require a training set. Given that it's a 510(k) submission, the focus is on substantial equivalence rather than novel AI algorithm validation with separate training/test sets. Performance is demonstrated through equivalency to predicates and standard engineering verification and validation activities.

9. How the Ground Truth for the Training Set was Established

This information is not provided as no training set or AI/ML model training is described.

Ask a specific question about this device