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The SpectraWAVE X1-FFR Software features segmentation of coronary vessels, and measurement and reporting tools to facilitate the following use:

• Calculate the dimensions of coronary vessels;
• Quantify stenosis in coronary vessels;
• Quantify pressure drop in coronary vessels;

The SpectraWAVE X1-FFR Software is intended to be used by or under the supervision of a cardiologist.

The SpectraWAVE X1-FFR Software is a standalone medical device which is used in the catheterization lab as an angiography image assessment tool for assessing Fractional Flow Reserve using non-invasive quantitative and functional analysis of coronary vasculature.

The SpectraWAVE X1-FFR software comprises image processing and computational algorithms to perform functional coronary angiography, providing longitudinal estimations of coronary pressure drop and Fractional Flow Reserve (FFR) during angiogram and percutaneous coronary intervention (PCI) procedures.
The SpectraWAVE X1-FFR Software is a procedural aid intended to be used to support diagnosis by clinicians.

AI-derived algorithms are deployed on the device to support vessel segmentation and contouring. Analytical (non-AI) models are used for generating FFR values.

The SpectraWAVE X1-FFR Software:

• provides measurements of localized coronary pressure drops over the length of a coronary vessel, including the right and left coronary tree.
• provides dimensions of the coronary vessels and the amount of stenosis in coronary vessels;
• enables physiology assessment in a non-invasive manner, without the need for adenosine and without the need for additional radiation and contrast administration.

Here's an analysis of the provided FDA 510(k) clearance letter for the SpectraWAVE X1-FFR Software, extracting the requested information about acceptance criteria and the supporting study:

SpectraWAVE X1-FFR Software: Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" for the X1-FFR's performance, but it does report on a key performance metric: the relationship between X1-FFR and invasive hyperemic pressure wire measurements.

Note: The phrase "All testing passed the acceptance criteria" is mentioned, suggesting that internal acceptance criteria were defined and met, but these specific criteria are not detailed in the public 510(k) summary. The reported Bland-Altman analysis results serve as a key demonstration of performance.

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

• Sample Size for Test Set: 306 vessels from 285 patients.
• Data Provenance: The study was a "retrospective clinical analysis." The country of origin is not specified in the provided document.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, the ground truth itself is defined by "invasive hyperemic pressure wire" measurements, which are considered the gold standard for FFR assessment and are performed by trained medical professionals (cardiologists).

4. Adjudication Method for the Test Set

The adjudication method for the test set is not explicitly described. Since the ground truth "invasive hyperemic pressure wire" is a direct physiological measurement, rather than a subjective interpretation, a formal adjudication of ground truth for the FFR values themselves is less common than for image-based diagnoses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size on how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the X1-FFR software against a gold standard.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The "retrospective clinical analysis" assessed the X1-FFR software's performance "relative to invasive hyperemic pressure wire." This implies the algorithm-only performance was evaluated without human-in-the-loop assistance for the FFR calculation itself. The software is described as a "procedural aid intended to be used to support diagnosis by clinicians," but the reported performance study specifically evaluates the software's calculation directly against the ground truth.

7. Type of Ground Truth Used

The ground truth used was invasive hyperemic pressure wire measurements. This is considered the current clinical gold standard (outcome/physiological measurement) for Fractional Flow Reserve (FFR).

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only describes the "retrospective clinical analysis" which served as the performance validation (test set).

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

The document does not specify how the ground truth for the training set was established, as the training set details are not provided.

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The HyperVue Software is intended to be used only with compatible HyperVue Imaging Systems and Starlight Imaging Catheter.

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

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

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

The HyperVue Software (2.0) is resident on the HyperVue Imaging System (K230691) and is used with the Starlight Imaging Catheter (K243016). The HyperVue Software provides a user interface for executing clinical workflows, acquiring and processing OCT-NIRS data, and exporting patient data. The software update introduces the ability to connect to hospital PACS servers for data export.

The provided FDA 510(k) clearance letter for the HyperVue™ Software primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general software verification and validation. It does not contain detailed information regarding clinical performance studies (e.g., MRMC studies, standalone performance), specific acceptance criteria, or the methodology for establishing ground truth for medical image analysis tasks, especially related to the NIRS capabilities like plaque assessment.

The text states that the software update "introduces the ability to connect to hospital PACS servers for data export" and discusses "historical software and algorithm changes." However, it does not provide specifics on how these "historical algorithm changes" were validated in terms of clinical performance metrics that would typically be included in an AI/ML medical device submission.

Based on the provided document, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document does not provide a specific table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) or reported device performance metrics related to diagnostic tasks (like lipid core detection or plaque assessment). The performance data section focuses on software engineering aspects (verification, validation, cybersecurity, and adherence to design controls) rather than clinical accuracy or effectiveness.

Table of Acceptance Criteria and Reported Device Performance (Based only on available information)

Study Details (Based only on available information, with many points missing)

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not specified. The document mentions "an established test plan that fully evaluated all functions performed by the software," but it does not specify the number of cases or patients used for performance testing, especially not for clinical performance.
   • Data Provenance: Not specified. There is no mention of the country of origin of data or whether it was retrospective or prospective. The testing described appears to be primarily software-level functional and cybersecurity testing rather than a clinical performance study.

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

   • Not specified. The document does not describe the establishment of a clinical ground truth, suggesting that the primary validation for this 510(k) was based on software engineering and safety, not on a new clinical performance claim requiring expert ground truth.

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

   • Not specified. Since a clinical performance study with expert ground truth establishment is not detailed, adjudication methods are not mentioned.

4. 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 MRMC study is mentioned or implied. The submission emphasizes substantial equivalence based on technological characteristics and software updates rather than a new clinical claim supported by a reader study.

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

   • Not explicitly stated in terms of clinical performance metrics. The document claims that the software "processes reflected optical signals to construct images" and makes "mathematical comparisons of image data." However, it does not provide standalone performance metrics (e.g., sensitivity/specificity for lipid plaque detection) for these algorithmic functions. The clearance is for the software (2.0) that is resident on the imaging system, implying it's part of the overall system that assists physicians, but no specific standalone diagnostic performance is reported.

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

   • Not specified for clinical claims. For the "software functions," ground truth would likely be based on technical specifications and expected software behavior. For the NIRS capabilities (lipid core detection, plaque assessment), the method for establishing ground truth for performance evaluation is not described in this document. This suggests that the current 510(k) submission did not hinge on a new clinical efficacy claim for these NIRS functionalities that would require a new, robust clinical study with defined ground truth. Instead, it seems to rely on the predicate device's existing clearance for these capabilities.

7. The sample size for the training set:

   • Not specified. The document does not discuss any machine learning model training or associated training sets. The primary focus of this 510(k) is a software update (version 2.0) mainly involving PACS connectivity and "historical" algorithm changes, which doesn't necessarily imply retraining a new ML model that would require a dedicated training set description in this context.

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

   • Not applicable/Not specified. Since a training set is not mentioned, the method for establishing its ground truth is also not.

Summary of Gaps:

The provided FDA 510(k) clearance letter is for a software update (HyperVue™ Software 2.0) that appears to be primarily a software modification/upgrade (PACS connectivity, historical algorithm changes) to an existing cleared device. As such, the submission focuses heavily on software engineering verification and validation, cybersecurity, and demonstrating substantial equivalence to the predicate device based on technological characteristics and intended use.

It does not contain the detailed clinical performance study information (e.g., specific acceptance criteria for diagnostic performance, quantitative performance metrics, sample sizes for clinical test sets, expert qualifications, ground truth methodology for clinical data) that would typically be seen for a novel AI/ML device making new clinical claims or demonstrating significantly improved diagnostic performance. The NIRS capabilities listed appear to be carried over from the predicate device's clearance.

Therefore, for aspects related to clinical accuracy and effectiveness of features like "detection of lipid core containing plaques," this document does not provide the specific study details you requested.

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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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