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The AptiVue™ E series software is intended to be used only with compatible OPTIS™ imaging systems.

The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS imaging system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

OPTIS™ Systems with AptiVue™ Imaging Software (version E.6) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. Version E.6 adds cloud connectivity to enable remote installation of software updates and transmission of system telemetry data.

The provided document (K232386) describes the premarket notification for the "ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6". This submission primarily focuses on the addition of cloud connectivity features (remote software updates and telemetry data transmission) to an existing device (predicate device K183320).

Crucially, the document explicitly states that "No clinical testing is provided in this pre-market notification" (page 4). Therefore, the information requested regarding acceptance criteria and study proving device performance (including sample sizes, expert involvement, ground truth, MRMC studies, and standalone performance) cannot be extracted from this document, as such studies were not performed or reported for this particular submission.

The document focuses on demonstrating substantial equivalence based on the updated software's functional similarity and verification and validation (V&V) testing.

Here's what can be inferred from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the non-clinical testing performed:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

The remaining requested information (2-9) pertains to clinical studies and performance evaluation of an AI/ML algorithm against a ground truth, which is explicitly stated as not included in this submission.

Here's a breakdown of why the other points cannot be answered:

2. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for AI/ML performance was used. The V&V testing would have involved engineering and software test cases, not patient data in the context of an AI performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth for AI/ML performance was established or reviewed for this submission.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. The submission is about adding cloud connectivity, not about AI-assisted interpretation or improvement of human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This submission concerns software and hardware systems for imaging, FFR, and RFR; the "AptiVue™ Imaging Software" is part of the system, but the document does not indicate a distinct AI/ML algorithm for standalone diagnostic performance beyond what the predicate device already provided. The predicate's capabilities (OCT, FFR, RFR) involve algorithms, but this submission does not describe a new or modified AI/ML algorithm requiring standalone clinical validation.
7. The type of ground truth used: Not applicable, as no clinical ground truth assessment (e.g., pathology, outcomes data) was reported for this submission. The "ground truth" for the V&V of the new features would be the expected functional behavior according to design specifications.
8. The sample size for the training set: Not applicable, as no machine learning model training was described or modified for this submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary primarily address an update to existing software with new cloud-based functionalities. It clearly states that "No clinical testing is provided." Therefore, the detailed questions about acceptance criteria for AI/ML performance, clinical test sets, experts, and ground truth are not relevant to the information contained within this specific document.

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The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal procedures. The compatible Dragonfly™ imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS imaging system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

OPTISTM with AptiVueTM Software (version E.5) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. FFR, Pd/Pa at rest, and RFR physiological waveforms measured by the system are used to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure).

Here's an analysis of the acceptance criteria and study information for the ILUMIEN OPTIS with AptiVue Software version E.5, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the validation of the Resting Full-cycle Ratio (RFR) feature, comparing its diagnostic performance against Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR). The acceptance criteria are implicitly defined by achieving comparable diagnostic accuracy and agreement metrics.

2. Sample Size and Data Provenance:

The document does not explicitly state the exact sample size for the test set. However, it refers to a "prospective study... of RFR for the physiological assessment of coronary artery disease in real-world patients." The confidence intervals provided in the table, such as "91.1%, 95.6%" for diagnostic accuracy, indicate a substantial number of cases. Given the context of a 510(k) summary, specific details on country of origin are typically not provided, but the language suggests a clinical trial setting. The study was prospective.

3. Number of Experts and Qualifications:

The document does not specify the number of experts used to establish the ground truth for the test set, nor their qualifications.

4. Adjudication Method:

The document does not explicitly describe an adjudication method for the test set. It outlines a "RFR-FFR Hybrid Method Result Interpretation" which includes a grey zone where the decision would be "based on FFR." This implies FFR serves as the primary ground truth, and the RFR values are being compared against it.

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

No MRMC study is mentioned. The document focuses on the performance of the RFR algorithm itself compared to established physiological indices (FFR and iFR). There is no information provided regarding the effect size of human readers improving with AI assistance vs. without AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was done. The "Summary of RFR Validation Study" directly compares the diagnostic accuracy and agreement metrics of the RFR algorithm (standalone, or hybrid with FFR for the grey zone) against FFR as the gold standard, and against iFR-FFR for equivalence.

7. Type of Ground Truth Used:

The ground truth used is primarily Fractional Flow Reserve (FFR). For the RFR-FFR hybrid method, when RFR falls within a defined grey zone (0.86 ≤ RFR ≤ 0.93), the decision is explicitly stated to be "based on FFR." Therefore, FFR serves as the reference standard for determining ischemia-causing lesions.

8. Sample Size for the Training Set:

The document does not provide information about the sample size for the training set used to develop the AptiVue Software.

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

The document does not provide information on how the ground truth for the training set was established. It describes the validation study of the RFR feature, not the development process of the software.

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The ILUMIEN OPTIS with Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The ILUMIEN OPTIS will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. It also includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the ILUMIEN OPTIS System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety.

The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor.

The provided text is a 510(k) summary for the ILUMIEN OPTIS device, which is an ultrasonic pulsed echo imaging system. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to set and meet specific acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the document focuses on demonstrating that the new device shares similar technological characteristics and performance to its predicate. It does not contain specific "acceptance criteria" presented as quantitative clinical performance metrics, nor does it describe a detailed "study that proves the device meets the acceptance criteria" in the way one might expect for a new clinical claim. Instead, the performance testing described is primarily focused on safety, fundamental functionality, and compliance with general medical device standards.

Here's an attempt to answer your request based on the available information, noting the limitations of a 510(k) summary for this type of request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity for a specific diagnostic task) or quantitative clinical performance metrics alongside reported device performance. It primarily focuses on compliance with general standards and demonstrating equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

The document does not mention a "test set" in the context of clinical data for performance evaluation (e.g., in vivo patient data). The testing described is primarily bench testing, software verification/validation, and compliance with electrical/safety standards. Therefore, information regarding sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not provided.

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

This information is not applicable and not provided. The testing described does not involve human experts establishing ground truth for a clinical test set.

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

This information is not applicable and not provided. There is no mention of a test set requiring adjudication in the context of clinical performance.

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 such study is described in the document. The device, ILUMIEN OPTIS, is an imaging system and FFR measurement device, not an AI-assisted diagnostic tool that aids human readers in interpreting images in the context of this 510(k). The document states it is an upgrade to an existing imaging system with improved performance through a modified engine design and updated software to accommodate FDML laser support. Its purpose is to acquire and display OCT images and FFR parameters. The physician uses these outputs.

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

This concept is not relevant to the described device as an imaging and FFR measurement system. The device produces images and FFR parameters for physician interpretation and use. No standalone algorithmic diagnostic performance is mentioned.

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

For the performance testing mentioned, the "ground truth" would be related to the specifications and expected outputs of the system (e.g., accurate optical coherence tomography images, correct calculation of FFR based on input pressure signals, compliance with safety and electrical standards, accurate software functionality). This is not a clinical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

This information is not applicable and not provided. The device is not described as using machine learning or AI that requires a "training set" in the conventional sense for clinical performance. The software upgrade is to "accommodate FDML laser support," which implies hardware and data processing adjustments, not AI model training.

9. How the ground truth for the training set was established

This information is not applicable and not provided, as no training set for an AI/ML model is mentioned.

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The ILUMIEN OPTIS with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The ILUMIEN OPTIS will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart. It also includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the ILUMIEN OPTIS System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety. The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor.

The Dragonfly OPTIS Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the inner rotating fiber optic imaging core.

The inner rotating fiber optic imaging core emits near infrared light to the tissue and receives reflected light. It is driven by a stainless steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the DOC. The emitted and returned reflected light are combined and processed by the Ilumien Optis System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

This document describes the ILUMIEN OPTIS system with the Dragonfly OPTIS Imaging Catheter, focusing on its substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested. Therefore, much of the specific information requested cannot be extracted directly from this document.

However, based on the provided text, I can infer and summarize what is available regarding performance testing and regulatory compliance.

Here's a breakdown of the information and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task or specific measurement tolerances) and corresponding reported device performance values. The performance testing section primarily lists compliance with general safety and electromagnetic compatibility standards, along with successful software verification/validation and design verification/validation through bench and pre-clinical animal testing. It concludes that the device is "safe and effective and is substantially equivalent to the predicate ILUMIEN OPTIS device," but no quantitative performance metrics against specific acceptance thresholds are provided.

Therefore, this section cannot be completed as requested based on the input document.

2. Sample size used for the test set and the data provenance:

• Test Set Description: The document mentions "bench testing and pre-clinical animal testing" as part of design verification and validation.
• Sample Size: The sample size for these tests is not specified in the document.
• Data Provenance: The document does not specify the country of origin of the data. It mentions "pre-clinical animal testing," indicating it's not human data. It's a "prospective" study in the sense that these tests were conducted to demonstrate performance for regulatory submission, but not a prospective clinical trial on human subjects.

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

This information is not provided in the document. For animal testing, ground truth might be established by other imaging modalities or histological analysis performed by veterinary pathologists, but the document does not elaborate.

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

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• AI assistance: The document describes an "Ultrasonic pulsed echo imaging system" and an "Imaging Catheter" for Optical Coherence Tomography (OCT) and Fractional Flow Reserve (FFR) measurements. While these are advanced technologies, the document does not indicate that the device involves AI (Artificial Intelligence) or machine learning components that would assist human readers in image interpretation or diagnosis.
• MRMC study: A comparative effectiveness study with human readers (with vs. without AI assistance) is not mentioned in the document.

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

The device is an imaging system (ILUMIEN OPTIS) and a catheter (Dragonfly OPTIS) that generates OCT images and FFR measurements for physician use. It's an "algorithm only" in the sense that the system calculates FFR and constructs OCT images without human intervention in that specific process, but the overall purpose is to provide information for a human physician's judgment. The document does not discuss a "standalone" performance evaluation of the algorithms for diagnostic accuracy independent of human interpretation in a clinical context.

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

For the "pre-clinical animal testing," it's likely that invasive measures, histological analysis, or other validated imaging modalities would form the ground truth, but the document does not specify the type of ground truth used.

8. The sample size for the training set:

The document does not mention or describe a training set. This is typical for medical device submissions focused on substantial equivalence where the device performs a measurement or creates an image, rather than making a diagnostic prediction based on learned patterns from a large dataset. The "software verification and validation" indicates software testing, but not a "training set" in the machine learning sense.

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

Since a training set is not mentioned, this information is not applicable/provided.

Summary of available information regarding performance:

The document primarily states that the ILUMIEN OPTIS and Dragonfly OPTIS Imaging Catheter have undergone:

• Electrical safety testing: Compliance with UL Standard No 60601-1, IEC 60601-1-2, EN 60601-1-2, IEC 60825-1, 21 CFR 1040.10, and CFR 47 FCC Part 15 Subpart B.
• Software verification and validation: Conducted according to FDA regulations, standards, and guidance, concluding that the software met requirements.
• Design verification and validation: Included "bench testing and pre-clinical animal testing" in compliance with internal design control procedures. The results led to the conclusion that the device is "safe and effective and is substantially equivalent to the predicate ILUMIEN OPTIS device."

Conclusion:

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed results of a new clinical performance study with specific acceptance criteria and outcome metrics for diagnostic accuracy, sensitivity, or specificity. The performance testing described is primarily related to safety, software functionality, and engineering design validation, concluding with an overall statement of safety, effectiveness, and substantial equivalence. Specific quantitative performance against predefined acceptance criteria for clinical use or AI diagnostic capabilities is not detailed in this document.

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The ILUMIEN OPTIS with Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The ILUMIEN OPTIS will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart. It also includes the Drivemotor and Optical Controller (DOC), which provides the interconnection between the ILUMIEN OPTIS System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety.

The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor.

The provided text describes a 510(k) summary for the LightLab Imaging, Inc. ILUMIEN OPTIS system, stating its intended use, technological characteristics, and performance testing. However, it does not contain detailed acceptance criteria, specific performance metrics, or study results in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (C7 XR™ Imaging System) by highlighting upgrades in performance (engine A-scan rate, frame rate, pullback speeds, pullback length, pullback time, display option, automated lumen measurement) and compliance with various safety and regulatory standards (UL, IEC, EN, DICOM, CFR, FCC).

Therefore, I cannot fulfill all parts of your request with the information provided.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Cannot create: The document lists general performance upgrades (e.g., increased A-scan rate, frame rate), but it does not provide specific quantitative acceptance criteria or corresponding reported device performance values for these metrics. It states "Design verification and validation was also performed on the ILUMIEN OPTIS in compliance with internal design control procedures which included bench testing. This testing included physical, mechanical, and optical characteristics testing. The system hardware was evaluated for range, speed, and rotation accuracy and durability. Optical testing was conducted and included scan range and rate, resolution, and sensitivity." However, the actual criteria and results are not presented.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot provide: The document mentions "bench testing" for design verification and validation but does not specify sample sizes for any test sets, data provenance, or whether the testing was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Cannot provide: The document refers to "software verification and validation" and "design verification and validation" (bench testing), but it does not mention the use of experts to establish ground truth for any test set, nor does it specify their number or qualifications. This type of expert assessment generally applies to clinical studies, which are not detailed here for performance.

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

• Cannot provide: There is no mention of adjudication methods as no human expert review or clinical trial results establishing ground truth are detailed.

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:

• Cannot provide: The document does not describe any MRMC studies or any studies evaluating human reader improvement with AI assistance. The device is an imaging system (ILUMIEN OPTIS) and does not appear to involve AI assistance for human interpretation in the way your question implies.

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

• Cannot provide: While software verification and validation were performed, the document does not detail specific algorithm-only performance studies or their results. It's an imaging device, and its "performance" largely relates to its hardware, software functionality, and physical/optical characteristics rather than a diagnostic algorithm's standalone accuracy against a ground truth.

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

• Cannot provide: The document only mentions "bench testing" and "software verification and validation." The nature of the ground truth (e.g., physical specifications, simulated data) for these tests is not explicitly defined in terms of clinical or pathological outcomes.

8. The sample size for the training set:

• Cannot provide: There is no mention of a "training set" as the context is not about a machine learning algorithm being trained.

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

• Cannot provide: (See point 8).

In summary, the provided text is a regulatory submission summary focused on demonstrating substantial equivalence and compliance with general safety and performance standards for a medical device upgrade. It does not contain the detailed study information regarding specific acceptance criteria, performance metrics, and validation methodologies that your request asks for.

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