Search Results

Date Cleared

2015-10-29

(91 days)

Product Code

NQQ

Regulation Number

Type

Panel

OPTIS Integrated System Mobile Workstation

Reference & Predicate Devices

K150878,K151286

Intended Use

The OPTISTM Mobile System with DragonflyTM DUO or DragonflyTM OPTISTM Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The DragonflyTM DUO or Dragonfly™ OPTISTM Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ DUO or DragonflyTM OPTISTM 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 OPTISTM Mobile System 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.

Device Description

The OPTIS Mobile System is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. It includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the OPTIS Mobile 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 OPTIS Mobile System is comprised of the following main components:

. A rapidly scanning laser engine
A host computer with embedded application software ●
A drive-motor and optical coupler (DOC) which connects to the imaging catheter ●
A mobile console with monitors, keyboard and mouse housing laser engine and host computer, and connected to the DOC.
An imaging catheter
An optional Tableside Controller (TSC) ●
o Video interfaces for interaction with the boom monitor and angiography system

The function of the Tableside Controller (TSC) is to provide tableside system control to the Physician. The TSC communicates with the console via wireless configuration or an optional wired configuration.

The OPTIS Mobile System can perform both OCT and FFR procedures, and is compatible with Dragonfly OPTIS, DUO and JP catheters and the PressureWire Aeris. The OPTIS Mobile system provides the ability to incorporate the angiography images into the GUI, which allows users to visualize the position of OCT image data on angiography images, tightening the linkage between anatomical assessment with OCT and subsequent therapeutic actions.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or performance study would typically describe for a new AI/ML device. The document is an FDA 510(k) clearance letter and summary for the LightLab Imaging, Inc. OPTIS™ Mobile System, which is an ultrasonic pulsed echo imaging system, not an AI/ML device in the context of typical AI study requirements.

The performance testing mentioned is primarily related to:

Electrical Safety and EMC: Compliance with standards like IEC 60601-1, IEC 60601-1-2.
Software Verification and Validation: Compliance with IEC 62304 and FDA regulations.
Laser Safety: Compliance with IEC 60825-1 and 21 CFR 1040.10.
Usability Engineering: Compliance with IEC 62366 and IEC 60601-1-6.
OCT Parameter and Hardware Testing: This is mentioned as part of design verification and validation, but specific acceptance criteria and results are not detailed.

The document asserts that "The results of this testing conclude the software has met these requirements" and "The results of this testing concludes the OPTIS Mobile System is determined to be safe and effective and is substantially equivalent to the ILUMIEN OPTIS predicate device." However, no specific performance metrics, sample sizes for test sets, ground truth methodology, or details of comparative effectiveness studies (like MRMC) are provided in the context of diagnostic accuracy, which would be typical for an AI/ML device.

Therefore, I cannot populate the requested table and answer many of the questions because the provided text does not contain this information. The device is cleared based on substantial equivalence to predicate devices, and the performance testing described is focused on safety, electromagnetic compatibility, software V&V, and basic system functionality, rather than detailed diagnostic accuracy metrics for an AI/ML algorithm.

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K Number

K151286

Device Name

Manufacturer

Date Cleared

2015-08-05

(83 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K141769

Intended Use

The OPTIS Integrated System 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 OPTIS Integrated System 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.

Device Description

The OPTIS Integrated System performs optical coherence topography (OCT) and fractional flow reserve (FFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The device utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. The device is compatible with Dragonfly OPTIS, Dragonfly Duo and PressureWire Aeris.

The OPTIS Integrated System configuration has the following components integrated into a single catheterization lab.

Component	Location
Laser and
Engine	Contained within the system cabinet (M5a)
PC Embedded
Software	Contained within the system cabinet
DOC	Located on the table side,
connected directly to the DOC Holster
Monitor
Keyboard
Video Mouse	Located in the control room
System
Cabinet	Located within the control room or technical closet
Remoting
Cable	The cable connects the DOC Holster to the system cabinet
DOC Holster	Located table side
Tableside
Controller	Located table side

The OPTIS Integrated System Mobile Workstation (MWS) is an accessory for the OPTIS Integrated System. The MWS is a mobile terminal that mirrors the functionality of the control room monitor, keyboard and mouse that is part of the OPTIS Integrated System. The Control room monitor, keyboard and mouse of OPTIS Integrated System is a desktop setup located in the control room for operating system controls.

The MWS consists of two major subassemblies:

MWS console is comprised of a cart, keyboard, mouse, monitor, wireless . Keyboard/Video/Mouse (KVM) receiver, cabling, branding labels and compliance label.
MWS transmitter is comprised of a wireless KVM transmitter, video splitter, power supplies and cabling. All items are shipped together in a single carton.

AI/ML Overview

The provided text is a 510(k) premarket notification for the OPTIS Integrated System Mobile Workstation. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does NOT provide the level of detail requested for acceptance criteria and a study proving the device meets those criteria, particularly regarding AI performance or human reader improvement with AI.

Here's an analysis based only on the provided text, highlighting what information is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document states that performance testing was conducted according to various IEC standards and internal design control procedures, and that the device "met these requirements." However, no specific acceptance criteria or quantitative performance metrics are listed for the core functionality of imaging or FFR determination. The testing primarily focuses on electrical safety, usability, and design verification of the Mobile Workstation accessory, not the clinical performance of the entire OPTIS system.

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

Not provided in the document. The document mentions "Hardware Design Verification, System Level Design Verification and Transport & Storage Conditions Verification," but does not specify any sample sizes for these tests, nor does it refer to a "test set" in the context of clinical data or algorithm performance. The device is for imaging coronary arteries, but no patient data is mentioned in relation to testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not provided. The document describes a medical device (OPTIS Integrated System) for imaging and FFR measurement. It does not mention any AI component or a need for expert-established ground truth for algorithm performance in the way a diagnostic AI would.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As there's no mention of a test set requiring ground truth, no adjudication method is discussed.

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

Not applicable/Not provided. The document does not describe an AI component within the OPTIS Integrated System that would assist human readers, nor does it discuss any MRMC studies comparing human readers with and without AI assistance. The focus is on the device's ability to acquire images and FFR data.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not provided. The device is an integrated system (hardware and software) for medical imaging and physiological parameter measurement. There is no mention of a standalone algorithm or a study evaluating its performance in isolation.

7. Type of Ground Truth Used

Not applicable/Not provided. Given the device's function (imaging and FFR measurement), the “ground truth” would likely be related to the accuracy of the physical measurements (e.g., FFR values against a gold standard manometer, image resolution/clarity against known phantoms). However, the document does not specify what ground truth was used for assessing the device's core performance, only that "Design Verification activities demonstrate that OPTIS Integrated System and the Mobile Workstation comply with the defined design and performance specifications."

8. Sample Size for the Training Set

Not applicable/Not provided. The document does not mention any machine learning or AI components that would require a training set.

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

Not applicable/Not provided. As there's no mention of a training set, the method for establishing its ground truth is not discussed.

Summary of Device Performance Information Provided in the Document:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K141769) for the OPTIS Integrated System, with the addition of a Mobile Workstation accessory. The "Performance Testing" section states:

The OPTIS Integrated System Mobile Workstation has been tested and is in compliance with:
- IEC 60601-1:2005 + A1: 2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- IEC 60601-1-6:2010 + A1: 2013 (Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability)
- IEC 60601-2-18:2009 (Medical equipment - Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment)
- IEC 60601-1-2 Ed. 3 (Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment. Class A for non-life supporting equipment)
Additionally, Hardware Design Verification, System Level Design Verification, and Transport & Storage Conditions Verification were conducted in accordance with FDA regulations, standards, guidance documents, and internal design control procedures.
Reported Conclusion: "The results of this testing conclude the OPTIS Integrated System and Mobile Workstation have met these requirements. The Design Verification activities demonstrate that OPTIS Integrated System and the Mobile Workstation comply with the defined design and performance specifications. The addition of Mobile Workstation does not affect the safety, efficacy and performance of OPTIS Integrated System. The results of this testing concludes the OPTIS Integrated System with Mobile Workstation is determined to be safe and effective and is substantially equivalent to the OPTIS Integrated System predicate device."

In essence, the document confirms that the device (including its new mobile workstation accessory) meets safety and performance standards as determined by its design verification, but it does not detail specific, measurable clinical acceptance criteria nor the results of a study demonstrating these criteria are met with quantitative data. The focus is on the substantial equivalence and the compliance of the new accessory with regulatory standards.

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K Number

K150878

Device Name

ILUMIEN OPTIS

Manufacturer

LIGHTLAB IMAGING,INC.

Date Cleared

2015-07-15

(105 days)

Product Code

Regulation Number

Type

Panel

ILUMIEN, Drageonfly OPTIS Imaging Catheter

Reference & Predicate Devices

K141453

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criterion (Compliance)	Reported Performance
IEC 62304:2006 (Software)	In compliance; software verification and validation conducted to FDA regulations, standards, and guidance document requirements. Results conclude software met requirements.
IEC 60601-1:2005+CORR.1(2006)+CORR.2(2007) (Basic Safety/Essential Performance)	In compliance.
IEC 60825-1:2nd Ed. 2007 (Laser Safety)	In compliance.
21 CFR 1040.10 (Light Emitting Products)	In compliance (sections b5 and b15).
IEC 60601-1-2 Ed.3 (EMC)	In compliance (Electromagnetic emissions and immunity requirements for medical electric equipment-Group 1 Equipment, Class A for non-life supporting equipment).
Hardware and OCT Imaging Parameter Performance	Bench testing and design verification/validation performed in compliance with internal design control procedures, including engine hardware design verification and OCT Imaging Parameter testing. Results conclude the ILUMIEN OPTIS is safe and effective and substantially equivalent to the predicate device.
FFR Measurement Accuracy	Not explicitly defined as a separate acceptance criterion with a specific threshold. The device acquires RF signals from pressure transducers to "determine" FFR, and the physician uses this parameter. The document implies its functionality is equivalent to the predicate by virtue of being an "upgrade" to the engine.

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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K Number

K150237

Device Name

Manufacturer

Date Cleared

2015-05-05

(92 days)

Product Code

Regulation Number

Type

Panel

ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER

Reference & Predicate Devices

K080813

Intended Use

The ILUMIEN 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, 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 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 Dragonfly OPTIS Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary.

Device Description

The ILUMIEN is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with a mains power cable. It also includes the Drive-motor and Optical Controller (DOC), which provides the interconnection between the ILUMIEN 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 and includes two AO and PW USB Receivers which accept the distal intracoronary and proximal aortic pressure signals and status information from the AO Interface Unit and PressureWire® Aeris (K080813) respectively, and communicate the FFR data for display on the ILUMIEN system.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Lightlab Imaging, Inc. ILUMIEN with Dragonfly OPTIS Imaging Catheter. It indicates that the device has been found substantially equivalent to a predicate device (Lightlab Imaging, Inc. ILUMIEN, K111200). However, the document does not contain specific acceptance criteria, reported performance metrics as a table, or details about patient studies for the new device's performance.

The document discusses performance testing in a general sense, noting that hardware/firmware are unchanged and that software verification/validation, as well as design verification/validation (bench testing), were conducted in compliance with FDA regulations. Crucially, it states: "The results of this testing conclude the software has met these requirements. Design verification and validation was also performed on the ILUMIEN and Dragonfly OPTIS Imaging Catheter in compliance with internal design control procedures which included bench testing. The results of this testing concludes the ILUMIEN and Dragonfly OPTIS Imaging Catheter is determined to be safe and effective and is substantially equivalent to the predicate ILUMIEN device."

This implies that the device meets safety and effectiveness requirements, demonstrating substantial equivalence to its predicate, but it does not provide a specific study with acceptance criteria and results. The 510(k) process is about demonstrating substantial equivalence to an already marketed device, not necessarily proving efficacy through new clinical trials with defined acceptance criteria for a novel device.

Therefore, many of the requested details are not available in the provided text.

Here is a summary of what can be extracted or inferred, and what is not available:

1. Table of acceptance criteria and the reported device performance

Not available in the provided text. The document states that testing was conducted and concluded the device is safe, effective, and substantially equivalent, but it does not specify quantitative acceptance criteria or detailed performance metrics. It refers to compliance with various electrical safety, EMI, laser safety, and DICOM standards, but these are compliance standards, not performance thresholds for clinical accuracy or diagnostic capabilities.

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

Not available in the provided text. The document mentions "bench testing" for design verification and validation but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for any test set that would evaluate clinical performance.

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

Not available in the provided text. There is no mention of experts establishing ground truth for evaluating clinical performance. The testing described focuses on engineering compliance and bench tests.

4. Adjudication method for the test set

Not available in the provided text. As clinical performance testing with a ground truth established by experts is not described, an adjudication method is also not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size

No, this was not done or at least not described in the document. The document does not mention any MRMC studies or human reader performance with or without AI assistance. The device is an imaging system and catheter, not an AI-based diagnostic tool that assists human readers in the way typically evaluated by MRMC studies.

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

Not explicitly described as such. The device is an imaging system that produces OCT images and FFR parameters for a physician's use. It's not an algorithm producing a diagnostic output without human interpretation. Its performance is evaluated mechanically and through software validation, as outlined in the general "performance testing" section, but not in terms of standalone diagnostic accuracy in a clinical sense.

7. The type of ground truth used

Not explicitly stated in a clinical context. For the engineering and software validation, the "ground truth" would be established by the specifications and expected behavior based on internal design control procedures and established standards (e.g., UL, IEC, DICOM, FDA regulations). For the "imaging" aspect, the ground truth would be the physical properties of the tested objects in bench experiments. No pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set

Not applicable/Not available. The document describes modifications and upgrades to an existing imaging system and catheter. It does not refer to a machine learning or AI model that would require a "training set" in the conventional sense. The "software has been upgraded to revision D.2," indicating software development and testing, but not machine learning training.

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

Not applicable/Not available. As there's no mention of a machine learning training set, there's no information on how its ground truth would be established.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through compliance with standards, verification, and validation of hardware and software modifications. It does not include specific clinical studies with defined acceptance criteria or expert-adjudicated performance data for the new device. The conclusion of substantial equivalence is based on the updated device having the same fundamental technological characteristics and indications for use as the predicate, with performance verified through bench testing and software validation against engineering standards and internal design controls.

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K Number

K141453

Device Name

Manufacturer

OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER

Date Cleared

2014-09-19

(109 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K123369

Intended Use

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.

Device Description

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 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.

AI/ML Overview

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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K Number

K141769

Device Name

Manufacturer

Date Cleared

2014-08-18

(48 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K123369

Intended Use

The OPTIS Integrated System 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 OPTIS Integrated System 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.

Device Description

The OPTIS Integrated System performs optical coherence topography (OCT) and fractional flow reserve (FFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The device utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. The devices is compatible with Dragonfly OPTIS, Duo, and I imaging catheters, in addition to the PressureWire Aeris.

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 OPTIS Integrated 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.

AI/ML Overview

This document is a 510(k) summary for a medical device and thus does not contain the detailed acceptance criteria or a comprehensive study report with all the requested information for device performance. It primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds nor directly report device performance against such criteria in a comparative table. Instead, it states that "Design verification and validation was also performed on the OPTIS Integrated System and Dragonfly OPTIS Imaging Catheter in compliance with internal design control procedures which included bench testing and pre-clinical animal testing. The results of this testing concludes the OPTIS Integrated System and Dragonfly OPTIS Imaging Catheter is determined to be safe and effective and is substantially equivalent to the ILUMIEN OPTIS predicate device."

This implies that the acceptance criteria were likely based on demonstrating equivalence to the predicate device's performance, as well as adherence to various safety and performance standards (e.g., IEC 60601 series for electrical safety, electromagnetic compatibility, and usability, and 21 CFR 1040.10 for light-emitting products). The performance reporting is qualitative, stating that the device is "safe and effective."

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

The document mentions "pre-clinical animal testing" but does not specify the sample size for this test set (e.g., number of animals, number of imaging procedures). It also does not provide the country of origin of the data or whether the study was retrospective or prospective.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No MRMC study is mentioned. The document focuses on showing substantial equivalence through design verification and validation, including bench and pre-clinical animal testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is an imaging system (OCT and FFR), which inherently involves a human operator (physician) for interpretation and clinical decision-making. The document does not describe an "algorithm only" standalone performance study in the way one might for an AI diagnostic tool. Its performance would be evaluated in terms of image quality, FFR measurement accuracy, and overall system functionality as used by a human.

7. Type of Ground Truth Used

The document doesn't explicitly state the "type of ground truth" used for the pre-clinical animal testing. For imaging systems, ground truth in animal studies often involves:

Histopathology: Microscopic examination of tissue samples after imaging to correlate image findings with actual tissue structures.
Other established imaging modalities: Comparison with a gold standard imaging technique if available for the specific features being evaluated.
Direct observation/measurement: For functional parameters like FFR, comparison against direct pressure measurements.

Given the nature of OCT imaging for coronary arteries, histopathology or highly detailed anatomical measurements would likely be involved. For FFR, direct pressure transducer measurements during the animal study would serve as ground truth.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. While the device uses software, the context here is a medical imaging system, not a deep learning algorithm that typically requires a large training dataset. The software upgrades mentioned (e.g., Angio Co-Registration, Continuous calibration, improved acquisition workflow) likely involve traditional software engineering and validation processes rather than machine learning model training.

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

As no training set (in the AI/ML sense) is mentioned, this information is not applicable or provided. The software validation would have involved testing against requirements and specifications, rather than a "ground truth" derived from a large dataset for training.

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K Number

K123369

Device Name

ILUMIEN OPTIS

Manufacturer

Date Cleared

2013-01-30

(90 days)

Product Code

NQQ

Regulation Number

Type

Panel

Reference & Predicate Devices

K111201

Intended Use

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.

Device Description

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.

AI/ML Overview

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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K Number

K111201

Device Name

C7 XR IMAGING SYSTEM

Manufacturer

LIGHTLAB IMAGING,INC.

Date Cleared

2011-08-10

(103 days)

Product Code

Regulation Number

Type

Panel

C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES

Reference & Predicate Devices

K093857,K092105,K080813

Intended Use

The C7 XR™ Imaging System with C7 Dragonfly™ 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™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 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 C7 XR™ Imaging System 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.

Device Description

The C7 XR™ Imaging System K093857 (C7 XR) and Dragonfly™ Imaging Catheter (Dragonfly Catheter or DF) provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real-time images. The C7 XR will include two USB receivers to accept radiofrequency signals from a distal intracoronary pressure transducer and a proximal aortic pressure transducer and display the acquired pressure waveforms and calculated Fractional Flow Reserve on the C7 XR system monitor.

The C7 with FFR system consists of the following components:

C7 XR Imaging System (K093857): A cart-mounted computer and optical engine control the device and function as user interface, display and data storage. It includes the Drive-motor and Optical Coupler (DOC). The DOC is an optical-electro-mechanical device that provides the optical interconnection between the C7 XR and Dragonfly Catheter, and controls the rotational and axial motion of the fiber-optic core within the catheter and will include two USB receivers to accept radiofrequency signals from the distal intracoronary pressure transducer and a proximal aortic pressure transducer.

AI/ML Overview

The provided text describes a 510(k) submission for the C7 XR™ Imaging System with Fractional Flow Reserve (FFR) and primarily focuses on its substantial equivalence to predicate devices and adherence to various standards. While it mentions "Clinical performance evaluation (Usability Testing)" for equivalence, it does not provide detailed information about specific acceptance criteria for system performance regarding FFR calculations or a study proving those criteria are met.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance.
Sample sizes used for the test set and data provenance.
Number of experts used to establish ground truth.
Qualifications of those experts.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study details.
Standalone (algorithm only) performance study details.
Type of ground truth used.
Sample size for the training set.
How the ground truth for the training set was established.

The text is a regulatory submission for a device modification, focusing on safety, effectiveness, and substantial equivalence, not a detailed clinical performance study report.

Information Extracted from the Text (as relevant to the request, even if it highlights missing information):

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

Acceptance Criteria: Not explicitly stated in terms of performance metrics for FFR accuracy or any other quantitative measure. The submission relies on "Usability Testing" and compliance with standards for substantial equivalence.
Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or numerical concordance for FFR values) are reported in this summary.

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

Sample Size: Not specified. The clinical performance evaluation is referred to as "Usability Testing," which typically focuses on user interaction rather than extensive FFR accuracy testing against a gold standard.
Data Provenance: Not specified.

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

Not specified.

4. Adjudication method for the test set

Not specified.

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 MRMC study is mentioned. The device provides "Fractional Flow Reserve (FFR)" which is a physiological parameter calculated from pressure transducers, not an AI interpretation of images requiring human reader comparative effectiveness. The text indicates that "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," implying FFR (the output of the device) is an input to human clinical judgment, rather than the device assisting human readers in interpreting complex images directly.

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

The device calculates FFR based on pressure transducer signals and displays it. It is inherently a "standalone" calculation, as it's an automated measurement. However, there are no reported performance metrics for this calculation within this document. The FFR calculation itself is well-established in cardiology. The submission focuses on the incorporation of this functionality into the C7 XR system and its equivalence to predicate FFR devices (RadiAnalyzer® Xpress and Pressure Wire®).

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

Not specified. For FFR, the ground truth would typically be the measurement itself using an established reference method, but no such comparison data is presented. The "Usability Testing" mentioned would not typically establish this kind of ground truth.

8. The sample size for the training set

Not applicable, as this is a device incorporating a known physiological measurement technique (FFR) and not a machine learning algorithm requiring a training set in the conventional sense. The "algorithm" for FFR calculation is based on principles of fluid dynamics.

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

Not applicable (see point 8).

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K Number

K093857

Device Name

Manufacturer

LIGHTLAB IMAGING,INC.

Date Cleared

2010-04-30

(135 days)

Product Code

NQQ,ORD

Regulation Number

Type

Panel