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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.

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.

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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QUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

QUANTIEN Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

QUANTIEN Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire (K113584, K080813, K062769) and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR) and data from ECG.

Information on screen can also be transferred to an external hemodynamic recording system or to an external video monitor. Recorded procedures can be viewed on a PC for review and analysis with application specific viewing software installed, such as RadiView™ software.

Additional functions allow for import of a patient work list from the hospital DICOM system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.

The provided text describes the QUANTIEN™ Measurement System and its 510(k) submission, focusing primarily on its intended use, technical characteristics, and substantial equivalence to a predicate device. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size or data provenance for a test set.
• Details on experts used for ground truth establishment.
• Adjudication methods.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used (beyond implying physiological parameters).
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on explaining that the QUANTIEN™ Measurement System "meets the design inputs and raises no new safety or efficacy concerns" and is "substantially equivalent to the marketed predicate device, RadiAnalyzer Xpress (K092105)." This implies that the acceptance criteria are met by demonstrating equivalence and adherence to design specifications, but the specific criteria and performance figures are not detailed.

Given the limitations of the provided text, I can only provide information based on what is available.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the QUANTIEN™ Measurement System emphasizes that the device meets its design inputs and is substantially equivalent to its predicate device, the RadiAnalyzer® Xpress (K092105). This implies that the acceptance criteria for the QUANTIEN™ system are largely based on demonstrating that it performs comparably to the predicate device in its intended function of recording, computing, displaying, and storing physiological data, including Fractional Flow Reserve (FFR), without introducing new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a specific table of acceptance criteria or reported device performance metrics for the QUANTIEN™ Measurement System. The core claim is that it "meets the design inputs" and is substantially equivalent to the predicate device.

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

The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study. The 510(k) submission primarily relies on technical characteristics, intended use, operational characteristics, and fundamental design similarities to the predicate device for demonstrating substantial equivalence.

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.

4. Adjudication method 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe an MRMC comparative effectiveness study nor does it mention AI assistance. The QUANTIEN™ Measurement System is described as a diagnostic computer for physiological measurements, not an AI-assisted diagnostic tool.

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

The document does not describe a standalone algorithm performance study. The device is intended to "compute and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices," implying human interaction in its use and interpretation.

7. The type of ground truth used

While not explicitly stated as "ground truth," the device's function is to "compute and display various physiological parameters." The implication is that the accuracy of these computed physiological parameters against established physiological measurement methods would serve as the ground truth for its performance. The document mentions "output from one or more electrodes, transducers or measuring devices" as the input, which suggests the ground truth would be against the direct measurements from these established sensors.

8. The sample size for the training set

The document does not specify a training set sample size.

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

The document does not provide information on how ground truth for a training set was established.

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PressureWire® is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output of the sensor is used for calculation and presentation of any physiological parameters, functions or indices based on temperature or pressure, e.g. Fractional Flow Reserve (FFR).

Pressure Wire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

The Subject Device, PressureWire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters.

The PressureWire is available in 2 configurations:

• . Wired version using a cable (PressureWire Certus) to connect with the diagnostic computer
• . Wireless version (PressureWire Aeris).

Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system and are available in two lengths, 183 cm or 300 cm.

I am sorry, but the provided text does not contain the information required to compose the type of response you are looking for. The document is a 510(k) summary for a medical device (PressureWire), outlining its description, intended use, indications for use, and a statement of substantial equivalence to a predicate device. It also includes the FDA's clearance letter.

However, the summary does not provide details regarding:

1. Acceptance criteria and reported device performance in a table.
2. Sample size, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
3. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size for human readers with and without AI assistance. The device described is a physical guidewire with a pressure/temperature sensor, not an AI-assisted diagnostic tool.
4. Whether a standalone (algorithm only) performance study was done. Again, this is not an AI algorithm.
5. The type of ground truth used.
6. Sample size for the training set or how ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device based on functional, safety, and biocompatibility testing, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for an AI or diagnostic algorithm. The "Summary of performance testing" section broadly states that "The successful completion of verification activities demonstrates that the PressureWire meets the required product specifications," but it doesn't quantify those specifications or the results in a detailed manner.

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