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The ILUMIEN™ 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 ILUMIEN 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.

ILUMIEN™ with AptiVue™ Software (version D.3) 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).

The provided FDA 510(k) summary for the ILUMIEN System with AptiVue Software version D.3 describes the device's equivalence to predicate devices, focusing on the addition of a new physiological index, RFR. However, it explicitly states, "No new clinical testing was completed, nor relied upon, in support of this Special 510(k)." This means there is no specific study described within this document that "proves the device meets the acceptance criteria" in the traditional sense of a new clinical trial for this specific software version.

Instead, the submission relies on:

• Equivalence to existing cleared devices: The new software version D.3 is deemed equivalent to the predicate ILUMIEN™ system (K150237) and the OPTIS™ Systems with AptiVue™ Version E.5 Software (K183320). The RFR feature is identical to the one cleared under K183320.
• Verification and Validation (V&V) testing: This includes software V&V and a usability study to demonstrate safety and effectiveness and ensure the device performs as intended with the new features. These are typically internal engineering and validation tests, not clinical studies with a ground truth established by experts for a specific diagnostic performance metric.

Therefore, many of the requested details about acceptance criteria met by a specific study, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or provided in this document for the new software version D.3. The document focuses on demonstrating that the modifications do not raise new questions of safety or effectiveness compared to already cleared devices.

Here's an attempt to fill in the table and answer the questions based only on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance (Based on Equivalence)

Since no new clinical study was performed for this specific submission, direct "acceptance criteria" and "reported device performance" in terms of diagnostic metrics are not provided for version D.3. Instead, the "acceptance" is based on demonstrating equivalence to predicate devices that presumably met their own acceptance criteria when originally cleared.

Study Details (Based on the provided document)

Since "No new clinical testing was completed, nor relied upon, in support of this Special 510(k)," many of the questions below cannot be answered directly from the provided text for the ILUMIEN System with AptiVue Software D.3. The answers reflect what is stated or explicitly absent.

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

   • Not applicable for a new clinical study for D.3.
   • For the usability study mentioned under "Verification and Validation," sample size, data provenance, and retrospective/prospective nature are not provided in this document. These are generally internal tests.

2. 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)

   • Not applicable. No new clinical study requiring expert ground truth establishment for a test set was performed or relied upon for this submission. The RFR feature is based on its previous clearance where such ground truth would have been established.

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

   • Not applicable. No new clinical study requiring adjudication was performed or relied upon.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No. The document explicitly states "No new clinical testing was completed, nor relied upon." There is no mention of an MRMC study or AI assistance. The device is for physiological parameter computation and display, not an AI diagnostic aid for human readers in the traditional sense.

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

   • Not explicitly stated for the D.3 update. The device "will further compute and display various physiological parameters." While the computation of RFR is an algorithm's standalone function, the performance details of this computation, particularly as a new standalone study for D.3, are not provided. Its equivalence to the previously cleared E.5 software is emphasized.

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

   • Not explicitly provided for D.3. For the RFR feature, the ground truth methodology would have been established during the clearance of the predicate device (K183320). Generally, physiological parameters like FFR, Pd/Pa, and RFR are compared against either direct pressure measurements or established physiological models as ground truth.

7. The sample size for the training set

   • Not applicable. This submission focuses on software updates and equivalence, not a new algorithm development requiring a separate training set. The algorithms for FFR, Pd/Pa, and RFR were developed and likely trained (if applicable to their computational nature) during previous versions or predicate clearances.

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

   • Not applicable. As above, no new training set is described as being used for this submission.

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