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CoroFlow is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases.

CoroFlow 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 measuring devices.

CoroFlow Cardiovascular system is used to calculate, display and store physiological parameters based on pressure and temperature measurements from Abbott Medical's PressureWire and Wi-box. Calculated parameters include physiological indices to assess coronary lesion severity (FFR, Pd/Pa, RFR) and indices to assess coronary micro-circulation (IMR, CFR). The system also provides novel indices based on the same raw pressure and temperature measurements (IMR_Corr, RRR, Absolute Flow/Resistance, dP/dt, Tau). CoroFlow™ is installed on a personal computer and receives measurement data wirelessly via the CoroHub™ Receiver. Information is displayed on the computer screen which can optionally be slaved to a monitor inside the coronary cathlab. Data can be stored on a local storage unit or transferred to a network location.

The provided document does not contain details about specific acceptance criteria and a study demonstrating the device meets those criteria. Instead, it describes the CoroFlow™ Cardiovascular System and asserts its substantial equivalence to predicate devices (QUANTIENT™ Measurement System (K183099) and RadiAnalyzer® Xpress (K092105)) based on non-clinical testing and clinical evaluation of Software as a Medical Device (SaMD) principles, rather than a direct clinical study to prove performance against pre-defined acceptance criteria.

The document explicitly states: "No clinical study was performed as a part of either the product development or in support of the substantial equivalence of CoroFlow as the intended use/indications for use and technological characteristics are equivalent to the predicate devices."

Therefore, I cannot provide concrete information for some of your requested points, as a direct clinical study with acceptance criteria and reported performance was not conducted for this specific device clearance.

However, I can extract information related to the device's technical specifications and the general approach to demonstrating substantial equivalence, which serves as an indirect form of meeting performance expectations established by the predicate devices.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of acceptance criteria for specific performance metrics of the CoroFlow™ system, nor does it report specific performance outcomes from a study designed to meet such criteria.
Instead, it highlights that the signal performance specifications (pressure and temperature) of the CoroFlow™ are identical to the predicate devices. This implies that the device is expected to perform at the same level as the predicate devices in these aspects.

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

• Test set sample size: Not applicable for a traditional clinical study with a test set. The substantial equivalence was demonstrated through comparison to predicate devices and a SaMD clinical evaluation. The document does not specify a "test set" in the context of a prospective study with patients.
• Data provenance: Not explicitly stated as a separate test set. The clinical evaluation followed FDA guidance for Software as a Medical Device (SaMD), which typically relies on existing clinical data (retrospective) or scientific literature to establish clinical association and validation. The document implies a broad clinical evaluation, not a focused test set from a specific country. However, since the device received clearance in the US, the supporting data would have been reviewed by the FDA.

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. As no traditional clinical study with a "test set" requiring ground truth establishment by experts was conducted, these details are not relevant to the clearance pathway described.

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

• This information is not provided. Again, this is typically relevant for studies involving human readers or expert consensus on a test set, which was not the primary method for this clearance.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device, CoroFlow™, is a "Programmable Diagnostic Computer" for calculating and displaying physiological parameters, not an AI-assisted diagnostic imaging interpretation tool in the context of MRMC studies. It assists human clinicians by computing parameters from measurement devices, rather than directly improving human reader performance in interpreting images or clinical data.

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

• Yes, implicitly. The "clinical evaluation" described for this SaMD involved establishing "clinical association, analytical validation and clinical validation of the SaMD" as per FDA guidance. This typically involves demonstrating that the algorithm (CoroFlow™ calculating parameters from raw pressure/temperature data) accurately computes these parameters correctly and that these parameters are clinically meaningful, similar to how predicate devices compute and display them. The device's "raison d'être" is the standalone calculation and display of these physiological parameters.

7. The type of ground truth used:

• The document states that the substantial equivalence was evaluated by following FDA guidance for Software as a Medical Device (SaMD): "the performed clinical evaluation showed a valid clinical association, analytical validation and clinical validation of the SaMD."
  • Analytical Validation: Likely involved comparing the device's computed parameters against established reference methods or highly accurate physical models, ensuring the calculations are correct.
  • Clinical Validation: Involved demonstrating that the calculated parameters (e.g., FFR, CFR, IMR) are clinically meaningful and correlate with patient outcomes or established diagnostic thresholds as widely accepted in cardiology. This would rely on existing clinical data and scientific literature that supports the utility of these physiological indices, rather than generating new ground truth from a dedicated prospective study.
  • For indices not present in the primary predicate (e.g., IMR_Corr, Absolute Flow, RRR, PB-CFR, Tau), the "clinical testing section below" (which refers back to the general SaMD clinical evaluation statement) would have addressed their clinical validation by leveraging scientific literature and existing clinical evidence for these emerging parameters.

8. The sample size for the training set:

• This information is not provided. The CoroFlow™ device is described as a software for calculating physiological parameters based on direct measurements, implying rule-based algorithms rather than a machine learning model that requires a "training set" in the conventional sense of AI/ML. The analytical and clinical validation would be sufficient for such a device.

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

• Not applicable, as there's no explicitly mentioned "training set" in the context of machine learning. The "ground truth" for the device's functionality would be the scientifically established physiological formulas for the calculated indices and the accurate measurements from the input sensing devices (Abbott PressureWire and Wi-box).

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