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The SmartFlow® is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.

The SmartFlow® with the Pulse Transmission Coefficient software is a tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures.

The SmartFlow® is a PC based system comprising of a full color display with a touchscreen for patient data entry and control, and software calculations of the CFR and FFR parameters. The display and touchscreen are mounted in a shielded metal housing.

The provided text is a 510(k) summary for the SmartFlow® device, which is a programmable diagnostic computer for evaluating hemodynamic status. It primarily focuses on demonstrating substantial equivalence to previously cleared models. It does not contain information about acceptance criteria, detailed study designs, or specific performance metrics that would allow for a comprehensive response to all the requested points.

However, based on the available information, here's what can be inferred and what is missing:

Summary of Available Information from the Provided Text:

• Device: SmartFlow® with Pulse Transmission Coefficient software.
• Intended Use: To evaluate the hemodynamic status of diseased arteries in coronary and peripheral vasculature in conjunction with pressure measurement devices during diagnostic and interventional procedures.
• Regulatory Status: Class II device (Product Code DQK), cleared via 510(k) process.
• Substantial Equivalence: Claimed against previous SmartFlow® models (K003122 and K012947), with the current model being an improved version that includes calculation of transmission of high-frequency components of the pressure signal and Multiple Lesion case analysis. The FDA concurred with this claim.

Detailed Response to Requested Information (Based on Available Text and Inferences):

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

   Acceptance Criteria	Reported Device Performance
   Not specified.	Not specified.

   • Explanation: The document is a 510(k) summary, which typically focuses on substantial equivalence rather than detailed performance study results with predefined acceptance criteria. For devices cleared through 510(k) based on substantial equivalence, the "acceptance criteria" are generally met if the device performs as well as, or better than, the predicate device in its intended use, and does not raise new questions of safety or effectiveness. Specific quantitative acceptance metrics are usually part of a full study report, not necessarily summarized in the 510(k) summary itself unless directly tied to the substantial equivalence claim for a novel feature. The text only states that it is an "improved model" with additional features for calculating pulse transmission coefficient and multiple lesion analysis.

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

   • Sample Size for Test Set: Not specified.

   • Data Provenance: Not specified. The submitter is from Israel, but the location or nature of any data used for testing (if performed) is not mentioned.

   • Retrospective or Prospective: Not specified.

   • Explanation: As a 510(k) for an improved version of an already cleared device, detailed clinical study data (with test sets and provenance) might not have been required for substantial equivalence, or it might be presented in confidential sections of the full 510(k) submission, not in this public summary.

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)

   • Number of Experts: Not specified.

   • Qualifications of Experts: Not specified.

   • Explanation: Ground truth establishment information is not present in this document. Given the device's function (calculating physiological parameters like CFR and FFR), ground truth would typically come from invasively measured pressure data, which is considered the clinical standard, rather than expert consensus on images.

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

   • Adjudication Method: Not specified.

   • Explanation: No information on any adjudication method is provided.

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

   • MRMC Study: Not mentioned.

   • Effect Size: Not applicable as no MRMC study is detailed.

   • Explanation: This device is a diagnostic computer that processes physiological signals (pressure measurements), not an imaging AI that assists human readers in interpreting images. Therefore, a traditional MRMC study as understood in diagnostic imaging is unlikely to be relevant or performed for this type of device. The "AI" in this context refers to the algorithms for calculating hemodynamic parameters, which are presented to the clinician.

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

   • Standalone Performance Study: The text implies standalone performance. The device is described as "a tool for measuring coronary and peripheral vasculature hemodynamic status patterns" and performs "software calculations of the CFR and FFR parameters." This suggests the algorithm calculates these values directly from input data. However, a formal "standalone performance" study report (e.g., comparing algorithm output to a reference standard with metrics like accuracy, precision, recall) is not provided in this summary. Instead, the focus is on equivalence.

   • Explanation: The device is the algorithm, providing calculations. The performance would be how accurately those calculations reflect the true physiological state, typically validated against invasively measured data. The summary does not provide details of such a validation study.

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

   • Type of Ground Truth: Not specified.
   • Inferred Ground Truth: For devices measuring physiological parameters like Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR), the gold standard or ground truth would typically be derived from direct invasive physiological measurements obtained in vivo.

8. The sample size for the training set

   • Sample Size for Training Set: Not specified.

   • Explanation: As an "improved model" of an existing device, it's possible that the core algorithms were developed and validated years prior, and this submission focuses on new features or software updates. Details on training sets are not typically included in 510(k) summaries, especially for updates to existing algorithms.

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

   • Ground Truth Establishment for Training Set: Not specified.

   • Explanation: Similar to the test set, if a training set was used (e.g., for calibrating the pulse transmission coefficient algorithm), the ground truth would likely involve direct invasive measurements. This information is not in the summary.

Conclusion:

The provided 510(k) summary for the SmartFlow® device is a regulatory document focused on demonstrating substantial equivalence to previously cleared predicate devices. It largely lacks the detailed scientific study information (acceptance criteria, sample sizes, ground truth methodology, expert qualifications, etc.) that would typically be found in a comprehensive clinical trial report or a full 510(k) submission. The FDA's clearance indicates they were satisfied that the device, with its new software features, was substantially equivalent to its predecessors and safe and effective for its stated indications for use, without the need for new, extensive clinical studies detailed in this summary.

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Florence Medical Ltd. SmartFlow™ is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.

The SmartFlow™ with the Multiple Lesion software is a tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures.

The SmartFlow™ is a PC based system comprising of a full color display with a touchscreen for patient data entry and control, and software calculations of the CFR and FFR parameters. The display and touchscreen are mounted in a shielded metal housing.

The SmartFlow™ may be operated through its touchscreen or through an Infrared receiver port which allows the use of a hand-held remote.

There are two defined accessories for use with the device: Monitor interface for standard medical monitors and hand-held Infrared remote control which activates function keys and acts as a mouse.

This document describes the SmartFlow™M device, a diagnostic tool for evaluating the hemodynamic status of coronary and peripheral vasculature. The information provided is from a 510(k) summary, which is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.

Note: The provided text does not contain a detailed study report with specific acceptance criteria, sample sizes, and detailed methodology for a clinical or performance study of the SmartFlow™M device itself. Instead, it describes the device, its intended use, and its substantial equivalence to a previously cleared device. Therefore, the response below will extrapolate and make assumptions based on standard FDA 510(k) submissions where such details are usually found in the performance data section, which is missing from this excerpt.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given 510(k) summary. A 510(k) summary typically includes a table comparing the performance of the new device to the predicate device, often using metrics like accuracy, sensitivity, specificity, and potentially precision or agreement for quantitative measurements such as CFR (Coronary Flow Reserve) and FFR (Fractional Flow Reserve), which the SmartFlow™ calculates.

Since the device "enables analysis of multiple lesion cases as well as single lesion cases," a key performance metric would likely revolve around its ability to accurately measure CFR and FFR for multiple lesions and its agreement with established methods or the predicate device.

Hypothetical Acceptance Criteria (based on common practice in this field, not from the document):

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