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The SmartFlow™ Flex Ventricular Catheter is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."

The Catheter has a stepped distal tip with a 30 cm removable rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. The stylet is removed after insertion to the desired point. Soft tubing protects the lumen in the center portion and at the distal end where it terminates. The fluid containing central lumen is manufactured from PEEK tubing.

The Catheter will be marketed in the following sizes:
Ventricular Catheter .008 x 7.5mm tip
Ventricular Catheter .008 x 15mm tip
Ventricular Cathcter .021 x 7.5mm tip
Ventricular Catheter .021 x 15mm tip

Each unit will provide for an approximate 23 inch tubing extension.

The provided document is a 510(k) summary for a medical device (MRII MR Compatible Ventricular Catheter) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria for a new AI/software device.

Therefore, the information required to populate most sections of the table and answer the subsequent questions is not present in the provided text, as this document describes a traditional medical device submission, not an AI/software device.

However, I can extract information related to the device's technical specifications and the Performance Testing – Bench section, which acts as the "study" proving the device meets certain operational criteria.

Here's a breakdown of what can be extracted based on the provided text:

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

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: Not explicitly stated for each test, but phrases like "All samples" and "All Bone Anchors" suggest that specific, likely small, batches of devices/components were tested. The exact number of units per test is not provided.
• Data Provenance: The studies are described as "Bench testing" performed by "MRII, Inc." This indicates the data is from in-vitro (lab/bench) testing of the physical device, not patient data. No country of origin for data is specified beyond the company's location (Irvine, CA, USA). It's prospective in the sense that the tests were conducted specifically for this submission.

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)

Not applicable. This is a traditional device submission focused on physical and material properties, not an AI/software device requiring expert ground truth for classification or detection tasks. The "ground truth" for these tests is based on objective physical measurements and adherence to engineering specifications.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, often for AI performance evaluation. The tests described here are objective bench tests.

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

Not applicable. This is not an AI/software device, and no MRMC study was performed.

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

Not applicable. This is not an AI/software device. The device's "performance" is its physical function, not an algorithm's output.

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

The "ground truth" for the performance tests is derived from:

• Pre-defined engineering specifications and limits (e.g., specific flow rates, pressure limits, force thresholds).
• Comparative performance against the legally marketed predicate device.
• Objective physical measurements (e.g., fluid volume, pressure, force, visual inspection for damage/leaks).
• Compliance with recognized standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11137-2 for sterility).

8. The sample size for the training set

Not applicable. This is not an AI/software device and does not involve training data.

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

Not applicable. This is not an AI/software device.

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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):

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

This information is not provided in the given 510(k) summary. For a device like SmartFlow, a test set would typically involve a cohort of patients undergoing coronary or peripheral procedures where hemodynamic measurements are taken.

• Sample Size (Test Set): Not provided. This would depend on the statistical power needed to demonstrate equivalence or performance.
• Data Provenance: Not provided. Often, data provenance includes details like the country/countries where the study was conducted, the number of clinical sites, and whether the data was collected retrospectively or prospectively. Given the submitter's location (Kfar-Saba, Israel), it's possible some data originated there, but this is speculative without explicit mention.

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

This information is not provided in the given 510(k) summary. For a device that measures FFR and CFR, the "ground truth" often involves established invasive pressure wire measurements, potentially correlated with imaging (e.g., angiography) interpreted by experienced interventional cardiologists or radiologists.

• Number of Experts: Not provided. Usually, multiple experts (e.g., 2-3 independent readers/interpreters) are involved, especially if subjective interpretation is part of the ground truth establishment.
• Qualifications of Experts: Not provided. Experts would typically be interventional cardiologists with significant experience (e.g., 5-10+ years of experience) in performing and interpreting these procedures.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary. If multiple experts were involved in establishing ground truth (which is common for these types of devices), an adjudication method would be used to resolve discrepancies. Common methods include:

• Consensus: Experts discuss and reach a joint decision.

• Majority Vote: If three experts, 2 out of 3 determines the ground truth.

• Senior Expert Adjudication: A designated senior expert makes the final decision in case of disagreement.

• Adjudication Method: Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improving with AI vs. Without AI Assistance

This information is not provided in the given 510(k) summary.

• MRMC Study: The document describes SmartFlow™ as a "tool for measuring" and "software calculations of the CFR and FFR parameters." It's a system to provide quantitative data. It is not presented as an "AI-assisted interpretation" device for human readers. Therefore, an MRMC study measuring human reader improvement with vs. without AI assistance is unlikely to have been the primary study performed for this device, as it doesn't appear to be an AI diagnostic aid in the context of improving human interpretation of images. The device calculates parameters directly.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the nature of the device suggests a standalone performance evaluation. The SmartFlow™ performs "software calculations of the CFR and FFR parameters." This implies that the algorithm itself takes input (likely pressure measurements) and outputs CFR and FFR values. The performance of these calculations, relative to a gold standard (e.g., highly accurate reference pressure wire systems or established formulas), would be a standalone evaluation of the algorithm's accuracy and precision.

• Standalone Study: Based on the description, yes, a standalone evaluation of the algorithm's performance in calculating CFR and FFR would be central to its clearance.

7. The Type of Ground Truth Used

The ground truth for a device calculating CFR and FFR would typically be:

• Established Invasive Measurements: Direct, invasive pressure wire measurements considered the clinical gold standard for FFR and CFR. These measurements are taken by highly accurate transducers during the diagnostic or interventional procedure.

• Correlation with Clinical Outcomes: While not the primary ground truth for algorithm accuracy, studies might also correlate the device's outputs with patient outcomes (e.g., recurrence of angina, need for revascularization) to demonstrate clinical utility.

• Ground Truth Type: Established Invasive Measurements (e.g., from an independent, highly accurate pressure measurement system) would be the most relevant ground truth for validating CFR and FFR calculations.

8. The Sample Size for the Training Set

This information is not provided in the given 510(k) summary. SmartFlow is described as a system that performs "software calculations" of CFR and FFR. While the software might incorporate algorithms, the term "training set" strongly implies a machine learning or AI component. The description doesn't explicitly state that the calculations are based on a machine learning model that requires a training set in the conventional sense. It could be based on well-established physiological models and mathematical equations.

• Sample Size (Training Set): Not provided. If the underlying algorithms are purely deterministic (based on physics and physiology equations), a "training set" in the AI sense wouldn't be applicable. If there are data-driven models, then a training set would be used, but its size is not mentioned.

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

This information is not provided and is dependent on whether a training set, as typically understood in machine learning, was even used.

• Ground Truth Establishment (Training Set): Not provided. If a training set was used, the ground truth would typically be established similarly to the test set: using established invasive measurements performed by expert clinicians.

In summary, the provided 510(k) excerpt focuses on the device description, indications for use, and substantial equivalence to a predicate device. It lacks the detailed performance study results, including specific acceptance criteria, sample sizes, and methodology for ground truth establishment that would typically be found in the "Performance Data" section of a full 510(k) submission.

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Ask a specific question about this device