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The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.

The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in varying configurations of length (105 cm, 130 cm, 150 or 155 cm, 180 cm), diameters (1.7 Fr., 1.9 Fr., 2.4 Fr. 2.7 Fr., 2.8Fr. and 3.0 Fr.) and tip shape (straight, SP1, SP2).

The provided text is a 510(k) summary for the Drakon™ and Sequre® microcatheters, and it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving those criteria.

Specifically, this document describes a device modification (addition of sizes and tip shapes) to previously cleared predicate devices, rather than an initial market clearance study with detailed performance metrics against specific disease detection criteria. The performance data presented are bench tests conducted to demonstrate that the modified device remains substantially equivalent to the predicate device, not a formal clinical efficacy study in the sense typically associated with AI/diagnostic device performance.

Therefore, many of your questions, particularly those related to clinical performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, cannot be effectively answered from this document.

However, I can extract the available information related to the acceptance criteria and the type of studies conducted:

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

The document states that the modified devices met "predetermined acceptance criteria" for various bench tests, but it does not explicitly list the quantitative acceptance criteria or detailed numerical results. It only reports that the devices "met the predetermined acceptance criteria."

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 specified. The document lists "bench tests," which typically involve a set number of physical samples of the device. The specific number of devices tested for each bench test is not provided.
• Data Provenance: Not applicable in the context of clinical data. These are laboratory/bench tests, not patient data trials.

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. These are bench tests for a microcatheter, not an AI/diagnostic device requiring expert interpretation for ground truth.

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

• Not applicable. These are 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

• No, an MRMC study was not done. This device is a microcatheter, not an AI diagnostic tool.

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

• No, this is a physical medical device, not an algorithm.

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

• For bench tests, "ground truth" generally refers to validated measurement standards, engineering specifications, and established limits for physical properties (e.g., tensile strength, burst pressure, leak rates). The document implies that these standards were used for the "predetermined acceptance criteria."

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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The Drakon™ and Sequre® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and Sequre® microcatheters are also intended for drug infusion in intraarterial therapy and infusion of embolic materials. The Drakon™ and Sequre® microcatheters should not be used in cerebral vessels.

The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in several different diameters (1.7 Fr., 1.9 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).

The provided FDA 510(k) Pre-Market Notification does not contain information about a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, nor does it detail a study involving human reader performance, ground truth establishment, or training/test set data for such a device.

The document pertains to the Drakon™ and Sequre® microcatheters, which are physical medical devices (intravascular catheters) used for infusing contrast media, drugs, or embolic materials. The "performance data" section (Section VII) outlines bench testing and biocompatibility testing conducted to demonstrate that the modified microcatheters are substantially equivalent to their predicate devices, and that these physical devices meet predefined acceptance criteria for metrics such as bead compatibility, tensile strength, burst pressure, torque strength, etc.

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, and the provided text is for a physical medical catheter, I cannot extract the requested information as it does not exist in this document.

Therefore, I must state that the provided text does not contain the information requested regarding acceptance criteria and studies for an AI/SaMD, human reader performance, training/test set details, or ground truth establishment relevant to an AI model. The document explicitly focuses on the substantial equivalence of a physical microcatheter based on bench testing.

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The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.

The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer laver. which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in several different diameters (1.7 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).

The provided text describes a 510(k) premarket notification for Drakon™ and Sequre® microcatheters. This document details the device description, indications for use, comparison with a predicate device, and performance data from various bench and biocompatibility tests. However, this document does not contain information about a study proving device performance against clinical acceptance criteria for an AI/algorithm-based device, or details about expert consensus, ground truth establishment, or multi-reader multi-case studies.

The information provided is typical for a traditional medical device (catheter) clearance, focusing on physical and biocompatibility testing. It doesn't involve AI or algorithms that would require the specific types of acceptance criteria and study designs outlined in your prompt (e.g., sensitivity, specificity, human reader improvement with AI).

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI device meets those criteria, as the provided document pertains to a physical medical device (microcatheter) and not an AI or algorithmic device.

The "acceptance criteria" mentioned in the document refer to the criteria for passing the various bench tests (e.g., tensile strength, burst pressure) and biocompatibility tests, not clinical performance metrics for an AI system.

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The SeQure® NF and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels.

The SeQure® NF and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials.

The SeQure® NF and the SeQure® microcatheters should not be used in cerebral vessels.

The SeQure® NF and SeQure® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The SeQure®'s distal end has side holes and two radiopaque markers while the SeQure® NF's distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters.

The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood.

The SeQure® NF and the SeQure® microcatheters are sterile single lumen devices and are available in several different diameters and lengths.

This document describes the regulatory submission for the SeQure® NF and SeQure® microcatheters, demonstrating their substantial equivalence to a predicate device. As such, the "acceptance criteria" discussed here refer to the performance standards and testing outcomes that were required for FDA clearance, rather than acceptance criteria for a diagnostic AI algorithm. Similarly, the "study that proves the device meets the acceptance criteria" refers to the engineering bench tests, biocompatibility tests, and animal studies conducted to demonstrate the safety and performance of the catheters according to established medical device standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device (catheters) are implicitly defined by the successful completion of various performance tests, demonstrating that the device is safe and performs as intended, comparable to the predicate device. The document states that "All tests met the predefined acceptance criteria."

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

• Test Set (Applicable to Animal Study): The document does not explicitly state the number of animals used in the GLP Animal Study. It refers to the study as "GLP Animal Study" implying a sufficient sample size for regulatory purposes, but the specific number is not provided.
• Data Provenance: The GLP Animal Study was performed at the Asaf Harophe GLP facility in Israel. The document does not specify if it was retrospective or prospective, but GLP (Good Laboratory Practice) studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable in the context of this device submission. The device is a physical catheter, not an AI diagnostic algorithm requiring expert annotation for ground truth. The "ground truth" for proving safety and performance comes from objective physical and chemical tests, and pre-clinical animal studies, not human expert consensus on interpreted data.

4. Adjudication method for the test set

Not applicable as this is not an AI diagnostic algorithm study. The animal study involved "different users" for comparison to the predicate device, and the evaluation included gross pathology and histopathology which would be interpreted by qualified personnel, but a specific adjudication method isn't detailed as it would be for reader-based image interpretation.

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 a submission for a physical medical device (catheter), not an AI algorithm, so 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 a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance and safety was established through:

• Objective Test Results: Passing results from various bench tests (e.g., burst pressure, trackability, tensile strength) and biocompatibility tests (e.g., cytotoxicity, hemolysis) against predefined, quantitative acceptance criteria.
• Animal Study Observations and Pathology: Direct observation of device performance, absence of adverse events, and histology/pathology findings from the animal study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. No training set was used for this type of device submission.

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