Search Results

The Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The Micro Catheter is available in three inner diameters (0.017″, 0.021″ and 0.027″), and two working lengths (150cm and 155cm). All models are designed with a straight tip, and are steam shapeable by the user. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of Micro Catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter body has a semi-rigid proximal end which transitions into the flexible distal end to facilitate the advancement of the catheter in the tortuous vasculature. The Micro Catheter is compatible with ≤ 0.014″ guidewires and 5F or larger guide catheters.

The provided 510(k) clearance letter pertains to a Micro Catheter and describes its performance and testing to demonstrate substantial equivalence to a predicate device. This document does not discuss an AI/ML powered device, nor does it present data from a study involving human readers or the establishment of ground truth for AI model training or testing. Therefore, I cannot address most of your specific questions related to AI device evaluation.

However, I can extract the acceptance criteria and performance data for the Micro Catheter based on the provided text.

Acceptance Criteria and Device Performance for Micro Catheter

The document describes the testing performed on the Micro Catheter to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are implied by the "Results" column in the tables, indicating whether the device met the required performance standards for each test.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary for a medical device like a micro catheter focuses on engineering and biocompatibility performance rather than AI-specific metrics. The "acceptance criteria" are implicitly met if the "Results" indicate compliance, comparability to a predicate, or "met the acceptance criteria."

Ask a specific question about this device

The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

BIOTRONIK's Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for dilatation of stenotic segments in peripheral vessels. The Passeo 35 Xeo Catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo 35 Xeo Catheter towards and through the lesion(s) to be dilated.

The Passeo-18 peripheral dilatation catheter is intended for dilatation of stenotic segments in peripheral vessels and arteriovenous dialysis fistulae. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen. The dilatation catheter has a hydrophobic silicone coating on the shaft outer surface and a hydrophobic patchwork coating on the balloon.

The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic segments in lower limb arteries. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen.

The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable guide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers. The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014" (Oscar 4F) and 0.018" (Oscar 6F) guide wires. The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately.

Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

The provided FDA 510(k) clearance letter (K250706) is for BIOTRONIK's peripheral and coronary dilatation catheters. This document describes several devices: Passeo-35 Xeo, Passeo-18, Passeo-14, Oscar Peripheral Multifunctional Catheter System, Pantera LEO PTCA Catheter, and Pantera Pro PTCA Catheter.

It's important to note that this 510(k) Summary does not describe an AI/ML powered device. Instead, it focuses on the physical and performance characteristics of medical devices (catheters). Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," and details about training data, are not applicable to this type of submission.

The "performance testing" mentioned throughout the document refers to bench testing and engineering assessments to ensure the physical device meets its design specifications and performs safely and effectively. It does not involve AI model performance evaluation with clinical data.

Here's an attempt to answer the applicable parts of your request based on the provided text, with clear indications where the information is not present or not relevant to an AI/ML device:

Acceptance Criteria and Study to Prove Device Meets Criteria

The acceptance criteria for these devices are implicitly derived from the design specifications and are demonstrated through performance (bench) testing. The study proving these devices meet the acceptance criteria is a series of performance (bench) tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes technological characteristics and states that "All necessary performance testing was conducted... to ensure that the devices conform to the design specification." The "Subject Devices" column in the tables explicitly states "Identical" for most characteristics, meaning they meet the same specifications as the predicate devices. The only explicit change mentioned is that "Components will be brought into compliance with ISO 80369-7:2021" for Luer connectors and manifolds. The full set of specific performance acceptance criteria values (e.g., specific burst pressure thresholds, flexibility requirements, etc.) are not explicitly detailed in this summary but are indirectly stated as being met for "consistent performance during its intended use."

Here's a summary derived from the comparison tables, focusing on the acceptance of "identical" characteristics:

Overall Performance Conclusion: "The collective results of the performed testing demonstrated that the materials chosen, the manufacturing processes, and design of the components meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not introduce new issues of safety or effectiveness when compared to the predicate device."

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

The document specifies "performance testing" or "bench testing," which refers to laboratory-based evaluations of the physical device. It does not mention a test set with patient data or any sample size related to clinical data. The provenance is not applicable as this concerns physical device characteristics, not data.

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 as the evaluation is not based on expert-labeled ground truth for an AI/ML algorithm but on physical measurements and engineering tests of the device.

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

This information is not applicable as the evaluation is not based on expert consensus or adjudication of clinical cases for an AI/ML algorithm.

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

This information is not applicable as the device is a physical medical instrument (catheter), not an AI/ML diagnostic or assistive tool.

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

This information is not applicable as the device is a physical medical instrument (catheter), not an AI/ML algorithm.

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

The "ground truth" for these devices is the established engineering specifications, material properties, and performance benchmarks that the predicate devices have successfully met. These are verified through various physical and mechanical bench tests (e.g., burst pressure, flexibility, lubricity, dimensional accuracy, etc.). The document indicates these tests confirm the new devices' conformity to these specifications.

8. The sample size for the training set

This information is not applicable as the device is a physical medical instrument (catheter) and does not involve AI/ML training.

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

This information is not applicable as the device is a physical medical instrument (catheter) and does not involve AI/ML training or a training set with ground truth.

Ask a specific question about this device

The Excelsior XT-27 Microcatheter and Excelsior XT-27 Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The Excelsior XT-27 Pre-Shaped Microcatheter and Excelsior XT-27 Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The subject devices hereafter referred to as Excelsior® XT-27® Microcatheters are sterile, single lumen, 0.027 inch inner diameter (ID) microcatheters with one tip marker designed to aid the physician in accessing distal neurovasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization® XT-27® Microcatheters are coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.

The Excelsior® XT-27® Microcatheters are available in effective lengths of both 135 cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and pre-shaped versions are available.

The provided text is a 510(k) summary for a medical device (Excelsior XT-27 Microcatheters) and details its acceptance criteria and the study performed to demonstrate substantial equivalence, but it does not describe an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and data provenance) are not applicable to this document.

However, I can provide the acceptance criteria and study information that is available for this mechanical microcatheter from the document.

1. Table of acceptance criteria and the reported device performance:

2. Sample sized 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: The document does not specify the exact number of samples (e.g., number of microcatheters tested) used for each bench test. It mentions testing with "ancillary devices that represent worst-case sizes" for the Guide Catheter Compatibility test and "worst-case sized ancillary devices and interventional devices" for the Tensile Strength test.
• Data Provenance: The study is described as "Bench testing," indicating it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies involving human or animal subjects.

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 as this is a mechanical device performance study, not an AI/ML diagnostic or prognostic study requiring expert opinion for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

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

• Not applicable for the same reason as point 3. Bench testing results are typically adjudicated by meeting predefined engineering specifications and criteria, not by expert consensus in the same way as diagnostic reads.

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 performed. This type of study is relevant for AI-assisted diagnostic devices, which is not what this device is.

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

• Not applicable. This is a physical medical device (microcatheter), not an algorithm.

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

• The "ground truth" in this context is based on engineering specifications and performance criteria for the physical device. For example, for tensile strength, the ground truth would be a defined minimum force the joints and marker band must withstand without failure. For compatibility, it would be the ability to successfully deliver and retrieve the microcatheter within the specified guide catheter with acceptable force.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable for the same reason as point 8.

Ask a specific question about this device

The Artix™ MT thrombectomy device is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels

· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Artix™ MT thrombectomy device is intended for use in the peripheral vasculature.

The Artix™ Thin-Walled Sheath is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.

· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

· Use as a conduit for endovascular devices.

· Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures.

The Artix™ Thin-Walled Sheath is intended for use in the peripheral vasculature.

The Artix™ MT is a single-use, over-the-wire catheter device used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The Artix MT is packaged with the following components: Artix MT (3-6 mm or 4-8 mm) Cleaning accessory 1-Way Stopcock The Artix MT is inserted over-the-wire through a compatible sheath (such as the Artix Thin-Walled Sheath) and advanced until its proximal marker band is distal to the target thrombus. The self-expanding element is deployed by retracting the delivery catheter. Thrombus is engaged and removed by retracting the Artix MT into the sheath and out of the patient. Once the procedure is complete, the system is completely withdrawn from the patient.

The Artix™ Thin-Walled Sheath ("Artix Sheath") is a single-use, over-the-wire system designed to facilitate the insertion and guidance of an intravascular catheter into a selected peripheral blood vessel and act as a conduit for endovascular devices. The Artix Sheath also non-surgically aspirates thromboemboli from selected vessels and is capable of infusion/aspiration of fluids into or from a selected vessel. The Artix Sheath is packaged with the following components: Artix Thin-Walled Sheath (65 cm or 90 cm) Sheath Dilator (0.035" guidewire compatibility) Funnel Catheter and Funnel Catheter Dilator (0.035" guidewire compatibility) Funnel Loading Tool (2) Large Bore Syringe, 30 mL The Artix Sheath is inserted over-the-wire and advanced to a desirable position. Any compatible endovascular device, such as the Artix MT, can then be inserted through the Artix Sheath for access into the peripheral vasculature. The provided funnel catheter accessory can also be inserted through the Sheath and deployed to provide flow occlusion of the vessel during the procedure to aid with the system's clot ingestion. Compatible endovascular devices, such as the Artix MT, can be used through the 6 Fr inner diameter of the funnel catheter as well. The provided 30 mL syringe can be used to aspirate clot in the vessel or Sheath and infuse contrast media and other fluids as required. Once the procedure is complete, the funnel catheter (if used) is removed prior to withdrawal of the entire system from the patient, and standard 7 Fr closure devices can be used.

The provided document describes the 510(k) premarket notification for two devices: Artix™ MT and Artix™ Thin-Walled Thrombectomy Sheath. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about acceptance criteria or studies involving human expert performance (such as MRMC studies, specific ground truth established by experts, or sample sizes for test/training sets relevant to AI/software performance).

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving device meets those criteria in the context of AI/software performance with human-in-the-loop. The document exclusively discusses the substantial equivalence of physical medical devices based on their design, materials, and non-clinical performance (e.g., burst strength, tensile strength, simulated use, biocompatibility).

The "study" mentioned in the document refers to a series of non-clinical tests conducted to demonstrate that the devices perform as intended and are as safe and effective as their predicate devices. These tests are not related to AI or human reader performance.

Here's an overview of the information that is available in the document, which primarily concerns the physical characteristics and performance of the devices:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria in a quantitative table with reported device performance in the way one might expect for AI or software. Instead, it lists various non-clinical tests (e.g., Biocompatibility, Sterilization, Packaging Testing, Visual and Dimensional Inspections, Simulated Use Testing, Hemostasis, Burst, Corrosion, Radiopacity, Radial Force, Chronic Clot Analog for Artix MT; and similar tests for Artix Thin-Walled Sheath) and states that "The passing results demonstrate that the subject device meets biological safety requirements" (for biocompatibility) and that "verification and validation testing were identified to support the substantial equivalence" and "The testing provided supports the Artix MT's substantial equivalence." This implies that the devices met their internal acceptance criteria for these physical and functional tests. However, the specific numerical acceptance criteria and performance outcomes for each test are not detailed in this summary.

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

• Test Set (Non-clinical): The document does not specify the sample sizes for the individual non-clinical tests conducted (e.g., how many units were tested for burst strength, or simulated use).
• Data Provenance: Not applicable in the context of device performance data presented, as it refers to non-clinical, lab-based testing of the physical devices.

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

• Not applicable. The "ground truth" for the performance of these physical medical devices is established through engineering specifications, material science, and physical testing protocols, not through expert consensus on interpretation of medical images or patient outcomes.

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

• Not applicable. This concept typically applies to human reader studies where disagreements in interpretations need to be resolved. For non-clinical device testing, results are typically objective measurements against pre-defined specifications.

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. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This means no human-in-the-loop or clinical studies were performed or are discussed here. MRMC studies are not relevant to this submission.

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

• Not applicable. These are physical thrombectomy devices, not AI algorithms.

7. The type of ground truth used:

• For the non-clinical tests ("verification and validation testing"), the "ground truth" is defined by engineering specifications, material properties, and performance benchmarks established through industry standards and the predicate device's known performance. For example, a "burst" test would have a pre-defined pressure or force target that the device must withstand to pass.

8. The sample size for the training set:

• Not applicable. This concept is for machine learning models. These devices are physical products.

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

• Not applicable.

In summary, the provided FDA 510(k) summary is for physical medical devices and does not describe acceptance criteria or studies related to AI performance or human reader studies. The "studies" mentioned are non-clinical verification and validation tests to ensure the physical device meets its design specifications and is substantially equivalent to existing predicate devices.

Ask a specific question about this device

The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.

The provided text is an FDA 510(k) clearance letter and summary for the Swan-Ganz catheter. It primarily details the regulatory process, device description, and indications for use.

Crucially, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of proving device performance against specific metrics. The document explicitly states:

"The subject Swan-Ganz Base and Advanced catheters are identical to the predicate devices cleared in K160084 and K222117 in terms of design, performance specifications, and technological characteristics with the exception of the indications for use statement and other portions of the labeling. The are no changes to the design, technology, performance, materials, or specifications of the devices in this 510(k). The modifications to the subject devices are limited to labeling changes."

This indicates that the current submission (K233824) is for a labeling change only, and therefore, the performance of the device itself (its ability to accurately monitor hemodynamic pressures) would have been established during the clearance of the predicate devices (K160084 and K222117), not in this particular submission.

Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria or a study proving the device meets acceptance criteria related to its performance.

Ask a specific question about this device

The XO Cath Microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic or therapeutic materials into the vessel.

The subject XO Cath Microcatheter is a single-lumen, metal alloy shaft with micro-cuts for flexibility, designed to support a guidewire during access of the peripheral vasculature, and to provide a conduit for the delivery of embolic applications. The XO Cath Microcatheter is available in two lumen sizes, 2.0Fr and 2.6Fr.

The XO Cath 2.0Fr and 2.6Fr Microcatheters are available with a straight or bern tip shape to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. Radiopaque markers are located at the distal tip to facilitate fluoroscopic visualization. The proximal end incorporates a standard luer for ease of use and to connect with a syringe.

The provided text describes a 510(k) premarket notification for the XO Cath Microcatheter, demonstrating its substantial equivalence to a predicate device. It is a medical device, specifically a microcatheter, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing conducted to demonstrate its functional equivalence to the legally marketed predicate device, rather than a clinical study or AI model validation study.

Here's a breakdown of the requested information based on the provided text, focusing on the device performance testing rather than a software algorithm or AI model:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All data met pre-determined acceptance criteria," but it does not explicitly list the numerical acceptance criteria for each test or the specific numerical results for the XO Cath Microcatheter. Instead, it relies on a comparative analysis to the predicate device.

Table: Acceptance Criteria and Reported Device Performance (as inferred from the text)

Ask a specific question about this device

The Peregrine System™ Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature.

The Peregrine System Infusion Catheter is a continuous flush catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 3-7 mm in diameter and is compatible with guide catheters of at least 7F.

This document is a 510(k) summary from the FDA for the Peregrine System™ Infusion Catheter. It does not describe a study involving AI or a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it detail acceptance criteria related to algorithmic performance.

Instead, this document details the substantial equivalence of a medical device (a catheter) to a previously cleared predicate device. The acceptance criteria and performance data discussed are related to the physical and functional properties of the catheter, not the performance of an AI algorithm in diagnosing or detecting conditions.

Therefore, I cannot extract the information required by your prompt, as the provided text pertains to a traditional medical device clearance, not an AI-based system. The prompt's questions (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are relevant to the evaluation of AI/ML-driven medical devices, which is not the subject of this FDA clearance letter.

Ask a specific question about this device

ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (ScleroSafe) is intended for the delivery of Asclera®, an FDA-approved sclerosant (Asclera®), in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.

The subject device, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (or ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe) is intended for the delivery of FDA-approved sclerosant Asclera® in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.

The ScleroSafe device includes a 5 Fr dual lumen catheter ("DLC"), mountable on a 0.018 inch straight-tipped guidewire in an over-the-wire configuration. The DLC is connected to a hub that splits the catheter into two separate tubes. One of the tubes ends with a blue luer lock for the aspiration extension and the other with a transparent luer lock for the injection. Following needle insertion into the guidewire is removed and a Dual Procedure Syringe ("DPS") is connected to the DLC hub via dedicated luers. The larger syringe (10 ml) is connected to blue luer lock connector (Aspiration Extension) of the smaller syringe (5 ml) is connected to a transparent luer lock connector of the catheter (Injection Extension) so fluids are simultaneously injected through one lumen and aspirated through another lumen. ScleroSafe is provided in two sizes: 150mm and 350mm.

The provided text describes a medical device, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm, and its premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons, rather than providing specific acceptance criteria and a detailed study report for a novel AI/ML device.

Therefore, many of the requested elements for AI/ML device evaluation (like MRMC studies, expert adjudication for ground truth of an AI model, training set size, etc.) are not present in this document as it pertains to a different type of medical device (a physical catheter/syringe system).

However, I can extract information related to the device's performance based on the clinical study part mentioned, even though it's not strictly "acceptance criteria" in the AI/ML sense, but rather a performance outcome from a human-in-the-loop clinical use evaluation.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent.

Device: ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe)

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" in a table format for the clinical performance. Instead, it describes subjective outcomes for safety and efficacy in a clinical study.

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

• Sample Size: 20 patients
• Data Provenance:
  • Country of Origin: Germany
  • Retrospective or Prospective: Retrospective (The company retrospectively evaluated the subject device in 20 ScleroSafe procedures that were performed in 20 patients in Germany between January and June 2019).

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 in the text. The clinical study describes outcomes (vein obliteration, recurrence, adverse events) which would have been assessed by treating physicians and follow-up clinicians, but the specific number and qualifications of independent experts establishing a "ground truth" for a test set are not mentioned, as this is not an AI/ML study involving image interpretation.

4. Adjudication method for the test set:

• This information is not provided. As it's a clinical follow-up rather than multi-reader image interpretation, formal adjudication methods like 2+1 or 3+1 are typically not described in this context for human clinical assessment.

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 comparative effectiveness study was not performed. This device is not an AI/ML diagnostic or assistive tool, but a physical medical device.

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

• No. This is not an AI/ML algorithm. The performance described is of the physical device used by clinicians.

7. The type of ground truth used:

• The "ground truth" in this context refers to the clinical outcomes and assessments by healthcare professionals.
  • Obliteration/Recurrence: Assessed by "duplex check at follow up session." This implies sonographic assessment.
  • Safety: Clinical observation and assessment of adverse events by treating staff.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires a training set. The clinical study described served as a performance evaluation.

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

• Not applicable. (See point 8).

Ask a specific question about this device

The TriSalus TriNav® LV Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The TriSalus® TriNav® LV Infusion System is a 0.025" lumen microcatheter, a self-expanding tip at the distal end. The TriNav® LV serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires with outer diameter up to 0.018" (0.46 mm), guiding catheters with inner diameter at least 0.048" (1.22 mm), embolic hydrogel particles 500 um or less in size and glass microspheres 110 um or less in size. The TriNav® LV has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, self-expanding tip is sized for use in vessels 3.0 mm to 5.0 mm in diameter. An optional, commercially available hemostasis valve (HV) is included. There are two radiopaque markers located at the distal end of the TriNav® LV device to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels. The TriSalus® TriNav® LV Infusion System is provided sterile (EtO) for single patient use.

The TriSalus® TriNav® LV Infusion System is explicitly stated as not having undergone clinical testing to demonstrate substantial equivalence. Instead, the submission relies on animal and bench performance test data. Therefore, the request for details on acceptance criteria and study proving the device meets them in the context of human clinical performance cannot be fully answered from the provided text.

However, based on the provided text, we can describe the performance testing conducted and the general acceptance criteria used:

The document states that the TriSalus® TriNav® LV Infusion System meets the same performance specifications and acceptance criteria as the predicate device. This implies that the acceptance criteria are tied to demonstrating equivalence or non-inferiority to the predicate device across various performance aspects.

Here's an attempt to extract relevant information based on the provided text, focusing on the type of studies conducted and what constitutes "performance" in this context for the device's clearance:

Device Performance Study (Bench and Animal Testing for Substantial Equivalence)

The performance of the TriSalus® TriNav® LV Infusion System was demonstrated through a series of bench testing and an animal study to show substantial equivalence to a predicate device (Surefire Spark Infusion System (rebranded as TriNav) K180677).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "meets the same performance specifications" and "acceptable/comparable" to the predicate device.
Since this document is a 510(k) summary, specific numerical acceptance thresholds and detailed performance results are not typically disclosed. However, the categories of performance evaluated are provided.

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

• Test Set (Bench Testing): Not specified.
• Test Set (Animal Study): Not specified. The text only states "An animal study was performed."
• Data Provenance: Not specified, but generally, bench testing would be conducted in a lab and animal studies in a vivarium. The studies are prospective in nature for device validation.

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

• Bench Testing: Not applicable in the context of human expert ground truth.
• Animal Study: The study assessed performance "as defined by physicians in a simulated clinical environment." The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

• Not specified. This is less relevant for bench and animal studies compared to human reader studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was NOT done. The document explicitly states: "No clinical testing was required to demonstrate the substantial equivalence of the subject device to its predicates. Therefore, no pre-market clinical testing was performed nor is any included within this 510(k) submission."

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

• Not applicable as this is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• Bench Testing: Engineering specifications, material standards, and comparisons against predicate device performance data (presumably internal data or published specifications for the predicate).
• Animal Study: Direct observation by "physicians" in a "simulated clinical environment" and relevant biological/physiological measurements. The "ground truth" for success was defined by "defined user needs" and "comparability to the predicate device."

8. The Sample Size for the Training Set

• Not applicable as this is a physical medical device, not a machine learning model.

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

• Not applicable.

Ask a specific question about this device

The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials such as contrast media as well as delivery of embolic coils.

The Wallaby 017 Micro Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device is a microcatheter with an inner diameter (ID) of 0.017", designed with a working length of 150 cm. The device has three different tip configurations: straight (0°), 45°, 90°, and is steam shapeable by the user. The device is supplied as a kit with an introducer sheath, shaping mandrel, and mandrel card provided with a single catheter. The distal tip of the Wallaby 017 Micro Catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each microcatheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous vasculature.

The Wallaby 017 Micro Catheter is a non-active, surgically invasive device intended for limited duration use within the vasculature.

Here's a summary of the acceptance criteria and the study details for the Wallaby 017 Micro Catheter, based on the provided document.

It's important to note that the document describes a medical device rather than an AI/ML powered device. Therefore, many of the typical questions for AI studies (like sample size for test/training sets, ground truth methodology with experts, adjudication, or MRMC studies) are not applicable here. The "performance" being evaluated is the physical and functional performance of the catheter itself, not the performance of an algorithm.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on passing various bench tests and biocompatibility evaluations. The full "acceptance criteria" are implied by "met all pre-defined acceptance criteria" for each test. Specific numerical thresholds for each criterion are not provided in this summary but would have been defined in detailed test protocols.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Applicable for a medical device cleared via 510(k))

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

   • The document does not specify exact sample sizes (N-values) for each bench test. For example, "The device was evaluated..." doesn't indicate if this was one unit or multiple units.
   • The data provenance is from non-clinical bench testing performed by Wallaby Medical for regulatory submission in the United States (as indicated by the FDA 510(k) process). It is prospective in the sense that the testing was conducted specifically to support this regulatory submission.
   • No human-collected test sets (like medical images) are involved, so country of origin of data in that sense is not applicable.

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 as this is a physical medical device, not an AI/ML algorithm. "Ground truth" for physical device performance is established through standardized engineering and biological tests against predefined specifications and industry standards (e.g., ISO standards).
   • For the "Physician Validation (Usability)" test, it states "The device was evaluated in a simulated anatomy model by physicians." The number and qualifications of these physicians are not detailed in this summary.

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

   • Not applicable. This concept pertains to expert review for AI/ML algorithm performance. For physical device testing, results are typically objective measurements or observations against predefined pass/fail criteria.

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:

   • Not applicable. This is a non-AI medical device without human "readers" in the context of an AI study.

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

   • Not applicable. The device itself is standalone in the sense that it is a physical product, but the concept of "standalone algorithm performance" does not apply.

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

   • "Ground truth" for this device's performance is established by engineering specifications, industry standards (e.g., ISO 10555-1, ISO 594-1, ISO 11135:2014, ISO 10993 series, USP ), and comparison to legally marketed predicate devices. The results of the bench tests and biocompatibility evaluations, when conforming to these standards and specifications, are the "ground truth" for proving the device's safety and effectiveness.

7. The sample size for the training set:

   • Not applicable. There is no AI/ML model for which to define a training set.

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

   • Not applicable. There is no AI/ML model or training set.

Ask a specific question about this device