Search Results

The VariFuse Adjustable Infusion Catheter is indicated for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

The VariFuse™ Adjustable disposable Infusion Catheter System consists of:

• An adjustable infusion catheter is comprised of the outer and inner catheters pre-assembled coaxially and inseparable, set at the maximum infusion length (i.e. 50 cm) with a Touhy Borst Adapter for shipping.
  • The inner infusion catheter is designed with infusion holes spaced unevenly along the infusion length of 50 cm, a valve at the distal tip, and a radiopaque marker at the distal tip.
  • The outer infusion catheter is designed to set the infusion length by covering the infusion holes and contains a radiopaque marker at the distal tip.
• A 1cc Luer Lock Syringe is included in the packaging for flushing

N/A

Ask a specific question about this device

The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into the neurovasculature.

The SurfRider 13 Microcatheter is a single-lumen microcatheter with a gradual stiffness change from tip to proximal end, reinforced with a metal braid to facilitate delivery to distal vessels and to serve as a delivery path of contrast media, embolic agents and coils. The distal end has two radiopaque markers to facilitate fluoroscopic visualization, and two types of tips: a straight tip and a pre-shaped tip. The proximal end of the Microcatheter incorporates a standard luer adaptor to facilitate the attachment of accessories. The outer surface of the Microcatheter has a hydrophilic coating to increase lubricity. The Microcatheter is designed to be introduced over a steerable guidewire into the vasculature.

N/A

Ask a specific question about this device

The Recana Thrombectomy Catheter System is indicated for:

• The non-surgical removal of thrombi and emboli from veins.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vein.

The Recana Thrombectomy Catheter System is indicated for use in peripheral venous vasculature.

The Recana Thrombectomy Catheter System is designed to remove thrombus and emboli from native vessels or stented veins. The system is comprised of the debulking catheter, collection basket(s) with delivery sheaths, and a family of sheaths. Together, the Recana Thrombectomy Catheter System functions to capture and remove obstructive / occlusive thrombus from the venous vasculature.

The debulking catheter utilizes an adjustable diameter stainless steel coring element to remove thrombus from the venous vasculature. Handle controls enable expansion and collapse of the coring element to achieve the desired working diameter. The debulking catheter is 0.035" guidewire and 0.060" basket shaft compatible and provides a working length of 80cm.

18mm and 30mm Collection basket(s) are self-expanding nitinol wire-form and braided structures designed to ensure capture and removal of thrombi and emboli. The basket shaft has a 0.035" guidewire compatible lumen for over the wire delivery through a 9Fr Delivery Sheath with a working length of 95cm.

Sheaths for introduction of the debulking catheter and collection baskets into the vasculature and for the recapture and removal of thrombi and emboli via the collection basket(s) are offered in four (4) size configurations (13Fr x 30cm, 13Fr x 90cm, 16Fr x 30cm, and 16Fr x 90cm) providing optionality based on access vessel size and location.

N/A

Ask a specific question about this device

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."

Based on the provided text, the following questions cannot be answered as they are relevant to AI/ML or image analysis devices, not the physical Micro Catheter:

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on physical bench and biocompatibility testing, not a "test set" of data for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of an AI model. Testing involves objective measurements and compliance with standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 physical device, not an AI assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" in this context is compliance with engineering standards and physiological responses (e.g., non-toxic, non-pyrogenic).
8. The sample size for the training set: Not applicable. There is no AI model or "training set."
9. How the ground truth for the training set was established: Not applicable.

This 510(k) clearance is for a conventional Class II medical device, and therefore the evaluation and acceptance criteria are based on established engineering, material science, and biological safety standards, not AI/ML performance metrics.

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)

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

The document describes bench testing and biocompatibility testing rather than a "test set" of patient data for an algorithm. Therefore, "sample size" here refers to the number of devices or materials tested. The exact sample sizes for each bench test are not specified in this summary.

• Data Provenance: The testing was conducted by Transit Scientific, LLC, to support a 510(k) submission to the FDA. This implicitly means the testing was performed in a controlled laboratory environment, likely in the US, and is prospective in the sense that the testing was specifically designed and executed to gather data for this submission.

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

This question is not applicable to this document. The submission is for a physical medical device (microcatheter), not an AI/software device that requires expert ground truth labeling of patient data. The "ground truth" for this device's performance is established through adherence to engineering specifications, recognized standards, and direct comparison to a predicate device's established performance characteristics via bench testing.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers are evaluating and labeling data (e.g., radiology images) to establish a consensus "ground truth" for a dataset. This document concerns a physical device's performance through bench testing, not human interpretation of data.

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 question is not applicable. An MRMC study is relevant for AI/software devices where human readers' performance with and without AI assistance is being evaluated. This document is for a physical microcatheter and does not involve AI or human image interpretation studies.

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

This question is not applicable. This submission is for a physical medical device, not a standalone algorithm.

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

For this type of device, the "ground truth" is established by:

• Adherence to engineering specifications and design requirements.
• Compliance with recognized industry standards (e.g., ISO 10993-1 for biocompatibility).
• Performance characteristics demonstrated through rigorous bench testing that simulate clinical use conditions and measure physical properties (e.g., flow rate, pressure resistance, kink resistance).
• Comparison to the established performance profile of the predicate device. The predicate device itself serves as a benchmark of "safe and effective."

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. There is no "training set."

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