Search Results

Ask a specific question about this device

The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.

The balloon provides temporary vascular occlusion during these procedures.

The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices.

The Branchor X Balloon Guide Catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced lumen. A balloon is attached to the distal end, and the dimensions of the balloon guide catheter and recommended balloon injection volume are provided on the product label.

The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section. This allows the guidewire and other devices to easily move through the section.

The Branchor X Balloon Guide Catheter is packaged with a luer-activated valve, a syringe, a three-way stopcock, a rotating hemostasis valve (RHV), and a peel-away accessories.

The provided text is a 510(k) clearance letter for a medical device, the Branchor X Balloon Guide Catheter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel efficacy or safety through large-scale clinical trials.

As such, the document details non-clinical bench testing and biocompatibility testing to show that the new device performs comparably to the predicate and meets established safety standards. It explicitly states that "Animal study was not deemed necessary to demonstrate substantial equivalence" and "Clinical study was not deemed necessary to demonstrate substantial equivalence."

Therefore, the information regarding acceptance criteria and the "study that proves the device meets the acceptance criteria" will be focused on these non-clinical tests. There is no information about human-in-the-loop studies (MRMC), standalone AI performance, ground truth establishment for a training set (as there's no AI component mentioned), or expert adjudication, simply because these types of studies were not required for this particular 510(k) submission.

Here's the breakdown of the available information:

Acceptance Criteria and Device Performance Study for Branchor X Balloon Guide Catheter

The device, Branchor X Balloon Guide Catheter, demonstrates substantial equivalence to its predicate device, the Branchor Balloon Guide Catheter (K221951), through extensive non-clinical bench testing and biocompatibility assessment. The aim of these studies was to confirm that the new device met pre-established acceptance criteria, functioned as intended, and had a safety and effectiveness profile similar to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test were "All samples met the acceptance criteria," indicating a 100% success rate for the tested samples against predefined engineering and safety specifications.

Biocompatibility Testing:

2. Sample Size and Data Provenance

• Sample Size: The document repeatedly states "All samples met the acceptance criteria" for non-clinical tests. However, the exact numerical sample size for each specific test (e.g., how many catheters were tested for burst pressure) is not specified in this 510(k) summary.
• Data Provenance: The device manufacturer is ASAHI INTECC CO., LTD., located in Japan, with a US presence. The testing is non-clinical bench testing and refers to ISO standards. The data is not from human patients and therefore does not have a country of origin in the typical sense (e.g., patient demographics). All testing appears to be prospective as it was conducted specifically to support this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This device is a physical medical instrument, not a diagnostic or AI-driven software. The "ground truth" for its performance is established through engineering and material science standards and physical measurements, not interpretation by human experts (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

• Not Applicable. As the tests are non-clinical, objective measurements against engineering specifications, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. No MRMC study was conducted. This type of study involves human readers (e.g., radiologists) evaluating cases, often with and without AI assistance, to assess diagnostic performance. This device is a catheter and does not involve image interpretation or AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. This device is a physical catheter, not an algorithm or AI software. Therefore, no standalone algorithm performance study was performed or is relevant.

7. Type of Ground Truth Used

• The "ground truth" refers to engineering design specifications, material science standards (e.g., tensile strength, burst pressure limits), and relevant international standards (ISO standards) for medical device performance and biocompatibility. For instance, for dimensional verification, the ground truth is the specified engineering drawing dimensions. For biocompatibility, the ground truth is the absence of toxic, sensitizing, irritant, or pyrogenic effects as defined by ISO 10993 series.

8. Sample Size for the Training Set

• Not Applicable. There is no AI component or machine learning model that requires a training set for this device.

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

• Not Applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

The FUBUKI XF-R Neurovascular Long Sheath is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. The FUBUKI XF-R Neurovascular Long Sheath is also intended to be used for injection of contrast media.

The FUBUKI XF-R Neurovascular Long Sheath is intended for use only in the neurovasculature.

The FUBUKI XF-R Neurovascular Long Sheath (FUBUKI XF-R) consists of a long sheath and a dilator. The long sheath is a single lumen neurovascular catheter designed for introduction of interventional devices, such as guidewires and other therapeutic devices. The long sheath consists of three sections: (1) a shaft, (2) a protector and (3) a connector. The distal portion of the shaft consists of a soft tip and a soft tube. The proximal part of the shaft is covered by the protector (strain relief) and the connector is bonded to the proximal end of the shaft.

The subject device is provided sterile, by ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.

The outer surface of the long sheath is coated with a hydrophilic polymer and the inner lumen of the shaft (excluding the connector portion) is lined with a fluoropolymer layer to facilitate movement of the guidewire and other devices.

The dilator consists of two parts: (1) a shaft and (2) a connector.

The FUBUKI XF-R is supplied with a dilator and rotating hemostasis valve (RHV) packed in a sterile package.

The provided FDA 510(k) Clearance Letter for the FUBUKI XF-R Neurovascular Long Sheath describes the device and its demonstrated substantial equivalence to a predicate device. However, it does not contain information about a study involving an AI/algorithm or a multi-reader multi-case (MRMC) comparative effectiveness study.

Therefore, many of the requested details regarding acceptance criteria, ground truth, expert opinions, and sample sizes for AI/algorithm performance studies cannot be extracted from this document because such a study was not conducted or reported for this submission. This is a medical device, specifically a catheter, not an AI/software device.

I will provide the information that is available in the document, framed as if it were a typical medical device clearance, rather than an AI/ML clearance.

Here's the breakdown based on the provided document:

Acceptance Criteria and Study for FUBUKI XF-R Neurovascular Long Sheath

This clearance pertains to a physical medical device (a neurovascular long sheath), not an AI/software device. Therefore, the "acceptance criteria" and "study" refer to non-clinical bench testing and biocompatibility testing to demonstrate the device's physical performance, safety, and substantial equivalence to a predicate device. There is no AI component involved in this device or its clearance documentation.

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

The document states that the device met all acceptance criteria, but it does not specify the numerical acceptance criteria for each test. Instead, it lists the types of tests performed and the conclusions.

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

• Sample Size: The document does not specify the exact number of devices tested for each non-clinical bench or biocompatibility test. It only states that testing was "performed." For biocompatibility, it refers to standard ISO test methods (e.g., "Rabbit Pyrogen Test" implies a certain number of rabbits, but the exact count isn't given).
• Data Provenance: Not explicitly stated, but typically, non-clinical lab testing data would originate from the manufacturer's own testing facilities or contract research organizations. No geographic origin is mentioned for the data, nor is it specified if the tests were retrospective or prospective; however, given that these are physical device tests for a 510(k) submission, they would inherently be prospective (i.e., new tests conducted specifically for this submission).

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

This information is not applicable to this type of device clearance. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically reserved for diagnostic devices, particularly those involving image interpretation or clinical decision support, or AI/ML-driven devices. For a physical medical device like a catheter, "ground truth" is established through standardized engineering and biological tests (e.g., tensile strength, fluid flow, material composition, biological response), rather than expert clinical interpretation of data.

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

This is not applicable. Adjudication methods are relevant for clinical trials or multi-reader studies where there might be disagreement in expert assessment (e.g., image interpretation). For bench and biocompatibility testing, results are quantitative or qualitative based on predefined scientific standards and validated test methods.

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 done. This type of study is specific to diagnostic devices, especially those that involve human interpretation assisted by algorithms (AI). This submission is for a physical percutaneous catheter, not a diagnostic or AI-assisted device. Therefore, a discussion of human reader improvement with AI assistance is not relevant to this device.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software.

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

The "ground truth" for this medical device is based on:

• Predefined engineering specifications and performance standards (e.g., dimensions, strength, lubricity).
• Validated test methods outlined in ISO standards (e.g., ISO 10555-1 for catheters, ISO 10993 series for biocompatibility).
• Chemical and material analysis.
• Biological responses observed in animal models (for biocompatibility).

This is fundamentally different from a ground truth established by expert clinical consensus, pathology, or outcomes data for diagnostic devices.

8. The sample size for the training set:

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

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

This is not applicable. There is no "training set" or "ground truth for a training set" as this is not an AI/ML device.

Ask a specific question about this device

The 93 NeuFlex™ Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Piraeus Medical 93 NeuFlex™ Catheter is a single lumen guide catheter that provides access to peripheral, coronary and neuro vasculature. The catheter is comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The catheter features a hydrophilic coating to enhance tracking through tortuous vasculature and facilitate the introduction of interventional devices to the peripheral, coronary and neuro vasculature. The 93 NeuFlex™ guide catheter is compatible with 0.035" or smaller guidewires. The distal soft tip facilitates tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The 93 NeuFlex™ Catheter has an inner diameter of 0.093" (compatible with 6F outer diameter catheters), and a maximum outer diameter of 0.110". The catheter is offered in working lengths of 110 cm and 100 cm. The 93 NeuFlex™ guide catheter is packaged with a loading tool to aid in insertion of the catheter into a short sheath.

Accessory devices required, but not supplied include:

• Guidewires
• Support/diagnostic catheters
• Introducer sheaths
• Rotating hemostasis valves (RHVs)

The provided text describes the FDA 510(k) clearance for the "93 NeuFlex Catheter." This is a medical device clearance document for a physical catheter, not a software-based artificial intelligence/machine learning (AI/ML) device. Therefore, the "acceptance criteria" and "study proving the device meets the acceptance criteria" in this document relate to the physical and functional performance of the catheter itself, primarily through non-clinical bench testing, rather than AI/ML performance metrics like sensitivity, specificity, or AUC, which would be derived from a clinical study with human readers or standalone algorithm performance.

The questions you've posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set ground truth) are highly specific to AI/ML software validation studies. Since the provided document is for a physical medical device (a catheter) and relies on bench testing for substantial equivalence, most of these questions are not applicable to the data provided.

However, I can extract the relevant "acceptance criteria" (in the context of bench testing) and the "reported device performance" from the document.

Acceptance Criteria and Reported Device Performance for 93 NeuFlex Catheter

The acceptance criteria for this physical medical device are implied by the "Pass" results in the performance testing. These are not statistical metrics related to diagnostic accuracy, but rather engineering and functional performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Inapplicable AI/ML Specific Questions:

The following questions are geared towards AI/ML software performance studies. Since this FDA clearance is for a physical medical device (a catheter) and the supporting evidence is non-clinical bench testing, these questions are not applicable in the context of the provided document.

2. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" here refers to physical catheter samples tested in benchtop models, not a dataset of medical images or patient records. The provenance is internal company testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is established through adherence to engineering specifications and standardized test methods, not expert consensus on medical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in interpreting medical images or data where human variability in judgment exists. This is a bench test for a physical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the catheter's performance is derived from standardized engineering and material science tests, often defined by international standards (e.g., ISO 10555-1) and FDA guidance for catheter performance, rather than clinical outcomes or expert medical consensus on diagnostic findings.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Device Meets Criteria (Based on Provided Text):

The manufacturer, Piraeus Medical, conducted a series of non-clinical bench performance tests on the 93 NeuFlex Catheter. These tests were performed per company-approved protocols, test methods, and performance standards, many of which reference international standards like ISO 10555-1 and FDA guidance for PTA and Specialty Catheters. The results of all listed tests indicated "Pass," meaning the device met the predefined performance specifications for each test. This extensive bench testing, along with comparison to a predicate device (87 NeuGlide Catheter, K240971) which shares similar intended use and basic technological characteristics, formed the basis for demonstrating substantial equivalence and thus FDA clearance. Biocompatibility and sterilization were leveraged from the predicate device's existing validations. Shelf-life was supported by accelerated aging based on ASTM F1980, also leveraging the predicate's packaging configuration.

Ask a specific question about this device

PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

The PATH Balloon Guide Catheter (PATH BGC) is a dual coaxial lumen catheter consisting of an inner coil reinforced variable stiffness lumen and an outer braid reinforced variable stiffness lumen. A radiopaque marker is included at the tip of the catheter and at the distal and proximal ends of the balloon. A compliant balloon is mounted near the distal end of the catheter to provide vascular occlusion during angiographic procedures. The catheter has hydrophilic coating at the distal and proximal end. A bifurcated luer hub on the proximal end allows attachments for flushing and balloon inflation.

The provided document is a 510(k) Clearance Letter for a medical device (PATH BGC) and does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance against a clinical ground truth.

Instead, this document describes the device's physical characteristics, intended use, comparison to a predicate device, and bench testing, biocompatibility testing, and shelf-life testing to demonstrate performance and safety. These tests are common for physical medical devices and confirm that the device meets pre-defined engineering specifications, not clinical accuracy in diagnosis or treatment based on AI.

Therefore, I cannot fulfill the request for information regarding AI acceptance criteria and study details based on the provided text. The document explicitly states:

• Clinical Study: "Clinical study was not deemed necessary to demonstrate substantial equivalence." (Page 11)
• Animal Study: "Animal study was not deemed necessary to demonstrate substantial equivalence." (Page 10)

The "acceptance criteria" discussed in the document refer to engineering specifications and performance metrics for a physical catheter, such as dimensional accuracy, kink resistance, lubricity, mechanical strength, and biocompatibility.

To answer your request, if this were an AI-powered device, the information you're asking for would typically be found in a separate section detailing the AI algorithm's validation study, which is absent here.

Here's a breakdown of why each point of your request cannot be answered from the provided text:

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

   • Not applicable for AI performance. The table provided (Table 2) lists bench tests for the physical catheter (e.g., Visual Inspection, Dimensional Inspection, Kink Resistance, Coating Lubricity, Radiopacity, etc.). The "results" column simply states "Pass – all samples met the pre-determined acceptance criteria," without providing specific numerical performance data against a clinical ground truth.

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

   • Not applicable for AI performance. The "samples" referred to in Table 2 are physical units of the catheter device, not data sets for an AI algorithm. There is no mention of data provenance for AI.

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 AI component, and thus no need for experts to establish a "ground truth" for clinical interpretation using the device.

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

   • Not applicable. This refers to clinical adjudication of AI outputs, which is not present.

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. No MRMC study was performed as no AI assistance is described.

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

   • Not applicable. No standalone algorithm performance is described.

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

   • Not applicable. No clinical ground truth is established as there is no AI performing diagnostics.

8. The sample size for the training set:

   • Not applicable. No AI training set is mentioned.

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

   • Not applicable. No AI training and ground truth establishment are mentioned.

In summary, the provided document describes a physical medical device (a catheter) and its clearance based on bench testing and biocompatibility, not an AI or software as a medical device (SaMD) that would require the type of clinical performance validation you are inquiring about.

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 AXS Lift Intracranial Base Catheter is introduction of interventional devices into the peripheral and neurovasculature.

The AXS Lift Intracranial Base Catheter ("AXS Lift") is a single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into the peripheral and neurovasculature. The distal catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end. The distal end of the catheter contains bovine derived tallow. It is packaged with one double port rotating hemostasis valve (RHV) and one peel-away introducer sheath. The peel-away introducer sheath is designed to protect the distal tip of the catheter during insertion into the short introducer sheath valve. The AXS Lift Intracranial Base Catheter is compatible with short introducer sheaths with an inner diameter of 7Fr or greater. AXS Lift is supplied sterile, non-pyrogenic, and is intended for single use only.

The provided text, K243593 for the AXS Lift Intracranial Base Catheter, describes the predicate device equivalence testing rather than a study proving the device meets acceptance criteria for an AI/ML algorithm. The document focuses on the mechanical and material performance of a catheter, not the performance of a software algorithm.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), cannot be extracted from this document as it does not contain information about an AI/enabled medical device.

The document definitively states on page 9:

"No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."

This reinforces that the approval is based on physical and material device characteristics, not an AI/ML algorithm's performance on clinical data or human-in-the-loop studies.

Ask a specific question about this device

The VersaD™ Delivery Catheter is intended for use with compatible guide catheters in facilitating the insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.

The VersaD™ Delivery Catheter is a single-lumen, variable stiffness catheter with a long, tapered tip delineated by radiopaque markers. The proximal end has a luer hub, and the distal portion has a hydrophilic coating to reduce friction. The delivery catheter is designed specifically for use with compatible catheters.

The provided text describes the acceptance criteria and the study that proves the Unity Medical VersaD™ Delivery Catheter meets these criteria. It applies to a medical device, not an AI/ML product, so some of the requested information (like multi-reader multi-case studies, expert ground truth for AI, training sets, etc.) is not applicable and thus cannot be provided from this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are primarily defined by successful completion of various performance tests, biocompatibility tests, and sterilization/shelf-life validations. The "Conclusion" column in the tables below indicates whether the device met these criteria.

Performance Testing - Bench

Biocompatibility

Sterilization and Shelf Life

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

The document does not specify exact sample sizes for each bench test or biocompatibility test. It indicates that testing was performed to demonstrate substantial equivalence.

Regarding data provenance:

• Country of Origin: Not specified. Standard medical device testing labs and animal models would typically be used.
• Retrospective or Prospective: All testing described is prospective bench and lab testing conducted specifically for this 510(k) submission. It's not based on retrospective clinical data.

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

This information is not applicable as the device is a physical medical catheter, not an AI/ML product requiring expert annotation for ground truth. The "ground truth" for this device is defined by passing established engineering specifications, biocompatibility standards, and sterility validations.

4. Adjudication Method for the Test Set

This is not applicable for a physical medical device. Testing results are typically quantitatively measured or visually assessed against predefined acceptance criteria by qualified personnel, not "adjudicated" by multiple experts in a consensus manner as would be done for image annotation in AI/ML.

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

No, an MRMC study was not conducted because this is a physical delivery catheter, not an AI-assisted diagnostic device. The study described focuses on the physical and biological performance of the catheter itself, demonstrating substantial equivalence to a predicate device through bench, biocompatibility, and sterility testing.

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 or software. The "standalone" performance refers to the engineering and biological performance of the catheter independent of human user skill in the tests performed (e.g., measuring burst strength of the catheter itself).

7. The Type of Ground Truth Used

The "ground truth" for this medical device is established by:

• Engineering Specifications/Standards: The device must meet predefined dimensional tolerances, mechanical strength requirements (e.g., tensile strength, burst strength), and functional performance (e.g., push/track, torque response, liquid/air leak).
• Biocompatibility Standards (ISO 10993): Adherence to established biological safety profiles (e.g., non-cytotoxic, non-irritant, non-sensitizing).
• Sterilization Standards: Achieving a specified sterility assurance level.
• Comparison to Predicate Device: Many tests (e.g., particulate generation, tip stiffness, delivery/retrieval force) compare the subject device's performance to that of the legally marketed predicate device to demonstrate substantial equivalence.

It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic interpretation, as it's a delivery catheter.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."

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

Not Applicable. As there is no training set for a physical medical device, the concept of establishing ground truth for it does not apply.

Ask a specific question about this device

The APRO 70 Swift Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 70 Swift Catheter is also indicated for use as a conduit for retrieval devices.

The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 70 Swift Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 70 Swift Catheter is provided with an Introducer Sheath.

This document is a 510(k) Premarket Notification from the FDA regarding the APRO 70 Swift Catheter. It focuses on demonstrating the device's substantial equivalence to a predicate device, primarily through non-clinical performance data.

Here's a breakdown of the information requested, based on the provided document:

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

Ask a specific question about this device

The Radical the Dude 8F Guide Catheter is indicated for the introduction of intravascular catheters into the peripheral, coronary, and neuro vasculature.

The Radical the Dude 8F Guide Catheter (Dude 8F Catheter) is an 8 French (Fr) guide catheter designed to aid the physician in accessing the target vasculature during interventional procedures. The Dude 8F Catheter has a usable length between 80 cm and 110 cm, and an outer diameter (OD) size designation of 8 Fr. The Dude 8F Catheter has variable stiffness along its length, incorporating hybrid ribbon technologies to maintain stability and vary stiffness along the device length. The distal portion of the Dude 8F Catheter has a hydrophilic coating. The Dude 8F Catheter is packaged with a rotating hemostasis valve (RHV) and a peel-away sheath.

The provided FDA 510(k) summary (K243577) describes a medical device, the Radical the Dude 8F Guide Catheter, and its substantial equivalence to a predicate device. However, this document does not describe a study involving AI or software performance evaluation with human-in-the-loop scenarios.

Therefore, most of the questions regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typically relevant for assessing the performance of AI/software medical devices, cannot be answered based on the provided text.

The 510(k) pertains to a physical catheter device and details traditional bench testing and biocompatibility assessments to establish substantial equivalence with a previously cleared device.

Based on the provided document, here's what can be extracted, and where limitations exist:

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

   The document provides a summary of "Nonclinical Performance Testing" (Bench Testing and Biocompatibility). The acceptance "criteria" are implied by the "Pass" result for each test.

   Table of Acceptance Criteria and Reported Device Performance

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

   • The document describes bench testing and biocompatibility testing. Specific sample sizes for each bench test are not specified in this summary.
   • For the "Thrombogenicity in Canine Model", it used an in vivo canine test, implying an animal study. The exact number of animals or the test setup details are not provided in this summary.
   • There is no mention of "test sets" in the context of clinical data or patient data, as this is a device for physical performance and biocompatibility.

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. The tests are physical or chemical evaluations (e.g., visual inspection, dimensional inspection, tensile strength, PTT). "Ground truth" in the context of expert review for diagnostic accuracy is not relevant here.

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

   • Not applicable. This is not a study requiring adjudication of expert opinions for a test set.

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, as this is neither an AI device nor does it involve human readers interpreting images.

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

   • No. This is not an algorithm or AI device.

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

   • For bench testing, the "ground truth" is established by adherence to engineering specifications, relevant ISO standards (e.g., ISO 10555-1), and comparison to the predicate/reference device's performance. For biocompatibility, it's based on standard biological evaluation methods and comparison to controls or reference devices.

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device employing a training set.

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

   • Not applicable. There is no training set for this device.

Ask a specific question about this device