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HydroPICC Single Lumen: Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0 ml/s

HydroPICC Dual Lumen: Indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for a maximum power injection flow rate of 5.0 ml/s

HydroMID Single Lumen: Indicated for short term access(

The HydroMID catheters are a family of midline catheters comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The HydroPICC catheters are a family of peripherally inserted central catheter (PICC) comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp. HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using an in vitro model. Pre-clinical in vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The purpose of this 510(k) is to add an additional statement to the indications for use.

The provided FDA 510(k) clearance letter (K243458) details the HydroPICC and HydroMID catheters. The focus of this submission is to add a statement to the indications for use regarding the anti-thrombogenic properties of the MIMIX® Technology incorporated into these catheters. The acceptance criteria and supporting studies are described below:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) submission is to demonstrate that the expanded Indications for Use statement, specifically concerning the anti-thrombogenic properties of the MIMIX® Technology, does not introduce new questions of safety or effectiveness and is supported by non-clinical data. The reported device performance is based on in vitro studies.

Note: The FDA letter explicitly states: "The clinical impact has not been evaluated in human clinical trials. This device is not intended for the treatment of existing vein thrombosis." This indicates that the acceptance criteria are based solely on in vitro performance for the anti-thrombogenic claims, not on in vivo clinical outcomes.

Study Details for Acceptance Criteria

The provided document does not fully delineate separate "test sets" for the in vitro studies in the way one might for an AI/algorithm-based device. Instead, the "studies" themselves are the performance evaluations for the stated acceptance criteria.

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

   • The document lists several in vitro tests.
   • Sample Size: The specific number of devices or experimental replicates used in each in vitro test is not explicitly stated in the provided text.
   • Data Provenance: All studies are indicated as "in vitro" (meaning conducted in a test tube, culture dish, or other controlled environment outside of a living organism). The country of origin is not specified but is presumably where Access Vascular Inc. conducts its research and development or contracts with testing facilities.

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

   • For in vitro studies of this nature (evaluating properties like thrombus accumulation), the "ground truth" is typically established by the experimental setup, validated measurement techniques, and potentially statistical analysis.
   • No specific number of experts or their qualifications are mentioned as having established "ground truth" for these in vitro tests in the context of expert consensus, as might be the case for image-based diagnostic devices. The results are based on objective physical or biological measurements.

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

   • Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective expert review (e.g., radiology image interpretation) to resolve discrepancies in independent assessments. As these are in vitro physical/biological tests, such adjudication methods are not relevant or mentioned.

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 device is a medical catheter, not an AI software/algorithm requiring human reader interpretation. No MRMC study was conducted or is relevant for this device.

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

   • Not applicable. This device is a physical medical device (catheter) with a material technology, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.

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

   • The ground truth for the in vitro studies described (e.g., "Assessment of PICC Catheter Thrombosis," "Thrombosis Accumulation Report") is based on objective measurements of physical and biological phenomena (e.g., quantification of thrombus accumulation, pressure required to remove occlusions) within controlled laboratory environments. This is a form of empirical scientific measurement, rather than expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" because this is a physical medical device, not an AI/machine learning model that requires training data.

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

   • Not applicable. As no training set is mentioned, the method for establishing ground truth for it is also not applicable.

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Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 4.0ml/s.

Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM): Indicated for short-or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media. Rated for maximum power injection flow rate of 5.0ml/s.

The HydroPICC catheters are a family of peripherally inserted central catheters (PICC) made of radiopaque hydrophilic material with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in catheter manufacturing. The catheters are provided in kit configurations with the necessary accessories for placement in clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp.

HydroPICC has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. These reductions were evaluated using in vitro and in vivo models. Pre-clinical evaluations do not necessarily predict clinical performance with respect to thrombus formation. HydroPICC 5F Dual Lumen Catheter Components include: HydroPICC 5Fr Dual Lumen Catheter Assembly, Dispensing Tube, 2 Channel Clip, and Guidewire Introducer and Straightener.

The provided FDA 510(k) clearance letter pertains to a medical device (PICC catheter), not an AI/Software as a Medical Device (SaMD) product. Therefore, the content of the letter does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD, such as:

• A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, etc.)
• Sample sizes used for test sets and data provenance (for image/data-driven AI)
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for ground truth
• MRMC comparative effectiveness study results or effect sizes
• Standalone algorithm performance
• Type of ground truth used (e.g., pathology, outcomes data)
• Sample size for training set
• How ground truth for the training set was established

The 510(k) summary for the HydroPICC Catheter focuses on physical device performance characteristics. It mentions:

• Acceptance Criteria/Performance (Implied through testing): The device was tested to demonstrate acceptable performance for the modified power injection ratings and device length.
• Study Type: Non-clinical tests were performed, specifically "Power injection Cyclical and Static Burst testing as well as dimensional verification testing."
• Conclusion: These tests demonstrated that "the modifications to the power injection rating and the length do not adversely impact product performance."

In summary, this document does not contain the specific information you requested relating to the acceptance criteria and study proving performance for an AI/SaMD device. The information provided is for a physical medical device clearance based on engineering and performance bench testing.

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The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access (

The HydroMID catheter is a 5 French, dual lumen, midline catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments.

HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

Catheter and accessories are supplied sterile. Product is sterilized by ethylene oxide (EO) except where labeled otherwise. Product should be stored in a cool, dry, dark place. The HydroMID Catheter is supplied in a dry state and must be hydrated before use.

The provided text describes a 510(k) summary for the HydroMID 5F Dual Lumen Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device through bench testing. The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader study or clinical performance with ground truth established by experts/pathology/outcomes data.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to engineering and performance bench testing of a physical medical device (a catheter), not a medical device software or AI algorithm. Therefore, many of the requested categories in the prompt (e.g., number of experts for ground truth, adjudication methods, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device submission.

However, I can extract the information relevant to the device's performance and the "acceptance criteria" as described in the 510(k) summary for this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance (Bench Testing):

The document states: "All tests passed the acceptance criteria specified for both the subject and predicate devices." It does not provide specific numerical acceptance criteria or numerical reported performance values for each test. Instead, it lists the types of tests conducted.

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

• Sample Size: The document states: "Testing was identical to the predicate in standard conformance, sample size, methods, and acceptance criteria." However, the specific numerical sample size for each test is not provided.
• Data Provenance: The tests are described as "Bench Data" conducted internally by the manufacturer, Access Vascular Inc. The country of origin for the data is not explicitly stated, but the company address is Billerica, MA, which implies the testing was conducted in the United States. The data is prospective in the sense that it was generated for this 510(k) submission to demonstrate the performance of the new device design.

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

• Not Applicable. This is a physical medical device. Ground truth for its performance is established by engineering and material science testing against predefined specifications, not by human expert review of images or clinical outcomes in the typical sense of AI/image analysis.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. Testing results are objective measurements against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• Not Applicable. This is a physical medical device (catheter), not a software or AI device intended to assist human readers.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance revolves around its physical and functional properties meeting predetermined engineering specifications and validated test methods (e.g., pressure resistance, flow rates, dimensional accuracy, material properties like tensile strength and kink resistance, sterility, and MRI compatibility). These are objective criteria, not based on expert consensus, pathology, or outcomes data in a clinical trial sense.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The device design and materials are based on established engineering principles and prior device iterations.

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

• Not Applicable. See point 8.

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The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.

The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wres, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.

The Introducer Sheath System devices consist of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface in length of 20cm on the distal portion.

The System consists of the following components:

• A One Introducer Sheath with hemostasis valve
• A One or two dilator(s)

The provided text describes a 510(k) premarket notification for a medical device called the Catapult Guide Sheath / Introducer Sheath System. It details the device, its intended use, comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.

However, the questions you've asked are typical for the evaluation of AI/ML-driven medical devices, especially related to diagnostic or classification tasks (e.g., image analysis for disease detection). The device described in the document (Catapult Guide Sheath) is a physical medical device (an introducer sheath system) used for physical introduction of interventional and diagnostic devices into the vasculature, not an AI/ML software device.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and study proving device meets acceptance criteria for an AI/ML device. Many of the questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are irrelevant to the type of device being reviewed in this FDA submission.

Here's why and what information is available:

• Type of Device: The Catapult Guide Sheath is a Class II physical medical device (introducer catheter). It's a tool, not a diagnostic or AI algorithm.
• Purpose of Submission (510(k)): This submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (Catapult Guide Sheath Introducer Sheath System, K240957). This is a common pathway for physical devices with modifications or new physical devices that are very similar to existing ones. The core of the substantial equivalence argument relies on demonstrating that the new device performs similarly to the predicate device, especially after a material change (insourced HVA).
• "Acceptance Criteria" for this device: For this type of device, "acceptance criteria" are related to mechanical performance, biocompatibility, sterilization, and shelf-life, ensuring the device functions as intended and is safe. These are detailed in Table 2, listing the tests performed and the applicable standards.
• "Study that proves the device meets the acceptance criteria": The document lists a series of non-clinical (laboratory) tests that were performed. These tests are the "study" demonstrating the device meets the performance requirements for substantial equivalence.

Therefore, I cannot fill out the detailed table and answer the specific questions about AI/ML device evaluation based on the provided text. The text focuses on the mechanical, material, and safety performance of a physical device, not the diagnostic or predictive performance of an AI algorithm.

If your intention was to ask about the evaluation of a physical medical device, I can re-frame the answer based on the provided document.

Assuming you are asking for information relevant to the physical medical device described, here's an attempt to interpret your questions in that context, recognizing that most are geared towards AI/ML:

Device: Catapult Guide Sheath / Introducer Sheath System

1. Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to meeting specifications derived from regulatory standards and predicate device performance. The "reported device performance" are the results of the listed tests that demonstrated compliance.

2. Sample Size for the Test Set and Data Provenance

For a physical device, "test set" refers to the number of units tested. The specific sample sizes for each mechanical test are not detailed in this summary (they would be in the full submission). The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer and external laboratories. It is not patient data, so "country of origin of the data," "retrospective or prospective" do not apply.

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

This question is not applicable. "Ground truth" in the context of AI/ML diagnostic devices refers to a definitive diagnosis or finding. For a physical device, the "ground truth" is established by the specifications and performance requirements derived from engineering principles and relevant ISO standards. No human experts are used to "establish ground truth" in this context; instead, engineers and technicians conduct specified physical and chemical tests.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" (e.g., consensus among readers) needed for a physical device's performance testing. Test results are quantitative measurements against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. MRMC studies are for evaluating human reader performance, typically with and without AI assistance, for diagnostic tasks. This device is not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This is a physical device, not an algorithm. Its "standalone performance" refers to its mechanical and material properties as tested in the lab.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for performance is defined by:

• International standards (ISO, AAMI, ASTM, EN): These standards define acceptable limits and testing methodologies for medical device properties (e.g., leakage, tensile strength, biocompatibility, sterility).
• Predicate device performance: The previously cleared predicate device provides a benchmark for expected performance characteristics of the new device.
• Manufacturer's internal design specifications and risk analysis: Derived from the intended use and safety considerations.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.

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

Not applicable. There is no "training set" or "ground truth" for training in the AI/ML sense for this device.

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Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device.

Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Pacing Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits. The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.

The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle in then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

The provided text is a 510(k) Summary for a medical device (Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)). It describes the device, its intended use, and comparability to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.

The text focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of Technological Characteristics: Tables comparing the subject device and the predicate device in terms of design, materials, and dimensions.
• Performance Data Summary: A list of various performance tests conducted (e.g., biocompatibility, electrical safety, mechanical tests, functional testing to standards like ISO 10555-1, IEC 60601-1, ISO 80369 series, ISO 11070). The document states that the devices met the requirements of the above standards and performance endpoints.

Therefore, I cannot provide the specific details requested in your prompt (a detailed table of acceptance criteria and reported device performance with numerical values, sample sizes for test sets, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment).

The document explicitly states that the device "met the requirements of the above standards and performance endpoints," implying that the acceptance criteria are defined by these referenced standards and internal specifications, but the specific numerical acceptance criteria and the quantitative results are not disclosed in this summary.

If you have a document that contains the detailed study results and acceptance criteria, please provide it.

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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply. The User Handle with the integrated driveshaft is sterile, single use, and disposable. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

The provided text describes a medical device, the FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere), and its substantial equivalence determination by the FDA. However, the document does not contain the level of detail requested regarding acceptance criteria and the specifics of a study proving a device meets these criteria in the context of an AI/human-in-the-loop system.

The "study" mentioned in this document refers to performance testing for a mechanical medical device, specifically:

• Dimensional Analysis Testing
• Orbit Characterization Testing (effectiveness of sanding technology, lumen diameter vs. speed vs. time, plaque removal efficiency)
• Simulated Life Test
• Torque Stall and Loaded Start Test
• Joint Tensile Test
• Joint Torque Test
• Particulate Analysis Comparison Test
• Electric System Human Cadaver Pre-Clinical Test

There is no indication that this device incorporates AI or sophisticated software that would necessitate human-in-the-loop performance studies, expert ground truth adjudication, or metrics like sensitivity, specificity, or AUC, which are typically associated with AI-powered diagnostic or assistive devices.

Therefore, I cannot provide the requested information in the format of the questions because the document describes a mechanical atherectomy system, not a device whose performance is measured in the ways implied by the prompt's questions (e.g., AI assistance, expert readers, ground truth establishment for AI training/testing).

If the prompt intended for me to infer or create a hypothetical scenario for an AI-powered atherectomy system, I would need additional context or a different document. Based only on the provided text, the questions are not applicable to the described device and its testing.

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The Medtronic guide catheter is designed to provide a pathway through which therapeutic devices are introduced. The guide catheter is intended to be used in the coronary or peripheral vascular system.

Launcher Guide Catheters are comprised of a cylindrical catheter having a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end is the section of the catheter towards the tip and the proximal end is towards the hub and strain relief. The guide catheter is comprised of a luer hub, strain relief, shaft, segments, tungsten marker band, sleeve, and soft tip. The catheter shaft is made of three distinct layers. The guide catheter is available in various lengths ranging from 45 cm to 130 cm and four French sizes [5F, 6F, 7F, and 8F]. Launcher Guide Catheters have a lubricious inner lumen that runs from the proximal to the distal end of the catheter via a lubricious liner material or coating on the inner lumen.

The provided document is a 510(k) summary for the Medtronic Launcher Guide Catheter. It outlines the product's description, intended use, and substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance/Conclusion |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility Assessment | 1) Cytotoxicity
2) Sensitization
3) Intracutaneous Reactivity
4) Material-Mediated Pyrogenicity
5) Hemocompatibility
6) Acute Systemic Toxicity | Performed in accordance with FDA Guidance "Use of International Standard ISO 10993-1" and demonstrated no safety or effectiveness concerns. |
| Product Performance Evaluation (Dimensional & Performance) | 1) Inner Diameters (shaft, tip, & hub)*
2) Outer Diameters (shaft, segment, soft tip sleeve, & segment/shaft overlap)
3) Total Segment Length
4) Effective Length*
5) Exposed Tip Length
6) Luer Connector Performance*
7) Leak Resistance*
8) Draw-through stiffness of primary and secondary curve
9) Shaft bending stiffness & bending kink resistance (Body temperature and room temperature)
10) Arch bending stiffness & bending kink resistance (Body temperature and room temperature)
11) Shaft & distal segment crush resistance
12) Torsional Stiffness, Rotational Kink Angle, and Rotations to Separation
13) Curve retention after simulated seating
14) Peak shaft & segment tensile load
15) Peak soft tip tensile load
16) Soft tip stiffness
17) Peak hub/shaft tensile load*
18) Internal lubricity | Necessary tests performed met the acceptance criteria and demonstrated that there are no safety or effectiveness concerns. The performance testing, along with biocompatibility testing, demonstrated substantial equivalence to the predicate device. Specific standards used for some tests are noted: ISO 594-1, ISO 594-2, EN ISO 80369-7 for Luer Connector Performance; ISO 10555-1 for Leak Resistance and Peak Hub/Shaft Tensile Load. |

Note: Tests marked with an asterisk () were specifically highlighted as being performed on the subject device to demonstrate substantial equivalence for modifications in this premarket notification.*

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

The document does not explicitly state the sample sizes used for the non-clinical and biocompatibility tests. It broadly mentions "Summary of Nonclinical Data/Performance Testing" and "Product Performance Evaluation". Given the nature of these tests for medical devices, they would typically involve a statistically relevant number of samples to ensure robust results, but the exact numbers are not provided in this summary.

The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer, Medtronic Vascular. No information regarding country of origin of the data or whether it was retrospective or prospective is mentioned (as these terms usually apply to clinical studies).

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

This information is not applicable to this submission. The "ground truth" concept usually applies to clinical studies where expert consensus or pathological findings are used to establish a definitive diagnosis or outcome. For non-clinical performance and biocompatibility testing, the "ground truth" is established by adherence to recognized international standards and engineering principles, with results evaluated against predefined acceptance criteria derived from these standards or predicate device performance. Experts involved would be engineers, scientists, and toxicologists specializing in medical device testing and regulatory compliance, but their specific numbers or detailed qualifications are not typically included in a 510(k) summary (beyond general statements about adherence to guidance documents like ISO 10993-1).

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials where multiple experts assess cases and their disagreements need to be resolved to establish a ground truth. For the non-clinical tests described, the "adjudication" is inherent in the test methodology and adherence to international standards and acceptance criteria. Any deviations or failures would be investigated and resolved according to quality system procedures.

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 MRMC comparative effectiveness study was done. This device is a physical medical device (catheter), not an AI-powered diagnostic or imaging tool that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance and biocompatibility testing is established by:

• Adherence to International/Recognized Standards: Such as ISO 594-1, ISO 594-2, EN ISO 80369-7, ISO 10555-1, and FDA Guidance "Use of International Standard ISO 10993-1".
• Predicate Device Performance: The subject device's performance is compared to the predicate device, aiming to demonstrate substantial equivalence by showing that any differences in characteristics do not raise different questions of safety and effectiveness.
• Engineering Specifications and Design Requirements: The tests verify that the device meets its own engineering specifications for parameters like dimensions, strength, flexibility, and resistance to various stresses.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this device. Training sets are used in machine learning and AI model development.

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

Not Applicable. As there is no training set for this physical medical device, there is no ground truth to be established for it.

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Indicated for short-or long-term peripheral access to the central venous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.

Rated for maximum power injection flow rate of 3.5ml/s

The HydroPICC peripherally inserted central catheter (PICC) is a 5 French, dual lumen catheter comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hubs, and extension tubes made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for each lumen is indicated on each extension tube clamp.

HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

This document is a 510(k) summary for the HydroPICC 5F Dual Lumen Catheter. It indicates that the device has undergone performance testing to demonstrate substantial equivalence to a predicate device. However, the document does not contain details about acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The provided text focuses on the physical and technological characteristics of the medical device and its predicate, along with the regulatory and biocompatibility testing performed to establish substantial equivalence. It does not describe an AI/ML device or its performance study in the way the request specifies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's the breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance: Not available in the provided text. The document refers to conformance with recognized standards but does not list specific acceptance criteria or performance metrics for the device in a study context.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available in the provided text.

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 available in the provided text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available in the provided text.

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 available in the provided text. This device is not an AI/ML product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in the provided text. This device is not an AI/ML product.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in the provided text. For the type of device (intravascular catheter), "ground truth" would typically refer to physical and mechanical properties, not diagnostic categories.

8. The sample size for the training set: Not available in the provided text. This device is not an AI/ML product.

9. How the ground truth for the training set was established: Not available in the provided text. This device is not an AI/ML product.

What can be extracted from the document regarding "performance testing" related to the device:

The document lists various performance tests conducted to demonstrate conformance with FDA-recognized standards for intravascular catheters. These tests are primarily focused on the physical, mechanical, and safety aspects of the catheter, rather than diagnostic or AI-driven performance.

Study Details (as much as can be inferred/is stated):

• Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for diagnostic AI/ML): Not applicable or not provided. The study mentioned for "reducing thrombus accumulation" used "in vivo models," but specific details like sample size, provenance, control groups, or exact endpoints are not given.
• Training Set Sample Size/Ground Truth: Not applicable for this type of medical device submission.

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The SecurAcath device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short or long-term securement of percutaneous indwelling catheters for abscess/general drainage

The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.

The provided text is a 510(k) Summary for the SecurAcath device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI/ML device.

Therefore, I cannot fully answer your request as it pertains to AI/ML device evaluation criteria. The document describes a medical device for catheter securement and its equivalence to a predicate, not an AI/ML system.

However, I can extract the general type of performance data mentioned and explain why it doesn't fit the AI/ML framework you've outlined:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Performance tests" that were conducted, but it does not provide specific acceptance criteria or quantitative performance metrics for these tests. Instead, it makes a general statement: "Test results demonstrate that the device functions as intended."

2. Sample Size for Test Set and Data Provenance: Not applicable as this is not an AI/ML study. The document refers to "Performance tests" but does not detail the sample sizes for these tests or the provenance of any data.

3. Number of Experts and Qualifications for Ground Truth: Not applicable as this is not an AI/ML study. The device's performance evaluation would involve engineering and clinical testing, not expert adjudication of AI outputs.

4. Adjudication Method: Not applicable.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone (Algorithm Only) Performance: Not applicable as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used: Not applicable in the AI/ML sense. The "ground truth" for this device would be established through engineering specifications, biomechanical testing outcomes, and clinical observations of catheter securement effectiveness, rather than expert interpretation of data.

8. Sample Size for Training Set: Not applicable as there is no AI/ML training involved for this device.

9. How Ground Truth for Training Set Was Established: Not applicable.

In summary, the provided FDA 510(k) summary is for a physical medical device (catheter securement device) and therefore does not contain the information requested regarding acceptance criteria and studies for an AI/ML device. The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and general performance testing (e.g., dimensional verification, functional tests, securement reliability, human factor design validation).

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The Cordis 4F Infiniti™ Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system.

Cordis Nylex™ Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Cordis Tempo™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.

The 4F Infiniti™ Angiographic Catheter is a single-use device designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Infiniti™ 4F catheter is supplied sterile and is available in various lengths and tip configurations.

The 4F & 5F Tempo "M Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a braided body. It is compatible with 0.038" guidewire. The Tempo™ 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations.

The 4F & 5F Nylex™ Angiography Catheters are single-use devices designed to deliver radiopaque contrast medium to selected sites in the vascular system. The device combines an atraumatic tip with a non-braided body. It is compatible with 0.035" guidewire. The Nylex "10 4F & 5F catheter is supplied sterile and is available in various lengths and tip configurations.

This document is a 510(k) premarket notification for angiographic catheters and does not describe acceptance criteria or a study proving that an AI device meets acceptance criteria. Instead, it describes how the modified devices (4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters) are substantially equivalent to their predicate devices based on design, intended use, and performance testing for biocompatibility, functional performance, and sterilization. Therefore, I cannot generate the requested table and information as it pertains to AI/algorithm performance.

The document specifies the following regarding the testing conducted for the device:

Performance Data:

• Biocompatibility Testing: Conducted on finished and sterilized Tempo 4F Angiographic Catheter in compliance with ISO 10993-1:2009/Cor 1:2010 and FDA guidance.
  • Tests included: In vitro cytotoxicity, Sensitization, Intracutaneous / irritation reactivity, Acute system toxicity, Material mediated pyrogenicity, Hemocompatibility (In vitro hemolysis, Partial thromboplastin time (PTT), Platelets and leukocyte counts, Complement activation (C3a & SC 5b-9), In vivo thrombogenicity).
• Device Functional Testing:
  • Pull force intermediate tip-to-distal tip
  • Pull force tip-to-body
• Sterilization Testing:
  • Bioburden
  • EO residuals
  • Bacterial Endotoxin

Conclusion: The design modifications were verified and validated through a series of tests ensuring that the proposed catheter meets all the required specifications and that the performance and functionality of the proposed devices are substantially equivalent to their predicate devices.

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