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The Ringer Perfusion Balloon Catheter is indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.

The Ringer perfusion balloon catheter is a rapid exchange catheter with a spiral-shaped inflatable balloon on the distal end and a wire lumen for delivery over a ≤ 0.014" guidewire. The inflated spiral balloon approximates a hollow cylinder. Radiopaque markers at the proximal and distal end of the balloon facilitate visualization and intravascular placement of the catheter prior to inflation. The catheter shaft has positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip. The Ringer perfusion balloon catheter has been sterilized with ethylene oxide.

The Ringer perfusion balloon catheter is indicated for balloon dilatation of coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 60 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, it refers to the study as "G200321, 'Ringer PTCA Study'," which suggests a dedicated clinical study, typically prospective in nature for device clearance.

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

The document does not provide specific details about the number of experts used or their qualifications for establishing ground truth within the clinical study. Angiographic estimations (e.g., final residual stenosis, TIMI flow grade) are typically performed by interventional cardiologists or trained core lab personnel, but this is not explicitly stated.

4. Adjudication method for the test set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). Clinical endpoints for device studies are often determined by the treating physician or a study's Clinical Events Committee (CEC), but this information is not elaborated upon.

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 with AI assistance was not done. This study focuses on the performance of a medical device (a balloon catheter) rather than an AI-powered diagnostic or assistive tool for human readers.

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

No, this is a study evaluating a physical medical device (balloon catheter) in human subjects, not a standalone algorithm.

7. The type of ground truth used

The ground truth for the clinical study was established through a combination of:

• Angiographic evaluation: Visual assessment of TIMI flow grade and residual stenosis.
• Clinical outcomes: Occurrence of clinically relevant events, freedom from MACE (Major Adverse Cardiac Events) at hospital discharge, and tolerance of prolonged inflations.
• Procedural observations: Successful delivery, inflation, deflation, removal, and absence of complications like vessel perforation or dissection.

8. The sample size for the training set

This information is not applicable as this is a clinical study for a physical medical device, not a machine learning model that requires a "training set."

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

This information is not applicable, as there is no "training set" in the context of this device's clinical evaluation.

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The Wattson temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure.

The Wattson temporary pacing guidewire is a dual-purpose 0.035" guidewire designed for the delivery of devices and for temporary pacing of the heart. The distal end of the device has an atraumatic pigtail shape. The shaft of the device has a hydrophilic coating. Pacing is achieved through a bipolar electrode configuration integrated in the guidewire. The electrodes terminate in a single positive electrode at the distal tip of the device and three discrete negative electrodes located proximal to the tip within the pigtail section. The entire device is visible using standard fluoroscopic methods. The device is packaged with a proprietary adapter that locks on to the proximal end of the guidewire and converts it to discrete positive and negative terminal pins. The terminal pins of the adapter are compatible with standard external pulse generators. Unshrouded adaptor pins are provided to ensure compatibility with all connecter cable terminals. The Wattson temporary pacing guidewire is sterilized with ethylene oxide.

This document is a 510(k) Summary for the Wattson Temporary Pacing Guidewire (Model 2250). It details the device's indications for use, its characteristics, and a comparison to a predicate device (K192454, also a Wattson temporary pacing guidewire). The summary also outlines the performance data gathered to support the claim of substantial equivalence.

Based on the provided text, the device is a medical guidewire used in cardiac procedures, specifically Transcatheter Aortic Valve Replacement (TAVR) and Balloon Aortic Valvuloplasty (BAV), which also has the capability to transmit an electrical signal for temporary cardiac pacing.

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

Important Note: The provided document is a 510(k) Summary, which is a regulatory submission for medical devices to demonstrate substantial equivalence to a legally marketed predicate device. It typically summarizes testing, but does not provide the full detailed study reports. Therefore, some information requested in your prompt (e.g., number of experts, specific effect sizes for MRMC studies, sample sizes for training sets for AI models) may not be present because this device is a traditional guidewire, not an AI/ML-driven diagnostic device. The questions you've asked are largely applicable to AI/ML device submissions, which is not what this document describes.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a physical medical device (guidewire) and not an AI/ML diagnostic tool, "acceptance criteria" are typically defined by engineering specifications, material biocompatibility, and functional performance benchmarks rather than diagnostic metrics like sensitivity/specificity. The document doesn't present a formal table of quantitative acceptance criteria and performance results in the way one would for an AI model.

However, the "Performance Data" section outlines the types of testing performed, which implicitly demonstrates "acceptance" based on successful completion of these tests.

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GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).

The GuideLiner Coast catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in four sizes - 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner Coast catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, hydrophilic coated guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semicircular shaped polymer that meets the proximal end of the full-round guide extension segment.

This device is a GuideLiner Coast catheter, intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, facilitate placement of interventional devices, and assist in crossing de novo coronary chronic total occlusions (CTO).

The submission focuses on establishing substantial equivalence to a predicate device (K212211, GuideLiner V3 catheter and TrapLiner catheter) by evaluating technological differences, specifically a new hydrophilic coating material, a reduction in coating length, and cosmetic changes to the hub. The information provided does not describe a clinical study involving human patients or the use of AI. Instead, it relies on a series of bench tests and biocompatibility tests. Therefore, many of the requested sections regarding clinical study design, ground truth, and AI performance are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for each bench test. The term "device samples" is used. The data provenance is from bench testing, meaning it's laboratory-generated data, not patient data from a specific country, and is not retrospective or prospective in the clinical sense.

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

Not applicable. The ground truth for bench tests is typically established by engineering specifications, material science standards, and established test methodologies, not by expert medical opinion.

4. Adjudication Method for the Test Set

Not applicable. As this is bench testing, there is no adjudication process involving multiple human evaluators of test results in the way described for clinical data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This submission does not involve an AI device or human readers.

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

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The ground truth for the performance tests (Deliverability, Hydrophilic Coating Evaluation, Tensile Strength, Hub Markings) is based on engineering specifications and established test methods for medical devices.

The ground truth for biocompatibility tests is based on ISO 10993-1 standards for biological evaluation of medical devices.

8. The Sample Size for the Training Set

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

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

Not applicable. This is not an AI device, so there is no training set or associated ground truth establishment process.

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Each Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

The Langston dual lumen catheters have two lumens, both with distal sideholes, to allow simultaneous pressure measurements from two sites. The high-pressure inner lumen, which extends the entire length of the catheter, can be used for pressurement and rapid delivery of contrast medium. The outer lumen ends proximal to the distal end of the catheter and is used for pressure measurement only. A side port fitted with an extension tube and a stopcock assembly is used for fluid flow and pressure measurement within the outer lumen. The Langston dual lumen catheter will accommodate a standard ≤ 0.038" diameter guidewire and is supplied with a single use pigtail straightener. The Langston dual lumen catheter is sterilized with ethylene oxide.

This document describes the FDA's 510(k) clearance for the Langston dual lumen catheter (K221470). It's a medical device submission, not a study proving the device meets acceptance criteria for an AI or diagnostic algorithm. Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this document.

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

Here's the breakdown of what can be found and what cannot:

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

Study that proves the device meets the acceptance criteria:

The study was a series of bench tests and biocompatibility evaluation to demonstrate substantial equivalence to a predicate device, focusing on a design modification to the strain relief to hub bond.

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

• Sample Size: Not specified in the document for any of the bench tests.
• Data Provenance: The tests were performed internally by Vascular Solutions LLC ("Performance Data" section). The country of origin and retrospective/prospective nature of data collection for these specific tests are not detailed, but they are generally considered prospective bench tests performed for regulatory submission.

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

• Not Applicable. This document concerns a physical medical device (catheter) and its design validation via bench testing and biocompatibility, not an AI or diagnostic algorithm requiring expert "ground truth" for interpretative accuracy.

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

• Not Applicable. As above, this is about physical device performance, not diagnostic interpretations requiring adjudication.

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-assisted diagnostic 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):

• For Bench Testing: The "ground truth" was defined by the specified acceptance criteria for each individual physical performance test (e.g., a minimum tensile strength, a maximum leak rate). These criteria are objective measurements, not subjective expert interpretations or biological outcomes.
• For Biocompatibility: Compliance with ISO 10993-1 is the standard used, which involves a series of tests to assess biological safety.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set."

In summary, this document is a regulatory clearance for a physical medical device. The "acceptance criteria" and "performance data" provided relate to the manufacturing and physical characteristics of the catheter, not to the diagnostic accuracy of an algorithm or the improvement of human readers with AI assistance.

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The R350 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).

The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).

The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).

The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing de novo coronary chronic total occlusions (CTO).

The Warrior guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).

R350 Guidewire:
The R350 guidewire is an extended length (350 cm) guidewire with a 0.013″ maximum outer diameter (OD) (0.012" nominal OD). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a polytetrafluoroethylene (PTFE) coating, while the distal 200 cm has a hydrophilic coating.

Spectre Guidewire:
The Spectre guidewire is a nitinol and stainless-steel guidewire with a 0.014″ diameter and straight shapeable tip. It is available in 200 cm and 300 cm lengths. The distal 25 cm of the guidewire has a spring coil with a 3 cm platinum coil on the distal tip that is visible under fluoroscopic methods. The distal 42 cm of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating.

Raider Guidewire:
The Raider guidewire is a stainless-steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 200 cm and 300 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.

Warrior Guidewire:
The Warrior guidewire is a stainless-steel core guidewire with a 0.014" diameter that tapers to a 0.009" diameter distal tip. It is available in 200 cm and 300 cm lengths. The distal 20 cm of the guidewire has a spring coil, of which the distal 2.5 cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.

Bandit Guidewire:
The Bandit guidewire is a 0.014″ diameter stainless steel core guidewire with a 0.008″ diameter tapered distal tip. It is available in 200 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm length is compatible with a guidewire extension.

The information provided describes the acceptance criteria and a clinical study conducted to demonstrate the safety and effectiveness of several guidewires (R350, Spectre, Raider, Bandit, Warrior guidewires) for use in crossing de novo coronary chronic total occlusions (CTO).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Successful recanalization (angiographic confirmation of crossing CTO and restoring blood flow)
• MACE (In-Hospital and 30-Day)
• Clinically significant perforation
• Technical Success | Successful recanalization: 140 (93.3%)
  MACE:
  In-Hospital: 29 (19.3%)
  30-Day: 0 (0.0%)
  Clinically Significant Perforations: 16 (10.7%)
  Technical Success: 140 (93.3%) |

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

• Sample Size for Test Set: 150 subjects.
• Data Provenance: Prospective, multi-center, single-arm study. The country of origin of the data is not explicitly stated 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)

The document describes a clinical study to evaluate the safety and effectiveness of the guidewires but does not specify the number of experts or their qualifications for establishing the ground truth of the outcomes. The endpoints (e.g., angiographic visualization, MACE) would typically be adjudicated by clinical experts, but this detail is not provided.

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

The document does not explicitly state the adjudication method used for the test set. It mentions "in-hospital MACE" as part of the primary endpoint, which would imply clinical events were assessed, but the process of adjudication (e.g., by an independent clinical events committee) is not detailed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a clinical trial evaluating the performance of medical devices (guidewires) in a procedural context, not an AI-assisted diagnostic study involving human readers.

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

This is not applicable. The study evaluates the performance of physical guidewire devices, not an algorithm.

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

The ground truth for the clinical study was based on clinical outcomes data and angiographic visualization. Specifically:

• Angiographic visualization of guidewire position (distal/proximal to CTO in the true vessel lumen).
• Absence of in-hospital Major Adverse Cardiac Events (MACE), which includes cardiac death, target lesion revascularization, or post-procedural MI (defined as CK-MB ≥ 3x ULN).
• Successful recanalization.
• Clinically significant perforations.

8. The sample size for the training set

This information is not applicable as the document describes a clinical trial for physical medical devices, not an AI model that requires a training set.

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

This information is not applicable as the document describes a clinical trial for physical medical devices, not an AI model that requires a training set.

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Turnpike catheters: The Turnpike catheters are intended to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/ deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO).

GuideLiner V3 catheter: GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature. to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).

TrapLiner catheter: The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo coronary chronic total occlusions (CTO).

Turnpike catheters: The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter shaft is constructed of two polymer layers that encapsulate a braid and a duallayer coil. The distal 60 cm of the Turnpike catheters are hydrophilic coated, and all models are compatible with 0.014" guidewires and 5F guide catheters. The turnpike catheters are available in four configurations: Turnpike, Turnpike Spiral, Turnpike Gold, and Turnpike LP.

GuideLiner V3 catheters: The GuideLiner V3 catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in five sizes - 5F, 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner V3 catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, silicone-wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semicircular shaped polymer that meets the proximal end of the full-round guide extension segment.

TrapLiner catheters: The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel hypotube pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The Nylon trapping balloon (3.1 mm diameter) is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon is reflowed, and an adhesive is applied on each end. The TrapLiner catheter has an over-molded Nylon hub on the proximal end to facilitate balloon inflation.

The provided text does not contain information about acceptance criteria or a study designed to prove a device meets acceptance criteria in the context of an AI/ML device. The document is an FDA 510(k) premarket notification for various catheters (Turnpike, GuideLiner V3, TrapLiner) and details their indications for use, technological characteristics, and a clinical study conducted to evaluate their safety and effectiveness for assisting in crossing de novo coronary chronic total occlusions (CTO).

The clinical study described is a prospective, multi-center, single-arm study of 150 subjects. It evaluates the safety and effectiveness of the catheters and specialized guidewires in patients undergoing CTO-PCI, not an AI device. The primary endpoint was "procedure success through discharge or 24 hours post-procedure, whichever came first," with specific components for angiographic visualization of guidewire placement and absence of in-hospital MACE.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size for a test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth type, or training set information as requested, because this information is not present in the provided text for an AI/ML device.

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The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.

The SuperCross microcatheters are single lumen catheters designed for use in the coronary and/or peripheral vasculature. The SuperCross microcatheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The SuperCross microcatheters are available in various tip configurations (straight, flexible, angled) and two working lengths (130cm, 150cm). The distal 40cm of the straight tip catheters and the distal 72 cm of the angled tip catheters has a hydrophilic coating. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing. The SuperCross microcatheters are compatible with .014" guidewires and 5F guide catheters.

The provided text is a 510(k) summary for a medical device (SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance criteria through a study involving diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, the typical elements requested about acceptance criteria, study design for diagnostic performance, sample sizes, expert ground truth adjudication, MRMC studies, and training set details are not applicable to this type of regulatory submission.

The "studies" mentioned in the document are engineering performance tests and biocompatibility tests, not clinical studies assessing diagnostic accuracy or human reader performance.

Here's a breakdown based on the provided document and why most of your questions cannot be answered:

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

The document lists types of tests performed, but it does not provide a table with specific quantitative acceptance criteria or the numerical results from these tests. It simply states that:

• "The device performance was verified through the following tests: Deliverability, Hydrophilic Coating Evaluation, Structural Integrity, ISO 10555-1 Verification, ISO 594 Hub Verification."
• "Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity."
• "The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness; therefore, the SuperCross microcatheters are substantially equivalent to the predicate device."

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

• Sample sizes: Not specified. The tests mentioned are likely bench tests using a certain number of device samples, not patient data.
• Data provenance: Not applicable, as this is related to bench and biocompatibility testing of the device itself, not patient data from a clinical setting.

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. Ground truth, in the context of diagnostic accuracy, is not relevant here. The "ground truth" for these engineering tests is adherence to established engineering standards (e.g., ISO) and predetermined acceptance limits for physical properties.

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

• Not applicable. This concept pertains to adjudicating disagreements among human readers or experts for diagnostic ground truth, which is not part of this 510(k) submission for a microcatheter.

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-enabled diagnostic device. It's a medical instrument used for accessing vasculature and delivering agents.

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" equivalent for these tests are the pre-defined engineering specifications and ISO standards that the device must meet to demonstrate safe and effective performance for its intended use. For biocompatibility, the ground truth is the absence of adverse biological reactions as per ISO 10993-1.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning model.

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

• Not applicable.

In summary: The provided document is a 510(k) summary for a Class II medical device (microcatheter) that demonstrates substantial equivalence primarily through bench testing and biocompatibility testing, not clinical performance studies involving diagnostic accuracy or human interpretation. The questions posed are highly relevant to AI/ML diagnostic device submissions but do not apply to this specific regulatory filing.

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The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the peripheral and coronary vasculature. The Twin-Pass catheter consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a hydrophilic coating on the distal 18cm of the catheter. The Twin-Pass catheter has a working length of 135cm and have white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively. The Twin-Pass catheter has a platinum-iridium marker band located 1mm from the distal tip and a second platinum-iridium marker band located 11mm from the distal tip, identifying the distal end of the OTW lumen.

The provided text is a 510(k) summary for the Twin-Pass Dual Access Catheter. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a report of a clinical study or performance evaluation with human subjects that would typically involve acceptance criteria for AI/ML devices or specific clinical endpoints.

Therefore, the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and human reader performance for an AI/ML device is not applicable to this document.

The document describes device performance verification tests to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy/effectiveness trials for an AI/ML diagnostic or prognostic tool.

Here's a breakdown of the available information:

• 1. A table of acceptance criteria and the reported device performance: This information is not presented in a table with specific quantitative acceptance criteria and reported performance values. Instead, the document lists various verification tests performed and states that "The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness." The specific numerical acceptance criteria and corresponding numerical results are not detailed in this summary.

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided. The "test set" in this context refers to physical device samples for engineering and biocompatibility testing, not patient data.

• 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. "Ground truth" in this context would relate to the validation of a diagnostic or prognostic capability, which is not the purpose of this device's submission. The tests are engineering and biocompatibility evaluations.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for clinical endpoint assessment by multiple experts, which is not described here.

• 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 device is a catheter, not an AI-powered diagnostic tool.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a catheter, not an algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the device's performance is based on established engineering standards (e.g., ISO 10555-1, ISO 594) and biocompatibility testing.

• 8. The sample size for the training set: 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: Not applicable.

Summary of Device Performance Verification (as provided in the document):

The device performance was verified through the following tests, and the results "met the specified acceptance criteria":

• Deliverability:
  • Track Force
  • Kink Resistance
  • Guide Catheter Compatibility
  • Guidewire Movement
• Hydrophilic Coating Evaluation:
  • Particulate
  • Coating Lubricity/Durability
  • Drops of Fluid
• Tensile Strength:
  • Shaft
  • Tip
  • Hub
• Torque Robustness
• Hub Markings
• ISO 10555-1 Verification:
  • Working Length
  • Crossing Profile
  • Radiopacity
  • Aspiration
  • Liquid Leak
  • Static Pressure
  • Dynamic Pressure
  • Surface Defects
• ISO 594 Hub Verification:
  • Luer Gage
  • Air Leakage During Aspiration
  • Liquid Leakage Under Pressure
  • Separation Force of Luer Fitting
  • Unscrewing Torque
  • Ease of Luer Fitting Assembly
  • Resistance to Overriding
  • Stress Cracking

Biocompatibility Tests (in accordance with ISO 10993-1):

• Cytotoxicity
• Sensitization
• Irritation
• Systemic Toxicity
• Material Mediated Pyrogenicity
• Hemolysis
• Complement Activation
• Thrombogenicity

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The D-Stat Radial Topical Hemostat is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

D-Stat Radial topical hemostat (D-Stat Radial) is a hemostatic band consisting of an application device containing a lyophilized pad consisting of thrombin, sodium carboxylmethylcellulose and calcium chloride in a nonwoven gauze, and an adjustable retention strap and attached foam pads. Hemostasis is achieved by the physiological coagulation-inducing properties of the lyophilized pad combined with the compression delivered by the application device.

The D-Stat Radial has been sterilized with irradiation.

The provided text is a 510(k) Pre-market Notification for the D-Stat Radial Topical Hemostat. It focuses on demonstrating substantial equivalence to a predicate device, not on validating the device's absolute efficacy via a clinical study with detailed acceptance criteria and outcome measurements. Therefore, much of the requested information cannot be extracted directly from this document.

However, I can provide what is present regarding the device's technical validation and comparison to a predicate.

The primary change in the device is to the retention strap material. The demonstration of substantial equivalence relies on:

• Performance Testing: "Securement Force"
• Biocompatibility Testing: "Cytotoxicity", "Sensitization", "Irritation"

Here's an analysis of what can be inferred or explicitly stated from the document:

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

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

• Test Set Sample Size: The document only states "Device samples" were used for performance and biocompatibility tests. No specific sample sizes are mentioned.
• Data Provenance: Not specified, but generally, 510(k) testing is performed by the manufacturer or a contract research organization. The manufacturing facility is listed in Minneapolis, MN, USA.
• Retrospective/Prospective: Not applicable in this context as these are laboratory and bench tests, not clinical studies on patient cohorts.

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

• Not Applicable. The validation methods described (Securement Force, Biocompatibility) are objective laboratory tests against established standards (e.g., ISO 10993-1), not subjective assessments requiring expert consensus for "ground truth".

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

• Not Applicable. As mentioned above, the tests are objective, not requiring adjudication.

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. This is not an AI/software device. The document describes a physical medical device (a hemostatic band).

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

• No. This is not an AI/software device.

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

• Ground truth for the performance and biocompatibility tests are the established specifications and ISO standards. For example, for biocompatibility, the ground truth is compliance with the limits set by ISO 10993-1. For securement force, the ground truth would be a predetermined force range or threshold.

8. The sample size for the training set

• Not Applicable. This is not a machine learning/AI device, so there is no concept of a "training set."

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

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

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The Wattson™ temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure.

The Wattson temporary pacing guidewire is a dual-purpose 0.035" guidewire designed for the delivery of devices and for temporary rapid pacing of the heart. The distal end of the device has an atraumatic pigtail shape. The shaft of the device has a silicone lubricant applied to the outer surface. Rapid pacing is achieved through a bipolar electrode configuration integrated in the shaft of the guidewire. The electrodes terminate in a single positive electrode at the distal tip of the device and three discrete negative electrodes located proximal to the tip within the pigtail section. The entire device is visible using standard fluoroscopic methods. The device is packaged with a proprietary adapter that locks on to the proximal end of the guidewire and converts it to discrete positive and negative terminal pins. The terminal pins of the adapter are compatible with standard external pulse generators. The Wattson temporary pacing guidewire is sterilized with ethylene oxide.

The provided document describes the Wattson™ temporary pacing guidewire and its substantial equivalence to predicate devices, but it does not explicitly state specific quantifiable acceptance criteria for the device performance or present a table comparing such criteria with reported performance values.

Instead, the document focuses on demonstrating substantial equivalence through various types of testing. I will extract information related to the closest aspects of 'acceptance criteria' and 'reported device performance' based on the safety and effectiveness testing conducted.

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantifiable acceptance criteria are not provided in the document, this table will summarize the types of tests and the outcomes as described for demonstrating substantial equivalence.

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