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The Frova Intubating Introducer is indicated to facilitate endotracheal intubation in patients where visualization of the glottis is inadequate e.g., as in grade II and III Cormack-Lehane views. This indication applies for introduction of a single lumen endotracheal tube with an inner diameter of 6 mm or larger.

The Frova Intubating Introducer is also designed for transient oxygenation or jet ventilation in combination with 14 Fr compatible Rapi-Fit Adapters (15 mm and female Luer lock connector). The Rapi-Fit Adapters should only be used when oxygen requirements are high.

The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque introducer with centimeter markings and a blunt, curved tip that can be passed into the trachea. The introducer has a through lumen design with two distal sideports to ensure adequate airflow. The Frova Intubating Introducer can be supplied with a stiffening stylet and two Rapi-Fit® Adapters for connection to an oxygen source.

The Frova Intubating Introducer is designed to facilitate airway intubation and allows for transient oxygenation and/or jet ventilation during the initial intubation.

The Rapi-Fit Adapter with a 15 mm connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation during intubation.

The Rapi-Fit Adapter with a female Luer lock connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation or jet ventilation during intubation.

The stiffening stylet is intended to add rigidity to the proximal and middle sections of the introducer, while the distal portion remains flexible.

The different configurations of the Frova Intubating Introducer are supplied sterile and are for single use only.

Based on the provided FDA 510(k) Clearance Letter for the Frova Intubating Introducer, it is explicitly stated that no performance testing was warranted in support of this 510(k) premarket notification. Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The reason provided is: "No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject device. Therefore, no performance testing was warranted in support of this 510(k) premarket notification." This indicates that the clearance relies on its substantial equivalence to a previously cleared predicate device (K161813), and the proposed changes are limited to labeling harmonization.

Consequently, I cannot fill out the requested information regarding acceptance criteria and performance studies from this document. If this were a new device or a device with significant changes, such information would be crucial for its clearance.

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

1. A table of acceptance criteria and the reported device performance: Not present. The document explicitly states no performance testing was warranted.
2. Sample sizes used for the test set and the data provenance: Not applicable, as no performance testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance testing was conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no performance testing was conducted.
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 physical medical introducer, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical introducer, not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance testing was conducted.
8. The sample size for the training set: Not applicable, as no performance testing was conducted (and no training set would be relevant for a physical device in this context).
9. How the ground truth for the training set was established: Not applicable, as no performance testing was conducted.

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The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

• · Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
• · Failure of anticoagulant therapv in thromboembolic diseases:
• · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and
• · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

• · Pulmonary thromboembolism when anticoaqulant therapy is contraindicated;
• · Failure of anticoagulant therapy in thromboembolic diseases;
• · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced: and
• · Chronic, recurrent PE where anticoaqulant therapy has failed or is contraindicated.

The Celect Platinum Filter implant mav be retrieved if clinically indicated: please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or juqular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Celect Platinum Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (49 mm long when compressed to a diameter of 30 mm) with platinum markers, preloaded on a femoral filter introducer with a flexible tip; a 7 French coaxial introducer system (compatible with a 0.035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Celect Platinum Filter implant is designed to act as a permanent filter or retrievable filter.

The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a 0.035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.

The provided text describes a 510(k) premarket notification for vena cava filters, specifically the Celect Platinum® and Günther Tulip® filter sets. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily due to updates in the device labeling to include clinical evidence and updated MRI safety information.

Therefore, the acceptance criteria and study proving the device meets the acceptance criteria are centered around demonstrating that the modified device (with updated labeling) is still substantially equivalent to the predicate device, and that the clinical evidence supports the updated labeling regarding the safety and effectiveness of the existing device. The document does not describe an AI/ML-based device or a study involving human readers or ground truth establishment in the typical sense of evaluating an algorithm's performance. Instead, it refers to clinical studies that already took place to gather data for the updated labeling of the physical medical device.

Given this context, I will address the questions as they relate to the information provided about the device's substantial equivalence and the underlying clinical studies. Many of the questions, particularly those related to "AI/ML acceptance criteria," "sample sizes for test and training sets," "expert adjudication," "MRMC studies," and "ground truth establishment" for AI, are not directly applicable to a 510(k) for a physical medical device. I will indicate where the information is not present or not relevant to the type of device and submission described.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence and Labeling Updates for a Physical Device)

The overall acceptance criterion for this 510(k) submission is Substantial Equivalence to the predicate devices (Cook Celect Platinum Vena Cava Filter Sets K211875 and Günther Tulip Vena Cava Filter Sets K211874). This means demonstrating that the modified devices (with updated labeling) are as safe and effective as the predicate devices. The performance testing detailed here supports this claim.

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

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

The document states that the clinical data to support the updated labeling originated from two studies:

• Cook IVC Filter Study
• PRESERVE Study

These were:

• Sample Size: Not explicitly stated for either study in the provided text. The term "subjects" is used, implying a cohort of patients.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but indicated as "multi-center" studies, suggesting various locations.
  • Retrospective or Prospective: Both studies were conducted as multi-center, prospective, Investigational Device Exemption (IDE) studies.

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)

This question is not applicable in the context of this 510(k) submission, as it relates to evaluating a physical medical device (vena cava filter) rather than an AI/ML algorithm that requires expert annotation for ground truth. The clinical studies evaluated the performance of the physical filters directly in patients. Decisions on safety and effectiveness (e.g., presence of PE, DVT, complications) would have been made by the medical professionals involved in the care of the patients in the studies.

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

This question is not applicable, as there is no "test set" in the sense of image data requiring expert adjudication for AI/ML algorithm evaluation. Clinical outcomes in the described IDE studies would have been assessed by the treating physicians and study investigators, likely with predefined diagnostic criteria and endpoints.

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 such MRMC study was conducted or described in the provided text. This type of study is relevant for evaluating the impact of AI assistance on human performance (e.g., radiologists interpreting images), which is not the subject of this 510(k) for a physical medical device.

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

Not applicable. This submission is not for an AI/ML algorithm; it is for physical medical devices (vena cava filters).

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

The "ground truth" for evaluating the performance of the vena cava filters in the two IDE studies (Cook IVC Filter Study and PRESERVE Study) was clinical outcomes data gathered prospectively from patients. This would include:

• Safety Endpoints: Rates of filter complications (e.g., filter embolization, clinically significant perforation, new DVT, caval thrombotic occlusion, SAEs).
• Effectiveness Endpoints: Prevention of pulmonary embolism (PE).
• Retrieval Measures: Data related to filter retrieval if applicable.

These outcomes would have been based on clinical assessments, imaging, and lab results collected during the studies.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device. Training sets are relevant for machine learning models, which are not described here.

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

Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for it.

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The Lunderquist Extra Stiff Wire Guides are intended to facilitate catherization and/or placement of devices during vascular diagnostic procedures and vascular interventional procedures. The Lunderquist Extra Stiff Wire Guides are intended for use in the major vessels, the aorta and vena cava, including their access vessels and adjacent vessels.

Straight (TSMG-/-LES) and Curved (TSCMG-/-LES) Lunderquist® Extra Stiff Wire Guide. PTFE-coated stainless steel wire guides with lengths ranging from 90 cm to 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil for enhanced visibility. The J-curve radius for the curved wire guides is either 3 mm or 7 mm.

Double curved (TSCMG-/-LESDC) and extended double curved (TSCMG-/-E-LESDC) Lunderquist® Extra Stiff DC Wire Guide. PTFE-coated stainless steel wire guides with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. TSCMG-/-LESDC has a primary/secondary curve radius on 75/15 mm, and TSCMG-/-E-LESDC has an extended primary/secondary curve radius on 55/15 mm.

The Lunderquist® Extra Stiff Wire Guide is used both to assist in anatomical access for other devices (notincluded) and to support the delivery of medical devices. The wire guide is introduced into the target vessel; other devices, such as a sheath, catheter, stent, or endo vascular graft can then be passed over the wire guide to be positioned or manipulated within the vascular system.

The Lunderquist® Extra Stiff Wire Guides are available in different lengths, shapes, etc. to accommodate different anatomical applications.

The provided document, a 510(k) premarket notification for the Lunderquist Extra Stiff Wire Guides, does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.

The document states that the purpose of the submission is to "clarify the intended use statement and update device labeling based on postmarket surveillance information." It explicitly mentions:

"No changes to the design, materials, manufacturing, sterilization, or principles of operation have been introduced with the subject devices. Therefore, performance testing was not warranted, and testing provided for the predicate device (K171513) remains applicable."

This indicates that new performance testing, particularly for the type of criteria and study you're asking about (which are typical for AI/ML device evaluations), was not conducted for this submission because the device itself and its function have not changed. The device is a physical catheter guide wire, not a software algorithm.

Therefore, I cannot provide the requested information based on the given text. The questions you've posed relate to the validation of AI/ML models, which is not applicable to a submission for a physical medical device like a wire guide, especially one where no design changes have been made.

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The Günther Tulip Filter implant is intended for the prevent pulmonary embolism (PE) via placement in the vena cava in the following situations:

• · Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
• · Failure of anticoagulant therapy in thromboembolic diseases;
• · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and
• · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French predilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.

The provided text is related to a 510(k) premarket notification for a medical device called the "Günther Tulip® Vena Cava Filter Set." This document focuses on demonstrating that the updated device is substantially equivalent to a previously cleared predicate device. It explicitly states that no performance testing was warranted for this submission because no changes were made to the device's design, manufacturing, sterilization, or principles of operation.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance results, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device's performance evaluation. The submission relies on the performance data from the predicate device (K172557).

To answer your request, if this were a submission requiring new performance testing for an AI/ML medical device, the following information would be necessary:

Hypothetical Study Information (Illustrative, NOT based on the provided document)

Since the provided document states "No performance testing was warranted," I cannot extract the requested information. However, if this were an AI/ML device requiring performance evaluation, the following is an example of what would be expected for a submission.

Acceptance Criteria and Device Performance (Hypothetical Example for an AI/ML Device)

1. Table of Acceptance Criteria and Reported Device Performance

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The Cook Celect Platinum Filter implant is intended or the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

·Pulmonary thromboembolism when anticoagulant therapy is contraindicated;

• · Failure of anticoagulant therapy in thromboembolic diseases;
• · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and
• · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Cook Celect Platinum Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Cook Celect Platinum Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (49 mm long when compressed to a diameter of 30 mm) with platinum markers, preloaded on a femoral filter introducer with a flexible tip; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Cook Celect Platinum Filter implant is designed to act as a permanent filter or retrievable filter.

The provided text is a 510(k) summary for the Cook Celect Platinum® Vena Cava Filter Set. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain any information about a study proving the device meets specific acceptance criteria based on performance metrics such as those found in AI/ML medical device submissions.

This 510(k) is for a physical medical device (a vena cava filter), and the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device, not performance benchmarks from a clinical or technical study. The "performance testing" section explicitly states:

"No changes to the materials, design, manufacturing, packaging, sterilization, or principles of operation have been introduced with the subject devices. Therefore, performance testing was not warranted, and the testing provided for the predicate submission (K171712) remains supportive."

This means the current submission relies on the testing supporting the previous predicate device (K171712) because the device itself hasn't changed. The only updates mentioned are to the device labeling based on post-market surveillance and risk management.

Therefore, I cannot provide the information requested in your prompt as it pertains to a different type of device evaluation (e.g., for AI/ML algorithms). The document does not discuss:

• A table of acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, or accuracy)
• Sample sizes for test sets or their provenance
• Number/qualifications of experts for ground truth establishment or adjudication methods
• MRMC studies or effect sizes for human readers
• Standalone algorithm performance
• Types of ground truth
• Training set sample sizes or how their ground truth was established

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The device is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.

The subject device, the Lunderquist Extra Stiff DC Wire Guide with an extended double curved tip, is considered a line extension of the predicate Lunderquist Extra Stiff DC Wire Guides. The subject device is a PTFE-coated 0.035 inch stainless steel wire with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. The length of the device is either 260 cm or 300 cm and the J-curve radius is 15 mm. The devices have the body and stiffness required to control large diameter, stiff devices without causing damage to the patient's anatomy or the lumen of the delivery system.

The provided text describes a 510(k) premarket notification for a medical device, the Lunderquist Extra Stiff Wire Guide. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria in the manner of an AI/software device.

Therefore, the information required to answer your questions regarding acceptance criteria and a study proving device capability, specifically for an AI device, is not present in this document. This document pertains to a traditional medical device (a guide wire), not an AI-powered device.

Here's why the required information is absent:

• Type of Device: The Lunderquist Extra Stiff Wire Guide is a physical medical instrument. The questions you've posed (acceptance criteria for AI, training sets, adjudication, MRMC studies, ground truth establishment) are relevant to the validation of AI/Machine Learning devices.
• Regulatory Pathway: A 510(k) submission for a physical device emphasizes performance data to show the device functions as intended and is as safe and effective as a legally marketed predicate device. This is different from the rigorous clinical validation required for many AI/ML-based medical devices, which would involve the type of studies you're asking about.
• Performance Data Provided: The "Performance data" section (page 5) lists various physical tests (Biocompatibility, Surface test, Tape adhesion, Friction, Flexing, Peak tensile force, Ultrasound test, Simulated Use Test, Torque test). These are standard engineering and material tests for a wire guide, not AI model performance metrics. Each test simply states "The predetermined acceptance criteria were met," without detailing what those criteria were or specific performance values.

In summary, this document does not contain the information needed to answer your questions about acceptance criteria and study data for an AI device.

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The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
• Failure of anticoagulant therapy in thromboembolic diseases;
• Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and
• Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Günther Tulip Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. The Günther Tulip Vena Cava Filter Set is available in a Femoral Set and a Jugular Set. Each set consists of a preloaded filter, a coaxial introducer system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. The Günther Tulip Vena Cava Filter Set is also available in a universal vein access version consisting of components for both femoral and jugular vein approaches; which includes a preloaded filter in the femoral approach. The Günther Tulip Vena Cava Filter is constructed from a cobalt chromium alloy. The end of each leg is hooked outward; this hook design enables securement of the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward the vein walls. These webs also increase the area into which emboli can be trapped. The filter is approximately 50 mm long along its main axis when compressed to a diameter of 30 mm.

This document is a 510(k) premarket notification for the Günther Tulip Vena Cava Filter Set. It explicitly states that "No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject devices; therefore, no performance testing was considered necessary." The purpose of this submission is to update device labeling based on post-market experience and to align with current international and regulatory standards, not to introduce a new device requiring new performance data.

Therefore, the input document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. The "Performance Testing" section explicitly states that no performance testing was considered necessary for this particular submission because the device itself had not changed.

To answer your request, I would need a different document that details the original performance testing and acceptance criteria for the Günther Tulip Vena Cava Filter, likely from its initial 510(k) clearance (K090140) or an equivalent premarket submission.

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The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulant therapy is contraindicated; .
• Failure of anticoagulant therapy in thromboembolic diseases; .
• . Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and
• . Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Günther Tulip Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. The Günther Tulip Vena Cava Filter Set is available in a femoral vein access version and in a universal vein access version consisting of components for both femoral and jugular vein approaches. Each set consists of a filter preloaded on the set for femoral approach, a coaxial introducer system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The femoral filter introducer has a flexible tip. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. The Günther Tulip Vena Cava Filter is constructed from a cobalt chromium alloy. The end of each leg is hooked outward; this hook design enables securement of the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward toward the vein walls. These webs also increase the area into which emboli can be trapped. The filter is approximately 50 mm long along its main axis when compressed to a diameter of 30 mm.

This document is a 510(k) summary for the Günther Tulip Vena Cava Filter Set, which states that no changes have been made to the filter or its delivery system. The submission primarily addresses updates to labeling and an extension of the device's shelf life. Therefore, the information provided does not describe a new study proving the device meets acceptance criteria in the context of clinical performance or effectiveness for this submission. Instead, it refers to nonclinical aging testing to support a shelf life extension.

Here's an analysis based on the provided text, addressing your questions where possible:

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 sample sizes for the nonclinical aging testing. It also doesn't provide information on data provenance (e.g., country of origin, retrospective/prospective) for clinical effectiveness, as no new clinical study was performed for this submission. The submission states, "No changes have been made to the Günther Tulip Vena Cava Filter or its delivery systems," and is primarily for labeling updates and shelf life extension based on "post-market experience".

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the provided document, as no clinical study requiring expert ground truth establishment for a test set is described.

4. Adjudication Method

This information is not applicable, as no clinical study requiring adjudication is described.

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

No MRMC study was done, as this submission concerns labeling updates and shelf life extension, not a comparative effectiveness study of the device's clinical performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable, as the device is a Vena Cava Filter, not an AI algorithm.

7. Type of Ground Truth Used

For the shelf life extension, the "ground truth" would be the observed physical and functional integrity of the device and its packaging after accelerated and/or real-time aging, evaluated against predefined engineering specifications (performance testing).

8. Sample Size for the Training Set

This information is not applicable, as this is a medical device, not an AI algorithm requiring a training set.

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

This information is not applicable, as this is a medical device, not an AI algorithm.

Summary of what the document does state:

The primary purpose of this 510(k) submission (K172584) is to update device labeling and extend the shelf life of the Günther Tulip Vena Cava Filter Sets. The manufacturer asserts substantial equivalence to the predicate device (K121057) because:

• No changes have been made to the filter or its delivery systems.
• The indications for use, principles of operation, design, materials, manufacturing, sterilization process, and basic technological characteristics remain identical to the predicate.

The acceptance criteria relevant to this specific submission relate to the nonclinical aging testing performed to support the three-year shelf life extension. The reported performance is that "all test results met the predetermined acceptance criteria" for both packaging and performance testing after aging. No details on these specific criterion values or test methodologies are provided in this summary.

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The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulant therapy is contraindicated; .
• Failure of anticoagulant therapy in thromboembolic diseases; .
• Emergency treatment following massive PE where anticipated benefits of conventional . therapy are reduced; and
• . Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Cook Celect Platinum Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of this booklet for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Cook Celect Platinum Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. The Cook Celect Platinum Vena Cava Filter Set is available in a Femoral Set and a Jugular Set. Each set consists of a preloaded filter, a coaxial introducer system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The femoral filter introducer has a flexible tip. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. The Cook Celect Platinum Vena Cava Filter Set is also available in a universal vein access version consisting of components for both femoral and jugular vein approaches. The Cook Celect Platinum Vena Cava Filter is constructed from a cobalt chromium alloy. Radiopaque markers constructed from a platinum tungsten alloy located on each primary leg enhance filter visibility on procedural imaging. The filter is approximately 49 mm long along its main axis when compressed to a diameter of 30 mm.

This document is a 510(k) summary for the Cook Celect Platinum Vena Cava Filter Sets. It primarily focuses on demonstrating substantial equivalence to a predicate device and updating labeling and shelf-life. As such, it does not describe AI/ML device performance or an acceptance criteria study in the typical sense for a diagnostic AI product.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance (for an AI product).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is about a physical medical device (vena cava filter) and its regulatory submission for updating labeling and extending shelf-life, not a diagnostic AI device.

The "Performance Testing" section mentions:

• "No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject devices."
• "Three-year shelf life was supported by nonclinical aging testing, which included packaging testing and performance testing; all test results met the predetermined acceptance criteria."
• "Final clinical study data were provided; interim data have been provided to FDA under previous 510(k)s and a summary of the final data has previously been provided to FDA under an IDE."

This indicates that the "acceptance criteria" here relate to the physical integrity, functionality, and sterility of the device over its extended shelf life, as well as previously conducted clinical studies that established the safety and effectiveness of the original device design. The current submission relies on the substantial equivalence to the predicate device, which itself had established performance.

To summarize for the context of this document:

Acceptance Criteria and Study:

The primary "study" described in this specific 510(k) submission is focused on demonstrating the stability of the device over an extended shelf life and the substantial equivalence to the previously cleared predicate device.

• Acceptance Criteria: For the shelf-life extension, the acceptance criteria relate to the physical and functional integrity of the device and its packaging after accelerated and real-time aging, ensuring it meets its original performance specifications for an extended period (three years). Specific quantitative criteria for these tests are not provided in this summary but would be detailed in the full submission.
• Reported Device Performance: All test results from the nonclinical aging testing (packaging and performance) "met the predetermined acceptance criteria." This implies the device maintains its intended performance and sterile barrier for the new three-year shelf life.
• Clinical Study: The document references "Final clinical study data were provided; interim data have been provided to FDA under previous 510(k)s and a summary of the final data has previously been provided to FDA under an IDE." This indicates that clinical performance (safety and effectiveness, as per the indications for use) was established for the original device through prior studies reviewed by the FDA, leading to its initial clearance and based on which substantial equivalence is claimed. This specific 510(k) does not present new clinical "performance" data beyond confirming the device's stability for an extended shelf-life, as no changes were made to the device itself.

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The Frova Intubating Introducer is intended to facilitate endotracheal intubation in patients where the visualization of the glottis in inadequate. The 14 French catheter has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger.

The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque catheter introducer with centimeter markings and a blunt, curved tip that can be passed blindly into the trachea, when visualization of the glottis is inadequate and only visualization of the epiglottis can be confirmed by laryngoscopy. The catheter introducer has a tubular design with two distal sideports to ensure adequate airflow. It can be supplied with or without a stiffening stylet and/or two Rapi-Fit adapters for connection to a ventilator device. Pressure and flow specifications for the device when used for oxygenation are as follows: mean delivered minute volume is 8.6 L/min and mean measured average maximum airway pressure is 12.1 cm H2O (when input pressure is set to 50 psi, lung compliance is 100 mL/cm H2O, and resistance is 3 cm H2O/L/s). Incremental centimeter markings are placed on the shaft of the catheter introducer, with the first measurement marking designating 10 centimeters from the distal tip. The centimeter marks along the catheter shaft facilitate accurate depth placement of the catheter introducer into the airway.

The provided text describes the regulatory clearance of a medical device, the Frova Intubating Introducer, and includes details about its performance testing. However, it does not describe an AI/ML-driven device or diagnostic study.

Therefore, many of the requested elements for an AI/ML study (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details, or type of ground truth) are not applicable to this document.

The document details engineering and performance validation tests for a physical medical device.

Here's the information that can be extracted relevant to the acceptance criteria and device performance:

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

2. Characterized delivered minute volume during simulated high pressure oxygenation insufflation.
3. Successfully couples with Luer Lock Rapi-Fit adapter during simulated clinical use. | Characterization study performed, demonstrating the device's ability to insufflate oxygen, characterize delivered minute volume (mean 8.6 L/min, mean max airway pressure 12.1 cm H2O), and successful coupling with the Rapi-Fit adapter. |
   | Transportation - Part 1 (Visual Inspection) | Damages accepted on shipping boxes as long as product boxes are without holes/loose pieces or damages due to humidity. Small visible damages like pressure marks allowed on product boxes, as long as sterile barrier and Frova catheter are intact. | All acceptance criteria were met. |
   | Transportation - Part 2 (Sterile Barrier) | No breaches in sterile barrier, no visual tears or pinholes. | All acceptance criteria were met. |
   | Transportation - Part 3 (Device Integrity) | Catheter introducer has a curved tip after simulated shipping test. No kinks or damages. For C-CAE-14.0-70-FII, adapter attaches/locks to catheter introducer per IFU, not removable by pulling when locked, and removable from catheter introducer per IFU. | All acceptance criteria were met. |
   | Ink adherence and radiopacity | Each test article receives a rating of 2 or 3 on a 3-point scale for legibility of printed markings and radiopacity. | All acceptance criteria were met. (Performed as simulated use testing in domestic swine) |
   | Accelerated Age Testing | (Equivalent of three years real time aging) | |
   | Tensile strength (catheter introducer) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
   | Tensile strength (stiffening stylet) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
   | Tensile strength (catheter introducer/Rapi-Fit adapter connection) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
   | Kink radius (catheter introducer) | No kinking at 40 mm Radius of Curvature (according to Annex H of ISO 5361:2012) | Met |
   | Unscrewing torque (Luer Lock) | Female Luer connection remains attached to reference fitting (ISO 594-2, Section 5.5) | Met |
   | Resistance to overriding (Luer Lock) | Reference fitting does not override threads of conical fitting (ISO 594-2, Section 5.7) | Met |
   | Separation Force (Luer Lock) | Remains attached to the reference fitting (ISO 594-2, Section 5.4) | Met |
   | Compliance verification (15mm adapter) | Leading edge of 15 mm Rapi-Fit adapter lies between minimum and maximum diameter step gauges (ISO 5356-1:2015, Section 3.1.2) | Met |
   | Sterile barrier and dimensional verification | Sterile barrier intact (bubble leak/dye test). Product appears intact visually. Tip angle within tolerances. Length 70 cm ± 3mm. ID 3.124 mm ± 0.05 mm. OD 4.674 mm ± 0.05 mm. Print clear and visible within tolerances. Rapi-Fit adapters attach and lock per IFU. | All acceptance criteria were met. |
   | Ink adherence and radiopacity | Each test article receives a rating of 2 or 3 on a 3-point scale for legibility of printed markings and radiopacity. | All acceptance criteria were met. (Performed as simulated use testing in domestic swine) |
   | Biocompatibility | | |
   | Cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material mediated pyrogenicity | Passed results in accordance with ISO 10993-1:2009 and FDA guidance. | All biocompatibility tests showed passed results. |
   | Volatile organic compounds (VOCs) | No VOCs detected greater than quantification limits; no additional VOCs detected. | No VOCs detected greater than quantification limits; no additional VOCs detected. Risk assessment determined negligible likelihood of toxic effect. |
   | Particulate matter emission | Presents a clinically insignificant health risk to patients. | Results demonstrated clinically insignificant health risk. |

Regarding the AI/ML-specific questions:

2. Sample size used for the test set and the data provenance: Not applicable; this is not an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; this is not an AI/ML device.
4. Adjudication method: Not applicable; this is not an AI/ML device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI/ML device.
7. The type of ground truth used: For physical characteristics, the ground truth is established by physical measurement against established specifications (e.g., tensile strength, dimensions, kink radius, Luer Lock standards, adapter fit, sterile barrier integrity). For biological safety, it's defined by the results of standardized biocompatibility tests. For simulated use, it involves performance ratings in a simulated environment or animal model (domestic swine).
8. The sample size for the training set: Not applicable; this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable; this is not an AI/ML device.

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