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The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:

· Pulmonary thromboembolism when anticoagulants are contraindicated

• Failure of anticoagulant therapy in thromboembolic disease

· Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced

· Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

· Pulmonary thromboembolism when anticoagulants are contraindicated

· Failure of anticoagulant therapy in thromboembolic disease

· Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced

· Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entional Procedure for Filter Retrieval" in patients who no longer require a filter in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).

The Option™ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach.

The self-centering Option™ELITE Filter is laser cut from nickel - titanium alloy (Nitinol) tubing. The Option™ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.

The constrained Option™ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.

The introduction kit is comprised of a filter housed in a filter cartridge. Catheter Sheath Introducer (5F ID). Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker.

The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

This document describes a 510(k) premarket notification for the Option™ELITE Vena Cava Filter System and Option™ELITE Vena Cava Filter 100cm System. The purpose of the submission is to incorporate results from the PRESERVE study summary data into the Instructions for Use (IFU).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not include a specific table of acceptance criteria or reported device performance metrics in the traditional sense of a performance study. This submission is for incorporating existing clinical study results (PRESERVE study) into the device's labeling, rather than presenting new performance data for a modified device. The document explicitly states:

"No new operating principles have been introduced with the subject device. The subject device operates using the identical fundamental scientific technology as the predicate device; therefore, no performance testing was necessary nor was any performed. The clinical testing was previously provided to FDA under the Investigational Device Exemption and the PRESERVE study."

Because no new performance testing was conducted for this specific 510(k) submission, there are no new device performance metrics to report against an acceptance criterion in this document. The existing performance would be based on the prior clearance of the predicate devices and the PRESERVE study.

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

The document refers to the "PRESERVE study." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for this study within the provided text. To obtain this information, one would need to consult the original PRESERVE study documentation.

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

The provided document does not contain information on the number of experts used to establish ground truth or their qualifications for the PRESERVE study's test set.

4. Adjudication Method for the Test Set

The provided document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set of the PRESERVE study.

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

An MRMC comparative effectiveness study is typically used for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. Since the device is a Vena Cava Filter System, it is a physical medical device, not a diagnostic imaging AI algorithm. Therefore, no MRMC comparative effectiveness study was done for this device.

6. Standalone (Algorithm Only) Performance

The device is a physical Vena Cava Filter System, not an algorithm or software-only device. Therefore, the concept of "standalone performance" for an algorithm does not apply to this device.

7. Type of Ground Truth Used

Given that this is a physical medical device (vena cava filter) and the PRESERVE study would be a clinical trial, the "ground truth" would likely be derived from patient outcomes, imaging data, and clinical assessments related to the filter's effectiveness in preventing pulmonary embolism and its safety profile. However, the document does not explicitly state the type of ground truth used for the PRESERVE study.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. Since the device is a physical medical device and not an AI/ML product, no training set was used in the context of algorithm development. Clinical trials, like PRESERVE, gather data for validation and effectiveness, not for training an algorithm.

9. How Ground Truth for the Training Set Was Established

As noted above, no training set was used in the context of an algorithm for this physical device. Therefore, how ground truth for a training set was established is not applicable.

In summary, the provided FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device and incorporating pre-existing clinical study (PRESERVE study) data into the device's labeling. It does not present new performance data or detail the methodology of the PRESERVE study in the way one might expect for a new device's initial clearance or an AI/ML product. To get specific details about the PRESERVE study (sample size, ground truth, expert involvement, etc.), one would need to refer to its full study report or publications.

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The ALN Optional Vena Cava Filter with Hook and without Hook are indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

• Pulmonary thromboembolism when anticoagulants are contraindicated,

• Failure of anticoagulant therapy in thromboembolic diseases,

• Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and

• Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

ALN Optional Vena Cava Filters with Hook and without Hook, may be retrieved with the ALN Extraction and /or Repositioning Kits according to the Instructions For Use of these devices.

The ALN Optional Vena Cava Filter with Hook may be also retrieved with a standard GooseNeck Snare according to the the Instructions For Use of this medical device.

The ALN Optional Vena Cava Filter is a conical-shaped structure made of 316LVM stainless steel and consisting of 9 legs (i.e., 9 filtering elements). The 6 shortest legs (i.e., anchoring legs) are ended with distal hooks and each leg has a different length to avoid intertwining when the filter is introduced into the sheath or released in the vessel. The 3 longest legs (i.e., centering legs) have no hooks and serve to line up the vena cava axis. The loop at the end of the longest one helps to push the filter during its implantation through the femoral vascular approach. All 9 legs are equally involved in capturing and breaking an embolus. The ALN Optional Vena Cava Filter is about 55 mm high and is suitable for vena cava diameters up to 32 mm. The implantation approaches may be jugular, brachial or femoral. The ALN Optional Vena Cava Filter with a Hook is the same ALN Optional Vena Cava Filter with an additional 4mm retrieval hook on the apex of the device.

This appears to be a 510(k) summary for a medical device (ALN Optional Vena Cava Filter), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The document states that the device itself is unchanged compared to the predicate device, and the submission is primarily for a labeling change requested by the FDA to include results from the PRESERVE study.

Therefore, the study described is not evaluating the performance of a new or modified device model. Instead, the PRESERVE study is cited as a clinical trial that demonstrates the safety and efficacy of IVC filters in general, including the predicate device (and thus, by substantial equivalence, the current device). The 510(k) process here relies on the equivalence of the device to one whose safety and efficacy performance has already been established, with the PRESERVE study providing updated clinical context for the class of device.

Given this context, many of your requested fields related to a direct study of the current device's performance will not be directly answerable from this document, as no such study on the unchanged device is described. Instead, I will parse the information about the PRESERVE study as presented.

Here's the information based on the provided text, focusing on the PRESERVE study as the relevant clinical data mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the ALN Optional Vena Cava Filter's performance as part of this 510(k) submission, because the device itself is unchanged. The PRESERVE study, mentioned as the clinical data, is an FDA-directed multicenter, prospective, open-label, non-randomized trial that studied the safety and efficacy of IVC filters from multiple manufacturers. The summary states:

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

• Test Set Sample Size: The document states PRESERVE is a "multicenter" study, implying a larger sample size than a single institution, but does not provide the specific number of participants or filters included in the study.
• Data Provenance: The document does not specify the country of origin of the data. It mentions it is an "FDA-directed multicenter, prospective, open-label, non-randomized trial," indicating it included data from multiple centers. It is prospective.

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

The document does not specify the number or qualifications of experts used to establish ground truth within the PRESERVE study. As a trial assessing safety and efficacy, it would likely involve clinical endpoints determined by treating physicians and potentially adjudicated by independent committees, but these details are not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the PRESERVE study's endpoints.

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

No MRMC study comparing human readers with and without AI assistance is described. The PRESERVE study is a clinical trial assessing device safety and efficacy, not an imaging or diagnostic AI performance study.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study is described. This device is a physical medical implant, not an AI or software device in the context of this submission. The PRESERVE study is a clinical trial involving physical devices and patient outcomes.

7. Type of Ground Truth Used

Based on the description of the PRESERVE study as assessing "safety and efficacy" and aiming to "treat venous thromboembolism (VTE)," the ground truth likely involved clinical outcomes data related to the prevention of pulmonary embolism, complication rates, and possibly other metrics of VTE prevention (e.g., freedom from new PE, successful filter implantation/retrieval). The document does not provide specific details on how these outcomes were defined or measured.

8. Sample Size for the Training Set

Not applicable. This document describes a physical medical device (vena cava filter) and primarily a labeling change based on a clinical study of such devices. There is no mention of a "training set" in the context of an AI/algorithm.

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

Not applicable, as no training set for an AI/algorithm is mentioned.

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The Denali™ Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

-Pulmonary thromboembolism when anticoagulants are contraindicated

-Failure of anticoagulant therapy for thromboembolic disease

-Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced

-Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The Denali™ Filter may be removed according to the instructions supplied under the Section labeled: Optional Procedure for Filter Removal.

The Denali™ Vena Cava Filter is a venous interruption device designed to prevent pulmonary embolism. The Denali™ Filter can be delivered via the femoral and jugular/subclavian approaches. A separate delivery system is available for each approach. The Denali™ Filter is designed to act as a permanent filter. When clinically indicated, the Denali™ Filter may be percutaneously removed after implantation according to the instructions provided under the "Optional Procedure for Filter Removal" section in the Instructions for Use.

The Denali™ Filter consists of twelve shape-memory laser-cut nickel-titanium appendages. These twelve appendages form two levels of filtration with the legs providing the lower level of filtration and the arms providing the upper level of filtration. The Denali™ Filter is intended to be used in the inferior vena cava (IVC) with a diameter less than or equal to 28mm.

The Denali™ Vena Cava Filter System consists of an introducer sheath, an 8 French dilator, and a preloaded Denali™ Filter in a storage tube with a pusher. The 8 French dilator accepts a 0.035" guidewire and allows for an 800 psi maximum pressure contrast power injection. Radiopaque marker bands on the end of the dilator aid in measuring the maximum indicated IVC diameter. They are spaced at a distance of 28mm (outer-to-outer). The 55cm, 8.4 French I.D. introducer sheath contains a radiopaque marker and hemostasis valve with a side port. The pusher advances the filter through the introducer sheath to the predeployment mark and is then used to fix the filter in place while the filter is unsheathed.

This document, K240257, pertains to a 510(k) premarket notification for the "Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit." It explicitly states that no changes have been made to the subject Denali™ Filter or Delivery System and that no performance testing was performed. The purpose of the submission is solely to update the Instructions for Use (IFU) for inclusion of the PRESERVE study summary data.

Therefore, there is no information in this document regarding new acceptance criteria for the device or a study performed to prove the device meets new acceptance criteria. The approval is based on the substantial equivalence to a predicate device (K160866) and the clinical testing previously provided to the FDA under an Investigational Device Exemption.

As the request asks to describe the acceptance criteria and the study that proves the device meets the criteria, and this document states no new testing was performed, I cannot provide the requested information from this document.

Summary of available information:

• No new acceptance criteria or device performance reported in this document. The submission focuses on updating the Instructions for Use with summary data from the PRESERVE study, which was previously conducted for the predicate device.
• No new studies were conducted for this submission. The document explicitly states: "Therefore, no performance testing was performed." and "The clinical testing was previously provided to FDA under the Investigational Device Exemption."

All other questions regarding sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, and training set details are not applicable or cannot be answered from the provided text, as no new studies or performance evaluations were conducted for this 510(k) 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 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 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 Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, in the following situations:

· Pulmonary thromboembolism when anticoagulants are contraindicated;

· Failure of anticoagulant therapy in thromboembolic diseases;

· Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.

The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE.

The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr).

The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by six Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall.

This 510(k) is submitted to support a change to the design and manufacturing process for the Introducer Sheath of the Delivery System.

The provided text is a 510(k) summary for the Sentry Inferior Vena Cava Filter, specifically concerning a modification to its Introducer Sheath. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets clinical acceptance criteria for its intended use through human studies.

Therefore, the information required to answer your prompt, particularly regarding multi-reader multi-case (MRMC) studies, expert ground truth, and comprehensive performance data for an AI/algorithm-based device, is not available in this document. This document describes a medical device, an IVC filter, which is a physical implant used to prevent pulmonary embolism, not a diagnostic AI or imaging device that would typically undergo the types of studies you are asking about.

However, I can extract the acceptance criteria and performance data for the specific modification described in this 510(k) submission:

The acceptance criteria here pertain to the Introducer Sheath of the delivery system, not the filter itself or its clinical efficacy in preventing PE. The study proves the modified Introducer Sheath functions equivalently to the previous version.

Here's what can be extracted from the provided text regarding the Acceptance Criteria and the study for the modified Introducer Sheath:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document confirms that all tests "met the pre-determined acceptance criteria," but it does not specify the quantitative values for these criteria (e.g., specific pressure limits for integrity, flow rates for patency) or the exact numerical results obtained.

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

• Sample Size: Not explicitly stated. The document refers to "Bench studies" and "design verification program," implying a laboratory setting with test articles.
• Data Provenance: The studies were undertaken as part of Novate Medical Ltd.'s design verification program. Location is likely Ireland, where the submitter is based. The data is prospective in the sense that it was generated specifically for this submission to assess the design modification.

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

Not applicable. This is a physical device modification, and the "ground truth" for its performance (integrity, patency) would be established through engineering specifications and objective measurements, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Performance was assessed via objective bench testing against pre-determined engineering specifications.

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

No. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. This document describes a physical medical device.

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

Not applicable. This is a physical medical device, not an algorithm. Bench tests were performed on the device itself.

7. The Type of Ground Truth Used

The ground truth was based on engineering specifications and measurable physical properties (e.g., material strength, dimensions, fluid flow characteristics) of the Introducer Sheath.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a physical device modification and bench testing for substantial equivalence.

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

Not applicable.

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The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, in the following situations:

· Pulmonary thromboembolism when anticoagulants are contraindicated;

· Failure of anticoagulant therapy in thromboembolic diseases;

· Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.

The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE.

The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr).

The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by 6 Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall.

Here's an analysis of the provided text regarding the Sentry Inferior Vena Cava Filter's acceptance criteria and the study proving its compliance, framed within your requested structure.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's comprehensive clinical trial results. Therefore, details regarding extensive clinical studies with specific performance metrics against pre-defined acceptance criteria (especially for a new AI/software device, which this is not) are limited. The information primarily pertains to bench testing and biocompatibility.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various evaluations performed but does not explicitly state quantitative acceptance criteria or specific performance values for the modified Sentry IVC Filter. It generally states that "All tests met the pre-determined acceptance criteria." and that "Test results demonstrate that the modified device meets the established specifications and is comparable to the predicate device."

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

• Test Set Sample Size: The document does not specify the exact sample sizes for each bench test conducted. It generally refers to "bench studies" and "design verification results."
• Data Provenance: The data is generated from bench studies and biocompatibility evaluations within the context of the manufacturer's design verification and validation program. This is not human patient data. There is no mention of country of origin for this testing, but the submitting company is based in Galway, Ireland, implying the testing was likely overseen by them or conducted by their chosen labs. The data is retrospective in the sense that the testing was performed to validate a modified device against pre-existing standards.

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

• This question is not applicable in the context of this 510(k) summary. The document describes bench testing and biocompatibility studies for a physical medical device (Inferior Vena Cava Filter), not an AI/software device that requires expert-established ground truth from images or clinical data. The "ground truth" for these tests would be the physical properties and performance measured against engineering specifications, often established by engineers and scientists, not clinical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical trials or studies where multiple human readers interpret data, and discrepancies need to be resolved to establish a gold standard. The tests mentioned here are primarily objective, quantitative engineering and laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

• This question is not applicable. The device is a physical medical implant (an IVC filter), not an AI system. Therefore, no MRMC study or AI-assisted human reader improvement analysis would have been conducted or applicable for this type of device.

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

• This question is not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For bench testing, the "ground truth" refers to pre-established engineering specifications, material properties, and performance standards (e.g., specific dimensions, fatigue limits, corrosion resistance measured in a lab, and successful deployment as per design).
• For biocompatibility, the ground truth is based on international standards (ISO 10993 series) and regulatory guidance from the FDA, evaluating the biological response of materials.

8. The Sample Size for the Training Set

• This question is not applicable. This refers to 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 question is not applicable, as there is no training set for a physical medical 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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