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The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0 mm.

The FiberNet Embolic Protection System consists of a fiber filter on a 0.014" guide wire with attachable actuator tool and a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer and a 40µm cell strainer cup.

The provided text describes a 510(k) summary for the FiberNet® Embolic Protection System. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility analysis, rather than setting specific performance acceptance criteria for a new clinical study or providing detailed results from such a study.

Therefore, many of the requested points regarding acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone), and ground truth establishment for a new device performance study cannot be directly extracted from this document as it details a regulatory submission based on equivalence testing.

However, I can provide the information that is present:

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

The document doesn't explicitly state quantitative acceptance criteria for each bench test, nor does it provide numerical results. Instead, it asserts that "The results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device."

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

This document describes a pre-market submission based on bench testing and biocompatibility to establish substantial equivalence. It does not involve a clinical test set with human patients. Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This was bench and biocompatibility testing, not human-read clinical data.

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

Not applicable. This was bench and biocompatibility testing, not human-read clinical data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document is for an embolic protection system, not an AI-assisted diagnostic device, and no MRMC study is mentioned.

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

Not applicable. This document is for a medical device that physically captures embolic material, not an AI algorithm.

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

For the bench testing, the "ground truth" would be established by standardized engineering measurements and defined performance specifications, often relative to the predicate device. For biocompatibility testing, the ground truth is established by recognized standards and scientific principles for assessing biological responses to materials.

8. The sample size for the training set:

Not applicable. This document describes testing for a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device submission.

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The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0mm.

The system consists of a fiber filter on a 0.014" guidewire with attachable actuator tool (capture wire) and a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529). System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40µm cell strainer cup.

Here's an analysis of the provided information regarding the FiberNet® Embolic Protection System and its acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria with specific thresholds for the FiberNet® Embolic Protection System. Instead, it refers to meeting a "performance goal based on ARCHeR3."

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

• Test Set Sample Size: The document does not explicitly state the exact sample size (number of patients) in the clinical study (EPIC Trial).
• Data Provenance: The EPIC Trial was a "non-randomized multi-center study." This indicates that the data was collected prospectively from multiple clinical sites. The country of origin is not specified, but typically for FDA submissions, studies are either conducted in the US or in countries with comparable regulatory and ethical standards.

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the EPIC Trial. Clinical studies for such devices typically involve expert clinicians (e.g., interventional cardiologists, vascular surgeons) for patient selection, procedure performance, and outcome assessment, but the document does not specify a separate "ground truth" establishment process by a distinct panel of experts.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set in the clinical study. Clinical trials typically have independent clinical events committees (CECs) to adjudicate adverse events, but this is not explicitly detailed here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described (EPIC Trial) focused on the safety and performance of the FiberNet EPS itself, comparing its performance against a statistical performance goal derived from a predicate study (ARCHeR3), not a comparison between human readers with and without AI assistance or any multi-reader setup involving different interpretations.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the FiberNet® Embolic Protection System. This is a medical device (physical product), not an artificial intelligence algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

Given that this is a clinical trial for a physical medical device, the "ground truth" would be based on:

• Clinical Outcomes: Observed patient outcomes related to device safety (e.g., adverse events, stroke rates) and performance (e.g., successful embolic material capture and removal, procedural success).
• Imaging Interpretation: For assessing device placement and effectiveness, imaging (angiography, ultrasound) would be used, interpreted by the treating physicians and potentially reviewed by an independent core lab, though specifics are not provided.
• Pathology/Histology: If embolic material was retrieved, it would likely be sent for pathological analysis, but the document does not elaborate on this.

The primary "ground truth" for the overall device performance would be the clinically observed event rates and outcomes in the study population.

8. Sample Size for the Training Set

This question is not applicable as the FiberNet® Embolic Protection System is a physical medical device, not an AI/software product requiring a "training set." The clinical study (EPIC Trial) serves as the primary evidence for its safety and effectiveness.

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

This question is not applicable, as there is no "training set" for this physical medical device.

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The LBI Embolectomy System is indicated for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

The system consists of a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529) and a fiber element on a 0.014" guide wire with attachable actuator tool. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40um cell strainer cup.

The provided text is a 510(k) premarket notification summary for the LBI Embolectomy System. It does not describe an AI/ML medical device, nor does it contain information about clinical studies with acceptance criteria, sample sizes, expert involvement, or comparative effectiveness with human readers.

Therefore, I cannot fulfill your request for this specific document.

The document discusses the substantial equivalence of the LBI Embolectomy System to legally marketed predicate devices, focusing on:

• Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
• Device Description: A 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly and a fiber element on a 0.014" guidewire with an attachable actuator tool, along with accessories.
• Safety & Performance: Demonstrated through comparison to predicate devices, biocompatibility testing, in vitro testing, and animal testing.

No information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance metrics (e.g., sensitivity, specificity, AUC) is present.

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The Xtract® Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The Xtract Catheter System consists of one (1) Catheter, one (1) Extension Tube with Stopcock, two (2) 30cc Aspiration Syringes, and one (1) 40µm Strainer. The catheter is a single-use, 0.014" guidewire compatible, temporary intravascular extraction and aspiration catheter. It has a distal radiopaque tip marker, a varying stiffness shaft, a rapid exchange port, and a proximal luer-lock hub.

The provided text is a 510(k) summary for the Xtract Catheter System, detailing its intended use and a comparison to a predicate device for substantial equivalence. It does not contain information about a study proving device performance against specific acceptance criteria. The summary states that "The results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device," but it does not describe the specific acceptance criteria, study design, or its results in detail.

Therefore, I cannot provide the requested table or detailed study information based on the provided document.

To directly address the prompts based on the available information:

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

• Acceptance Criteria: Not specified in the provided document. The document states that "the results of the in vitro bench and biocompatibility testing demonstrated the system is equivalent to the predicate device." This implies that the acceptance criteria were based on demonstrating equivalence to the predicate device (LBI Aspiration Catheter, K053372) rather than explicit performance metrics.
• Reported Device Performance: Not detailed in the provided document. The document only states that the in vitro bench and biocompatibility testing confirmed equivalence to the predicate device.

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

• Not specified in the provided document. The document only mentions "in vitro bench and biocompatibility testing," without detailing sample sizes, data provenance, or study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as the document describes bench and biocompatibility testing, not clinical studies involving expert interpretation or ground truth establishment in a diagnostic context.

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

• Not applicable for the type of testing described (bench and biocompatibility).

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. The Xtract Catheter System is a medical device (catheter), not an AI-powered diagnostic tool. The document does not describe any MRMC studies.

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

• Not applicable. The Xtract Catheter System is a medical device, not an algorithm.

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

• Not applicable. The document describes in vitro bench and biocompatibility testing, where "ground truth" would be defined by engineering specifications and biological response standards, not clinical diagnostic ground truth methods.

8. The sample size for the training set

• Not applicable. The document describes testing for a medical device's equivalence to a predicate, not an AI model's training.

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

• Not applicable. See point 8.

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The LBI Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The Lumen Biomedical Inc. (LBI) Xtract™ Catheter System is a single-use, 0.014" guidewire compatible, temporary intravascular extraction and aspiration catheter system. It has a distal radiopaque tip marker, a varying stiffness shaft, a rapid exchange port, and a proximal luer-lock hub. The system consists of one (1) Catheter, one (1) Extension Tube with Stopcock, two (2) 30cc Aspiration Syringes, and one (1) 40um Strainer.

The provided text describes a 510(k) submission for the LBI Catheter System (also referred to as Xtract™ Catheter System) and mentions that in vitro bench, biocompatibility, and animal tests were conducted to demonstrate substantial equivalence to predicate devices. However, the document does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria, especially in terms of clinical performance or effectiveness.

It primarily focuses on compliance with standards and the claim of substantial equivalence for safety and performance based on these types of tests, rather than clinical efficacy.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or clinical performance comparisons (like MRMC studies) is not available in the provided text.

Here's an attempt to answer the questions based only on the information available:

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

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

• Sample size for test set: Not specified. The document mentions in vitro bench tests and animal tests, but not the number of samples or animals used.
• Data provenance: The tests mentioned are in vitro (bench) and animal, implying a pre-clinical setting. Country of origin not specified, but the manufacturer is in Plymouth, MN, USA. The study type mentioned (bench, animal) indicates prospective testing specific to the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. The tests mentioned are physical (bench) and animal, not reliant on expert review for ground truth in the way a clinical imaging study would be.

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

• Not applicable/Not specified. The tests mentioned are physical (bench) and animal, not involving human interpretation for adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done or mentioned. This device is a catheter system, not an AI diagnostic tool.

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

• Not applicable/Not specified. This is a medical device (catheter), not an algorithm.

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

• For the in vitro bench tests, ground truth would be based on engineering specifications, physical measurements, and performance standards outlined in ISO and ASTM documents.
• For the animal tests, ground truth would be based on physiological responses, tissue analysis, and direct observation of the device's performance within the animal model, observed against pre-defined success criteria for the procedure.
• No human clinical outcomes or pathology data are mentioned for establishing ground truth in this document.

8. The sample size for the training set

• Not applicable/Not specified. This is a medical device, not an AI model requiring a training set in the conventional sense.

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

• Not applicable/Not specified. As it's not an AI model, a training set and its ground truth are not relevant in this context.

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