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The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the site of the Filtration Element should be between 2.5 and 7.0 mm.

The Emboshield NAVO Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during interventional procedures within carotid arteries or atherectomy in the arterial vasculature of the lower extremity. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element and RX Retrieval Catheter and ancillary items which include loading funnel, flushing syringes, introducer tool and torque devices.

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

Important Note: The provided text is a 510(k) summary for a medical device (Embolic Protection System), not an AI/ML device. Therefore, many of the requested categories related to AI model development, such as training sets, expert adjudication of ground truth, and MRMC studies, are not directly applicable or discussed in this document. The focus of this submission is on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and clinical data on safety and efficacy in an expanded indication for use.

Acceptance Criteria and Device Performance for Emboshield NAV6 Embolic Protection System (K191173)

1. Table of Acceptance Criteria and Reported Device Performance

• Deployment and Retrieval Force
• Simulated Use | The assessment concluded these tests should be performed, and the overall conclusion states the device met all acceptance criteria. (Specific pass/fail results for individual non-clinical tests are not detailed in this summary.) |
  | Technological Equivalence | Show substantial equivalence to predicate in:
• Intended Use
• System Components
• Technological Characteristics
• Sterilization
• Materials and Biocompatibility | "The conclusion of the comparison analysis is that the subject Emboshield NAV6 EPS is substantially equivalent to the predicate device." |
  | Safety - Filter Specific | Low occurrence of events directly reflecting filter performance (distal embolization, perforation at filter level, unplanned amputation) | One case of distal embolization, no cases of perforation at the level of the filter, and no unplanned amputations among MAEs. |
  | Overall Safety & Effectiveness | No new safety or effectiveness issues raised. | "The clinical and non-clinical data demonstrate that the subject Emboshield NAV6 EPS met all acceptance criteria and performed similarly to the predicate device and that no new safety or effectiveness issues were raised." |

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

• Sample Size for Clinical Study: n=162 patients.
• Data Provenance: Retrospective clinical data from a "real-world population" of peripheral arterial disease (PAD) patients treated at the Mount Sinai Health Center (USA, implied by FDA submission context, though not explicitly stated as country of origin). The data represents routine clinical practice.

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

• This document does not describe the use of experts to establish a "ground truth" for the clinical test set in the way it would be for an AI/ML diagnostic device. The clinical outcomes (MAE) were observed clinical events, not interpretations by experts for the purpose of a ground truth.
• The MAE definition is a composite of clinical events (death, MI, thrombosis, dissection, distal embolization, perforation, unplanned amputation, TVR). These are typically determined by clinical observation and data collection according to study protocols, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

• Not applicable in the context of this device. The clinical events (MAE) are observed outcomes, not interpretations requiring adjudication.

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

• Not applicable. This is not an AI/ML device. The study evaluates the performance of a medical device (embolic protection system) in a clinical setting, not how human readers' diagnostic accuracy changes with AI assistance.

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

• Not applicable. This is not an AI/ML algorithm. The device's performance is measured in its intended use during a clinical procedure.

7. The Type of Ground Truth Used

• The "ground truth" for the clinical study was the occurrence or non-occurrence of predefined clinical events (Major Adverse Events - MAE) in real-world patients. This can be considered a form of "outcomes data."
• For non-clinical testing, the "ground truth" relies on predefined engineering specifications and simulated use outcomes.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device or an algorithm that requires a "training set" in the machine learning sense. The clinical data was used to demonstrate the device's performance in a real-world setting.

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

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

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The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.

The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.

The provided text describes a 510(k) summary for the Emboshield NAV6 Embolic Protection System. It outlines the device description, its intended use, a comparison to predicate devices, and a list of performance tests conducted. However, it does not include information about acceptance criteria, specific study results demonstrating device performance against those criteria, or details regarding ground truth, expert involvement, or multi-reader studies.

The "Performance Data" section lists various tests performed (e.g., Bioburden Testing, Wire Movement, Coating Integrity, Particulate Testing, Biocompatibility). While these tests were "successfully completed," the document does not report specific metrics or thresholds that define "successful completion" for each test. Consequently, it's impossible to create a table of acceptance criteria and reported performance with quantitative data based on the provided text.

Here's an analysis of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text only states that these tests were "successfully completed." It does not provide any specific quantitative (e.g., "bioburden

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The Emboshield NAV6 Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.

The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.

The provided text describes a 510(k) summary for the Emboshield NAV® Embolic Protection System. It outlines the device description, its intended use, and states that a modification was made to the adhesive used for a radiopaque marker on the delivery catheter. The document then lists performance tests conducted to demonstrate substantial equivalence to predicate devices.

However, the provided text does not contain the detailed acceptance criteria for specific performance metrics, nor does it present a study that directly proves the device meets those criteria in the typical format of a clinical trial or algorithm performance study.

The "Performance Data" section merely lists the types of tests conducted (biocompatibility and tensile testing for marker band integrity). It does not provide:

• Quantitative acceptance criteria (e.g., "tensile strength must exceed X N with a P-value

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The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the Filtration Element placement should be between 2.5 and 7.0 mm.

The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Emboshield NAV6 Embolic Protection System:

This document describes a 510(k) submission for a medical device. It does not contain information about acceptance criteria or a study proving acceptance criteria related to AI/algorithm performance. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices through bench testing, biocompatibility, sterilization, and aging data.

Therefore, many of the requested categories related to AI/algorithm performance studies cannot be filled from the provided text.

Here's what can be extracted and inferred:

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

Based on the provided text, the "acceptance criteria" are implied by successful completion of various performance tests to demonstrate substantial equivalence to predicate devices. There are no specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) explicitly stated for the device's emboli capture effectiveness or other clinical outcomes, as this is a traditional medical device, not an AI/software device.

2. Sample sized 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 in the provided text for any of the performance tests. These are likely bench tests using a number of device units.
• Data provenance: Not specified. Given the nature of the tests (bench, biocompatibility, sterilization, aging), they would typically be conducted in a laboratory setting.

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

• Not applicable. This device is a physical medical device, not an AI/imaging device requiring expert ground truth for a test set. The "ground truth" for its performance is determined by established engineering and biological testing methods.

4. Adjudication method for the test set

• Not applicable. This is not a study requiring adjudication of expert interpretations for a test set.

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

• No. This is not an AI-assisted device, and no MRMC study is mentioned.

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

• No. This is not an algorithm, but a physical medical device.

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

• Bench test results, biological assays, engineering measurements. The "ground truth" for this device's performance is derived from the objective results of the various performance tests listed (e.g., cytotoxicity assays, tensile strength measurements, flow dynamics, sterility tests).

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

• Not applicable.

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Ask a specific question about this device

The Emboshield® Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.

The Emboshield NAV6 Embolic Protection System is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: Bare Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.

The provided text describes a 510(k) premarket notification for the Emboshield NAV6 Embolic Protection System. It outlines the device's intended use and design, and summarizes the substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria or provide a detailed study report proving the device meets specific performance criteria beyond general statements of safety and performance.

Thus, a direct answer to the request to populate the table with "acceptance criteria" and "reported device performance" is not possible from the provided text, as these specific metrics are not present. Similarly, details for most of the other questions are either not provided or only vaguely mentioned.

Here's an analysis of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Provided in the Text. The document states:

• "Results of testing have demonstrated that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
• "In vitro and in vivo testing was conducted."
• "The PROTECT Study was conducted enrolling a total of two hundred and twenty (220) patients at 34 sites."
• "In summary, the results of the testing and clinical study support the safety and performance of the Emboshield NAV6 device and its components for the intended indication when used in accordance with the Instructions for Use."

These are general conclusions, not specific quantitative acceptance criteria or reported performance metrics.

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

• Sample size for the test set: 220 patients (from the PROTECT Study).
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective outside of "clinical study"), but given it's a 510(k) submission to the US FDA, it likely includes US data, potentially multi-national given "34 sites". The study was "conducted," implying prospective collection for the clinical study.

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

Information Not Provided in the Text.

4. Adjudication method for the test set

Information Not Provided in the Text.

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

The device is an Embolic Protection System (a physical medical device, not an AI or imaging diagnostic tool). Therefore, an MRMC comparative effectiveness study involving human readers (typically associated with AI/imaging for diagnosis/detection) is not applicable to this type of device. The "PROTECT Study" seems to be a clinical trial for the device's safety and performance in patients, not an AI efficacy study.

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

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

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

For the PROTECT Study (clinical trial): It can be inferred that outcomes data (related to safety and efficacy in removing embolic material during carotid procedures) would be the primary ground truth. Specific details on how "embolic material" removal or "protection" was quantified and verified are not provided.

8. The sample size for the training set

Not applicable. This is 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 above, no training set for a physical device.

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