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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 < X CFU," "friction < Y N") or detailed qualitative (e.g., "no visible particulates," "coating remained intact after Z cycles") acceptance criteria or the measured performance values.

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

• Sample Size: Not specified in the provided text. The document lists types of tests but not the number of units or samples tested for each.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

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

• This information is not provided as the document focuses on engineering and biocompatibility testing of a medical device, not diagnostic performance or interpretation by experts. Ground truth, in this context, would typically refer to objective measurements from laboratory tests rather than expert consensus on clinical data.

4. Adjudication method for the test set

• This information is not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple experts independently review data and then reconcile differences, which is not described here.

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

• No MRMC study was mentioned or implied. The device (Embolic Protection System) is a physical medical device designed to capture embolic material, not an AI-powered diagnostic tool that assists human readers. Therefore, this question is not applicable to the provided context.

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

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

7. The type of ground truth used

• For the performance tests listed (e.g., Bioburden, Coating Integrity, Biocompatibility), the "ground truth" would be established by objective laboratory measurements and validated test methods (e.g., ISO standards). For example, for bioburden, the ground truth is the measured microbial load, compared against predefined acceptable limits. For coating integrity, it's the physical observation and measurement of the coating after stress, compared against engineering specifications. No clinical outcomes data or pathology reviews are mentioned for these specific performance tests.

8. The sample size for the training set

• Not applicable. The device 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 is relevant for this type of device.

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