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EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.

EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.

The provided text is an FDA 510(k) summary for a medical device called the EMBOGUARD™ Balloon Guide Catheter (K233924). This document primarily focuses on establishing "substantial equivalence" of the new device to a previously cleared predicate device (K212340), rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance metrics for AI/software.

The context of your request seems to imply the device might be an AI or software-based product given your detailed prompts about MRMC studies, ground truth, and expert adjudication. However, this FDA submission is for a physical medical device (catheter) and not an AI or software device. Therefore, many of the specific questions you've asked (e.g., sample size for test/training sets for AI, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of device submission.

The "acceptance criteria" discussed in this document relate to bench testing, biocompatibility, and sterilization to demonstrate that the modified physical device performs as safely and effectively as its predicate.

Based on the provided text, here's what information is available and how it aligns (or doesn't align) with your request:

Device Type: Physical Medical Device (Balloon Guide Catheter), not an AI/software device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests with "Pass" results, indicating adherence to pre-determined acceptance criteria. However, quantitative acceptance criteria are generally not explicitly stated with specific numerical values in this summary, but rather implied by meeting internal specifications or relevant standards.

Here's a summary of the performance categories and their reported outcomes:

Note on Quantitative Data: For most bench tests, the summary states "All samples met the pre-determined acceptance criteria." without providing the specific numerical criteria or the actual measured values. For "Kink to Failure" and "Particulates", it's noted as "Characterization only" or "found comparable," indicating that precise numerical "pass/fail" limits might not have been applied as rigorously as for other tests, but rather assessed for equivalence to the predicate.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the summary for each individual test. The document mentions "All samples" for the bench tests, implying a sufficient number were tested per internal protocols and relevant standards. For biocompatibility, it refers to standard test methods where sample sizes are typically defined by those standards.
• Data Provenance: Not applicable in the context of patient data. The "data" here comes from laboratory bench testing and biological assays conducted according to established protocols and standards. The testing was conducted by or for Neuravi Ltd., based in Ireland.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This is a physical device, not an AI/software system requiring expert interpretation of medical images. Ground truth for its performance is established through physical measurements, chemical assays, and mechanical tests according to engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not Applicable: There is no "adjudication" in the sense of multiple human readers independently evaluating data for consensus, as would be done for an AI/software device. Performance is determined by objective measurements against predefined engineering specifications and biological safety limits.

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

• No: This type of study is relevant for AI/software devices that assist human interpretation of medical data. It is not applicable to a physical catheter.

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

• Not Applicable: As stated, this is a physical medical device, not an algorithm.

7. The type of ground truth used

• Physical/Chemical Standards and Measurements: For biocompatibility, ground truth is based on established biological responses (e.g., cell viability for cytotoxicity, skin reaction for irritation, blood parameters for hemolysis) as defined by ISO 10993 series standards. For bench testing, ground truth is based on engineering specifications and mechanical properties (e.g., measured burst pressure, inflation time, pull strength, visual inspection against defects).

8. The sample size for the training set

• Not Applicable: This is not an AI/software device that requires a training set. The device itself is manufactured, not "trained."

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

• Not Applicable: No training set or ground truth in the context of machine learning. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory standards for medical devices.

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