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LC Bead Microspheres & Bead Block™ Compressible Microspheres is intended for embolization of hypervascular tumors and arteriovenous malformations.

LC Bead and Bead Block™ Compressible Microspheres are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). LC Bead and Bead Block ™ Compressible Microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. Bead Block™ Compressible Microspheres is dyed blue (LC Bead are available in natural color) to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.

LC Bead Microspheres is supplied sterile and packaged in sealed glass vials. Bead Block™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL LC Bead /Bead Block™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL, and (2) 2.0mL LC Bead/Bead Block™ Compressible Microspheres in sterile PBS to a volume of 8 mL.

LC Bead and Bead Block Compressible Microspheres are supplied in several unit sizes covering the range from 100um to 1200um diameter.

At the time of use, LC Bead/Bead Block™ Compressible Microspheres is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.

The provided text describes the 510(k) submission for "Bead Block and LC Bead" microspheres. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically seen for AI/ML-driven devices (e.g., sensitivity, specificity, or reader study results). This submission is for a medical device (embolic microspheres), not a diagnostic algorithm or AI system.

Therefore, most of the requested information regarding acceptance criteria and study details (like sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this particular document.

Here's an attempt to address the request based only on the provided text, while highlighting the limitations:

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

The document lists "Performance Standards" which are primarily regulatory and quality standards for medical devices, rather than specific numerical performance metrics related to diagnostic accuracy or efficacy in the way an AI/ML device would be evaluated.

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

This information is not provided in the document. The document describes a medical device (microspheres) and its regulatory submission, not a study involving a test set of data for an AI/ML algorithm. The "Performance Standards" listed are for the device itself (biocompatibility, sterilization, etc.), not for evaluating an algorithm's performance on a dataset.

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 information is not provided and is not applicable to the type of device described. Ground truth for an AI/ML test set would involve expert annotations or pathology, which is not relevant for the regulatory approval of embolic microspheres based on biocompatibility and manufacturing standards.

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

This information is not provided and is not applicable.

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

This information is not provided and is not applicable. MRMC studies are typically for evaluating the impact of AI/ML systems on human reader performance, which is not the subject of this 510(k) submission.

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

This information is not provided and is not applicable. The device is a physical medical product (microspheres), not an algorithm.

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

For the device itself, the "ground truth" would relate to its physical and biological properties meeting established standards (e.g., sterility confirmed by lab tests, biocompatibility confirmed by in-vitro/in-vivo studies, particle size confirmed by measurement). The document references various ISO/EN standards which would implicitly define the "ground truth" for compliance. There is no mention of expert consensus, pathology, or outcomes data in the context of proving the device meets acceptance criteria as would be relevant for an AI/ML system.

8. The sample size for the training set

This information is not provided and is not applicable. This is not an AI/ML device.

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

This information is not provided and is not applicable.

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