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

LC Bead/Bead Block 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/Bead Block consists 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 is dyed blue (LC Bead are available as blue and 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 is supplied sterile and packaged in sealed glass vials. Bead Block is supplied sterile and packaged in polycarbonate syringes. The product configurations are described in the table. LC Bead/Bead Block are supplied in several unit sizes covering the range from 100-1200um diameter. At the time of use, LC Bead/Bead Block is mixed with a nonionic contrast agent, e.g. Omnipaque™, to make a 30-50% by weight solution.

The provided text describes the LC Bead/Bead Block Embolic Agent, a vascular embolization device, and includes information relevant to its acceptance criteria and the studies conducted to demonstrate its performance.

Acceptance Criteria and Device Performance

The acceptance criteria for the LC Bead/Bead Block devices are primarily defined by successful outcomes in various biocompatibility tests, in-vitro physical property tests, and pre-clinical animal model performance, all demonstrating substantial equivalence to predicate devices and adherence to relevant standards.

Here's a table summarizing the acceptance criteria and the reported device performance based on the provided document:

Study Details

The primary study mentioned to demonstrate device performance is a pre-clinical evaluation in a swine model and various in-vitro and biocompatibility tests.

2. Sample Size and Data Provenance

• Test Set (Pre-clinical Swine Model):
  • Sample Size: LC Bead Embolic Agent (n=36) and Embosphere® microspheres (n=36). Total of 72 cases.
  • Data Provenance: Prospective animal study (swine model), likely conducted in a controlled laboratory setting. The country of origin is not specified but assumed to be within the regulatory framework of the submitting company (UK) or a contracted research organization.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not specify the number or qualifications of experts used to establish a "ground truth" in the clinical sense for the animal study. The evaluation appears to be based on direct observations and pathological analyses rather than expert consensus on diagnostic images. Outcomes assessed include recanalization, tissue reactions, ease of delivery, rupture, and migration. These would typically be evaluated by a team of veterinary surgeons, pathologists, and potentially radiologists, but their specific qualifications are not detailed.

4. Adjudication Method (Test Set)

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the pre-clinical swine study outcomes. The assessment appears to be based on direct measurement and observation by the study investigators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study involving human readers or AI assistance is described. This device is a physical embolization device, not an AI software or diagnostic tool that would typically involve such a study with human readers interpreting images.

6. Standalone Performance Study

The "pre-clinical testing in a large animal model" and the "in-vitro testing" sections describe studies of the device's standalone performance. These are intended to demonstrate the device's intrinsic characteristics and biological safety without human interaction beyond its intended use (delivery by a clinician).

7. Type of Ground Truth Used for Test Set

• Pre-clinical Swine Model: The ground truth was established through direct observation during procedures (e.g., ease of delivery, vessel rupture), gross pathological examination (e.g., non-target embolization, device migration), and histological analysis of explanted tissues (e.g., recanalization, local and systemic foreign body tissue reactions).
• Biocompatibility Tests: Laboratory assays and animal studies according to ISO standards, providing biological and toxicological endpoints.
• In-vitro testing: Direct physical measurements and observations of device properties (e.g., size distribution, compressibility, catheter deliverability, residual materials).

8. Sample Size for the Training Set

The document does not mention a training set. This is because the device is a physical medical device, not a machine learning or AI algorithm that requires a training set. The performance data presented are from verification and validation studies.

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

Not applicable, as no training set for an AI/ML algorithm is described.

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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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