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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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GelSpheres™/Bead Block™ Compressible Microspheres are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's).

GelSpheres™ 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). GelSpheres™ 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 (GelSpheres™ 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.

GelSpheres ™ 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 GelSpheres™ /Bead Block™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL, and (2) 2.0mL GelSpheres™/Bead Block™ Compressible Microspheres in sterile PBS to a volume of 8 mL.

GelSpheres™ and Bead Block Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200um diameter. At the time of use, GelSpheres"™/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 FDA 510(k) Pre-Market Notification for GelSpheres™ Microspheres and Bead Block™ Compressible Microspheres does not describe a study that uses acceptance criteria related to device performance metrics, nor does it report on such performance metrics for the device itself.

Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K023089 and K033761). The core of the submission is that the current device (K042231) is identical in design, intended use, warnings, contraindications, product, manufacturing, and primary packaging to the predicates. The only reported change is the final packager from BioCure, Inc. to Biocompatibles UK Ltd.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in this document.

The document lists Performance Standards that the device meets, but these are generic regulatory and biological evaluation standards, not specific performance metrics (e.g., accuracy, sensitivity, specificity) for evaluating its efficacy in embolization. These standards ensure the device meets safety and manufacturing requirements, but not a clinical performance standard regarding, for example, the success rate of embolization or reduction in tumor size.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable. No performance metrics (e.g., embolization success rate, AVM reduction) or associated acceptance criteria are stated or evaluated in this document. The "acceptance criteria" here are implied to be meeting the listed performance standards (e.g., ISO, AAMI for biocompatibility, sterility, packaging), and the "device performance" is deemed equivalent to the predicate devices.

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical or performance test set data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for performance evaluation is established or discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This device is a medical implant (microspheres for embolization), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence based on design and intended use rather than presenting new clinical or performance data against pre-defined acceptance criteria for efficacy. The "study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission process, which asserts equivalence and compliance with general safety and performance standards rather than specific performance metrics directly related to its therapeutic effect.

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GelSpheres™ Compressible Microsphere and BeadBlock™ Compressible Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.

GelSpheres™ and BeadBlock™ 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). GelSpheres™ and BeadBlock 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. GelSpheres™ and BeadBlock Compressible Microspheres is dyed blue 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.

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

GelSpheres™ and BeadBlock Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200μm diameter. At the time of use, GelSpheres™/BeadBlock™ 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.

Biocompatibles UK Ltd.'s submission for GelSpheres™ Compressible Microspheres and BeadBlock™ Compressible Microspheres is a 510(k) pre-market notification, which largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting a new clinical study to establish performance from scratch.

Therefore, the document explicitly states: "The Intended Use of GelSpheres™/BeadBlock™ Compressible Microspheres and the predicate device are the same and unchanged other than product names. This pre-market notification addresses the change of the final packager from Biocure, inc to Biocompatibles UK LTD." and "There are more similarities than differences when comparing Biocompatibles, GelSpheres ™/BeadBlock™ to the predicate devices."

This means the submission does not contain a new, comprehensive clinical study with specific acceptance criteria directly assessing the device's clinical performance in the way a de novo device or a device with new indications would. Instead, the acceptance criteria are largely met by demonstrating adherence to established performance standards and equivalence to a device (K023089) that has already proven its safety and effectiveness.

Here's an breakdown based on the provided text, noting where specific information requested is not present in a 510(k) of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable for a 510(k) focused on a packaging change and substantial equivalence. There is no specific "test set" of patient data presented or analyzed for clinical performance in this submission. The demonstration of safety and effectiveness relies on the predicate device's existing data and the new device's adherence to relevant standards for physical and biological properties.

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

Not applicable. No new clinical test set requiring expert ground truth establishment is presented in this 510(k). The clinical efficacy is leveraged from the predicate device.

4. Adjudication method for the test set

Not applicable. No new clinical test set is presented.

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 device is an embolization agent, not an AI-powered diagnostic tool.

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

Not applicable. This device is an embolization agent, not an algorithm.

7. The type of ground truth used

For the purpose of this 510(k), the "ground truth" for the device's safety and effectiveness is largely based on:

• The established safety and efficacy profile of the predicate device (K023089).
• Adherence to recognized national and international performance standards (e.g., ISO, AAMI, FDA Guidance) for medical devices, particularly regarding biocompatibility, sterility, and manufacturing quality.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of device performance testing for this 510(k). Performance is established through physical, chemical, and biological testing against standards, and by demonstrating equivalence to a legally marketed predicate device.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or justification for meeting acceptance criteria in this 510(k) is a comparative analysis and documentation of adherence to recognized standards and guidance.

• Comparative Analysis: The core of the submission is a comparison stating, "There are more similarities than differences between the predicate device and the Biocompatibles GelSpheres™/BeadBlock™ Compressible Microspheres. The product and primary packaging are identical and unchanged from K023089. The predicate device and GelSpheres™/BeadBlock™ Compressible Microspheres have the same intended use, warnings and contraindications. The predicate device and GelSpheres™/BeadBlock™ Compressible Microspheres are identical in design, and unchanged from K023089." This establishes that because the new device is essentially the same as the predicate (which has already been, or its clinical performance has been, demonstrated to the FDA), it can be considered safe and effective for the stated indications. The only change highlighted is the final packager.
• Adherence to Performance Standards: The submission also lists numerous ISO, EN, AAMI standards, and FDA guidance documents that the device "meets." These standards cover aspects like biological evaluation (biocompatibility, genotoxicity, systemic toxicity, local effects), packaging, and sterilization. By conforming to these standards, the manufacturer demonstrates that the device meets generally accepted criteria for safety and performance in its physical and biological characteristics.

In essence, the device's acceptance is based on its substantial equivalence to a previously cleared device and its compliance with a comprehensive set of recognized industry standards for medical devices. No new clinical efficacy study was required or performed for this specific 510(k) submission.

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