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Bead Block microspheres are intended to be used for the embolization of hypervascular tumours, including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block microspheres are also intended for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Bead Block, a permanent intravascular implant, is made up of preformed soft, compressible, biocompatible, hydrophilic, non-resorbable and precisely calibrated microspheres that occlude vessels for the purpose of blocking the blood flow to a target tissue. Bead Block compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be suspended in contrast agents and delivered through microcatheters to the target location. Bead Block is available in bead sizes from 100 – 1200µm and supplied sterile in 20ml syringes which contain 1 or 2 ml of beads suspended in 6 or 5 ml of phosphate buffered saline, respectively. The different bead sizes of the product are differentiated by differently colored labels and syringe end caps. Bead Block is provided as a single use, non-pyrogenic, sterile (steam sterilized) device.

This document is a 510(k) Premarket Notification from the FDA regarding the "Bead Block" device. It attests to the device's substantial equivalence to previously marketed predicate devices for the specified indications for use.

Based on the provided text, the Acceptance Criteria and Device Performance for this medical device (Bead Block) are not defined in terms of typical AI/ML-based image analysis performance metrics (e.g., sensitivity, specificity, AUC). Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on safety and effectiveness for its intended use, which is embolization.

The "study" described is a retrospective data review of the clinical outcomes of patients treated with Bead Block for prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH). This is a clinical effectiveness study, not a study of an AI/ML device's diagnostic or analytical performance.

Therefore, many of the requested points related to AI/ML device study parameters (e.g., test set, ground truth experts, MRMC studies, standalone performance) are not applicable to this document.

Here's an attempt to answer the prompt based on the provided text, reinterpreting the "acceptance criteria" and "study" in the context of a medical device submission for substantial equivalence:

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

The "acceptance criteria" for this 510(k) submission are not explicitly stated as quantitative thresholds for clinical performance but rather are implicitly tied to demonstrating safety and effectiveness comparable to predicate devices. The "reported device performance" refers to the clinical outcomes observed in the retrospective study.

• 85% of patients: decrease in total IPSS by at least 3 points.
• 62% of patients: dropped at least 1 symptom category (severe to moderate to mild).
• Statistically significant and clinically relevant improvements in total IPSS, QoL, PSA, and prostate volume (p

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Bead Block™ microspheres are intended to be used for the embolization of hypervascular tumors, including uterine fibroids and arteriovenous malformations (AVMs).

Bead Block™ is made up of preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a fibroid or a cancerous tumor. Bead Block™ compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block™ microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.5-5Fr range.

The provided document is a 510(k) summary for the Bead Block™ device, which is a vascular embolization device. The information requested pertains to the acceptance criteria and the study that proves the device meets the acceptance criteria. The document largely focuses on demonstrating substantial equivalence to a predicate device rather than performance against specific numeric acceptance criteria for the new device.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not present a table of explicit numeric acceptance criteria. Instead, it relies on demonstrating that Bead Block™ is "as safe and effective as the predicate device" and that its performance is "similar to the predicate device". The "performance" is described qualitatively through the results of non-clinical and animal testing.

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LC Bead LUMI are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

LC Bead LUMI™ is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g. fluoroscopy and CT). The beads are non-resorbable microspheres with calibrated size ranges. LC Bead LUMI™ are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVM).

LC Bead LUMI™ are supplied in a saline buffer solution within a sealed glass vial. A vial access device is also provided within the secondary packaging. LC Bead LUMI™ is provided sterile (moist heat sterilization).

LC Bead LUMI™ consist of a macromer derived from a sulphonate modified polyvinyl alcohol (PVA) macromer which contains a radiopaque moiety that is covalently bound within the hydrogel structure. The incorporation of this radiopaque moiety into the co-polymer imparts Xray imageability by rendering the microspheres radiopaque.

LC Bead LUMI™ has been designed as a radiopaque version of the LC Bead™. Currently embolization with LC Bead™ lacks post-procedural imaging feedback on exact bead location. The embolization process with LC Bead™ is monitored by detecting changes in antegrade flow of soluble iodinated contrast in which the beads are diluted. The embolization is continued until a desired embolization endpoint is reached. This process is completed without specific feedback on the bead location. In order to address this limitation, the manufacturer has developed an imageable spherical embolic bead that can be visualised by X-ray based imaging.

At the time of use, LC Bead LUMI™ is mixed with non-ionic contrast agent in order to monitor the delivery of the product during the embolization procedure. LC Bead LUMI™ is delivered via typical microcatheters to physically block the target vessel. Once the product has been delivered the iodine moiety allows for visualization of the microspheres. LC Bead LUMI™ is a single use, tissue contacting, implantable device available only for prescription use.

The provided document does not contain information regarding traditional acceptance criteria or a study design that outlines specific performance metrics for a diagnostic device. Instead, this document is a 510(k) premarket notification for a medical device called "LC Bead LUMI™," which is a vascular embolization device, not a diagnostic one.

The document focuses on demonstrating substantial equivalence to a predicate device (LC Bead™) by comparing various characteristics and providing performance data relevant to safety and effectiveness for its intended use as an embolization agent.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC study details and effect size with AI assistance.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These elements are typically found in submissions for diagnostic or AI-powered devices that assess a specific outcome or condition, often requiring metrics like sensitivity, specificity, accuracy, etc., against a defined ground truth.

What the document does provide in terms of "performance data" for LC Bead LUMI™ is:

• Bench testing data: To show that the device performs as expected in controlled laboratory settings.
• Verification and validation studies: To confirm that the device meets its design specifications and user needs.
• In vitro and in-vivo biocompatibility studies: To assess the safety of the material in biological systems.
• In-vivo safety and performance studies: To evaluate the device's safety and how it functions within living organisms.
• The conclusion is that these studies demonstrate equivalent safety and performance to the predicate device (LC Bead™), especially considering the key difference is the added radiopaque moiety for visualization.

The studies were conducted in accordance with "FDA Guidance - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices, December 29, 2004".

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