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510(k) Data Aggregation
(341 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Properties: | |
| Residual starting material | Specifications met (details not provided) |
| Residual solvent material | Specifications met (details not provided) |
| Physical Appearance: | |
| Visual inspection | Visual defects, color, solution clarity evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Delivery & Functionality: | |
| Catheter delivery | Evaluated for catheter clogging, aggregation, ease of injection, and particle shape after injection (results not explicitly stated, but implied to be acceptable for substantial equivalence, and "similar to the predicate device") |
| Particle size range | Confirmation performed (results not explicitly stated, but implied to be within specified range as per product configurations table, e.g., 100-300μm, 300-500μm, etc.) |
| Particle fiber shedding | Evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Biocompatibility: | |
| pH | Evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Endotoxin | <0.06 EU/ml |
| Biocompatibility | Evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence and "minimal tissue necrosis and a common foreign body reaction; however, the intensity of inflammatory reaction is moderate, without humoral response or cytotoxicity" in animal studies) |
| Sterility & Packaging: | |
| Packaging integrity | Evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Shelf life | Evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Sterilization validation | Performed (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Animal Study - UAE: | |
| Short term performance | "similar to the predicate device, with both showing normal, thrombosis and some rupture of the internal elastic lamina" |
| Side effects | "minimal tissue necrosis and a common foreign body reaction; however, the intensity of inflammatory reaction is moderate, without humoral response or cytotoxicity" |
| Distribution | Evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Clinical - Adverse Events: | "Review of the published and unpublished data regarding adverse events associated with Bead Block™ has not identified any unique safety concerns." (This implies a qualitative comparison to expected adverse events for similar devices). |
2. Sample size used for the test set and the data provenance
- Non-clinical testing: No specific sample sizes are mentioned for the non-clinical tests (e.g., material specifications, visual inspection, catheter delivery). These typically involve lab-based testing.
- Animal studies:
- Study 1 (sheep penetration model): The sample size is not explicitly stated. The provenance is likely a research lab setting.
- Study 2 (side effects in sheep uteri): The sample size is not explicitly stated. The provenance is likely a research lab setting.
- Clinical information: This involved a "review of Bead Block™ published and unpublished data on the use of Bead Block™ for the treatment of leiomyoma uteri (uterine fibroids) [outside the United States] over the last ten years."
- The exact sample size (number of patients/cases) is not provided.
- Provenance: This data is retrospective, collected over "the last ten years," and originated from "outside the United States."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not detail the use of "experts" to establish a ground truth in the typical sense of a diagnostic device. The evaluation of non-clinical tests would be performed by qualified lab personnel. For animal studies, the assessment of tissue necrosis, inflammation, and vascular effects would be done by veterinary pathologists or other trained researchers, but no specific number or qualifications are given. For the clinical data review, it's not described as an adjudication process by experts to establish ground truth for a test set, but rather a review of existing clinical outcomes/adverse events.
4. Adjudication method for the test set
There is no mention of an adjudication method (like 2+1 or 3+1) for establishing ground truth from multiple readers/experts. This type of adjudication is typically relevant for diagnostic imaging studies where agreement on subtle findings is crucial. The studies described are primarily performance and safety assessments of an embolic device.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The device (Bead Block™) is an embolic agent, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the question of human reader improvement with or without AI assistance is not applicable to this device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. Bead Block™ is a physical medical device (microspheres for embolization), not an algorithm or AI system. Its performance is inherent to its physical properties and interaction with biological systems when used by a clinician, not a standalone software performance metric.
7. The type of ground truth used
- Non-clinical testing: Ground truth is established by standard laboratory test methods, specifications, and physical measurements (e.g., chemical analysis for residual materials, microscopy for particle size, functional testing for catheter delivery).
- Animal studies: Ground truth is established by histological examination and pathological assessment of tissue samples from the embolized animals, comparing observed effects to normal physiology and effects seen with the predicate device.
- Clinical data review: Ground truth is the documented adverse events and clinical outcomes collected in real-world use outside the US, reviewed descriptively (not as a systematically adjudicated "ground truth" for a specific test set, but rather a summary of real-world safety data).
8. The sample size for the training set
The concept of a "training set" is not applicable here. This is a medical device submission based on non-clinical, animal, and existing clinical data, not a machine learning model developed with training data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an algorithm/AI in this submission.
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