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510(k) Data Aggregation
(165 days)
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.
| Acceptance Criteria (Implicit from 510(k) Process) | Reported Device Performance (from Retrospective Study) |
|---|---|
| Safety: Device is safe for intended use, with acceptable adverse event profile compared to predicate. | Observed AEs: 149/232 patients (64.2%) reported at least one AE. Most AEs were non-serious and transient. Most common were renal/urinary disorders (15.2%), dysuria (41.4%), pollakiuria (45.3%). Conclusion: "well tolerated treatment." |
| Effectiveness: Device effectively achieves intended clinical outcome, comparable to predicate. | Clinical Improvements at 12 Months: - 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<0.001). - Improvement tendency in Qmax (p=0.059) and PVR (p=0.1). - PAE did not impair sexual function (IIEF). Conclusion: "effective... with comparable outcomes to Embosphere Microspheres." |
| Technological Characteristics: Similar to predicate devices, or differences do not raise new safety/effectiveness questions. | Technological Comparison: - Similar size-calibrated spherical microspheres, delivered by microcatheters. - Similar size ranges, steam sterilized, single-use, biocompatible, non-resorbable polymer. - Delivery via microcatheter, visualization via radiographic imaging. - Minor material difference (PVA vs. acrylic/porcine gelatin) "do not raise different questions of safety and effectiveness." |
| Biocompatibility: Device material is biocompatible for intended use. | Previous Biocompatibility Testing: Genotoxicity, implantation, sensitization, intracutaneous reactivity, acute, subchronic toxicity. Studies showed material is biocompatible. |
| Material/Device Performance: Physical and chemical properties suitable for intended use. | Previous Bench Testing: Residuals, visual defects, color, solution clarity, catheter delivery (clogging, aggregates, injection ease), particle fiber shedding, pH, packaging integrity, shelf life, sterility, endotoxins. |
| MR Safety: Demonstration of MR safety/compatibility. | MR Safe: Based on scientific rationale (non-ferrous composition) in alignment with FDA guidance. Labeling updated to reflect MR safety. |
2. Sample size used for the test set and the data provenance
- Sample Size: 232 patients.
- Data Provenance: Retrospective data review. The country of origin is not explicitly stated in this document but implied to be from a clinical setting where Bead Block was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a retrospective clinical outcomes study, not a study involving expert readers establishing ground truth for image interpretation by an AI device. The "ground truth" here is the observed clinical outcomes in patients.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was a clinical outcomes study, not an imaging study requiring reader adjudication. Clinical outcomes (IPSS, QoL, prostate volume, Qmax, PVR, IIEF, AEs) were measured directly.
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 document describes a PMA (pre-market approval) or 510(k) submission for a physical medical device (embolization microspheres), not an AI/ML-based diagnostic or assistive device. Therefore, no MRMC study or AI assistance comparison was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the effectiveness portion of the study was clinical outcomes data (e.g., International Prostate Symptom Score (IPSS), erectile function (IIEF), Quality of Life (QoL), Prostate volume (PV), objective measures of urinary flow (Qmax, PVR)) and adverse events (AEs) reported by patients or clinicians over the course of the study.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "study" described is a retrospective clinical review, which would be analogous to a "test set" in an AI/ML context, if at all.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm. The clinical data collected was used to demonstrate the performance of the device itself.
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