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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.

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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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.

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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