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The HydroPearl® Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

The HydroPearl TM Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl TM Microspheres are offered in a variety of diameters ranging from 75-1100µm and are provided in a sterile syringe pre-filled with microspheres in phosphate buffered saline. The pre- filled syringe is packaged in a sealed sterile dispenser tray. The HydroPearl TM Microspheres are delivered to the treatment site through a delivery catheter.

The provided document describes the acceptance criteria and study for the HydroPearl Microspheres, specifically for the expanded indication of prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., "IPSS score reduction must be X%"). Instead, it reports the observed clinical outcomes and concludes that these results support safe and effective use. The "acceptance criteria" here are implied through the positive clinical outcomes and the comparison to established understanding of PAE effectiveness.

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

• Sample Size (Test Set): 17 patients
• Data Provenance: Retrospective analysis from a single US center.

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

The document does not specify the number or qualifications of experts for establishing ground truth for the clinical data. The data appears to be derived from standard clinical assessments (IPSS, QoL scores, observation of complications) and procedural records (technical success of embolization), rather than an explicit "ground truth" established by independent expert panel review.

4. Adjudication method for the test set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical outcomes in the retrospective study. Clinical outcomes were reported based on collected patient data.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the device's clinical performance in patients, not on comparing AI assistance to human readers.

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

This is not applicable as the HydroPearl Microspheres are a medical device (embolization agent), not an AI algorithm. The study assesses the performance of the physical device when used by clinicians.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the clinical study's effectiveness was established through patient-reported outcomes data and objective clinical assessments:

• International Prostate Symptom Score (IPSS) and Quality of Life (QoL) scores (patient-reported).
• Observation of BPH medication usage reduction/cessation.
• Objective assessment of technical success (bilateral PAE).
• Adverse event reporting.

8. The sample size for the training set

The document does not describe a "training set" in the context of an AI algorithm. For the clinical performance anaysis, it refers to a retrospective analysis of existing data.

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

Not applicable, as this is not an AI algorithm study requiring a training set with established ground truth in that context.

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The HydroPearl Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids.

The HydroPearl Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl Microspheres are offered in a variety of diameters ranging from 75-1100 um and are provided in a sterile syringe pre-filled with microspheres in phosphate buffered saline. The pre-filled syringe is packaged in a sealed sterile dispenser tray. The HydroPearl Microspheres are delivered to the treatment site through a delivery catheter.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the HydroPearl Microspheres:

This document is a 510(k) Summary for a medical device called HydroPearl Microspheres. It provides a summary of the pre-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing specific performance metrics against pre-defined acceptance criteria for diagnostic efficacy.

Therefore, the requested information elements related to diagnostic performance (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable in the context of this 510(k) submission. This submission focuses on pre-clinical equivalency, biocompatibility, and functional performance.

Acceptance Criteria and Reported Device Performance

The provided document details various pre-clinical tests and their outcomes, indicating a "Pass" or "Meet" result against internal criteria rather than specific numerical acceptance criteria for diagnostic accuracy.

Information Not Applicable/Provided for this 510(k) Summary:

As this is a 510(k) submission focused on substantial equivalence through pre-clinical testing, it does not include the detailed diagnostic study information typically associated with AI/software devices aiming to establish diagnostic performance.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" primarily refers to physical samples of the device components and animal models for pre-clinical evaluation, not a diagnostic data set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in a diagnostic sense, is not established for this type of submission. Animal testing involved histopathological evaluation, implicitly performed by qualified personnel, but not for establishing a "ground truth" for a diagnostic algorithm.
3. Adjudication method for the test set: Not applicable.
4. 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 is a physical embolic device, not an AI/software diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the animal study, histopathology was used to evaluate embolization effectiveness and tissue response (necrosis, inflammation, off-target embolization). This serves as a biological ground truth for the device's effect in vivo, not a diagnostic ground truth.
7. The sample size for the training set: Not applicable. There is no algorithm training set for this device.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Verification and Test Summary):

The study described is a series of pre-clinical bench tests and animal studies designed to evaluate the physical, chemical, and biological performance of the HydroPearl Microspheres and to demonstrate their substantial equivalence to a legally marketed predicate device (Biosphere Embosphere Microspheres).

• Mechanical Tests: Evaluated the microspheres' ability to deform, maintain their dimensions, transfer between syringes, and be delivered through catheters within specifications.
• Chemical Tests: Assessed residual solvents, pH stability, and leachables from the syringe.
• Safety Tests: Included MR safety, catheter compatibility, compatibility with contrast agents, shelf life, and extensive biocompatibility testing according to ISO 10993 standards (cytotoxicity, sensitization/irritation, hemocompatibility, systemic toxicity, implantation, and genotoxicity).
• Animal Testing: Compared the HydroPearl Microspheres to the predicate device in an animal model to assess embolization effectiveness and histopathological responses (necrosis, inflammation, and off-target embolization) at 1, 7, and 30 days post-embolization.
• Other Validations: Packaging and sterilization validations were also performed.

Conclusion: All tests passed or met the established criteria, leading to the conclusion that the HydroPearl Microspheres are as safe, effective, and perform as well as the predicate device. The submission leveraged existing published studies/literature for uterine fibroid embolization for additional clinical information, but did not present a new clinical study with specific acceptance criteria for diagnostic performance.

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