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510(k) Data Aggregation
(118 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance (HydroPearl Microspheres) |
|---|---|
| Primary Endpoint: Reduction in IPSS score during follow-up | Mean baseline IPSS: 20.7 (range; 4-30) Mean IPSS at latest follow-up (8.6 months): 9.1 (range; 2-18) (p<0.05) |
| Secondary Endpoint: Improvement in Quality of Life (QoL) | Mean baseline QoL score: 3.7 (range; 1-6) Mean QoL score at follow-up: 1.2 (range; 0-3) (p<0.05) |
| Technical Success: Bilateral prostatic artery embolization | Achieved in all 17 patients (100%) |
| Clinical Success (based on symptom improvement/medication reduction) | Achieved in 16/17 patients (94%) One patient considered a "clinical failure" (had LUTS well controlled on medication, wanted to cease medication, which was achieved, but symptoms mildly worsened from IPSS 4 to 10). Half of patients on BPH medications at baseline no longer required them after PAE; two additional patients reduced daily medications. Patient relying on CIC: Catheterized 5 times/day before PAE, 0 or 1 time/day after PAE. |
| Safety: Low rate of adverse events | One major complication: hospitalization for acute prostatitis (n=1), resolved without residual effects. Minor complications: hematuria (n=1), hematospermia (n=1), considered expected for PAE and likely due to mild non-target embolization. |
| Equivalence to Predicate Device | Comparative mechanical testing showed equivalent performance to Embosphere Microspheres. Pre-clinical animal testing showed similar performance to Embosphere Microspheres with favorable embolization results. |
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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