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HRSpheres Narrow-Size Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.

HRSpheres Narrow-Size Embolic Microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials. HRSpheres Narrow-Size Embolic Microspheres consist of a macromer derived from PVA, and are hydrophilic, non-resorbable, and are available in a variety of diameters ranging from 70 - 1,200 um. The preservation solution is 0.9% sodium chloride solution. The water content of a fully polymerized microsphere is 91% ~ 94%. Microspheres are compressible to enable smooth delivery through the indicated delivery catheter. The HRSpheres are available in dyed (blue) and clear (undyed with natural color). Blue-dyed microspheres aid in the visualization of the microspheres in the delivery syringe. HRSpheres Narrow-Size Embolic Microspheres are packaged in sterile sealed glass vials for single use only and available with 1 mL, 2 mL, or 3 mL microspheres volumes per vial.

HRSpheres Narrow-Size Embolic Microspheres can be delivered to a targeted area through typical microcatheters in the 1.7 – 4 Fr range. By blocking the blood supply to the target area, the tumor or malformation is starved of nutrients and shrinks in size. At the time of use. HRSpheres Narrow-Size Embolic Microspheres are mixed with a nonionic contrast agent to form a suspension solution and aid in visualization during a procedure.

The user is asking for information regarding acceptance criteria and a study to prove a device meets those criteria, specifically for the HRSpheres Narrow-Size Embolic Microspheres.

Based on the provided text, this document is a 510(k) Pre-Market Notification for a medical device seeking substantial equivalence to a predicate device, not a study describing a new device and its performance against acceptance criteria as might be seen for an AI/ML medical device. Therefore, a direct response to some of the requested points (like MRMC study, ground truth for training data, number of experts for test set ground truth) is not applicable or cannot be extracted.

However, I can extract the non-clinical performance evaluations and their results, which serve as acceptance criteria for the device's physical and biological properties.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists non-clinical performance evaluations with "Met predefined acceptance criteria" as the result for each. While specific numerical acceptance criteria are not detailed in this summary, the overall outcome indicates compliance.

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

• Non-clinical Bench Testing (Test Set): For shelf-life testing, "3 batches of each tested for all device specifications" were used. Specific sample sizes for other in-vitro tests are not explicitly stated, but "Met predefined acceptance criteria" implies sufficient testing was performed.
• Animal Study (Test Set):
  • Sample Size: A total of 15 female domestic swine.
    • Test Article Group (HRSpheres): 7 pigs
    • Control Article Group (CalliSpheres): 8 pigs
  • Data Provenance: The study was performed on healthy swine models, indicating prospective animal study data. The country of origin for the animal study is not specified, but the applicant company is in China.

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

• Not applicable for this type of device. This is a physical embolic microsphere device, not an AI/ML diagnostic device requiring expert interpretation of images for ground truth. The "ground truth" for this device's performance is established by direct measurement (e.g., size, pH), chemical analysis, and biological responses in animal models and in-vitro tests.

4. Adjudication method for the test set

• Not applicable for this type of device. Adjudication is relevant for subjective expert interpretation, which is not the primary method of evaluation for this physical device. Performance was measured objectively.

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 device is an embolic microsphere, not an AI/ML software for image analysis or diagnosis. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical performance testing and animal study:

• Physical/Chemical Properties: Measured values against predefined specifications (e.g., pH, size range, water content).
• Biological Endpoints: Direct observation of biological responses in in-vitro assays and animal models (e.g., cytotoxicity, hemolytic activity, pyrogenicity, tissue reactions, systemic toxicity).
• Animal Study Outcomes: Comparison of physiological, imaging, and pathological changes between the test and control groups over time points (3, 8, and 29 days post-embolization). This includes:
  • Recanalization of vessels/durability of occlusion
  • Local and systemic foreign body reactions
  • Ease of delivery
  • Rupture or puncture of blood vessels
  • Non-target embolization/device migration
  • Clinicopathological examination results (hematology, blood coagulation, serum biochemistry).

8. The sample size for the training set

• Not applicable for this submission. This document describes the non-clinical and animal testing for a physical medical device for 510(k) clearance, not the development or validation of an AI/ML model that would require a distinct training set. The data presented are for product verification and validation.

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

• Not applicable for this submission. (See point 8).

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