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Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).

Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Bearing nsPVA particles are irregularly-shaped, hydrophilic, non-resorbable particles made of 100% crosslinked poly(vinyl alcohol). These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon placement through a catheter.

The particles of the subject device, the Bearing nsPVA Express, are provided sterile and for single use in a 20 mL polycarbonate syringe with a luer-lock connector, individually packaged in a sterile foil peel pouch.

Bearing nsPVA particles are calibrated and available in 7 size ranges (see table below) to enable the physician to choose depending on the diameter of the vessel to be embolized. Each syringe contains 100 mg of Bearing nsPVA particles.

The provided text describes testing conducted for the Bearing nsPVA Express™ device, which is an embolization particle packaged in a syringe. The majority of the testing relates to hardware and packaging, and does not describe a clinical study for establishing performance against specific acceptance criteria in a human population, nor does it involve AI or human readers.

Therefore, many of the requested categories are not applicable to the information provided in this document.

Here's a breakdown of the available information:

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

The document details various engineering and biological testing with associated acceptance criteria. Instead of "device performance" in a clinical sense, these refer to the manufacturing quality, sterility, packaging integrity, and biocompatibility of the physical product.

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

The document does not specify general "test set" sample sizes or data provenance in terms of patient data. The tests are primarily laboratory-based and follow established standards for medical device testing. For example:

• Sterilization Validation: Involves testing a certain number of units to establish a sterility assurance level. The exact number of units is not specified but would follow ISO 11137-2.
• Pyrogenicity: "routine pyrogen testing for each lot"
• Biocompatibility: Involves animal models for certain tests (e.g., acute systemic toxicity, intracutaneous irritation, sensitization) and in vitro tests (e.g., cytotoxicity, hemocompatibility). The specific number of animals or repetitions is not provided but would be dictated by the ISO 10993 standards cited.

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

Not applicable. This document describes physical and biological testing of a medical device, not a diagnostic or AI-assisted clinical study requiring expert human interpretation or ground truth establishment.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication is mentioned.

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 is not an AI-assisted diagnostic device, and no MRMC study was mentioned.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

For the biological and physical performance testing described:

• Sterility: Achieved through rigorous validation adhering to ISO standards and verified by microbiological methods.
• Pyrogenicity: Verified by the Limulus Amebocyte Lysate (LAL) test against a quantitative limit.
• Biocompatibility: Established through standardized in vitro and in vivo biological tests according to ISO 10993 guidelines, measuring specific biological endpoints (e.g., cell viability, immune response, blood compatibility).
• Design Verification (Product/Packaging): Established through visual inspections and mechanical integrity tests against internal specifications and relevant ASTM/ISO packaging standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable. This device does not involve machine learning or a training set.

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