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The Occlusin® 500 Artificial Embolization Device is intended to be used as an artificial embolization device in the treatment of unresectable/inoperable hypervascularized tumors.

The Occlusin® 500 Artificial Embolization Device is a collagen-coated polymeric embolization microparticle. It is provided sterile and non-pyrogenic.

The provided document describes the Occlusin® 500 Artificial Embolization Device and its premarket notification (510(k)) for substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. Instead, it focuses on non-clinical and animal model testing to demonstrate safety and effectiveness compared to a predicate device.

Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, Number of experts, Adjudication method, MRMC study, Standalone performance, Type of ground truth, Sample size for training set, How ground truth for training set was established) cannot be filled as they are not present in the provided text.

Here's a summary of the information that is available based on your request:

1. A table of acceptance criteria and the reported device performance
Not applicable. The submission is for a physical medical device (embolization microparticles), not an AI/ML device, and thus does not present performance metrics in the same way an AI/ML study would (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating compliance with design specifications and comparable performance to a predicate device in non-clinical and animal models.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Description: Two animal models were used for "in vivo testing."
  • Short-term testing: Porcine model (acute and 1 month).
  • Long-term testing: Ovine model (3 months, 6 months, and 12 months).
• Sample Size: Not explicitly stated (e.g., number of pigs, number of sheep).
• Data Provenance: The studies were "prospectively defined verification and validation testing." The country of origin of the data is not specified, but the applicant's address is Edmonton, AB, Canada.
• Retrospective/Prospective: Prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth was established through animal model observations and measurements of device performance, not expert consensus for diagnostic tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to human expert review for establishing ground truth, which was not the method used here.

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 MRMC study was not done. This type of study is relevant for AI/ML diagnostic tools, not for a physical embolization device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this refers to AI/ML algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or standard for evaluation in this context was based on:

• Biocompatibility testing against ISO 10993-1
• Stability testing
• Catheter compatibility testing
• Characterization of finished product against release specifications (visual appearance, packaging integrity, mass per vial, density, particle count per gram, particle size distribution, residual PVA, molecular weight, collagen content, sterility, endotoxin, melting range)
• In vivo performance in animal models (porcine and ovine) compared to a predicate device, presumably assessing parameters like embolization efficacy, tissue response, and degradation over time.

8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established
Not applicable.

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