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PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (Pva) foam. The devices do not contain any colorant or other additive, and are uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe, through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single-use.

This document is a 510(k) summary for Modified PVA Foam Embolization Particles. It outlines the device details, its intended use, and its comparison to predicate devices. Crucially, it states that no clinical tests were performed because the modification is limited to the packaging configuration. The submission relies entirely on non-clinical tests to establish substantial equivalence to existing predicate devices. Therefore, the questions related to clinical study design, acceptance criteria, sample sizes, expert involvement, and ground truth are largely not applicable in the context of this 510(k) submission.

Here's an analysis based on the provided text, indicating where information is present and where it is explicitly stated as "not applicable" or not provided due to the nature of the submission:

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

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a non-clinical testing program focused on the aspects affected by the packaging change, namely sterility and shelf life. For all other aspects (material, configuration, manufacturing, biocompatibility, indications, method of use), the device is deemed substantially equivalent to the predicate devices because these characteristics are unchanged.

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

• Sample Size for Test Set: Not specified in the provided text for sterility and shelf-life testing.
• Data Provenance: Not specified for the non-clinical tests.

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, as this was not a clinical study involving ground truth established by medical experts. The non-clinical tests would have involved laboratory personnel and validated testing methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this was not a clinical study requiring adjudication of expert opinions.

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 embolization particle, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is an embolization particle, not an algorithm.

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

For the non-clinical tests (sterility, shelf life), the "ground truth" would be established by validated laboratory testing methods and standards (e.g., ISO, ASTM). For the unchanged aspects of the device, the "ground truth" is that they are identical to the predicate devices, which were previously cleared by the FDA based on their own testing or substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

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