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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 (AVM's) and neoplastic lessions 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 submission (K073419) is for PVA PLUS™ Vial PVA Foam Embolization Particles and related convenience kits. It is a 510(k) premarket notification for a Class II medical device (neurovascular embolization device, product code HCG).

Here's an analysis of the provided text in relation to your questions:

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

The provided document does not contain any acceptance criteria or reported device performance metrics in the way you would typically see for an AI/algorithm-based device. This submission is for a physical medical device (PVA foam embolization particles), not a diagnostic or prognostic algorithm.

The document states:

• "5.7 Summary of Non-Clinical Tests (Not Applicable)"
• "5.8 Summary of Clinical Tests (Not Applicable)"
• "5.9 Conclusions of Non-Clinical and Clinical Tests (Not Applicable)"

This "Not Applicable" designation is crucial. It means the manufacturer did not conduct new non-clinical or clinical studies for this submission because they are claiming substantial equivalence to existing predicate devices based on the product being identical to previously cleared devices from Surgica Corporation and Protein Polymer Technologies, Inc. The only changes are the manufacturer and distributor.

Therefore, a table of acceptance criteria and device performance cannot be generated from this document because such data was not central to this particular 510(k) clearance process. The acceptance criteria were essentially met by demonstrating the new manufacturer could produce the same device as the predicate.

Regarding your other questions (2-9), these are primarily relevant to studies involving AI/ML algorithms, especially those that involve diagnostic or predictive capabilities and require evaluation against a ground truth established by experts. Since this submission is for a physical medical device and explicitly states "Not Applicable" for clinical and non-clinical tests, the information requested for AI/ML evaluation is not present and not relevant to this specific K073419 submission.

However, to directly address each point based on the absence of such information in the document:

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: Not applicable (no test set discussed).
• Data Provenance: Not applicable (no data discussed).

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)

• Number of Experts: Not applicable (no ground truth established for a test set).
• Qualifications of Experts: Not applicable (no experts used for this purpose in this submission).

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

• Adjudication Method: Not applicable (no test set or adjudication process described).

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

• MRMC Study: No. This is not an AI/ML device, so such a study would not be relevant.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This is not an AI/ML device.

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

• Type of Ground Truth: Not applicable (no ground truth established for an AI/ML evaluation).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable (no training set for an AI/ML model).

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

• Ground Truth Establishment for Training Set: Not applicable (no training set or associated ground truth discussed).

In Summary:

This 510(k) submission (K073419) is a resubmission for a physical PVA foam embolization device under a new manufacturer/distributor. The substantial equivalence was established by demonstrating the device's identity to already-cleared predicate devices, rather than through new performance studies using test sets, expert ground truth, or AI/ML evaluations. Therefore, the information requested regarding acceptance criteria and study details relevant to AI/ML devices is not present in this document.

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