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PVA particles are indicated for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncol ted. Each is offered in a range of particle sizes, from which the clinician may saleot the particle size most appropriate for the desired effect and targeted vasculature. The devices are delivered to the selected vascular location by means of a syringe, through an infusion catheter of diameter appropriate for the selected particle size.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the PVA Foam Embolization Particles:

It's important to note that this document is a 510(k) summary for a medical device submitted to the FDA. Unlike a detailed clinical trial report for an AI-powered diagnostic device, this type of submission focuses on demonstrating substantial equivalence to predicate devices based on performance, material, and intended use, rather than setting specific acceptance criteria and proving them through a standalone efficacy study for a new, complex AI algorithm.

Therefore, many of the requested points, especially those related to AI-specific study design (like MRMC studies, training set details, or expert ground truth for AI performance), are not applicable to this type of device and submission. The "study" here refers to non-clinical tests demonstrating equivalence to existing, cleared devices.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (as derived from the 510(k) summary)

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. The submission states "Nonclinical tests, both in vitro and in vivo, have demonstrated the substantial equivalence." This implies various lab tests and potentially animal studies (in vivo), but specific sample sizes are not provided in this summary.
• Data Provenance: Not explicitly stated. Non-clinical tests are typically performed in a laboratory setting. For "in vivo" tests, this could imply animal studies, but the origin country is not mentioned. The manufacturer is Protein Polymer Technologies, Inc. (PPTI) in San Diego, California, USA, and manufacturing is by Surgica Corporation in El Dorado Hills, CA, USA, suggesting the tests were likely conducted in the US.

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

• Not Applicable. This is a medical device submission, not an AI diagnostic submission. "Ground truth" in the context of AI refers to verified labels used to evaluate algorithm performance. For a physical device, performance is typically assessed against established engineering and biological standards, or compared directly to predicate devices through physical observation and measurement, not against an expert-established "ground truth" in the AI sense.

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

• Not Applicable. Pertains to expert review for AI diagnostic performance, not physical device testing.

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 a medical device submission for physical embolization particles, not an AI device. No human-reader studies for diagnostic improvement are relevant or mentioned.

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

• Not Applicable. This is a medical device, not an AI algorithm.

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

• For the non-clinical tests, the "ground truth" would be the established performance characteristics and safety profiles of the predicate devices, against which the new device was compared using engineering measurements, laboratory assays, and potentially animal study observations. The goal was to prove the new device performed equivalently to these established benchmarks.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI algorithm requiring a "training set."

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

• Not Applicable. As above, no training set for an AI algorithm is involved.

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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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