(85 days)
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
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Material Composition | Chemically identical to predicate devices (PVA foam) | "Substantially equivalent" to predicate devices. The devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam, without colorant or other additive, and uncolored. |
| Particle Configuration | Same physical characteristics as predicate particles | "Substantially equivalent" to predicate devices. Each is offered in a range of particle sizes. |
| Range of Sizes Offered | Matches or falls within the range of predicate devices | "Substantially equivalent" to predicate devices. Offered in a range of particle sizes. |
| Biocompatibility | Demonstrates equivalent biocompatibility as predicate devices | "Substantially equivalent" to predicate devices. Nonclinical tests demonstrated equivalence. |
| Packaging | Comparable to predicate devices for sterility and integrity | "Substantially equivalent" to predicate devices. |
| How Supplied | Comparable to predicate devices (e.g., individual packs, sterile) | "Substantially equivalent" to predicate devices. |
| Indications for Use | Identical or substantially similar to predicate devices | "Substantially equivalent" as stated in the intended use: arterial embolization of AVMs and hypervascular tumors in the peripheral vasculature, and vascular occlusion within the neurovascular system for AVMs and neoplastic lesions. |
| Method of Use | Consistent with predicate devices (syringe delivery through catheter) | "Substantially equivalent" to predicate devices. Delivered to selected vascular location by syringe, through an infusion catheter. |
| Performance (In vitro/In vivo) | Equivalent structural integrity, flow characteristics, and occlusive properties to predicate devices. | "Nonclinical tests, both in vitro and in vivo, have demonstrated the substantial equivalence of the subject devices to commercially-available predicates in terms of 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.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).