(454 days)
The M-BolusTM Embolic Microspheres are intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors. They may be used for vascular occlusion of vessels within the neurovascular system when presurgical devascularization is desirable.
M-BOLUSTM Embolic Microspheres are made out of a biocompatible, non-degradable and non-absorbable synthetic polymer called Polyvinyl Alcohol (PVA). The M-BOLUSTM Embolic Microspheres are precisely manufactured spheres, with a smooth and lightly porous surface with hydrophilic characteristics. The M-BOLUSTM Embolic Microspheres, which are supplied in a hydrated state (0.9% Sodium Chloride), are soft and flexible allowing them to be compressed/deformed as they travel through the lumen of a delivery catheter or the vasculature. The Scion Cardio-Vascular M-BOLUSTM Embolic Microspheres are substantially equivalent to the predicate devices.
The provided text is a 510(k) summary for the M-BOLUS™ Embolic Microspheres. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies in the way one would for a novel device or AI algorithm.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission. This document is a premarket notification for a medical device that claims substantial equivalence to an already approved device.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific quantitative acceptance criteria or detailed performance results in the format of a table as typically seen for AI/software-based devices. The basis for acceptance is stated as "substantial equivalence" to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Boston Scientific Contour SE™ Microspheres) | "The Scion Cardio-Vascular M-BOLUS™ is substantially equivalent to the currently marketed Contour SE™ Microspheres." |
| "No new issues of safety or efficacy have been raised." | |
| "M-Bolus™ successfully completed biocompatibility testing per ISO 10993-1." | |
| Design and Material Characteristics | "The technological characteristics of the M-Bolus™ Embolic Microspheres are the same as the predicate devices, including design and material." |
| Biocompatibility | "The M-Bolus™ successfully completed biocompatibility testing per ISO 10993-1." |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a physical embolic microsphere, not an AI algorithm. There is no "test set" of data in the typical sense for an AI model. Biocompatibility testing was mentioned, but no sample sizes or data provenance for that testing are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" to be established by experts for a physical device like embolic microspheres in this context. The evaluation is based on material properties, design, and intended use as compared to a predicate device.
4. Adjudication method for the test set
Not applicable. There is no "test set" and thus no adjudication method needed for expert consensus.
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 a physical medical device (embolic microspheres), not an AI algorithm intended for use by human readers. Therefore, an MRMC study and AI assistance effect size are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used
Not applicable. As this is a physical device, the "ground truth" concept in the context of expert consensus or pathology for diagnostic AI is not relevant. The substantial equivalence claim is based on comparing the device's technical characteristics, materials, and intended use to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm that requires a training set or ground truth for its development.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).