(161 days)
LIFEPEARL™ Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations (AVM's).
The LifePearl Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The LifePearl Microspheres are offered in a variety of diameters ranging from 100-400 um and are provided in a polycarbonate syringe pre-filled with microspheres in phosphate buffered saline. The microspheres are dyed green to aid in visualization in the delivery syringe. The pre-filled syringe is packaged for single use and sterile in a sealed dispenser tray. The LifePearl Microspheres are delivered to the treatment site through a delivery catheter of internal diameter of ≥ 0.017 inch. At time of use, LifePearl is mixed with non-ionic contrast agent for visualization under fluoroscopy.
The provided document is a 510(k) summary for the LifePearl Microspheres, describing its design, indications for use, and pre-clinical testing for substantial equivalence to a predicate device. It is not a study report for an AI/ML device, and therefore the requested information regarding AI device acceptance criteria, performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted from this document.
The document focuses on the device itself (LifePearl Microspheres, a physical vascular embolization device), and not on a digital health or AI/ML product. As such, the concept of "acceptance criteria" is tied to the physical and biological performance of the microspheres, and the "study" refers to various pre-clinical tests demonstrating these performances.
Here's a breakdown of the information that can be extracted, organized as requested, with explicit notes for what is not applicable to this physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
For a physical medical device like LifePearl Microspheres, "acceptance criteria" are typically defined by engineering specifications, material standards, and biological compatibility requirements. The "reported device performance" reflects whether these criteria were met during testing.
| Acceptance Criteria Category/Test | Specific Acceptance Criteria (Inferred from "Description") | Reported Device Performance ("Result") |
|---|---|---|
| Mechanical Testing | Microspheres are capable of: | |
| • Temporary deformation with smooth passage through catheter | ||
| • Syringe to syringe transfer | ||
| • Delivery through catheter within force specification | ||
| • Maintains diameter (after compression, implied) | ||
| • Suspension (for reference, criteria not explicitly stated) | ||
| • Meets criteria for residuals (mechanical residuals, e.g., particulate matter, implied) | Meets mechanical specifications | |
| Chemical Testing | Microspheres/solution: | |
| • Meets criteria for residuals (chemical residuals) | ||
| • Maintains pH | ||
| • Syringe does not leach into microsphere/PBS | Meets chemical specification | |
| Magnetic Resonance Compatibility | Tested to be MR Safe | Pass |
| Catheter Compatibility | Microspheres can be delivered through a catheter of ID ≥ 0.017" | Pass |
| Compatibility with Contrast Agents | Microspheres are compatible with contrast agent per IFU | Pass |
| Shelf Life (product/packaging) | After aging conditioning, the microspheres/packaging meet specifications (specifics of specifications not detailed, but imply maintenance of performance and integrity) | Pass |
| Animal Testing (Swine) | To assess embolization effectiveness and histopathological evaluation (necrosis, inflammation, and off-target embolization) with results comparable to predicate device. | Results were comparable to predicate device (for embolization effectiveness, necrosis, inflammation, and off-target embolization over 7 and 30 days) |
| Biocompatibility Testing | Subjected to full battery of biocompatibility testing per ISO 10993-1, -3, -4, -5, -6, -10, -11 criteria (e.g., passing MEM elution assay for cytotoxicity, absence of sensitization/irritation, acceptable hemolysis, systemic toxicity, pyrogenicity, acceptable implantation response, and genotoxicity tests like Ames and chromosomal aberration). | Met all biocompatibility criteria |
| Packaging Validation | Packaging tested for adequacy under ISTA conditions. | Pass |
| Sterilization Validation | Meets criteria for ISO 17665-1 (for moist heat sterilization). | Pass |
Regarding the specific questions about AI/ML device studies:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable (N/A). This document describes a physical medical device, not an AI/ML device. The "test set" here refers to physical samples of the microspheres and animal subjects for preclinical evaluation.
- For animal testing, swine were used, but the exact number of animals is not specified, nor is their "country of origin" in the context of data provenance. The study was prospective in the sense of being planned preclinical testing.
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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):
- N/A. Ground truth as defined for AI/ML performance against human expert labels is not relevant here. For animal studies, histopathological evaluations would typically be performed by veterinary pathologists, but the number and qualifications of such experts are not stated in this summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically for resolving discrepancies in human expert labeling in AI/ML performance studies. This is a preclinical evaluation of a physical device.
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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:
- N/A. This refers to studies evaluating AI assistance for human interpretation (e.g., reading medical images). This document is about a physical embolization device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This question pertains to the performance of an AI algorithm in isolation. The document describes a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal testing, histopathology (assessment of necrosis, inflammation, off-target embolization) and potentially imaging confirmation (effectiveness of embolization) served as the basis for evaluating device performance. Other tests rely on physical property measurements (e.g., dimensions, force), chemical analyses (e.g., pH, residuals), and standardized biological assays (e.g., cytotoxicity, hemocompatibility).
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The sample size for the training set:
- N/A. This concept applies to AI/ML models. For a physical device, there isn't a "training set" in the same sense. There would be a product development and testing phase where designs are refined based on iterative testing, but not a dataset for training an algorithm.
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How the ground truth for the training set was established:
- N/A. As there is no AI/ML training set, this question is not applicable.
§ 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).