(30 days)
ONCOZENE Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors including hepatoma.
ONCOZENE Microspheres (hereafter may be referenced as ONCOZENE Microspheres or ONCOZENE) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage.
ONCOZENE Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml or 3 ml of microspheres in approximately 7 ml of transport solution. The ONCOZENE Microspheres are available in 40, 75 and 100 um sizes.
The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding a medical device called "ONCOZENE Microspheres." The document primarily addresses the substantial equivalence of a modified device (new syringe) to a previously cleared predicate device.
Based on the provided text, the device in question is a medical device (microspheres for embolization), not an AI/software-based medical device that would require the types of studies and acceptance criteria typically associated with AI performance.
Therefore, I cannot extract information related to:
- A table of acceptance criteria and reported device performance (in the context of AI performance metrics like sensitivity, specificity, AUC). The document speaks of "acceptance criteria" but in the context of physical device testing such as mechanical performance, sterilization, biocompatibility, packaging integrity, and shelf-life.
- Sample size used for the test set and data provenance (for AI model evaluation).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi reader multi case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
- Standalone (algorithm only without human-in-the-loop performance) study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI evaluation.
- Sample size for the training set (for AI models).
- How the ground truth for the training set was established (for AI models).
The document outlines the following types of performance data and their "acceptance criteria" in a general sense:
- Non-clinical Testing: To demonstrate the design and performance met established design criteria and is substantially equivalent to the predicate device. Specifically, mechanical testing was performed to verify the Syringe Volume Identification, and results "met all related specifications."
- Sterilization: To ensure a minimum sterility assurance level of 10⁻⁶ in accordance with ISO standards. Half and full cycles were used, and results "met all acceptance criteria."
- Biocompatibility: In accordance with ISO 10993-1, demonstrating that patient-contacting components are biocompatible. Testing was performed for genotoxicity, hemocompatibility, cytotoxicity, implantation effects, irritation and sensitization, pyrogenicity, subacute/subchronic systemic toxicity, toxicological risk assessment of chemistry results, chemical characterization, and irritation. The text states testing "demonstrated compliance."
- Packaging Integrity and Shelf Life: Performed in accordance with ISO 11607-1 and ISO 11607-2, supporting a three-year shelf-life. Testing included label adhesion, legibility, packaging seal integrity, bubble leak test, peel strength test, and dye penetration.
In summary of what is available in the provided text:
- Device Type: Vascular embolization device (ONCOZENE Microspheres). This is a physical medical device, not an AI/software device.
- Study Purpose: To demonstrate substantial equivalence of a device with an updated syringe to a predicate device.
- Methods: Non-clinical testing, sterilization testing, biocompatibility testing, packaging integrity, and shelf-life testing.
- Acceptance: For all listed performance data, the results "met all acceptance criteria" or "demonstrated compliance/substantial equivalence."
- Ground Truth: For these types of physical device tests, "ground truth" is typically defined by adherence to established engineering specifications, ISO standards, and regulatory requirements (e.g., a specific sterility assurance level, a certain peel strength, or passing toxicology tests).
Since the nature of the device and the provided documentation does not pertain to AI/software performance evaluation, the requested details regarding AI model acceptance criteria, test sets, expert involvement, and ground truth for AI are not applicable and thus not present in the provided text.
§ 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).