(28 days)
QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to Biosphere Medical, S.A. regarding their Quadrasphere Microspheres. This document largely focuses on regulatory approval and indications for use, and therefore does not contain information about acceptance criteria or a study proving the device meets said criteria.
The typical content of such a study would include:
- Acceptance Criteria Table and Device Performance: A table outlining specific performance metrics (e.g., size distribution, mechanical strength, biocompatibility, embolization efficiency, clinical success rates, complication rates) with pre-defined acceptance limits and the observed performance of the Quadrasphere Microspheres.
- Sample Size and Data Provenance: Details about the number of patients or samples included in the test set, as well as the geographical origin of the data (e.g., USA, France, multi-national) and whether the data was collected retrospectively (from existing records) or prospectively (specifically for the study).
- Ground Truth Experts: Information on the number of medical experts (e.g., interventional radiologists, pathologists) who established the ground truth for the test set, along with their qualifications (e.g., years of experience, board certifications).
- Adjudication Method: If applicable, how discrepancies among experts were resolved to establish the ground truth (e.g., 2+1 means two experts agree, and a third is consulted if they disagree; 3+1 implies a similar consensus-based approach).
- MRMC Comparative Effectiveness Study: If a multi-reader, multi-case study was conducted, the document would describe its design and report the effect size quantifying how much human readers' performance (e.g., accuracy, diagnostic confidence) improved when using Quadrasphere Microspheres compared to a control or alternative treatment.
- Standalone Performance Study: Whether a study evaluating the device's performance in isolation (without human intervention, if applicable to the device type) was performed. For an embolic agent, this might relate to its physical properties and in-vitro performance.
- Ground Truth Type: The specific method used to establish the "true" clinical outcome or characteristic against which the device's performance was measured (e.g., confirmation by pathology after embolization, long-term patient outcomes, expert consensus on imaging results).
- Training Set Sample Size: If a machine learning component were involved (which is not the case for this physical medical device), the size of the dataset used to train the algorithm would be specified.
- Training Set Ground Truth: How the ground truth for any training set was established.
Without a detailed study report, which is not part of this 510(k) letter, I cannot provide the requested information.
§ 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).