(28 days)
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
The Prestige Coil System is intended for use in the peripheral vasculature to endovascularly obstruct or occlude blood flow in vascular abnormalities of the peripheral vessels.
The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be permanently placed in the peripheral vessels to create blood stasis, reducing flow into the anomaly, and thrombosing the target site.
The provided FDA 510(k) Clearance Letter for the Prestige Coil System (Prestige Packing Coil Line Extension) does not describe a study involving an AI/Machine Learning device, human readers, or image interpretation. Instead, it describes a vascular embolization device and its mechanical and physical performance testing.
Therefore, many of the requested points in your prompt are not applicable to this document, as they relate to studies of AI performance or human reader studies in diagnostic imaging, which is not the subject of this 510(k) clearance.
However, I can extract the relevant information from the provided text regarding the device's acceptance criteria and the performance testing conducted.
Here's the breakdown based on the provided document:
Device: Prestige Coil System (Prestige Packing Coil Line Extension)
Type: Vascular Embolization Device (mechanical medical device)
Purpose: Arterial and venous embolizations in the peripheral vasculature.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection, Dimensional Inspection, and Resistance Check | The test samples shall meet established test acceptance criteria for visual physical damage, secondary diameter and length, and resistance. | Pass (All tested samples met the established acceptance criteria.) |
| Simulated Use | The test samples shall be prepared in accordance with the instructions for use and meet established test acceptance criteria for device performance in a clinically relevant model. | Pass (All tested samples met the established acceptance criteria for device performance in a clinically relevant model.) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document repeatedly mentions "test samples" but does not specify the exact number of samples used for each test (Visual Inspection, Dimensional Inspection, Resistance Check, and Simulated Use).
- Data Provenance: Not applicable in the context of clinical data. This refers to bench testing involving physical device samples. No specific country of origin or retrospective/prospective data collection is mentioned as this relates to device manufacturing and testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. "Ground truth" in this context refers to the defined engineering specifications and performance characteristics of the device. These are established through design controls, manufacturing standards, and engineering principles, not through expert consensus on medical image interpretation. The "experts" would be engineers and quality control personnel involved in the device's design and testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a concept related to consensus building among human readers (e.g., radiologists) for establishing ground truth in image-based studies. For physical device bench testing, the "adjudication" is based on objective measurements against pre-defined engineering specifications and Pass/Fail criteria. No multi-reader adjudication method applies here.
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 document describes a vascular embolization device, not an AI/Machine Learning diagnostic device. Therefore, no MRMC study or AI assistance was involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm. Standalone performance refers to the device's inherent functional capabilities as demonstrated in the bench tests, which are independent of a human operator's actions beyond following the instructions for use during the test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance testing is based on pre-established engineering specifications, design requirements, and manufacturing tolerances for the physical device. The device passes if its measured physical and functional characteristics meet these objective, pre-defined criteria. There is no biological "ground truth" (like pathology or outcomes data) in this specific submission, as it focuses on demonstrating the substantial equivalence of a modified mechanical device through bench testing.
8. The sample size for the training set
- Not Applicable. This applies to AI/Machine Learning models, not physical medical devices undergoing bench testing. The device itself is not "trained."
9. How the ground truth for the training set was established
- Not Applicable. As above, this applies to AI/Machine Learning models.
§ 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).