(29 days)
The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
The Prestige Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize peripheral vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into anomalies to create blood stasis, reducing flow in the target vasculature, and inducing thrombosis. Upon positioning coils into the vasculature, the coils are thermally detached from the delivery pusher in serial manner until the target vasculature is occluded.
The provided text is a 510(k) summary for the Prestige Coil System, a vascular embolization device, which explicitly states that it is not an AI/ML powered device. Therefore, it does not involve any of the AI/ML related concepts you asked about, such as training sets, test sets, ground truth establishment, MRMC comparative effectiveness studies, or AI performance metrics.
However, I can still extract the acceptance criteria and information about the studies performed for this non-AI medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Biocompatibility | The samples shall be biocompatible for their intended use based on the requirements of ISO 10993-1. | Pass |
| Shelf Life | The samples shall meet established acceptance criteria based on device specifications after simulated aging and transportation/distribution simulation. | Pass |
| Packaging | The samples shall meet established acceptance criteria for packaging performance. | Pass |
| Gamma Sterilization | The samples shall meet established acceptance criteria for sterility. | Pass |
| Corrosion | The samples shall meet established acceptance criteria for corrosion. | Pass |
| Detachment Zone Tensile | The samples shall meet established acceptance criteria for tensile strength. | Pass |
| Visual and Dimensional Inspection | The samples shall meet established acceptance criteria for visual physical damage and secondary diameter and length. | Pass |
| Simulated Use | The samples shall be prepared in accordance with the instructions for use and meet established acceptance criteria for device performance in a clinically relevant model. | Pass |
| Stretch-Resistance Thread Tensile Testing | The samples shall meet established acceptance criteria for tensile strength. | Pass |
| Usability Validation | The devices shall be prepared in accordance with their respective instructions for use and meet established acceptance criteria for device performance in a clinically relevant model. The labeling shall be clear and understandable by the intended user. | Pass |
2. Sample size used for the test set and the data provenance
As this is a non-AI/ML device, the concept of a "test set" in the context of AI does not directly apply. The studies mentioned are bench tests and non-clinical device assessments. Specific sample sizes for each test are not provided in this summary. The data provenance is from non-clinical bench testing performed by the manufacturer (Balt USA, LLC) to demonstrate substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/ML device and does not involve establishing ground truth through expert review for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device and does not involve adjudication of expert assessments for a test set.
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, as this is not an AI/ML device and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI/ML device and does not have an algorithm to be evaluated in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as this is not an AI/ML device. The "ground truth" for the device's performance in these non-clinical tests is based on pre-defined acceptance criteria derived from device specifications and recognized standards (e.g., ISO 10993-1).
8. The sample size for the training set
Not applicable, as this is not an AI/ML device and therefore no training set was used.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device and therefore no training set was used or ground truth established for it.
§ 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).