(268 days)
The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The i-ED COIL System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and venous embolizations in the peripheral vasculature.
i-ED COIL System is a neurovascular and vascular embolization device, which consists of two component devices, i-ED COIL Detachable Coil (hereafter i-ED COIL) and ELECTRO DETACH GENERATOR v4 Detachment System (hereafter EDG v4).
The i-ED COIL is composed of a detach coil and a sheath adapter. Furthermore, the detach coil consists of a platinum coil (embolization material), to be placed at the site of vascular diseases, a pusher (delivery wire) to guide the platinum coil to the site and a PVA (polyvinyl alcohol) rod that connects the platinum coil and the pusher. The sheath adapter consists of a PP (polypropylene) sheath and an adapter. The i-ED COIL is designed for use with the EDG v4.
The EDG v4 consists of a power source and connection cables attached with clips. EDG v4 is a medical electrical equipment to be used to detach the implantable platinum coil from the delivery wire of the i-ED COIL. It is intended for use in multiple coil detachments performed during a single procedure.
The i-ED COIL and EDG v4 are provided sterile (EtO), and separately packaged and distributed in the U.S.
The provided document describes the performance testing, biocompatibility testing, electrical safety, electromagnetic compatibility, and software verification and validation testing for the i-ED COIL System. However, it does not explicitly define "acceptance criteria" as a single, consolidated table with specific numerical thresholds for each test, nor does it present a "study" in the traditional sense (e.g., a multi-reader multi-case clinical study for an AI algorithm).
The document details various performance tests to demonstrate that the device meets pre-specified acceptance criteria. These acceptance criteria are generally qualitative or described in terms of meeting manufacturing specifications, equivalence to a control device, or compliance with standards.
Here's an attempt to extract the requested information based on the provided text, with not applicable (N/A) for information that is not present for this type of device (e.g., AI-specific metrics, ground truth for AI):
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (as implied or stated) | Reported Device Performance |
|---|---|---|
| Appearance | Visual appearance meets pre-specified acceptance criteria and is clinically usable. No visual abnormalities. | All samples had no visual abnormalities and passed the acceptance criteria. |
| Dimensional Verification | Dimensional values meet pre-specified acceptance criteria and are designed as intended. | All samples were confirmed to meet all acceptance criteria based on the dimensional specification. |
| Strength | Physical strength meets pre-specified acceptance criteria; can withstand forces in clinical usage. | All samples without deviation passed each acceptance criterion. Demonstrated necessary strength for clinical usage. |
| Delivery Performance | Delivery performance is at least equivalent to the control device. | All samples met the acceptance criteria about maximum load based on the result of the control device. |
| Detachment Performance | i-ED COIL detachable with EDG v4 within pre-specified time; reliable detachment mechanism for clinical usage. | All test samples could be detached within the pre-specified time and met the acceptance criteria. |
| Detachment Durability (EDG v4) | Sufficient power output from EDG v4 for i-ED COIL detachment during 30 operations; stable outputs. | Outputs from all EDG v4 samples during 30 detachment procedures were stable; acceptance criteria met. |
| Corrosion Resistance | No signs of corrosion in the intended clinical use. | In all test samples, there was no sign of corrosion. Result met acceptance criterion. |
| Particulate Evaluation | Quantity and size of particulates generated are equivalent to or less than particulates from control device. | Particulates generated from i-ED COIL were equivalent to or less than the control device. Result met acceptance criterion. |
| Simulated Use Evaluation | Judged to be usable without problems even in very tortuous vasculature (worst case). | Judged to be able to use without problems even in the very tortuous vasculature considered to be the worst case. |
| Usability Evaluation | Physicians score usability as equal to or greater than the acceptance criterion. Adequate usability. | In all stages, all physicians scored the usability as equal to or greater than the acceptance criterion. Adequate usability. |
| MRI Compatibility | MR conditional, similar to predicate devices. | Concluded that i-ED COIL was MR conditional as same as the predicate devices. |
| MRA Artifact | Worst-case image artifact is minimal, similar to predicate device. | The worst-case image artifact by i-ED COIL was considered as minimal as with the predicate device. |
| Shelf Life Testing | All aging tests meet acceptance criteria (same as performance testing). Sterility maintained. | All results of the aging tests met the acceptance criteria were the same as those of the performance testing. Three-years shelf-life of i-ED COIL established. |
| Biocompatibility | Meets biological safety requirements; non-toxic, non-sensitizing, non-pyrogenic, non-mutagenic, non-carcinogenic. | Analysis showed no definite toxic substances. Not cytotoxic. No-skin sensitizing. Acceptable intracutaneous reactivity. No acute systemic toxicity. Non-pyrogenicity. Non-mutagenic. No properties injurious to paravertebral muscle of rabbits. Non-hemolytic. Thrombogenesis risk equivalent or lower than legally-marketed devices. Complement activation within acceptable range. No chronic systemic toxicities. Non-carcinogenic. |
| Electrical Safety (EDG v4) | Complies with IEC 60601-1 standard. | Device complies with the IEC 60601-1 standard. |
| Electromagnetic Compatibility (EDG v4) | Complies with IEC 60601-1-2 standard. | Device complies with the IEC 60601-1-2 standard. |
| Software Verification and Validation | Meets recommended guidance for software in medical devices. | Documentation provided as recommended by FDA guidance. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Specific numerical sample sizes are generally not provided for each test, other than phrases like "All samples" or "all EDG v4 samples," implying multiple units were tested. For particulate evaluation, an unspecified "test sample solution" was analyzed. For shelf life, "samples" that underwent simulated transportation and accelerated aging were tested.
- Data Provenance: The studies are described as "in vitro tests," "bench testing," and "simulated use tests." Given the nature of a neurovascular embolization device, these are laboratory and simulated environment tests. There is no mention of country of origin for the data or whether it's retrospective or prospective, as these are not clinical studies primarily.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: For the "Simulated use evaluation on i-ED COIL System," "Physicians who participated in this study, semi-quantitatively evaluated trackability and delivery performance..." The exact number of physicians is not specified, but it implies more than one. For "Usability evaluation on i-ED COIL System," it states "physician trained for neuro-interventional procedures" and "all of physicians scored the usability," again implying multiple.
- Qualifications of Experts: For simulated use and usability evaluation, the experts are identified as "Physicians who participated in this study" and "physician trained for neuro-interventional procedures," suggesting relevant medical expertise in the field where the device would be used. Specific years of experience are not provided.
4. Adjudication method for the test set
- Adjudication Method: Not explicitly stated. For the evaluations involving physicians (Simulated Use, Usability), it's implied that their assessments directly formed the "results" for those tests. There's no mention of a formal adjudication process (e.g., 2+1, 3+1 consensus) for these types of bench or simulated use tests.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a neurovascular embolization coil system, not an AI or imaging diagnostic algorithm that involves human readers interpreting images. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a physical medical device, not an AI algorithm. There is no "algorithm only" performance to assess in this context. While software verification and validation were performed for the EDG v4, this refers to the control software of the detachment generator, not a diagnostic or prescriptive AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the performance tests, the "ground truth" is typically defined by pre-specified manufacturing specifications, established engineering standards (e.g., ISO, ASTM), and the performance of legally marketed control devices. For aspects like simulated use and usability, the "ground truth" comes from the qualitative or semi-quantitative assessments of qualified physicians using the device in a simulated environment. There is no biological "ground truth" like pathology or outcomes data directly for these bench and simulated tests, though the biocompatibility section relates to biological responses.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document does not describe the development or testing of an AI model, so there is no training set. The device is a physical medical device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no AI training set for this device.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).