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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 of vascular diseases 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 System is a neurovascular embolization device. The provided text describes the 510(k) summary for a modification to this system, specifically focusing on changes to the sterilization packaging materials and an extension of the shelf-life for the EDG v4 component.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All samples passed the acceptance criteria" for each test. However, it does not explicitly list the quantitative acceptance criteria for each test. It generally refers to "acceptance criteria" without providing the specific thresholds or metrics.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes (number of units or tests performed) for any of the performance tests. It refers to "samples" being tested.
• Data Provenance: The study is described as performance testing conducted to "mitigate risks identified in our risk analysis of the modifications" and "demonstrate substantial equivalence." This is internal testing performed by Kaneka Medical America LLC as part of their 510(k) submission. The country of origin for the data is not explicitly stated beyond the submitter's location (New York, USA) and the official correspondent being in Japan, implying internal company testing. It is a prospective study in the sense that new tests were conducted for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the tests conducted (package integrity, shipping, shelf-life) are engineering/performance verification tests for a medical device's physical and functional properties, not clinical studies requiring expert ground truth for interpretation of medical data (e.g., image analysis, disease diagnosis).

4. Adjudication Method for the Test Set

This section is not applicable for the type of engineering verification tests described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving multiple human readers interpreting medical data.

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

This section is not applicable. The device is an embolization coil system and detachment generator, which is a physical implant/instrument. It is not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance testing mentioned:

• Package integrity: The ground truth for package integrity would be established by predefined physical and sterility requirements (e.g., no leaks, no microbial ingress, seal strength within specifications).
• Shipping and detachment test: The ground truth would be the device's ability to function as intended (correct output measurements, successful coil detachment) after simulated transport.
• Shelf-life testing: The ground truth would be the device's ability to maintain its specified performance and integrity for the extended shelf life (2 years) after accelerated aging and simulated transport.
  These are all based on engineering specifications and established test methods (like ASTM standards).

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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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

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.

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