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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima 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 for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and 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 aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

The provided text describes a 510(k) premarket notification for a medical device called the Optima Coil System (OptiBlock Line Extension). This submission focuses on demonstrating substantial equivalence to a predicate device (Optima Coil System, K223386) for which it is a modification or line extension.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

The document explicitly states "The following non-clinical bench testing was performed to evaluate the device changes and to demonstrate substantial equivalence...". It mentions "test samples" but does not specify the sample size for either of the tests performed. The data provenance is from bench testing for a medical device line extension, not involving human subjects or clinical data in this submission. Therefore, country of origin is not applicable in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. Given that the studies are non-clinical bench tests, the "ground truth" would be established by engineering specifications and objective measurements rather than expert consensus on clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided and is generally not applicable to non-clinical bench testing. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases.

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 information is not applicable as the described device is a neurovascular embolization coil system, not an AI software or a device that assists human readers in interpreting medical images. There is no mention of AI in the document.

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

This information is not applicable for the same reasons as point 5. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

For the "Visual Inspection, Dimensional Inspection, and Resistance Check," the ground truth would be engineering specifications and manufacturing tolerances. For "Simulated Use," the ground truth would be pre-defined performance criteria within a clinically relevant model, also based on engineering and functional specifications for the device's intended operation. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these non-clinical tests.

8. The sample size for the training set:

This information is not provided and is not applicable given that this is not an AI/machine learning device. The concepts of "training set" and "ground truth for the training set" are relevant to machine learning model development, not for a physical medical device.

9. How the ground truth for the training set was established:

This information is not provided and is not applicable for the reasons stated in point 8.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima 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 for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and 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 aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

The provided text is a 510(k) Summary for a medical device called the "Optima Coil System." It describes the device, its intended use, and its comparison to a predicate device. It also includes a table of performance data from bench testing. However, this document does not contain information about a study involving human readers or AI assistance, or any data related to diagnostic accuracy, sensitivity, or specificity.

The "acceptance criteria" and "device performance" described are for bench testing only, which evaluates the physical and functional characteristics of the device itself, not its performance in a clinical scenario involving human interpretation or AI.

Therefore, I cannot fulfill the request for information related to:

• A table of acceptance criteria and reported device performance in a human-AI study. The provided table only covers bench tests.
• Sample size used for the test set and data provenance for a human-AI study.
• Number of experts used to establish ground truth and their qualifications for a human-AI study.
• Adjudication method for a human-AI study.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a human-AI study.
• Sample size for the training set for an AI study.
• How ground truth for the training set was established for an AI study.

The document's "Performance Data - Bench" section is directly relevant to the acceptance criteria of the device's physical properties and functionality, not an AI or diagnostic performance study.

Here's the information that can be extracted from the provided text regarding device acceptance criteria and performance (bench testing):

Device Acceptance Criteria and Reported Performance (Bench Testing)

Explanation of the Bench Study (based on the provided text):

The performance data presented is from non-clinical bench testing. Its purpose was to evaluate changes made to the Optima Coil System (e.g., new coil sizes and combinations of dimensions) and to demonstrate its substantial equivalence to the previously cleared predicate device (K200030).

• Sample size: Not explicitly stated for each bench test, but implied to be "test samples."
• Data provenance: Bench testing results, implying in-house lab testing, not clinical data from patients or specific countries. It is retrospective in the sense that it evaluates a final product design.
• Experts for ground truth: Not applicable for this type of bench testing. Ground truth is based on engineering specifications, physical measurements, and performance standards.
• Adjudication method: Not applicable. Results are based on physical measurements and functional checks against pre-defined engineering criteria.
• MRMC Comparative Effectiveness Study: No, this document does not describe such a study.
• Standalone Performance: Not applicable in the context of AI; this refers to the physical device's performance.
• Type of Ground Truth: Engineering specifications, physical dimensions, material properties, and functional performance in simulated environments.
• Training Set Sample Size/Ground Truth for Training Set: Not applicable, as this document describes bench testing of a physical medical device, not the development or training of an AI algorithm.

In summary, the provided document focuses solely on the substantial equivalence of a physical neurovascular embolization device based on bench testing of its modifications. It does not contain any information related to AI performance, human-in-the-loop studies, or diagnostic efficacy.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima 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 for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other 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 aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided document describes the Optima Coil System, a neurovascular embolization device. The submission is a Special 510(k) to obtain market clearance for a modified device, primarily involving the addition of new sizes (coil OD, length) and combinations of primary wind and filar diameters. The document asserts that the modified device is substantially equivalent to the predicate device (Optima Coil System K172390).

Here's an analysis of the acceptance criteria and supporting study information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size used for each test set. It repeatedly mentions "All samples," suggesting that a representative number of devices were tested for each criterion.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission for a medical device and the types of tests conducted (bench testing, simulated use), it is safe to infer that this is prospective bench testing data conducted by the manufacturer (Balt USA, LLC) as part of their design verification and validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the document describes a 510(k) submission for a physical medical device (embolization coils) and the performance data presented is from bench testing. The "ground truth" here is defined by engineering specifications and objective measurements (e.g., visual inspection, dimensional requirements, tensile strength, detachment attempts, performance rating for simulated use). Human expert evaluation for establishing ground truth in the way it's typically understood for AI/diagnostic studies (e.g., radiologists interpreting images) is not relevant for this type of device and testing.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. Bench testing of a physical medical device does not typically involve adjudication among human experts to establish ground truth. The acceptance criteria are objective measurements and pass/fail results based on predefined engineering limits.

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 described is a neurovascular embolization coil system, not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance is not relevant.

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

This section is not applicable. The device is a physical medical implant (embolization coils) and a delivery system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the test results in this document is established by engineering specifications and quantifiable physical properties. This includes:

• Dimensional requirements: For secondary diameter and length.
• Visual inspection criteria: For physical damage.
• Performance ratings: For introduction, tracking, deployment, and repositioning in simulated use. These ratings would be based on predefined operational standards and potentially expert observation during the simulated procedure.
• Objective detachment criteria: Detachment within a specified number of attempts.
• Minimum tensile strength values: For detachment zone and stretch-resistance thread.
• Established clinical performance metrics: For usability in the benchtop model, likely reflecting real-world performance expectations.

8. The sample size for the training set

This section is not applicable. The device is a physical medical product, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima 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 for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other 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 aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided document is a 510(k) Pre-Market Notification for the Optima Coil System. It focuses on demonstrating substantial equivalence to a predicate device through performance bench testing, animal testing, biocompatibility studies, sterilization validation, and shelf-life/packaging testing. It does not contain information about studies involving human readers, AI assistance, or expert-established ground truth which are typically associated with performance evaluations of diagnostic or AI-driven medical devices.

Therefore, I cannot provide information for points 1-9 as they are not applicable to the content of this document. The document describes a medical device (neurovascular embolization coil system) and its mechanical, material, and biological performance, not an AI or diagnostic tool.

The "device performance" mentioned in the document refers to how the physical device (the coil system) performs in various mechanical and biological tests, not its accuracy in diagnosing or interpreting medical conditions.

Here's an explanation of why the requested information isn't present in the document:

• Acceptance Criteria and Reported Device Performance (Table): The document lists "Test Method Summary" and "Results" for various tests (e.g., Corrosion Resistance, MRI Compatibility, Biocompatibility). The acceptance criterion for all these tests is implicitly "All test samples passed testing", which is consistently reported as the result. However, the exact numerical acceptance ranges or thresholds are not detailed for each specific test, only the pass/fail outcome.
• Sample Size (Test Set) and Data Provenance: Sample sizes are not explicitly stated for individual bench tests. For animal testing, it mentions "acute porcine model" but not the number of animals. Biocompatibility studies specify "3 Rabbits" for a 4-week implantation and "4 Rabbits" for a 13-week implantation. No data provenance in terms of country of origin is mentioned. All studies appear to be prospective lab/animal studies.
• Number of Experts and Qualifications (Ground Truth): Not applicable. This document does not describe studies that require human experts to establish ground truth, as it's not a diagnostic or AI-driven device.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• Standalone Performance: The "device performance" shown is standalone performance of the physical device via bench and animal testing.
• Type of Ground Truth: For the mechanical and biological tests, the "ground truth" is defined by established scientific and engineering principles, international standards (e.g., ISO, ASTM), and the requirements for a safe and effective medical device. For example, for biocompatibility, the ground truth is that the device should not be cytotoxic, sensitizing, irritant, etc., as determined by standardized biological assays.
• Sample Size for Training Set: Not applicable, as this is not an AI/machine learning device.
• Ground Truth for Training Set: Not applicable.

In summary, the provided text details the regulatory submission for a physical medical device. The types of evaluations described are standard for such devices (mechanical, material, biological safety), and do not involve AI performance metrics or human reader studies.

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