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Axium™ Detachable Coil:

Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Axium™ Prime Detachable Coil:

(Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS)

The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Axium™ Prime Detachable Coil:

(Models: FC-X-Y-3D)

The Axium™ Prime Detachable Col is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

The Axium™ Detachable Coil and Axium™ Prime Detachable Coil consist of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The I.D. is sold separately.

The document provided focuses on the substantial equivalence of the "Axium™ Detachable Coil" and "Axium™ Prime Detachable Coil" with the addition of fluorosafe markers. The primary purpose of the submission is to demonstrate that these changes do not raise new questions of safety and effectiveness compared to the predicate devices. Therefore, the "device" in question is not an AI/ML powered diagnostic device, but rather a neurovascular embolization device with a minor design change.

As such, many of the typical acceptance criteria and study details relevant to AI/ML powered devices, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or provided in this document. The provided text describes bench testing and biocompatibility testing for the physical device itself.

However, I can extract the relevant "acceptance criteria" and "reported device performance" as presented for the specific tests conducted for this submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for each test, but standard for device verification and validation. For biocompatibility, animal models were used (guinea pig, rabbit, mice). For bench tests, "devices" (plural) were evaluated, implying a sample size greater than one but not specified numerically.
• Data Provenance: Not applicable in the context of AI/ML data sets. These are laboratory tests on physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. The "ground truth" for this device modification is established through physical and objective measures against predefined specifications and recognized international standards (e.g., ISO 10993, USP 151) and user needs (for marker visibility). The "clinical users" who evaluated fluorosafe marker visibility are mentioned, but their number and specific qualifications are not detailed.

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

• Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). These tests involve objective measurements and evaluations against specified criteria and standards.

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 submission is for a physical medical device (embolization coil) with a minor design change (adding fluorosafe markers), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This is not an algorithm or AI device.

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

• The "ground truth" here is based on objective measurements against established engineering specifications, chemical/biological compatibility standards (ISO 10993, USP 151), and documented user needs. For example, meeting the criteria for "non-cytotoxic" or demonstrating "no corrosion."

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set."

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Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial anewrysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The Axium™ Prime Detachable Coil is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

The Axium™ Detachable Coil and Axium™ Prime Detachable Coil (referred to collectively as "Axium™ device family"), consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The Instant Detacher (I.D.) is sold separately.

This document does not describe an AI/ML device and therefore does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance.

The document is a 510(k) premarket notification summary for the Axium™ Detachable Coil and Axium™ Prime Detachable Coil, which are neurovascular embolization devices. It describes a proposed change to the labeling concerning the accessory sheath (from femoral to arterial, allowing radial access) and the removal of certain peripheral vasculature indications for specific models.

The performance data presented are for bench testing of the physical device (e.g., ease of delivery, detachment reliability, retractability, retrieval) and explicitly states:

• "The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction." (Regarding animal and clinical data).

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes for test sets or data provenance for AI/ML model evaluation.
3. Number and qualifications of experts for AI/ML ground truth.
4. Adjudication methods for AI/ML test sets.
5. MRMC studies or human reader improvement with AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth used for AI/ML.
8. Sample size for AI/ML training set.
9. How ground truth for an AI/ML training set was established.

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The Axium™ Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.

The Axium™ Detachable Coil System consists of a platinum/tungsten embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Axium™ I.D. (Instant Detacher) which, when activated, detaches the coil from the delivery pusher tip. The Axium™ I.D. (Instant Detacher) is sold separately.

This submission expands the size offerings of the Axium™ Detachable Coil (subject device) by adding thirty-five (35) new model numbers to the currently cleared Axium product portfolio (predicate device). These new model numbers are a line extension of the currently sold predicate device and range in size from 1mm diameter x 1cm length to 3.5mm diameter x 10cm length. All thirtv-five (35) new SKUs have a smaller primary wire diameter than the predicate device. This line extension includes six (6) coils having a 1mm diameter which is outside of the currently cleared Axium size range of 1.5mm diameter x 1cm length to 25mm diameter x 50cm length.

The second modification features a change to the Implant Delivery Pusher by replacing the PET material of the Positive Load Indicator (PLI) and Hypotube Break Indicator (BI) with a laser mark.

These modifications to the currently cleared predicate device were made solely to accommodate the new smaller implant coil size of the subject line extension. All other aspects of the subject device (materials of construction of the implant coil, principles of operation, packaging, labeling and indications for use) are identical to the predicate device.

This document describes a 510(k) submission for a medical device called the Axium™ Detachable Coil System. The submission is for a line extension of an already cleared device, introducing new coil sizes and a minor change to the implant delivery pusher.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the bench tests performed. The acceptance criteria for each test are implicitly that "All devices met acceptance criteria." The device performance is reported as meeting these criteria.

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

• Test Set (Bench Testing): The document does not explicitly state the sample sizes for each specific bench test (e.g., "n=X coils"). It states "All devices met acceptance criteria," suggesting that multiple units of each new SKU were tested. The total number of new SKUs is 35.
• Data Provenance: The data is based on bench testing performed by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular). It is prospective in the sense that the tests were conducted specifically for this 510(k) submission to demonstrate substantial equivalence of the new offerings. There is no mention of geographical origin for the bench testing data; it's assumed to be from the manufacturer's testing facilities.

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

• This submission relies primarily on engineering and performance bench testing, not clinical data or expert visual assessment in the traditional sense of diagnostic imaging.
• For the "Physician Usability Testing," the document states, "The device was navigated through a tortuous benchtop model and deployed into a simulated silicone aneurysm in order to assess coil softness, conformability, ease of delivery and biomechanical stability." It doesn't specify the number or qualifications of physicians who performed or assessed this usability testing. Given it's a benchtop test, it likely involved internal engineering or R&D personnel with relevant medical device experience, possibly overseen or advised by clinicians. It is not mentioned as a formal clinical study with expert ground truth establishment.

4. Adjudication Method for the Test Set:

• Not applicable in the typical sense of diagnostic performance or clinical outcomes. The bench tests have defined parameters and measurements, with results either meeting or not meeting the acceptance criteria. The "Physician Usability Testing" outcome is reported as "All test results met the acceptance criteria," indicating a singular decision based on the assessment criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model numbers."

6. Standalone (Algorithm Only) Performance Study:

• No, this is a physical medical device (embolization coils), not an AI or software algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

• Engineering Specifications and Performance Standards: For the bench testing, the "ground truth" is defined by established engineering specifications, performance requirements, and industry standards for medical devices of this type. These standards relate to dimensions, mechanical properties (e.g., force, tensile strength, resistance to deformation), and functional performance (e.g., detachment, deliverability).
• Predicate Device Data: A significant portion of the "ground truth" or basis for comparison comes from the predicate Axium™ Detachable Coil System. The new devices are deemed substantially equivalent by demonstrating similar performance to the already cleared predicate device, and in many cases, adopting the predicate's testing data for aspects where no change occurred or where the change (e.g., smaller size, laser mark) was proven not to negatively impact performance.

8. Sample Size for the Training Set:

• Not applicable. This device does not use machine learning or AI algorithms that would require a 'training set.'

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set for this type of device submission.

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The Axium ™ Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.

The Axium™ Detachable Coil System consists of a platinum coil secured to a composite delivery wire and is compatible with a 2-marker band micro catheter and a mechanical detachment system. The Axium™ Detachable Coil System consists of three (3) components: 1 -- Implantable Coil, 2 - Implant Delivery Pusher, 3 - Instant Detacher. The Instant Detacher is packaged and sold separately. Axium™ coil configurations include bare platinum, PGLA enlaced platinum and Nylon enlaced platinum coils. Bare configuration coils are non-fiber-enlaced, whereas PGLA and Nylon are enlaced with PGLA and Nylon fibers respectively. This submission expands the size offerings of the Axium™ Detachable Coil System by adding one (1) new model number to the Axium bare product portfolio with a new diameter and coil length combination (SKU QC-1.5-1-Helix). Currently cleared sizes for Axium™ bare under K081465 already include a coil diameter of 1.5mm and a coil length of 1cm; however, not in combination.

This document describes a 510(k) submission for the Axium™ Detachable Coil System, which is a neurovascular embolization device. The submission is for expanding the size offerings of an already cleared device.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The provided document describes the performance data in textual form, stating that "The following test(s) was performed to support the addition of the new size offering" and then lists several categories of bench testing. It does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it states that these tests were "adopted from existing test data for currently cleared Axium™ coil sizes" and that the conclusion is based on "successful completion of non-clinical testing; a thorough assessment of existing test data; as well as identical principles of operation, materials of construction, dimensions, packaging, and indications for use."

Therefore, the acceptance criteria are implicitly that the new size offering (SKU QC-1.5-1-Helix) performs comparably to the previously cleared Axium™ coils in the listed bench tests. The reported device performance is that it did successfully meet these implied criteria.

Implied Acceptance Criteria and Reported Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily refers to "bench testing" and "existing test data" for currently cleared devices. It does not specify the sample size for the new SKU (QC-1.5-1-Helix) or the provenance (country of origin, retrospective/prospective) of the data. Given it's a 510(k) for an additional size, it's highly likely this is internal R&D data from the company, likely prospective for the new SKU but leveraging retrospective data for comparison to the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This submission does not involve clinical studies with human expert evaluation for establishing ground truth in the traditional sense of a diagnostic or AI device. The testing is bench-based and focuses on physical and mechanical properties. Therefore, these questions are not applicable to this type of submission.

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

Not applicable, as this is bench testing, not a clinical study requiring adjudication of expert opinions.

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

No. This submission is for a physical medical device (detachable coil system) and does not involve AI or a multi-reader, multi-case study. This question is not applicable.

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

No. This submission is for a physical medical device and does not involve an algorithm or standalone performance testing in this context. This question is not applicable.

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

For the bench testing, the "ground truth" would be the established engineering and materials specifications and performance characteristics derived from recognized standards and internal quality control protocols for the predicate devices. These are quantitative and measurable physical properties.

8. The sample size for the training set

This is not an AI/machine learning device; therefore, there is no training set in the conventional sense. The "training data" equivalent in this context would be the extensive manufacturing specifications, material properties, and performance data accumulated from the predicate devices' development and testing.

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

As there is no training set for an AI algorithm, this question is not applicable. The "ground truth" for the overall device's performance is established through rigorous engineering design, material science characterization, and comprehensive bench testing against established industry standards and internal acceptance criteria for medical devices.

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The AXIUM™ DETACHABLE COIL SYSTEM is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The AXIUM™ DETACHABLE COILS are also indicated for arterial and venous embolizations in the peripheral vasculature.

The AXIUM™ DETACHABLE COIL SYSTEM consists of a platinum coil secured to a composite delivery wire and is compatible with a 2-marker band micro catheter and a mechanical detachment system. The AXIUM™ coil configurations include bare platinum, PGLA laced platinum and Nylon laced platinum coils. The AXIUM™ DETACHABLE COIL SYSTEM consists of three components: 1- Implantable Coil, 2- Implant Delivery Pusher, 3- Instant Detacher (called the LRS (Linear Release System) actuator in K060747). The Instant Detacher is packaged and sold separately.

The provided text describes a medical device, the AXIUM™ DETACHABLE COIL SYSTEM, and its regulatory clearance process, focusing on an expanded indication for use. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the way typically required for AI/algorithm performance.

The document is a 510(k) summary for a medical device (a coil system for embolization), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative metrics through a clinical trial or algorithm validation study.

Therefore, many of the requested bullet points regarding acceptance criteria, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it pertains to a physical medical device, not an AI or algorithmic medical device.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not applicable / Cannot be extracted from this document. This document is for a physical medical device's 510(k) clearance, not an AI or algorithmic device. It does not provide quantitative acceptance criteria or performance metrics in the context of an algorithm's output (e.g., sensitivity, specificity, accuracy). The "Performance Data" section refers to bench and animal testing for the physical device, not for an algorithm.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Cannot be extracted from this document. This document does not discuss a "test set" in the context of validating an algorithm. The performance data mentioned (bench and animal testing) relates to the physical device. The information about sample sizes or data provenance for such studies is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Cannot be extracted from this document. This document does not describe the establishment of ground truth for an algorithmic test set.

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

• Not applicable / Cannot be extracted from this document. This document does not involve an algorithmic test set or adjudication.

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 / Cannot be extracted from this document. This device is a physical embolization coil system, not an AI-assisted diagnostic or treatment planning system. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

• Not applicable / Cannot be extracted from this document. This device is a physical medical implant, not a standalone algorithm.

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

• Not applicable / Cannot be extracted from this document. As there's no algorithm involved, there's no "ground truth" to establish for an algorithm's performance. The "performance data" refers to the physical characteristics and safety of the implant itself, likely validated through engineering tests, animal studies, and comparison to predicate devices, rather than a diagnostic ground truth.

8. The sample size for the training set

• Not applicable / Cannot be extracted from this document. There is no "training set" as this is not an AI/ML device.

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

• Not applicable / Cannot be extracted from this document. There is no "training set" or corresponding ground truth for an algorithm.

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