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The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The Micrus Deltapaq 10 Stretch-Resistant Microcoil Systems consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile)

The provided document is a 510(k) summary for the Micrus Deltapaq 10 Stretch-Resistant Microcoil System, a neurovascular embolization device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with specific acceptance criteria and detailed performance studies against a defined ground truth.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance against those criteria, details of a study with a test set, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML device.

Instead, the document emphasizes the following:

1. Comparison to Predicate Device:

The submission states: "The Micrus Deltapaq 10 Stretch-Resistant Microcoil System has shown substantial equivalence to the Micrus Stretch-Resistant Microcoil System in terms of intended use, design, material of construction, implant dimensions including wire dimensions, coil dimensions, coil pitch, and coil stiffness. The Deltapaq 10 Stretch-Resistant microcoils use the same method and material of construction, packaging, and sterilization method as its predicate. The modification has not altered the fundamental technology of the sponsor's predicate device."

2. Conclusion:

"Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Micrus Deltapaq 10 Stretch-Resistant Microcoil System is substantially equivalent to the predicate device in safety and effectiveness."

In summary, as this is a 510(k) submission for a non-AI/ML medical device, the detailed information about acceptance criteria, performance studies with test sets, expert ground truth, and training data as typically required for AI/ML device evaluations is not present in this document. The "study" here refers to non-clinical testing demonstrating equivalence to a predicate device, rather than a performance study against specific diagnostic or prognostic metrics.

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The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The Micrus Deltapaq 10 Cerecyte Microcoil Systems consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile)

Here's an analysis of the provided text regarding the Micrus "Deltapaq 10 Cerecyte" Microcoil System (K080437) and its acceptance criteria and supporting study:

Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate "substantial equivalence" to a predicate device, rather than rigorously proving performance against pre-defined acceptance criteria through a standalone study with a test set, ground truth, and expert adjudication in the way an AI/CAD device would. This document focuses on demonstrating that the new device is fundamentally similar to an already cleared device and thus doesn't raise new questions of safety or effectiveness. Therefore, many of the requested data points (e.g., sample size for test set, number of experts, adjudication method for ground truth, MRMC study, how ground truth for training set was established) are not applicable or not provided in this type of regulatory submission.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a device like a microcoil, the "acceptance criteria" are generally interpreted as demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing key attributes.

Study Details (as inferable from a 510(k) for a physical device)

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

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of comparing algorithm performance. For a physical device like this, testing typically involves bench testing (e.g., mechanical properties, deployment, embolization effectiveness in models) rather than a clinical "test set" of patient data for diagnostic accuracy. The document mentions "non-clinical testing performed by Micrus Endovascular Corporation" but does not detail sample sizes for these tests.
   • Data Provenance: The "non-clinical testing" would have been conducted by the manufacturer, Micrus Endovascular Corporation. It's retrospective in the sense that the testing was completed before the 510(k) submission. No country of origin for data (like patient studies) is provided as it's not a diagnostic AI device.

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

   • N/A. As this is a physical medical device (microcoil) and not a diagnostic imaging AI, there isn't a "ground truth" established by human experts on a medical image test set in the conventional sense. The "ground truth" for demonstrating substantial equivalence for a physical device would be based on engineering specifications, material science, and performance in bench models, judged against the predicate device's established performance or regulatory standards.

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

   • N/A. Not applicable for a physical device compliance demonstration.

4. 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 type of study is specifically for diagnostic AI/CAD systems that assist human readers. The Micrus Deltapaq 10 Cerecyte Microcoil System is a therapeutic device for embolization, not a diagnostic tool requiring human interpretation improvement.

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

   • No. This question is also specific to AI/CAD algorithms. The microcoil is a physical medical implant, not a standalone AI algorithm. Its performance is inherent to its physical properties and how it's used by a clinician.

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

   • For this type of device, "ground truth" for substantial equivalence would primarily be:
     • Engineering Specifications: Confirmation that the new device meets the same design, material, and dimensional specifications as the predicate device.
     • Bench Testing Results: Data from physical tests (e.g., tensile strength, flexibility, deployment characteristics, embolization effectiveness in a simulated model) showing comparable performance to the predicate.
     • Intended Use Alignment: Verification that the proposed indications for use align exactly with the predicate device.

7. The sample size for the training set:

   • N/A. This device is not an AI/ML algorithm that requires a "training set."

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

   • N/A. As there is no training set, this is not applicable.

In summary, the K080437 submission for the Micrus Deltapaq 10 Cerecyte Microcoil System is a typical 510(k) for a modified physical medical device. It focuses on demonstrating "substantial equivalence" to a predicate device (Micrus Cerecyte Microcoil, K033813) by showing that the new device shares the same intended use, fundamental technology, design, materials, and manufacturing processes, and performs comparably in non-clinical testing. The framework of acceptance criteria and studies for AI/CAD devices (e.g., test sets, ground truth by experts, MRMC studies) does not apply to this type of submission.

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The Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The Micrus Microcoil System cach consist of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single usc, sterile).

This 510(k) premarket notification for the Micrus Microcoil Delivery System does not contain a study that establishes performance against acceptance criteria in the manner typically seen for AI/ML devices or novel technologies with specific performance metrics. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The provided document does not specify quantitative acceptance criteria or report device performance against such criteria. The basis for clearance is "substantial equivalence" to predicate devices, implying that the device performs similarly to devices already on the market.

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

Not applicable. There is no mention of a "test set" or specific study data, as the submission relies on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth establishment is not relevant in a substantial equivalence filing for this type of medical device where performance is based on similarity to existing products, rather than novel diagnostic or interventional outcomes requiring expert-driven validation.

4. Adjudication Method

Not applicable. There is no mention of a study involving adjudication.

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

No. An MRMC study is not mentioned. This type of study is typically used for diagnostic devices involving human interpretation of data, often comparing AI-assisted performance to unassisted performance. This device is an interventional tool, not a diagnostic one.

6. Standalone Performance Study

No. A standalone performance study for the algorithm (without human-in-the-loop) is not applicable or mentioned, as the device itself is a physical medical instrument, not software.

7. Type of Ground Truth Used

Not applicable. The concept of "ground truth" as it applies to diagnostic or prognostic AI/ML algorithms is not relevant here. The "truth" in this context is that the device functions as intended and is safe and effective similarly to its predicates.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device that learns from data.

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

Not applicable.

Summary of the Document's Approach:

The core of this 510(k) submission for the Micrus Microcoil Delivery System is the argument of substantial equivalence to predicate devices. This means the manufacturer is asserting that:

• Intended Use: The device shares the same intended use as legally marketed predicate devices (endovascular embolization of intracranial aneurysms, neurovascular abnormalities, and peripheral arterial/venous embolizations).
• Design and Specifications: The design, specifications, and materials are comparable to the predicate devices.
• Safety and Effectiveness: Because of the similarities in intended use, technology, and materials, the device is considered as safe and effective as the predicate devices.

The clearance letter from the FDA confirms this determination: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "study that proves the device meets the acceptance criteria" in this case is the comparison to predicate devices and the FDA's agreement that this comparison demonstrates substantial equivalence, rather than a clinical trial with specific performance metrics against pre-defined acceptance criteria.

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The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The Micrus Cashmere-Cerecyte and Cashmere-SR Microcoil Systems each consists of an embolic coil (“Microcoil”) attached to Device Positioning Unit (DPU) (single use, sterile)

This document describes a 510(k) premarket notification for the Micrus Microcoil Delivery System and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, I cannot fulfill the request to provide information based on acceptance criteria and a study from the provided text.

Here's why the prompt cannot be answered with the given text:

• Type of Submission: The document is a "Summary of Safety and Effectiveness" for a 510(k) submission. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, predefined acceptance criteria through a clinical or performance study.
• Content Focus: The text explicitly states, "Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Micrus Cashmere-Cerecyte and Cashmere-SR Microcoil Systems are substantially equivalent to the predicate devices in safety and effectiveness." This indicates that the "study" was primarily a comparison to existing devices and non-clinical testing, not a formal study with acceptance criteria being met.
• Missing Information: The document lacks the detailed information requested in the prompt, such as:
  • Specific acceptance criteria values.
  • Quantitative performance results for the new device against those criteria.
  • Sample sizes for test sets, data provenance, ground truth establishment, expert information, adjudication methods, MRMC studies, or standalone algorithm performance.
  • Training set details.

In summary, the provided text is a regulatory clearance document for a medical device based on substantial equivalence, not a detailed report of a study designed to meet specific acceptance criteria.

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The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The Micrus MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). An "introducer sheath" covers the microcoil and DPU and is attached to a re-sheathing tool

I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for the Micrus Microcoil Delivery System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria.

The information provided primarily covers:

• Device Description and Intended Use: The Micrus MicroCoil Delivery System is for endovascular embolization of intracranial aneurysms.
• Comparison to Predicate Devices: The submission argues that the device, with its new introducer sheath and re-sheathing tool, is substantially equivalent to previously cleared Micrus Microcoil Systems based on intended use, design, materials, and method of construction.
• Conclusion: The submission concludes substantial equivalence based on design, materials, function, intended use comparison, and "non-clinical testing." However, the details of this non-clinical testing are not provided.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The Micrus Cashmere-14 MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile).

This document is a 510(k) summary for the Micrus Cashmere-14 Microcoil System. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study of device performance against acceptance criteria in the typical sense of a clinical trial for an AI/ML device.

Therefore, many of the requested categories are not applicable to this type of regulatory submission for a medical device that is not an AI/ML product.

Here's a breakdown of the information that is available or applicable from the provided text, and an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not present because this is a 510(k) submission focused on substantial equivalence to existing predicate devices, rather than meeting novel performance acceptance criteria through a standalone study. The "performance" described is the device's design, material, function, and manufacturing being equivalent to predicate devices.

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

• Not Applicable: This document does not describe a clinical study or a "test set" of patient data in the context of an AI/ML device or novel performance criteria. The evaluation is based on non-clinical testing (likely bench testing, material testing, and design comparisons) and comparison to predicate devices, not data from a test set of patient cases.

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

• Not Applicable: There is no "test set" of patient cases for which ground truth would be established by experts. The evaluation focuses on engineering and material equivalence.

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

• Not Applicable: No clinical 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: This device is a physical medical implant (a microcoil), not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not Applicable: This device is a physical medical implant, not an algorithm.

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

• Not Applicable: For a 510(k) submission showing substantial equivalence of a physical device, the "ground truth" is typically the established safety and effectiveness of the predicate device(s) and demonstrable equivalence in design, materials, and function through engineering tests and analyses, rather than clinical outcomes or pathology data for a new device.

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device requiring a training set.

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

• Not Applicable: This is not an AI/ML device requiring a training set.

Summary of the document's content:

The document is a 510(k) Premarket Notification for the Micrus Cashmere-14 Microcoil System. It asserts that the device is substantially equivalent to several predicate devices (Micrus SR Helical-18 Microcoil System, Boston Scientific GDC 360, Cordis Trufill DCS Orbit Detachable Coil) in terms of:

• Intended Use: Endovascular embolization of intracranial aneurysms.
• Design: Including implant dimensions (wire diameter, primary wind diameter, pitch, coil stiffness, coil diameter, coil length).
• Material of Construction: Same method and material.
• Manufacturing Method.
• Packaging.
• Sterilization Method.

The conclusion is based on design, materials, function, intended use, and non-clinical testing performed by Micrus Endovascular Corporation, leading to the determination of substantial equivalence in safety and effectiveness. The FDA concurred with this determination, allowing the device to be marketed.

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The MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The Micrus Presidio 18-System Microcoil consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Presidio 18-System Microcoil is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.017" and 0.021." The coils are available in spherical shapes and are available in various diameters and lengths: Coil lengths range from 30 to 50 centimeters. Coil diameters range from 8 to 20 millimeters. Micrus Presidio 18-System Microcoils are fabricated from the same diameter platinum alloy wire as used in the Cerecyte 18 system platinum Microcoils, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The Microcoils are subjected to the same thermal treatments for primary and secondary shaping processes. The addition of Presidio 18-System Microcoil to the Cerecyte 18-System line means these 18-System Microcoils will be identical to the current CE Marked / FDA Cleared Cerecyte 18-System with only a single point of difference (length). The platinum alloy wire will match the diameter of all Micrus Microcoil 18 Systems (Platinum only and Cerecyte). The catalog number for Presidio-18 is PC4. The 18 System Presidio Microcoils maintain the same design features as all the current Microcoil Systems. Compared with the current design, size 18 Presidio Microcoil Systems have: The same intended use Connect to the same connecting cables. Detach using the same Detachment Control Box. It is important to reiterate, the Micrus Presidio-18 MicroCoils are identical to the current FDA cleared Micrus Cerecyte-18 MicroCoils except for length

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification for the Micrus Presidio-18 MicroCoil System, which focuses on establishing substantial equivalence to previously cleared predicate devices.

The key points from the provided text are:

• Device: Micrus Presidio-18 MicroCoil System
• Intended Use: Endovascular embolization of intracranial aneurysms.
• Predicate Devices: Micrus MicroCoil System, Cerecyte-18 (K053160), MicroVention MicroPlex Complex 3D (K012145), Micrus MicroCoil Delivery System (K002056).
• Basis for Equivalence: The Presidio-18 MicroCoil सिस्टमs are described as "identical to the current FDA cleared Micrus Cerecyte-18 MicroCoils except for length." This suggests that the substantial equivalence argument relies on the similarity of design, materials, manufacturing processes, and intended use with an already cleared device, rather than new performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence based on prior device characteristics.

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The Micrus MicroCoil System is intended for endovascular embolization of intracranial aneurysms.

The current Micros Spherical MicroCoil System (510k # K002056) is available in 10 and 18 system sizes.
The 10 System Spherical MicroCoils are available in diameters ranging from 2 mm to 10 mm and in lengths ranging from 2 cm to 20 cm.
The 18 System Spherical MicroCoils are available in diameters ranging from 2 mm to 19 mm and in lengths ranging from 2 cm to 30 cm.
The proposed longer Spherical MicroCoil, which is the focus of this submission, is designed to provide move aneurysm-framing loops to provide better aneurysm wall and aneurysm neck coverage in aneurysms ranging from 6 to 10 mm in size:
The "Long 10 System Spherical" MicroCoils will be available in diameters ranging from 6 mm to 10 mm and in lengths ranging from 20 cm to 30 cm.
These long Spherical MicroCoils are a line extension of the current regular length Micrus Spherical MicroCoils.
Both the original length and long length Spherical MicroCoil Systems are "framing" coils, to be used interchangeably to frame the inner wall of the aneurysm prior to filling it with Helical MicroCoils. All Micrus MicroCoils are part of the complete Micrus MicroCoil Delivery System, which has three components (sold and provided individually):

1. Micrus Platinum MicroCoil Systems, Spherical, Straight, and Stretch Resistant configurations, consist of an embolic coil attached to a variable stiffness Device Positioning Unit (DPU). The DPU has a radiopaque marker band located three (3) centimeters from its distal end for compatibility with infusion microcatheters with 2 tip markers.
2. Detachment Control Boxes (DCB). This device provides the energy to detach the MicroCoil from the DPU at the clinician's command. The DCB is provided NON-STERILE.
3. Connecting Cable. The Connecting Cable is used to bring the energy from the DCB to the MicroCoil System, and is approximately 5-ft (1.5 m) long.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to address your specific questions:

Acceptance Criteria and Device Performance

Study Details

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

   • The document describes non-clinical tests. There is no mention of a human test set, clinical data, or data provenance (country of origin, retrospective/prospective). The tests referenced are in vitro (flow model and frictional force testing).

2. 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 tests are non-clinical, mechanical/performance evaluations. Ground truth for clinical data is not mentioned.

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

   • Not applicable, as there is no human test set or clinical data requiring adjudication.

4. 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 is a medical device for embolization, not an AI diagnostic tool. No MRMC study was performed.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • The "ground truth" for these non-clinical tests would be the pre-defined performance specifications (refer to "Acceptance Criteria" table above) for mechanical properties and functional performance (durability, ability to advance/retract/frame, and frictional forces). These are engineering specifications rather than clinical ground truth like pathology or expert consensus.

7. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

   • Not applicable for the same reason as above.

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Micrus MicroCoil Systems are intended for endovascular embolization of intracranial aneurysms.

Micrus MicroCoil Systems are platinum embolic coils ("MicroCoils") attached to Device Positioning Units (DPUs (single use, sterile). The Micrus MicroCoil Systems are available in a 10-System size (compatible with 10 and 14 sized microcatheters) and 18-System size (compatible with 14 and 18 sized microcatheters). Both 10 and 18 sizes are available in various diameters/dimensions. Shapes can be spherical, helical, or straight. Lengths range from 1 to 30 centimeters and diameters range from 2 to 20 millimeters. Implant material for the non stretch resistant MicroCoils is a platinum alloy: implant material for the stretch resistant MicroCoils is a platinum alloy and a stretch resistant member (non-absorbable polypropylene suture).

A MicroCoil is detached from its Device Positioning Unit through heat shearing of a highly oriented, high tensile strength polyethylene (PE) fiber upon the clinician's command. The Device Positioning Unit is then removed from the microcatheter and discarded.

A Micrus MicroCoil System connects to a Micrus Connecting Cable (single use, sterile) which traverses the sterile field to connect to a Micrus Detachment Control Box (DCB) (reusable, non-sterile). The Connecting Cable and Detachment Control Box are sold separately. A MicroCoil System plus Connecting Cable and Detachment Control Box is referred to as a Micrus MicroCoil Delivery System.

This response is structured based on the provided document, K031578. The information regarding acceptance criteria and the study that proves the device meets them is primarily found in sections G and H.

Acceptance Criteria and Device Performance Study for Micrus MicroCoil Systems

This submission focuses on a labeling change for the Micrus MicroCoil Systems, specifically a change to the "Indication for Use" statement based on clinical outcomes from the International Subarachnoid Aneurysm Trial (ISAT). The device itself (Micrus MicroCoil System) remains unchanged from its predicate devices K002056 and K022420. Therefore, the device's technical acceptance criteria were established and met in the predicate device clearances, and the current submission provides a summary of those non-clinical tests. The "study that proves the device meets the acceptance criteria" in this context refers to the clinical evidence (ISAT) used to justify the broader indication for use.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)

The following table summarizes the non-clinical tests and results, previously reviewed for the predicate devices, for which the Micrus MicroCoil System was found "Equivalent." These represent the fundamental performance acceptance criteria for the device itself.

• Detachment reliability. | - No filling defects evident on angio.
• No premature detachment / auto-detach caused by exposure to blood, body fluids, body temperatures or repeated manipulation.
• 100% first detach-cycle detachment achieved. |
  | Coil Stability / Aneurysm Occlusion | - Positional stability and aneurysm occlusion. | - Positional stability and aneurysm occlusion maintained through 6 months of implant.
• No coil compaction present at 6-month angio. |
  | GDC Bench Marking | - Established specifications for delivery force, tensile strength, and stiffness.
• Micrus Stretch Resistant MicroCoil must be substantially equivalent to predicates. | - Showed substantial equivalence in delivery force, tensile, and stiffness. |
  | Coil Stiffness/Softness | - Stiffness limit desired for Finishing Stretch Resistant MicroCoil. | - Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil stiffness is within desired stiffness limit. |
  | Friction in the Microcatheter (Delivery Force) | - Average push force must be substantially equivalent to predicates. | - Finishing Stretch Resistant MicroCoil and Helical Stretch Resistant MicroCoil average push force exhibit comparable delivery forces. |
  | MDR Database Review | - Review for clinical risks. | - MSR01 risk assessment includes and addresses all risks encountered in review of predicate device MDR review. |
  | Biocompatibility of Materials | - Meets the requirements of ISO 10993. | - The only new material in the Micrus Stretch Resistant MicroCoil is polypropylene monofilament # 6523, which is identical to the pre-approved GDC stretch resistant suture. (Implies compliance by equivalence to approved material). |
  | Sterilization Validation | - Minimum Sterility Assurance Level of 10-6. | - Passed minimum sterility assurance level of 10-6. |
  | Shelf Life Test | - No performance degradation after 1 year of shelf life aging. | - Minimum tensile strength after 1 year accelerated aging shows no degradation. |
  | Tensile Strength | - Tensile strength of suture ball tip and MicroCoil to DPU must be substantially equivalent to predicates. | - Tensile strength meets desired strength criteria. |
  | Durability (Reliability after Fatigue) | - Withstand deployment and retraction 6 times in a tortuous anatomy. | - No knotting, no breakage, no stretching occurred.
• Durability meets desired durability criteria. |
  | MRI Compatibility of Implant | - No change impacting MRI compatibility. | - No change was made which would impact MRI compatibility. (Implies existing compatibility from predicates is maintained, thus meets this inherent criterion). |

Acceptance Criteria for Clinical Outcomes (New Indication for Use):

The acceptance criteria for the expanded "Indication for Use" are implicitly derived from the results of the ISAT study, which demonstrated clinical superiority of endovascular coiling over surgical clipping for ruptured intracranial aneurysms.

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

• Sample Size for the Clinical Test Set (ISAT):
  • Total patients enrolled: 2143
  • Patients randomly assigned to endovascular treatment with platinum coils: 1073
  • Patients randomly assigned to neurosurgical clipping: 1070
• Data Provenance: The study was a "multi-center study published in the Lancet," referred to as the International Subarachnoid Aneurysm Trial (ISAT). It involved patients with ruptured intracranial aneurysms. The data is prospective as it involved random assignment and follow-up. The document does not explicitly state the countries of origin for all participating centers, but "International" implies multiple countries, likely involving European and other centers given its publication in The Lancet and prior clinical practice in Europe. Micrus Corporation received CE Marking in May 2000 and FDA clearance in January 2001, joining ISAT in February 2001, indicating its international scope prior to US market entry.

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

The ISAT study was a large, randomized controlled trial comparing two treatment modalities for ruptured intracranial aneurysms. The "ground truth" for the primary outcome (neurological assessment of dependency at 1 year) was established through clinical outcomes data collected directly from patients. The document states, "The primary outcome was a neurological assessment of dependency at 1 year (using the Rankin neurological outcome scale)." This implies that trained clinical personnel (e.g., neurologists, nurses, or other healthcare professionals) conducted these assessments. The exact number of experts/assessors is not specified, but for a trial of this magnitude, it would involve numerous qualified healthcare professionals at each participating center, following standardized protocols for outcome assessment. Their qualifications would be as medical professionals trained in neurological assessment and the use of the Rankin scale.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the primary outcome assessment itself (neurological assessment of dependency). For large, multi-center trials like ISAT, it is common best practice to have:

• Standardized training for assessors.
• Centralized review of case report forms.
• Possibly masked outcome assessment (though not explicitly stated whether assessors were blinded to treatment arm).
• A Clinical Events Committee (CEC) to adjudicate serious adverse events or difficult-to-classify outcomes.
  The text primarily focuses on the direct "Findings" from the collected data, implying a robust methodology for data collection and analysis rather than a specific "adjudication" of the primary outcome by external experts.

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

No, an MRMC comparative effectiveness study was not done as part of this submission or the ISAT. ISAT was a randomized controlled trial comparing treatment modalities (endovascular coiling vs. surgical clipping) and their clinical outcomes, not comparing human reader performance with or without AI assistance. The Micrus MicroCoil System is a physical device, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not conducted. The Micrus MicroCoil System is a medical device, not an algorithm or AI system for diagnosis or standalone analysis. Its performance is assessed through its physical characteristics and clinical outcomes when used in patients.

7. Type of Ground Truth Used for the Clinical Test Set (ISAT)

The ground truth used for the clinical test set (ISAT) was outcomes data, specifically:

• Clinical outcomes: Neurological assessment of dependency at 1 year using the Rankin neurological outcome scale.
• Survival data: Implied by "dependent or dead at 1 year."
• Rebleeding events: Documented occurrence of rebleeding at 1 year.
  This is direct patient outcome data, collected prospectively as part of the randomized controlled trial.

8. Sample Size for the Training Set

• For the non-clinical tests (physical performance, durability, etc.): Not applicable in the context of "training set" as these are engineering and materials tests, not machine learning based.
• For the clinical justification (ISAT): Not applicable. ISAT was a clinical trial used for validation/comparison, not a "training set" for a device, as the Micrus MicroCoil System is a physical medical device and not a data-driven model requiring a training phase for its core function.

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

Not applicable, as there was no explicit "training set" in the context of an AI/ML algorithm or data-driven model described in this submission. The "ground truth" for evaluating the clinical efficacy of the device (as part of endovascular coiling) was established through the rigorous, prospective data collection and follow-up within the ISAT clinical trial design.

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