Search Results

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

The Micrus Modified MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Micros Modified MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are available in helical and spherical shapes and are available in various diameters/lengths: Coil lengths range from 1 to 30 centimeters. Coil diameters range from 2 to 10 millimeters. Micrus Modified MicroCoils are fabricated from a platinum alloy wire, 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 difference between the Micros Modified MicroColl and the Micros Stretch Resistant MicroCoil is that the Modified MicroCoil and the MicroCoil contains absorbable polyglycolic acid (PGA) suture whereas the Stretch Resistant MicroCoil contains non-absorbable polypropylene suture. The Modified MicroCoils are available in both stretch resistant and non-stretch resistant configurations with different stiffness characteristics and stretch resistant properties.

Here's a summary of the acceptance criteria and study information for the Micrus Modified MicroCoil System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Acute Animal Testing: 5 aneurysms were tested. The study did not specify the type of animal used, but "animal testing" implies a prospective animal study. The country of origin is not specified.
• Chronic Animal Testing: Covers 6 months of implant. The study did not specify the type of animal used, but "animal testing" implies a prospective animal study. The country of origin is not specified.
• Other tests (Coil Stiffness, Friction, Biocompatibility, Sterilization, Shelf Life, Tensile Strength, Durability, Package Integrity, Ship/Transit): The specific sample sizes for these bench and materials tests are not explicitly stated in the provided text. The data provenance is laboratory testing.

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

• This document describes pre-market device testing (bench, animal) for substantial equivalence to predicate devices, not studies involving human image analysis or diagnostic performance. Therefore, there is no mention of experts establishing ground truth in the context of image analysis or clinical diagnosis. The "ground truth" for these tests relates to physical measurements and biological responses defined by established scientific and engineering principles.

4. Adjudication Method for the Test Set:

• As explained above, this document does not describe studies requiring expert adjudication of a test set in the typical sense (e.g., medical image interpretation). The evaluation of results from the non-clinical tests would have been based on pre-defined criteria and measurements.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This device is an implantable medical device (microcoil), and the studies described are non-clinical (bench and animal) tests to demonstrate safety and effectiveness for a 510(k) submission, not comparative effectiveness studies of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This question is not applicable. The device is a physical medical implant, not an AI algorithm. The performance described is the standalone performance of the physical device in laboratory and animal models.

7. The Type of Ground Truth Used:

• The ground truth varied depending on the test:
  • Acute/Chronic Animal Testing: Pathological findings, angiographic results (aneurysm occlusion), and observation of device stability and detachment success.
  • Biocompatibility: Conformance to ISO 10993 standards.
  • Mechanical Tests (Stiffness, Friction, Tensile Strength, Durability): Quantitative physical measurements against established engineering specifications and comparison to predicate device performance.
  • Sterilization, Shelf Life, Package Integrity, Ship/Transit: Conformance to relevant ISO standards and industry best practices.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. (See #8).

Ask a specific question about this device

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.

Ask a specific question about this device

The MicroCatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.

The Micrus Microcatheter consists of 4 major components:

• A flexible shaft with a lubricious liner extruded from Teflon. The liner is reinforced with a metal wire made from stainless steel. The outer shaft jacket is made from Pebax,
• An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
• A standard luer hub insert, which is molded onto the flexible shaft.
• A hydrophilic coating, which covers the distal 100 centimeters of the Microcatheter.

This 510(k) submission (K032624) is for a medical device called the "Micrus Microcatheter," which is a diagnostic and therapeutic intravascular catheter. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K960806, Tracker Excel 14 Microcatheter) rather than presenting a study with specific acceptance criteria and performance metrics for the new device.

Therefore, many of the requested sections related to acceptance criteria, device performance, ground truth, and specific study designs (MRMC, standalone algorithm) do not apply directly to this type of regulatory submission as described in the provided text. This submission focuses on non-clinical testing and comparison to an already cleared device to establish safety and effectiveness.

Here's a breakdown of the information that can be extracted or deduced from the provided text, and where the requested details are not applicable:

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

   This information is not provided in the document. This 510(k) submission doesn't detail specific performance criteria or a study with numerical performance results for the Micrus Microcatheter itself. Instead, it states that based on non-clinical testing and comparison to a predicate device, it is considered substantially equivalent in safety and effectiveness. The "non-clinical testing" is not further elaborated upon for specific acceptance criteria.

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

   This information is not provided in the document. As no clinical study results are presented, there is no mention of a test set, sample size, or data provenance. The submission refers to "non-clinical testing," which typically includes bench testing (e.g., mechanical, material properties) rather than human subject data.

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 information is not provided in the document. There is no mention of ground truth establishment or expert involvement for evaluating device performance in a clinical setting.

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

   This information is not provided in the document. No adjudication method is described, as there is no clinical test set or human evaluation of diagnostic results.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices. The Micrus Microcatheter is a physical medical device (catheter) and is not an AI algorithm.

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

   No, a standalone algorithm performance study was not done. This type of study is relevant for AI-powered diagnostic devices. The Micrus Microcatheter is a physical medical device (catheter) and is not an AI algorithm.

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

   This information is not provided in the document. As there is no clinical study assessing diagnostic or intervention outcomes, no ground truth type is defined.

8. The sample size for the training set

   This information is not provided in the document. There is no training set mentioned, as this is not an AI or machine learning device.

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

   This information is not provided in the document. There is no training set or ground truth establishment relevant to the type of device.

Summary based on the provided text:

The submission for the Micrus Microcatheter primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Tracker Excel 14 Microcatheter, K960806). The basis for this equivalence is stated as:

• Design, materials, function, and intended use of the new device being comparable to the predicate.
• Non-clinical testing performed by Micrus Corporation. While the specifics of this testing are not detailed in the provided excerpts, it would typically involve bench testing for material biocompatibility, mechanical properties (e.g., tensile strength, kink resistance, pushability, trackability), and fluid dynamics, ensuring these properties are equivalent or superior to the predicate device.

Crucially, this 510(k) does not contain information about clinical studies with human subjects, diagnostic performance metrics, or AI algorithm evaluation. The FDA's letter (K032624) confirms the finding of substantial equivalence based on the information provided in the premarket notification.

Ask a specific question about this device

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.

Ask a specific question about this device

The Micrus Stretch-Resistant MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms that – because of their morphology, their location or the patient's general medical condition -- are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques or b) inoperable.

The Micrus Stretch Resistant MicroCoil System consists of a platinum embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Micrus Stretch Resistant 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. The Micrus Stretch-Resistant MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are helically shaped and are available in various diameters/dimensions. Coil lengths range from 1 to 15 centimeters and diameters range from 2 to 10 millimeters. The Stretch Resistant MicroCoils are available in two levels of softness: 1. The Micrus Soft, Stretch-Resistant MicroCoil (catalog # FSR) corresponds to the 10-System GDC Ultra Soft Stretch Resistant Coil, using a primary wind of 0.0015" to create softness. 2. The Standard Micrus Stretch-Resistant MicroCoil (catalog # HSR) corresponds to the 10-System GDC Soft, Stretch Resistant coil, using a primary wind of 0.00175". Micrus Stretch Resistant MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing a non absorbable polypropylene suture inside the wind) and then formed into a secondary helical shape. The Micrus Stretch-Resistant MicroCoil System is identical to the FDAcleared MicroCoil System with the 4 following exceptions: 1. The coil's primary wind wire diameter has been reduced from 0.00175" to 0.0015" to create softness in the Micrus Soft Stretch-Resistant MicroCoil. (The Standard Micrus Stretch-Resistant MicroCoil uses the same 0.00175" diameter primary wind as is used in the Micrus 10-System Helical MicroCoil.) 2. A non absorbable polypropylene suture has been inserted inside the primary wind coil to create stretch-resistance. 3. The polypropylene suture is connected to the distal coil end to make a non-traumatic distal ball tip. 4. A loop of polypropylene suture has been added to the socket/ring connection at the coil to Device Positioning Unit junction to secure the polypropylene suture to the Device Positioning Unit.

The Micrus Stretch-Resistant MicroCoil System (MSR01) underwent several non-clinical tests to demonstrate its safety and effectiveness, and substantial equivalence to predicate devices (GDC Soft and Ultra Soft Stretch-Resistant). The study primarily focuses on bench testing and comparisons to established specifications of predicate devices rather than human clinical trials.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical bench testing.

• Sample Size for Test Set: The exact sample sizes for each specific test (e.g., number of coils tested for detachment, number of "implants" for coil stability) are not explicitly stated in numerical terms (e.g., 100 coils, 20 coils). However, the narrative implies a sufficient quantity of samples were tested to generate the "Test data" against the "Characteristics" (acceptance criteria).
• Data Provenance: The data is from non-clinical bench tests performed on the "Micrus Stretch-Resistant Delivery System (MSR01)". This indicates the data was generated in a lab setting, likely within the manufacturing facility or a contracted testing facility, rather than from human patients. The document does not specify a country of origin beyond "Micrus Corporation" in Mountain View, California, USA. The data is prospective in the sense that the tests were conducted specifically for this submission to prove performance against established criteria.

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

The concept of "ground truth established by experts" typically applies to clinical studies or image-based diagnostic systems. For these non-clinical, bench-level performance tests:

• Number of Experts: Not applicable in the context of establishing ground truth for these types of engineering and material performance tests.
• Qualifications of Experts: The "ground truth" (acceptance criteria) for these non-clinical tests is established based on engineering specifications, recognized industry standards (e.g., ISO 10993 for biocompatibility, sterility assurance levels), and the established performance characteristics of the predicate devices. These criteria would be developed and validated by engineers, quality control specialists, and regulatory affairs personnel with expertise in medical device design, manufacturing, and testing, rather than clinical experts like radiologists.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are relevant for clinical studies, especially those involving human readers or subjective assessments. For these non-clinical bench tests:

• Adjudication Method: Not applicable. The results are typically quantitative measurements against objective criteria (e.g., "no filling defects," "100% first detach-cycle detachment," "within desired stiffness limit"). The determination of whether a test "passed" or "failed" is based on meeting these pre-defined, measurable criteria, not on expert consensus or adjudication of subjective interpretations.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly focuses on non-clinical tests and substantial equivalence to predicate devices based on technological characteristics and bench performance.
• Effect Size of Human Readers with/without AI: This information is not applicable as no MRMC study or AI component is mentioned.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance: No, a standalone algorithm performance study was not done. The device is a physical medical implant (microcoil system), not a software algorithm.

7. Type of Ground Truth Used

For the non-clinical tests described:

• Ground Truth: The "ground truth" is defined by engineering specifications, material science standards (e.g., ISO 10993, sterility standards), and established performance characteristics of the legally marketed predicate devices. For example, "complete occlusion of aneurysms" (as assessed in a simulated environment or animal model for aneurysm packing ability), "10^-6^ Sterility Assurance Level," and "delivery force, tensile strength, and stiffness" that are comparable to predicate devices. This is a form of objective, pre-defined technical and biological performance criteria.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set" in the context of algorithm development.

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

• Establishment of Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Ask a specific question about this device