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Intended for the endovascular embolization of:

• Intracranial aneurysms. .
• Other neurovascular abnormalities such as arteriovenous . malformations and arteriovenous fistulae.
• Arterial and venous embolizations in the peripheral vasculature. .

The Boston Scientific Neurovascular Guglielmi Detachable Coil (GDCTM) is a device which facilitates endovascular embolization of intracranial aneurysms and other vascular abnormalities. The GDCTM Detachable Coil is a platinum/tungsten alloy coil attached to a stainless steel delivery wire. The GDCTM Detachable Coil is detached (using the GDCTM Power Supply) by electrolytically dissolving a small portion of the delivery wire upon its desired placement within an aneurysm or other vascular site via a microcatheter. Multiple coils can be delivered into an aneurysm or other vascular site through the same microcatheter until the aneurysm or other vascular site is densely packed.

The acceptance criteria for the Guglielmi Detachable Coil (GDC™) are implicitly met by demonstrating substantial equivalence to the predicate device, specifically regarding an expanded indication for use. The primary basis for this expanded indication is the results of the International Subarachnoid Aneurysm Trial (ISAT).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The International Subarachnoid Aneurysm Trial (ISAT) included 2143 patients.
• Data Provenance: The study was an "International Subarachnoid Aneurysm Trial." While specific countries are not listed in the provided text, the name "International" suggests data from multiple countries. The study is a prospective, randomized trial, comparing two treatment methods.

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

The provided summary of the ISAT study focuses on the clinical outcomes of the patients rather than the establishment of a "ground truth" for diagnostic purposes by experts in a specific image interpretation scenario. The study's design as a randomized controlled trial inherently establishes the "truth" through patient outcomes (dependency or death at 1 year) following different interventions.

Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications in the context of interpreting medical images for device performance validation (as one might see in an AI/imaging device submission) is not directly applicable here. The "ground truth" is the observed clinical outcome of the patients in the trial, determined by standard clinical follow-up and assessment, not by expert consensus on a set of images.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set in the way it might for a diagnostic study. As a clinical trial comparing two interventions and their outcomes, the "adjudication" would refer to how patient outcomes (dependency or death) were assessed and classified during follow-up. While not detailed, such large-scale clinical trials typically employ:

• Standardized outcome measures: e.g., modified Rankin Scale for dependency.
• Blinded assessment (if feasible): Assessors of outcomes (e.g., neurologists) might be blinded to the initial treatment arm (coiling vs. clipping), though this is often challenging in interventional trials due to visible procedural scars or imaging findings that reveal the treatment.
• Independent monitoring committees: These committees often review adverse events and critical outcomes to ensure proper reporting and adherence to the study protocol.

The specific "2+1, 3+1" adjudication methods are typically for image interpretation tasks, which is not the primary focus of this clinical effectiveness study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This was not an MRMC comparative effectiveness study in the traditional sense of evaluating human reader performance with or without AI assistance. The ISAT study was a direct clinical trial comparing two different medical interventions (endovascular coiling vs. neurosurgical clipping) in patients with ruptured intracranial aneurysms. It evaluated the effectiveness of the GDC™ device itself against the predicate surgical clipping, not a diagnostic algorithm's impact on human readers.

Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable to this study.

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

This was not a standalone performance study of an algorithm. The GDC™ is a physical medical device (detachable coil) for embolization, not a diagnostic algorithm. Its performance is intrinsically linked to the interventional procedure performed by a human clinician.

7. The Type of Ground Truth Used

• Clinical Outcomes Data: The ground truth used was patient clinical outcomes at 1 year post-treatment, specifically the rates of dependency or death. This is based on direct observation of patient health status following the intervention.

8. The Sample Size for the Training Set

The concept of a "training set" is not directly applicable to this premarket notification as it pertains to a physical medical device and a clinical trial. The ISAT study is a pivotal clinical trial designed to test the device's expanded indication, not to train an algorithm. Previous clinical experience and trials would have informed the development and initial indications of the GDC™, but ISAT is the primary evidentiary support mentioned for this specific submission.

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

As explained above, a "training set" in the context of algorithm development is not relevant here. The ISAT study provides the evidence (the "truth" in a clinical trial sense) for the device's performance regarding an expanded indication. This "truth" was established through the rigorous methodology of a randomized controlled clinical trial, where patient characteristics, interventions, and outcomes were systematically recorded and analyzed by the ISAT Collaborative Group.

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Matrix Detachable Coils are intended for embolization of those 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 o) inoperable. Matrix Detachable Coils are also intended for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Matrix Detachable Coils are also intended for arterial and venous ambolizations in the perioheral vasculature.

Matrix Stretch Resistant Detachable Coils are comprised of a platinum-tungsten alloy coil which is coated with a biocompatible absorbable polymer.

Packaging of the device is identical to that of the predicate Matrix Detachable Coils: the finished device is loaded into an introducer sheath and is then placed in a dispenser coil contained within a foil pouch. The foil pouch is then placed into a cardboard display box with a copy of the instructions for use.

Matrix Stretch Resistant Detachable Coils are detached using Boston Scientific's GDC® Power Supply. The system consists of the power supply, powered by two 9 volt batteries, an occlusion coil attached to a delivery wire, a set of connecting cables and a patient return electrode. A positive cable (red) supplies current to the delivery wire while a negative cable (black) completes the circuit by connecting to the patient return electrode (either an adhesive patch attached to the patient's skin or a hypodermic needle inserted subcutaneously through the patient's skin). After placement of the coil in the anatomy, detachment occurs through the clectrolytic dissolving of a small portion of the delivery wire.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Matrix™ Stretch Resistant Detachable Coils:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). The studies appear to be bench-top verification tests.

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

This information is not provided in the document. The tests described are engineering/performance-based, not clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided. The tests described are objective measurements against predefined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on technical verification tests to demonstrate substantial equivalence to predicate devices, not clinical effectiveness studies with human readers.

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

Yes, the studies described are standalone performance tests of the device itself, without human-in-the-loop performance considerations. These are material and mechanical property tests.

7. The Type of Ground Truth Used

The "ground truth" for these tests would be objective, pre-defined engineering specifications and measurable physical properties of the device components and its function, primarily mechanical and material characteristics. This isn't a clinical "ground truth" based on pathology or outcomes data.

8. The Sample Size for the Training Set

This document does not describe a "training set" as it would be used in the context of an AI/ML algorithm. The studies are traditional device verification tests.

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

Not applicable, as there is no "training set" in the context of this device's verification. The "ground truth" for these engineering tests would have been established through a combination of industry standards, internal design specifications, and performance characteristics of the predicate devices.

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GDC Coils (All Versions except GDC 18-Fibered VortX™ Shape): The Guglielmi Detachable Coil is intended for embolization of those 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 GDC is also intended for embolization of other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

GDC 18-Fibered VortX Shape: This product is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. GDC-18 Fibered VortX Shape is also intended for arterial and venous embolizations in the peripheral vasculature.

Guglielmi Detachable Coils (GDC®) are used as part of a system indicated for endovascular occlusion in patients with high surgical risk intracranial aneurysms and other neurovascular abnormalities. The GDC system consists of the following items, each of which is sold separately - · GDC Power Supply - · GDC SynerG TM occlusion coil attached to a delivery wire - · set of GDC connecting cables - · patient return electrode - · two 9-volt batteries GDC SynerG coils are available in regular (secondary helical), 2D (secondary helical with distal helix) and 3D (tertiary) shapes, in a range of sizes, and in Standard, Soft and Stretch Resistant versions, all of which are compatible with Boston Scientific Target Infusion Catheters with two tip markers. GDC is also available as an UltraSoft™ Coil, developed to address physicians' requests for a softer Stretch Resistant coil and a wider range of coil sizes to treat intracranial aneurysms. Boston Scientific Target also offers a Fibered GDC device, GDC 18-Fibered VortX Shape, incorporating synthetic fibers through the main coil for a more rigid coil. All of the coils are manufactured from a platinum-tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, a coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC). The distal tip of the coil is welded to form a smooth tip (with the exception of Stretch Resistant GDC). The coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. Using fluoroscopic guidance and a guiding catheter to access the lesion, the physician delivers the GDC coil to the targeted site through an infusion catheter. Upon desired placement in the anatomy, the coil is detached by use of a battery-operated power supply designed specifically for use with the GDC system. The GDC SynerG Power Supply used to initiate and control detachment is a self-contained unit that applies a constant current through the GDC system until detachment is detected. Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting. After selecting a current setting and initiating detachment, the current flowing through the delivery wire begins to dissolve, by electrolysis, the exposed stainless steel at the junction with the platinum-tungsten coil. Over a period of several minutes, the exposed steel completely dissolves and the platinum-tungsten coil detaches. When coil detachment is detected, the GDC SynerG Power Supply immediately halts current flow, freezes the displays and emits an audible signal that coil detachment has occurred. Using fluoroscopy, the physician then verifies that the delivery wire can be withdrawn without disturbing the newly placed coil, and can resume electrolysis if necessary. Multiple GDC coils may be placed within a single aneurysm, at the discretion of the interventional team, to achieve optimum occlusion of the lesion.

The provided document describes a Special 510(k) modification for Boston Scientific Target's GDC® Stretch Resistant Detachable Coils, specifically the replacement of an "Anchor Twister" with an "Anchor Chain." The submission aims to demonstrate that the modified device is substantially equivalent to predicate devices. The information provided is primarily focused on the physical and performance characteristics of the device and how the modification does not negatively impact these characteristics.

Crucially, this submission is for a medical device (Guglielmi Detachable Coil) which is a physical product, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (like "human readers improve with AI vs without AI assistance," "standalone performance," "training set size," "ground truth for the training set") are not applicable to this document. The document describes a traditional medical device premarket notification.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a quantitative, pass/fail table format with specific numerical thresholds. Instead, it states that the modified device "Meets acceptance criteria" for various performance characteristics, implying that internal quality and performance standards were met.

The table below summarizes the reported device performance, noting that the modification has no effect on some critical parameters, indicating equivalence to the predicate device.

Study Information (Based on available document)

Since this is a submission for a physical device modification, the studies mentioned are engineering verification tests to ensure the modified device performs comparably to the predicate. It does not involve a "study" in the typical clinical trial sense with patient data, experts establishing ground truth, or adjudication methods for diagnostic accuracy.

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "Verification Test Summary Table: Predicate GDC Devices vs Modified Devices," implying in vitro or bench testing. No human or animal data is mentioned. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of engineering test.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance tests is typically established through standard engineering measurements and specifications, not expert consensus on diagnostic images.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective assessments, primarily in clinical or image-based studies.
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 for a physical medical device, not an AI/ML product.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device, not an AI/ML product.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For engineering verification, the "ground truth" would be established by predefined engineering specifications, material properties, and physical testing standards (e.g., measuring tensile strength against a specified minimum).
7. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
8. How the ground truth for the training set was established: Not applicable.

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The Atlantis TM PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The Atlantis™ PV Imaging Catheter consists of two main assemblies: an over-the-wire (OTW) exchange style sheath assembly and an imaging core assembly. The sheath is comprised of the following three sections: Radiopaque soft tip, Proximal dual lumen, and Telescoping section. The imaging core is composed of a hi-torque flexible, rotating drive cable with a radially looking 15 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the MotorDrive Unit (MDU) / Instrument. A flush port with a one-way valve is used to displace air near the transducer. The catheter is for use with the BSS ClearView Ultra™ and Galaxy™ IVUS Imaging Systems.

The Boston Scientific Scimed (BSS) Atlantis™ PV Imaging Catheter is an intravascular ultrasound imaging catheter. The provided submission describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against pre-defined acceptance criteria with human subjects or expert readers.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) found in a clinical study for a new diagnostic or AI device. Instead, it details various non-clinical tests performed to demonstrate the device's safety and efficacy for its intended use and its substantial equivalence to predicate devices. The "performance" reported is that the device met the requirements of these tests.

| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bench Testing | Ensure physical integrity, functionality, and performance of the catheter components (sheath, telescoping assembly, imaging core assembly) and the final sterile device, consistent with its design and intended use. | Testing included dimensional testing, sheath bond tensile testing, and various functional performance tests. This testing demonstrated the physical integrity and functionality of the catheter. |
| Acoustic Output Testing | Acoustic output levels must be below the FDA Track 1 limits as described in the FDA Guidance, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Sept. 30, 1997)." | Acoustic output test results for the Atlantis™ PV imaging catheter are below the FDA Track 1 limits. |
| Animal Testing | In-vivo functional and imaging characteristics must be assessed and found consistent with the intended clinical use of the device. | The performance of the Atlantis™ PV imaging Catheter was consistent with the intended clinical use of the device. |
| Biological Safety Testing | Satisfy biocompatibility requirements per ISO 10993, and meet bioburden, endotoxin, and sterility assurance testing standards. | The Atlantis™ PV Imaging Catheter was subjected to and passed a series of biocompatibility tests per ISO 10993, bioburden, endotoxin, and sterility assurance testing. |

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it describes non-clinical testing rather than a patient-based test set with specific data samples.
• Data Provenance: The document does not specify the country of origin for the animal study. The other tests are bench tests performed within the manufacturer's testing environment. All testing appears to be "retrospective" in the sense that it's performed on manufactured devices/components for regulatory submission, rather than prospective clinical trials.

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

• Number of Experts: Not applicable. The ground truth for these non-clinical tests is established by engineering specifications, regulatory standards (like FDA guidance for acoustic output, ISO 10993 for biocompatibility), and observed physical/biological responses in animal models. No human experts are explicitly mentioned as establishing a "ground truth" for interpretation in the same way they would for reading images.
• Qualifications of Experts: N/A as per the above.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The testing described does not involve human interpretation or subjective assessment that would require an adjudication method. The outcome of these tests is determined by objective measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on hardware safety and performance in a non-clinical setting, not on the diagnostic accuracy with human readers.
• Effect Size of Human Readers Improve with AI vs without AI: Not applicable, as no MRMC study or AI component is described.

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

• Standalone Study: Not applicable. This device is an imaging catheter; it does not contain an AI algorithm that would have a standalone performance. The "performance" described is the functionality of the physical device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the verifiable correctness or compliance with established standards for device performance and safety:

• Bench Testing: Engineering specifications, design tolerances, and functional requirements.
• Acoustic Output Testing: FDA Guidance values (FDA Track 1 limits).
• Animal Testing: Physiological and imaging observations in an animal model, judged against expected normal and pathological states to determine the device's functional and imaging characteristics, consistent with its intended use.
• Biological Safety Testing: ISO 10993 standards and recognized methods for bioburden, endotoxin, and sterility assurance.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a medical device (catheter) and its non-clinical testing, not an AI algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm described in this submission.

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The Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included to facilitate directional manipulation of the guidewires.

The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The 300cm length allows exchange of therapeutic devices without the use of other exchange devices, i.e. extension wires. The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire have a nominal diameter of 0.014".

All device materials, manufacturing processes and product dimensions are identical to the Boston Scientific Scimed ChoICE™ ES 300cm exchange guidewire and the ChoICE™ 300cm Floppy exchange guidewire.

The provided document describes the safety and effectiveness of the Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire, primarily through a comparison to predicate devices and in vitro performance testing. It does not detail an AI-driven device, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm-only performance study. Therefore, sections pertaining to these aspects, ground truth, and expert evaluation are not applicable based on the provided text.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

The acceptance criteria for the Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are implicitly defined by their "substantial equivalence" to predicate devices and successful in vitro and biocompatibility testing, indicating that the devices perform according to their intended use and are safe. The document directly compares features and explicitly states the outcomes of testing.

Study Details

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

The document explicitly states "In vitro performance testing" for the guidewires, including particle analysis, friction testing, angular rotation, tip buckling, and tip stiffness. However, no specific sample sizes for these tests are provided in the document. The data provenance is implied to be laboratory-based (in vitro) testing conducted by Boston Scientific Target. There is no mention of human subject data, retrospective or prospective studies.

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

This information is not applicable. The studies described are in vitro performance and biocompatibility tests for medical devices, not diagnostic or AI-based assessments requiring expert ground truth for interpretation of images or patient data.

4. Adjudication method for the test set

This information is not applicable, as the tests described are objective, physical, and chemical performance evaluations rather than subjective interpretations requiring 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

This information is not applicable as the document describes a guidewire device, not an AI-assisted diagnostic tool or system that would involve human readers.

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

This information is not applicable as the document describes a physical medical device (guidewire) and its in vitro performance, not an algorithm or AI system.

7. The type of ground truth used

For the in vitro performance tests (particle analysis, friction, angular rotation, tip buckling, tip stiffness), the "ground truth" would be established by objective, predetermined engineering and material science specifications or industry standards for guidewire performance.
For biocompatibility testing, the ground truth was established by adherence to ISO-10993, which provides a framework for biological evaluation of medical devices.

8. The sample size for the training set

This information is not applicable as the document describes a guidewire device, not an AI or machine learning model that would require a training set.

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

This information is not applicable for the same reason as above.

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Boston Scientific Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific Target's Guglielmi Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

The GDC system consists of the following items, each of which is sold separately

• · GDC Power Supply
• · GDC occlusion coil attached to a delivery wire
• · set of GDC connecting cables
• · patient return electrode
• two 9-volt batteries

The GDC is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.

GDC coils are manufactured from a platinum / tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, the coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC).

GDC coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC cleared under K991139.

GDC coils are available in a range of sizes for use with either Boston Scientific Target's -10 or -18 Infusion Catheters with two tip markers.

The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm.

Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting.

The GDC Power Supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by:

• 1. sensing the amount of resistance to current flow through the GDC System, and
• 2. adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the GDC System and to recognize those changes which indicate detachment.

Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.

This document describes a Special 510(k) submission for a modification to the Boston Scientific Target's GDC™ Power Supply. A Special 510(k) is typically used for device modifications that do not significantly alter the device's fundamental technology or intended use, meaning extensive new clinical studies are often not required. The information provided focuses on demonstrating that the modified device remains substantially equivalent to its predicate.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way one might expect for a new device requiring rigorous performance evaluation. Instead, it details changes made to the GDC Power Supply and asserts that for most attributes, no change was made, and it remains the same as the predicate device. For the one functional change—the current settings—it's presented as a modification rather than a performance target with a specific metric.

The implicit acceptance criterion for most parameters is "no change from the predicate." For the current settings, the acceptance criterion is that the device now offers the specific new settings.

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

The document does not mention any clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). This is typical for a Special 510(k) for a device modification, where the focus is on engineering verification and validation that the changes do not negatively impact safety or effectiveness, rather than a new clinical performance study. The "Verification Test Summary Table" lists various engineering/technical tests (e.g., EMC, Operating System Test), but not clinical trials.

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

Not applicable. No clinical test set requiring expert ground truth establishment is described in this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. No MRMC study or any comparative effectiveness study with human readers is mentioned or implied. The device (GDC Power Supply) is an accessory used by a neurosurgical team, not an AI-assisted diagnostic tool.

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

Not applicable in the context of AI/algorithms. The GDC Power Supply is a hardware device that controls the detachment of coils. Its function is to apply current and detect detachment. The "Operating System Test (Assembly Source Code)" mentioned in the verification table hints at internal software verification, but this is a standard engineering test for embedded systems, not an AI algorithm performance test.

7. The Type of Ground Truth Used

For the design verification that was performed, the "ground truth" would be established engineering specifications and performance standards for electrical devices, EMC, and software functionality. For example, for current settings, the ground truth is simply whether the device outputs the specified 0.5 mA, 0.75 mA, or 1.0 mA when selected, and whether it correctly detects coil detachment as designed. This is assessed through bench testing and functional verification, not clinical expert consensus or pathology.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

Not applicable. This device does not involve machine learning or AI.

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The In-Time™ Retrieval Device is designed for use with a guiding catheter for the retrieval of intravascular foreign objects such as coils, balloons, portions of catheters and / or loop wires misplaced during interventional radiologic procedures in peripheral, neuro and cardiovasculature.

The In-Time™ Retrieval Device consists of a braided catheter shaft, with a radiopaque basket attached to the distal tip of the catheter. The inner lumen of the catheter contains a flexible, guiding corewire, which is tapered from the proximal to distal end. The corewire extends distally 3 cm from the basket and is not removable from the catheter. The corewire can be rotated freely as well as moved distally and proximally within the catheter approximately 1.5 cm. The 3 cm radiopaque distal coil extending from the basket facilitates fluoroscopic visualization. A luer fitting is located on the catheter hub and is used for the attachment of accessories and to facilitate the continuous flush of solution. The catheter shaft is coated with HYDROLENE™, a hydrophilic coating that reduces friction during manipulation in a guide catheter and in blood vessels. The In-Time™ Retrieval Device is designed to be used with a guide catheter. The In-Time™ Retrieval Device can be used in vessel diameters ranging from 2 mm to 4 mm.

The provided text describes the In-Time™ Retrieval Device, a medical device designed for retrieving foreign objects from the vasculature. The document details its technological characteristics and compares them to a predicate device, as well as providing a summary of its verification tests.

However, it does not contain information related to software or AI-powered devices. Therefore, the requested information regarding acceptance criteria and studies (such as sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment) for an AI device is not present in the provided text.

The document focuses on the mechanical and material performance of a physical medical device. The "acceptance criteria" mentioned refer to engineering and biocompatibility standards for the device itself, not for the performance of an algorithm.

Therefore, I cannot fulfill the request as it pertains to an AI/software device, as the provided input describes a non-AI medical device.

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The Matrix™ Detachable Coils have the same indications for use as the predicate GDC" coils.

Matrix™ Detachable Coils are intended for embolization of those 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,

and for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The Matrix™ Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

The Matrix™ Detachable Coil system consists of the following, each of which is sold seperately:

• · GDCTM SynerGTM Power Supply
• · Matrix™ Detachable Coil attached to a delivery wire
• · Set of GDCTM SynerGTM connecting cables
• Patient return electrode
• · Two 9-volt batteries

The coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.

Matrix™ Detachable Coils are manufactured from platinum wire, which is first wound into a primary coil and then formed into a secondary helical shape. Coating the platinum coil is a proprietary biocompatible absorbable polymer mixture.

Coils are attached to a delivery wire, which consists of a ground stainless-steel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is identical to that employed for the predicate GDCTM Coils cleared under K001083.

The GDCTM SynerGTM power supply is a battery-operated, selfcontained unit designed to initiate and control the electrolytic detachment of a GDC™ Coil or Matrix™ Detachable Coil inside an aneurysm.

The GDC™ SynerG™ Power Supply is designed to apply a constant current through the GDC™ System and to detect when coil detachment has occurred. It maintains a constant current by:

1. sensing the amount of resistance to current flow through the Matrix™ Detachable Coil, and

2. adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the Matrix™ Detachable Coil and to recognize those changes, which indicate detachment.

Once those patterns are identified, the GDCTM SynerGTM power supply signals detachment and stops the flow of current through the Matrix™ Detachable Coil.

The provided document is a 510(k) Premarket Notification for the Matrix™ Detachable Coils, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the information typically requested for a software algorithm/AI device, such as detailed acceptance criteria with specific performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, blinding protocols, and expert ground truth establishment, is largely absent or not applicable in this context.

However, based on the information provided, I can infer and extract the relevant details as much as possible for a device of this nature.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are predominantly demonstrated by showing that the Matrix™ Detachable Coils are substantially equivalent to the Guglielmi Detachable Coil (GDC™) and GDC™ Power Supply (K001083), the predicate device. The performance is assessed against criteria established for the predicate device, indicating no degradation in safety or effectiveness with the modifications made (addition of a biocompatible absorbable polymer and ultraviolet curing adhesive).

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

The document does not specify a "test set" in the context of diagnostic performance involving patient data or images (as would be common for AI/software devices). Instead, the "tests" refer to engineering and biocompatibility evaluations on the physical device components and system. The sample sizes for these specific engineering tests are not described in this summary. The data provenance is associated with the device manufacturing and testing process by Boston Scientific Target. This is a premarket notification, not a clinical trial report, so concepts like "country of origin of the data" are not directly applicable to an AI device's test set.

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

Not applicable. This device is a physical medical implant (embolization coil) and associated power supply, not an AI/software diagnostic device that requires expert-established ground truth from images or patient data for performance evaluation. The "ground truth" for these engineering tests would be the established specifications and performance parameters for medical devices of this type, ensuring manufacturing quality and safety.

4. Adjudication method for the test set

Not applicable. There is no "adjudication method" in the traditional sense of resolving discrepancies among experts for diagnostic interpretation, as this is not an AI/software diagnostic device. The "tests" described are physical and electrical engineering evaluations.

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 document pertains to a physical medical device (embolization coil) and its power supply. It is not an AI/software device intended to assist human readers (e.g., radiologists) in diagnostic tasks, so an MRMC study is not relevant.

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

Not applicable. This device is not an algorithm or AI system. Its function is to physically embolize aneurysms and vascular malformations, with human intervention for placement and detachment control.

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

The "ground truth" for the tests performed on the Matrix™ Detachable Coils is based on established engineering specifications, safety standards (e.g., ISO 10993-1 for biocompatibility), and performance metrics defined for the predicate device (GDC™ Coils). For example, "Friction" would have a specified acceptable range of frictional force, and "Polymer Mass Loss Tests" would have a maximum allowable mass loss over a given period. The overall "ground truth" for the submission is demonstrating substantial equivalence to a device already deemed safe and effective.

8. The sample size for the training set

Not applicable. As this is not an AI/software device, there is no "training set" in the context of machine learning.

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

Not applicable. As this is not an AI/software device, there is no "training set" or corresponding ground truth to establish in that context.

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The Excelsior SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

The Excelsior SL-10 Microcatheter is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guide catheter and guidewire. The device shaft is comprised of graded materials of varying durometers, from a flexible tip to a semirigid proximal end. Stainless steel wire reinforcement provides for strength during torque transmission while the inner liner provides for lubricity. The hub / strain reliefs provide for kink resistance from the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories. The radiopaque tip with one or two markers allows for visualization under fluoroscopy. The outer surface is coated with a hydrophilic coating which reduces friction during navigation in the vasculature. A steam shaping mandrel accessory is packaged with the catheter.

This submission describes the Excelsior™ SL-10 Microcatheter. The manufacturer is seeking substantial equivalence to existing predicate devices based on in vitro performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly provide a table of acceptance criteria with specific thresholds. Instead, it states that "All testing indicates that the device is safe and performs according to its intended use." This is common for predicate device comparisons where the performance is expected to be at least equivalent to the predicate, rather than meeting a specific numerical benchmark.

However, based on the testing mentioned, we can infer the performance aspects evaluated:

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

The document does not specify the sample sizes used for the in vitro performance tests. The data provenance is not explicitly stated as retrospective or prospective, nor are countries of origin mentioned. However, since these are in vitro performance tests, they are typically conducted in a laboratory setting by the manufacturer.

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

Not applicable. The ground truth for this device is established through objective in vitro measurements and comparison to predicate devices, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards (like ISO-10993) and comparison to predicate devices, not subjective expert reviews requiring 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. This is a medical device (microcatheter), not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. 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.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on:

• Objective Measurements: Results of the in vitro performance tests (dimensional, tensile, burst, flow rate, withdrawal force).
• Established Standards: Biocompatibility verified according to ISO-10993.
• Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is substantial equivalence to the legally marketed predicate devices (Tracker-10 Microcatheter and Excelsior 1018 Microcatheter) in terms of functionality, intended use, design, materials, and method of operation.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm; therefore, there is no "training set."

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

Not applicable, as there is no training set.

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