Search Results

The Sugita AVM Microclips are designed for occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures.

Sugita AVM Microclips are not intended as a replacement for bipolar electrocoagulation of smaller vessels nor do they negate the need for immediate post-operative angiography following arteriovenous malformation surgery.

The Sugita AVM Microclips were cleared by the FDA through 510(k) K960037. The Sugita AVM Microclips are manufactured from Elgiloy, a cobalt-chromiummolybdenum alloy. They are designed for the occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures. The Sugita AVM Microclips are available in the following sizes: 2mm, 3mm, 4mm and 5mm. Other than the modifications identified above, there have been no other changes to the Sugita AVM Microclips.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided text does not specify exact sample sizes for each MRI compatibility test beyond implying "Sugita AVM Microclips" were used for testing. For the Spatial Gradient Magnetic Field testing, it mentions "5mm Sugita AVM Microclips" were attached to "a porcine blood vessel." The provenance of this data is not explicitly stated as retrospective or prospective, nor is the country of origin. It can be inferred that these are prospective in-vitro tests conducted specifically for this submission.

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

Not applicable. The tests performed are engineering-based performance tests (MRI compatibility, sterilization validation) and do not involve human expert interpretation or ground truth establishment in the traditional clinical sense. These tests rely on established scientific and engineering standards (e.g., ASTM, ISO).

4. Adjudication Method for the Test Set

Not applicable. As the tests are objective engineering measurements against predefined standards, there is no need for an adjudication method by human experts.

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 (microclips), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is irrelevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the performance tests relies on established engineering and scientific standards and measurements as defined by:

• ASTM F2503-13 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment)
• Guidance for Industry and Food and Drug Administration Staff (Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, document issued on May 20, 2021)
• ASTM F2052-15 (Standard Test Method for Measurement of Magnetically Induced Translational Force on Medical Devices in the Magnetic Resonance Environment)
• ASTM F2213-17 (Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment)
• ASTM F2182-19 (Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging)
• ASTM F2119-2013 (Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants)
• ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices)

8. The Sample Size for the Training Set

Not applicable. This device undergoes physical performance testing, not machine learning model training.

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

Not applicable. There is no training set for this type of device.

Ask a specific question about this device

Permanent D-Aneurysm-Clips are intended for permanent occlusion of cerebral aneurysms. Temporary D-Aneurysm-Clips are intended for temporary occlusion of intracranial blood vessels and cerebral aneurysms.
The D-Aneurysm Clip Appliers are intended to be used for holding and applying D-Aneurysm-Clips. The D-Aneurysm Clip Appliers are not compatible with other systems.

D-Aneurysm-Clips are available in two principle sizes (Standard and Mini) and several forms of jaws (straight, curved, angled, bayonet, fenestrated, non-fenestrated). Both sizes are available for permanent or temporary occlusion.
D-Aneurysm Clip Appliers are designed to be used with both principle sizes of D-Aneurysm-Clips, Standard and Mini.
The D-Clip is manufactured out of three parts, two of those forming the body and one the spring. With D-Clip Appliers it is grasped from the outside to open, close and guide the clip.
The D-Clip Appliers exists in two versions: a version with double action handles and one version with memory effect. Both versions are applied the same way. Pressing the handle will open the jaw.

This document describes the performance testing for the Peter Lazic GmbH D-Aneurysm-Clips and D-Aneurysm Clip Appliers, demonstrating their substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• D-Aneurysm-Clips:
  • Microbiological performance qualification: 10 samples of worst-case clips.
  • Degradation of closing force tests: Not explicitly stated, but the test mentions "The tested D-Clips did fulfill..." and "The test results of the L-Clips and the Yasargil Clips fulfilled..." implying multiple samples for each.
• D-Aneurysm Clip Appliers:
  • Microbiological efficiency (automated/manual cleaning & disinfection): Three contaminated reference products for each method.
  • Microbiological efficiency (steam sterilization): Three qualification runs with three inoculated test samples each.
  • Defining the bending cycles to possible function restrictions: 10 applying forceps.
  • Behavior after repeated use and reprocessing: 10 D-Clip appliers.

The data provenance is retrospective as the studies were conducted to support the 510(k) submission, referencing existing standards and predicate device data. The country of origin of the data is Germany, as the applicant is Peter Lazic GmbH in Tuttlingen, Germany.

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

This submission does not involve a clinical study with human subject data requiring expert consensus for ground truth. The tests conducted are benchtop and laboratory performance tests, comparing the new device against established standards (e.g., ISO 9713, ISO 5832) and predicate device specifications. Therefore, the concept of "experts establishing ground truth for the test set" in a clinical sense does not apply here. The "ground truth" for these engineering and sterility tests is derived from adherence to recognized testing standards and validated methodologies.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study involving human readers or clinical data that would require an adjudication method. The results are from physical and microbiological tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for a physical medical device (aneurysm clips and appliers), not an AI-powered diagnostic or assistive tool.

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

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

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

• International Standards: Adherence to standards like ISO 9713 (for closing force), ISO 5832 (for materials), and methods for sterility and cleaning validation.
• Predicate Device Performance: Direct comparison of the D-Aneurysm-Clips and D-Aneurysm Clip Appliers against the performance characteristics of the legally marketed predicate devices (L-Clip, Yasargil Aneurysm Clip, and their appliers), which have established safety and effectiveness.
• Validated Test Methodologies: Scientific and engineering principles applied in laboratory settings to determine physical properties, material compatibility, and biological safety.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study, so there is no "training set."

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

Not applicable. There is no training set as this is not an AI/machine learning study.

Ask a specific question about this device

The Yasargil Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied with Aesculap clip appliers, which contain titanium alloy or phynox jaws.

The Yasargil Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are manufactured from either titanium alloy according to ISO 5832/3 or phynox (cobalt alloy) per ISO 5832/7. The clips range in size from 3 mm to 40 mm and are available in straight, curved, angled, bayonet. T-bar, offset T-bar, concave T-bar, fenestrated, and non-fenestrated styles.

The Yasargil Clip Appliers are manufactured from stainless steel (body) with either a titanium allov or phynox jaw. The appliers are available in short (50mm), standard (90 mm) and long (110 mm) lengths, as well as straight, angled and bayonet shapes.

The provided text describes a 510(k) summary for Aesculap Yasargil Aneurysm Clips and Clip Appliers (K131500). This document is a premarket notification for a medical device, asserting its substantial equivalence to previously marketed devices. It focuses on the manufacturing and biomechanical properties of the clips and appliers, rather than a clinical study evaluating diagnostic accuracy or a human-in-the-loop AI system. Therefore, many of the requested categories for AI/diagnostic device studies are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The "test set" here refers to physical components of the device (clips and appliers) that underwent biomechanical and MRI compatibility testing, not a dataset of patient information. The document does not specify the number of individual clips or appliers tested.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed on manufactured devices.

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

• Not applicable. Ground truth as typically defined for diagnostic or AI studies (e.g., expert consensus on medical images) is not relevant here. The "truth" for this device's performance is established by compliance with engineering and material science standards (ISO, ASTM). The expertise involved would be in manufacturing, materials science, and biomedical engineering.

4. Adjudication method for the test set

• Not applicable. There was no expert adjudication process for this type of device performance testing. Performance was measured against predefined engineering and material standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted diagnostic device. It is a surgical instrument.

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

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

7. The type of ground truth used

• The "ground truth" for this device is based on pre-defined engineering standards (ISO 9713, ASTM F2119, F2182, F2213, F2052, F2503) and the physical properties of the materials and design of the device. The testing aimed to demonstrate that the device met these established standards for biomechanical performance and MRI compatibility.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

Ask a specific question about this device

Codman Slim Line Standard Clip is used for permanent occlusion of intracranial aneurysm.

Codman Slim Line Mini Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.

Codman Slim-Line Graft clip is used to encircle an artery in which a hole has developed as a result of a traumatic injury to the vessel or from an aneurysm tearing at its base that cannot be sutured as the hole is in such a position that it is difficult for the surgeon to rotate a needle.

Codman Slim-Line Reinforcing clip is used to reinforce aneurysm clips that may not be of adequate strength to occlude the aneurysm.

Codman Slim-Line Temporary Aneurysm Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structure.

Codman AVM Micro Clip System is designed for occlusion of small vessels when controlling bleeding on arteriovenous malformation or other smaller venous structures.

Aneurysm clips have two parts, a spring section and two blades. The spring section determines the strength of the clip. The blades grasp the aneurysm.

The provided text describes a 510(k) premarket notification for various aneurysm clips from Codman & Shurtleff, Inc. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria with a novel study design for AI/ML devices. Therefore, much of the requested information (like acceptance criteria tables, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or explicitly stated in the document as it pertains to a different type of regulatory submission (medical device approval for physical devices, not AI/ML software).

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in the context of this 510(k) submission. A 510(k) for physical devices like aneurysm clips focuses on substantial equivalence to predicate devices, meaning the new device is as safe and effective as a legally marketed device. It does not typically involve pre-defined performance metrics and acceptance criteria in the way an AI/ML device might. The "performance" here is demonstrating that the device functions as intended and is comparable to existing devices.

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

Not explicitly stated. The submission mentions "Bench testing has been completed," but does not specify the sample sizes of devices tested or the data provenance (e.g., how many clips were tested under what conditions).

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

Not applicable. Ground truth, in the context of AI/ML, refers to a validated reference standard against which an algorithm's output is compared. For a physical device like an aneurysm clip, "ground truth" is established through engineering specifications and the functional demonstration of the device (e.g., successful occlusion, strength tests). There's no mention of experts establishing a ground truth for a "test set" in the sense of data labeling.

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

Not applicable. This is relevant for studies involving human interpretation or AI output, where disagreements need to be resolved. For bench testing of physical devices, the results are typically direct measurements or observations.

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. MRMC studies are used for evaluating diagnostic performance, often comparing human performance with and without AI assistance. This submission is for a physical medical device (aneurysm clips), not an AI/ML diagnostic tool.

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

Not applicable. There is no algorithm or software component being evaluated in this submission for standalone performance.

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

The "ground truth" for these physical devices would be their conformance to design specifications and mechanical properties that are historically proven safe and effective for aneurysm occlusion or vessel coarctation. This is established through engineering design, material testing, and functional bench testing.

8. The sample size for the training set:

Not applicable. There is no AI/ML model involved in this submission that would require a training set.

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

Not applicable.

What the study does mention regarding acceptance and proof:

• Acceptance Criteria/Performance Goal (Implied): The implied acceptance criterion is "substantial equivalence" to predicate devices. This means the new devices (Codman Slim-Line Standard Aneurysm Clip, Mini Clip, Graft Clip, Reinforcing Clip, Temporary Aneurysm Clip, Codman AVM Micro Clip System) must perform as safely and effectively as previously cleared devices.
  • Predicate Devices: K912456 SUNDT SLIM-LINE GRAFT CLIPS, K902544 SUNDT AVM MICRO CLIP SYSTEM (and likely the "Codman Slim Line Standard Aneurysm Clip" mentioned in the description, implying existing versions or a family of clips).
• Study That Proves Substantial Equivalence: "Bench testing has been completed and demonstrates that the device performs according to its description and intended use which is the same as the predicate device."
  • Study Outcome: "All test results demonstrated the substantial equivalence of the products to the previously cleared products from the FDA and the safety and effectiveness has not been compromised."

In essence, this 510(k) demonstrates that the Codman aneurysm clips are very similar in design, materials, and intended use to existing, cleared clips, and bench testing confirmed they function comparably.

Ask a specific question about this device

Permanent GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for Permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary permianent occlusion of blood vessel clips are intended for temporary occlusion Gilvilli Aneurysin Olips (Tabargi) and cerebral aneurysms. They are also intended to be applied exclusively with the corresponding Clip Appliers.

GIMMI Aneurysm Clips and their Clip Applying Forceps are used for the occlusion of aneurysms. "Mini" and "Standard" Clips can only be applied with the according Applying forceps; these forceps are labelled with "Mini" or "Standard". Clips are available in different sizes and shapes, to have the right size and shape due to the size and shape of the aneurysm.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the GIMMI Aneurysm Clips and Applying Forceps:

Executive Summary:

The provided document (K081640) is an Abbreviated 510(k) submission for the GIMMI Aneurysm Clips and Applying Forceps. This means that the manufacturer is demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) rather than providing extensive de novo performance data. Crucially, the document explicitly states that "performance testing was not warranted" due to the device's equivalence in design and materials to predicate devices and their long use history. Therefore, there is no detailed study described that establishes explicit acceptance criteria beyond regulatory standards and then proves the device meets those criteria through novel testing.

The "acceptance criteria" can be inferred as compliance with relevant industry standards, material specifications, and the demonstration of substantial equivalence to predicate devices in terms of intended use, performance attributes, materials, and basic design.

1. Table of Acceptance Criteria and Reported Device Performance

As performance testing was not warranted, explicit quantitative acceptance criteria for device performance (e.g., clip strength, fatigue, closure force) are not detailed in this submission. The "reported device performance" is primarily based on the demonstrated equivalence to predicate devices and material biocompatibility.

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

• Performance Testing: No dedicated test set in the traditional sense for evaluating device performance against new, quantitative acceptance criteria was used. The submission explicitly states, "Based on the equivalence in design and materials to predicate devices and their use since over 15 Years, performance testing was not warranted."
• MR Compatibility Test: A "non-clinical testing" was performed.
  • Sample Size: Not explicitly stated for the number of clips tested, but it refers to the "GIMMI Aneurysm Clip system."
  • Data Provenance: This was a prospective non-clinical test conducted internally (likely by GIMMI GmbH or a contracted lab) using a "SIEMENS MAGNETOM MAESTRO CLASS SYMPHONY MR scanner." Specific country of origin beyond "Germany" (GIMMI's location) for the testing facility is not provided.

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

This is not applicable as there was no "test set" requiring expert ground truth for evaluating novel performance. The FDA's substantial equivalence determination relies on comparing the device to existing predicate devices.

4. Adjudication Method for the Test Set

This is not applicable as there was no "test set" requiring adjudication of results against a ground truth.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study would compare human performance with and without AI assistance, which is irrelevant for this medical device submission, as it is a physical implant, not an AI diagnostic tool.

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

No, a standalone algorithm-only performance study was not done. This device is a physical implant, not an algorithm or AI.

7. The Type of Ground Truth Used

For the overall submission, the "ground truth" for demonstrating safety and effectiveness relies on:

• Predicate Device History and Regulatory Approval: The long-standing safe and effective use (over 15 years) and prior regulatory approvals of the identified predicate devices made of similar materials (Titanium, Phynox) and having similar intended uses and designs.
• Material Standards and Biocompatibility: Compliance with ISO 5832 for materials and historical evidence of biocompatibility.
• Non-Clinical Testing for MR Compatibility: For MR safety, the "ground truth" was established by the experimental results of temperature rise and movement measurements in a specified MR scanner.

8. The Sample Size for the Training Set

This is not applicable as this is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.

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

This is not applicable as there is no "training set" for this device.

Ask a specific question about this device

Permanent L-Aneurysm-Clips and YASARGIL aneurysm and vessel clips are intended for permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary L-Anaurysm-Clins and Yasargil aneurysm and vessel clips are intended for temporary occlusion of intra cranial blood vessels and cerebral aneurysms.

The L-Aneurysm-Clip Appliers are intended to be used for holding and applying L-Aneurysm-Clips.

The Yasargil-Aneurysm-Clip Appliers are intended to be used for holding and applying Yasargil-Aneurysm-Clips.

The L-Aneurysm-Clip Appliers and the Yasargil-Aneurysm-Clip Appliers are not compatible to other traded systems.

L-Aneurysm Clips and Yasargil-Aneurysm Clips are available in two principle sizes (Standard and Mini) and several forms of jaws (straight, curved, angled, bayonet, fenestrated, non-fenestrated). Both sizes are available for permanent or temporary occlusion.

L-Aneurysm Clip Appliers are designed to be used with both principle sizes of L-Aneurysm Clips. Yasargil Clip Appliers are available in two principle sizes (Standard and Mini), matching the respective size of the applied Yasargil Aneurysm Clip.

The provided document is a 510(k) Premarket Notification for Peter Lazic GmbH's Aneurysm Clips & Appliers. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study against defined acceptance criteria. Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets such criteria in the way a clinical trial for a novel device would.

Instead, the document details the following as part of its substantial equivalence argument:

1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The document lists "Performance Standards" to which the devices conform, specifically: ASTM F1542-94(2000), ASTM F2129(2004), and ISO 9713. These are industry standards for medical devices, but the document does not include specific pass/fail criteria or results from tests against these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or associated sample size is mentioned, as this is not a clinical study. The submission relies on demonstrating equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no "ground truth" establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no test set requiring adjudication is described.

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 is for medical devices (aneurysm clips and appliers), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The submission is based on demonstrating substantial equivalence to predicate devices, not on proving clinical efficacy against a "ground truth" derived from patient data.

8. The sample size for the training set:
Not applicable as there is no training set for an algorithm.

9. How the ground truth for the training set was established:
Not applicable as there is no training set.

Summary of what is provided in the document (relevant to device performance and regulatory approval):

• Conformance to Standards: The devices conform to ASTM F1542-94(2000), ASTM F2129(2004), and ISO 9713. These standards likely cover aspects like material safety, mechanical performance, and design requirements for aneurysm clips and appliers.
• Substantial Equivalence: The primary "proof" in this submission is the demonstration of substantial equivalence to several legally marketed predicate devices, including KIRWAN L-Aneurysm Clips and Appliers, REBSTOCK Aneurysm Clips, Von Zeppelin GmbH Perneczky Aneurysm Clips and Clip Applier/Remover, and Aesculap, Inc. Yasargil Clip Appliers. This means the device is considered as safe and effective as these previously cleared devices, implying their performance is acceptable.
• Device Description: Detailed descriptions of the L-Aneurysm Clips and Yasargil-Aneurysm Clips (sizes, forms of jaws, permanent/temporary) and their corresponding appliers are provided.
• Intended Use: Clearly defined intended uses for both permanent and temporary clips for occlusion of blood vessels and cerebral aneurysms, and for the appliers to hold and apply these clips.
• Sterilization: Information on sterile or non-sterile conditions for clips and non-sterile for appliers.
• Regulatory Clearance: The FDA's letter (SEP 25 2008) indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to proceed to the market.

Ask a specific question about this device

The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurysms. They are also intended to be applied exclusively with the Kirwan 45.XXX and 65.XXX Series Appliers.

The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurvsms. They are also intended to be applied exclusively with the 45.XXX and 65.XXX Series Appliers.

The provided 510(k) summary for the Kirwan Series of Aneurysm Clips and Appliers does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving those criteria. This type of regulatory submission typically focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting novel clinical study data or detailed performance metrics against specific acceptance criteria.

However, based on the available information, I can fill in what is present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document describes a technical assessment based on comparison to predicate devices and compliance with standards, not a clinical study with a test set of data.

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

• Not applicable. No test set or ground truth establishment by experts is described in this regulatory summary.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is described.

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 surgical implant/tool (aneurysm clips and appliers), not an AI-assisted diagnostic or decision support system. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.

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

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

7. The type of ground truth used:

• Not applicable. The "ground truth" in this context is adherence to manufacturing standards, material specifications, and a hazard analysis, rather than clinical outcomes or expert consensus on diagnostic data. The primary "truth" being established is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

• Not applicable. There is no training set mentioned.

Ask a specific question about this device

The Aesculap T-Bar Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner.

The Aesculap T-Bar Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are made from either Phynox (oobalt alloy) per ISO 5832/7 or Titanium Alloy per ISO 5832/3. The clips are a fennstrated design with the jaws at 90 and 45 degree angles. They are applied with previously cleared Aesculap aneurysm clip appliers.

The provided text is a 510(k) summary for the Aesculap T-Bar Aneurysm Clips. This document asserts substantial equivalence to a predicate device rather than presenting a study against specific acceptance criteria for a novel device. Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not applicable or cannot be extracted from this document.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a clinical study with a specific test set. The performance data refers to biomechanical testing, not clinical data from patients. Therefore, information regarding sample size for a test set (e.g., number of patients or images) and data provenance (country of origin, retrospective/prospective) is not applicable in this context. The testing was likely conducted in a lab setting.

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

Since this is not a study involving human-interpreted data, there were likely no experts used to establish ground truth in the way envisioned for software performance evaluation. The "ground truth" for biomechanical testing would be defined by engineering standards, test methodologies, and material specifications.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as there was no test set of human-interpreted data requiring adjudication.

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

No, an MRMC comparative effectiveness study was not performed, nor is it relevant for this type of medical device (physical aneurysm clips). The device is not an AI-assisted diagnostic tool for human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone algorithm study was not performed. This device is a physical medical implant, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation of the Aesculap T-Bar Aneurysm Clips, based on the description, would be established through engineering standards, material specifications (ISO 5832/7, ISO 5832/3), and biomechanical testing protocols outlined in the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)". It is not expert consensus, pathology, or outcomes data in the typical sense of a clinical study.

8. Sample Size for the Training Set

There is no training set in the context of this device. This is a physical product, not a machine learning model that requires training data.

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

Not applicable, as there is no training set for a physical device.

Ask a specific question about this device

The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms.

The Aesculap Yasarqil Aneurysm Clip Booster Clip is designed to provide additional pressure for occlusion of cerebral aneurysms when used with a standard aneurysm clip during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are for use with Phynox aneurysm clips only.

This document describes the Aesculap Yasargil Aneurysm Clip Phynox Booster Clip. The device is intended to increase the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms. The performance data for this device primarily relies on biomechanical testing to demonstrate substantial equivalence to a predicate device.

Here's the information requested, 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

The document does not specify the exact sample size used for the biomechanical testing (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It just states "Biomechanical testing results."

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

Not applicable. The ground truth for this device's performance is established through biomechanical testing, not expert interpretation of outputs like images.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, as this is a medical device for surgical intervention and not an AI/imaging diagnostic tool.

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

No, this is a physical medical device, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable. The performance described relates to the physical properties and function of the clip.

7. The Type of Ground Truth Used

The ground truth used for this device is based on biomechanical engineering principles and measurements of clip force enhancement, compared against a predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

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

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

Ask a specific question about this device

Temporary placement in the brain to facilitate occlusion of cerebral aneurysms. Clips are only to be applied with V. Mueller titanium coated clip appliers.

The temporary titanium aneurysm clip is bent wire that provides a spring operated, self-closing aneurysm clip of various lengths/sizes.

The document describes the Temporary Titanium Aneurysm Clip. Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided summary does not specify a sample size for any "test set" in the context of clinical performance or diagnostic accuracy. The studies mentioned are focused on device performance characteristics like sterilization and material properties, not on a patient test set for diagnostic or treatment outcome evaluation.

The data provenance is related to in-vitro testing ("repeat sterilization performance study" and "sterilization performance studies"). No country of origin for this data is explicitly stated, nor is it specified as retrospective or prospective in a clinical sense.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not applicable as the document describes technical/material testing, not a study requiring expert-established ground truth for a clinical test set.

4. Adjudication Method (Test Set)

This information is not applicable as the document describes technical/material testing, not a study requiring adjudication of expert opinions for a clinical test set.

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

A MRMC comparative effectiveness study was not conducted. The document describes a medical device (aneurysm clip) and its technical performance, not a diagnostic or treatment effectiveness study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable as the device is a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth used for the studies mentioned appears to be based on technical specifications and established testing protocols. For example, "no adverse effect on closing force" would be measured against a predefined technical standard or original specifications of the clip's closing force. Similarly, "Titanium material certification to ASTM F136-98" means the material was verified against the standards outlined in ASTM F136-98.

8. Sample Size for Training Set

This information is not applicable as the device is a physical medical implant. There is no concept of a "training set" for an algorithm in this context.

9. How Ground Truth for Training Set Was Established

This information is not applicable as the device is a physical medical implant.

Ask a specific question about this device