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The Sugita AVM Microclip Applier is exclusively designed to place Sugita AVM Microclips during surgical procedures.

The Sugita AVM Microclip Applier has a spring handle design with a ratchet. The Sugita AVM Microclip Applier serves to open and close the Sugita AVM Microclips. Using the Sugita AVM Microclip Applier, the Sugita AVM Microclips are removed from their packaging and applied, repositioned or removed from the target tissue. The Sugita AVM Microclip Applier has no function of its own and may only be used in combination with the Sugita AVM Microclips. The Sugita AVM Microclip Applier has the same design and materials as the clip applier in the K960037. The body of the Sugita AVM Microclip Applier is manufactured from stainless steel and the jaws are manufactured from Elgiloy, a cobalt-chromium-molybdenum alloy.

The provided document is a 510(k) summary for the Sugita AVM Microclip Applier (K221524). It details the device, its intended use, and its comparison to a predicate device. However, it does not describe an acceptance criteria table, a study proving device performance against acceptance criteria, or any of the detailed study information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Aesculap Slim Clip Applier, K211572) based on similar indications for use, materials, design, and technological characteristics. The only "performance testing" mentioned is non-clinical sterilization and cleaning validation, which supports updated instructions for use, not a clinical performance study using patient data.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a type of performance study that was not conducted or reported here.

Here's what can be extracted and a clear indication of what is not present in the document based on your request:

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

Information Not Available: The document does not provide a table of acceptance criteria or reported device performance against such criteria. The submission focuses on demonstrating substantial equivalence through comparison of design, materials, and intended use, along with validating sterilization and cleaning parameters.

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

Information Not Available: No clinical test set or patient data was used for performance evaluation as described in this document. The "tests" performed were non-clinical validation of sterilization and cleaning parameters.

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

Information Not Available: No clinical test set requiring expert ground truth establishment was conducted or reported.

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

Information Not Available: No clinical test set requiring adjudication was conducted or reported.

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

Information Not Available: This device is a mechanical surgical applier, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable and was not conducted.

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

Information Not Available: This device is a mechanical surgical applier, not an algorithm. Therefore, standalone algorithm performance is not applicable and was not assessed.

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

Information Not Available: No clinical ground truth was established as no clinical studies were performed for this 510(k) submission.

8. The sample size for the training set

Information Not Available: No training set was used as this is not an AI/machine learning device. The "training" for this submission would involve the development and validation of manufacturing processes, sterilization, and cleaning instructions.

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

Information Not Available: No training set or associated ground truth, in the context of AI/machine learning, was established. The "ground truth" for the non-clinical validations would be successful completion of specified sterilization and cleaning cycles according to established scientific and regulatory standards.

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The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips.

The Aesculap Slim Clip Appliers are manufactured from stainless steel and are available in various lengths, jaw angulations, with or without latches. This submission intends to add a coating to the previously cleared clip appliers. Each clip applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aesculap Slim Clip Applier, formatted as requested:

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 size used for the mechanical "Verification test for clip opening." It merely states "Pass" for the test.

For biocompatibility testing, the sample sizes are implied by the test descriptions:

• Cytotoxicity: "Test articles were extracted for 24 hours per ISO 10993-5." (Specific number of test articles not given).
• Sensitization: "in the guinea pig." (Specific number of guinea pigs not given).
• Pyrogenicity: "following intravenous injection in rabbits." (Specific number of rabbits not given).
• Irritation: "All animals appeared normal throughout the study." (Specific number of animals not given).
• Systemic Toxicity: "extracts injected into mice." (Specific number of mice not given).
• Hemolysis: "The test article extract was tested in vitro." (Specific number of test articles or replicates not given).

The data provenance is not explicitly stated regarding country of origin or whether it's retrospective/prospective. However, given that these are bench and biocompatibility tests conducted for a 510(k) submission, they are typically conducted prospectively in a controlled laboratory setting by the manufacturer or a contract research organization.

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

Not applicable for this type of device and testing. The ground truth for mechanical performance is based on engineering specifications and physical measurements. The ground truth for biocompatibility is based on established ISO standards and observed biological reactions in animal models or in vitro tests, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This document describes bench testing and biocompatibility testing against defined physical and biological parameters, not subjective assessments requiring adjudication by multiple experts.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. The Aesculap Slim Clip Applier is a surgical instrument, and its evaluation focuses on mechanical performance and biocompatibility.

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

Yes, the studies described are essentially "standalone" in the sense that they evaluate the device's intrinsic mechanical properties and biocompatibility without a human operator's performance being the primary subject of the test (beyond the execution of the test itself). The "Verification test for clip opening" directly assesses the applier's mechanical function, and the biocompatibility tests evaluate the material's interaction with biological systems. There isn't an "algorithm" per se, but the device's performance is tested independently.

7. Type of Ground Truth Used

• For Clip Opening Verification: Engineering specifications and physical measurements of the clip's opening width.
• For Biocompatibility Tests: Established biological endpoints and standards (e.g., ISO 10993 series) for cytotoxicity, sensitization, pyrogenicity, irritation, systemic toxicity, and hemolysis.

8. Sample Size for the Training Set

Not applicable. The Aesculap Slim Clip Applier is a mechanical surgical instrument, not an AI/machine learning device that requires a training set of data. The "training" in manufacturing would relate to process validation and quality control, not a data-driven model.

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

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

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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.

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The Aesculap Slip Clip Applier forceps are used for opening, closing, and applying Aesculap Y ASARGIL aneurysm clips.

The Aesculap Slim Clip Appliers are manufactured from stainless steel (body & jaw). The previously cleared appliers are available in lengths ranging from 50 mm to 110 mm in 10 mm increments. In addition to the straight jaw configuration (0%), the Clip Appliers are available with jaws angled up & down (5° to 15°), left & right (5° to 15°), in increments of 5° in all lengths. This submission intends to add additional lengths of 120 mm and 130 mm in these configurations. This submission intends to add additional jaw angulations of 20° to 45° up and down and 20° to 30° left and right in 5° increments and lengths ranging from 50-130 mm in 10 mm increments. In addition to these configurations, clip appliers with latches will be available in lengths ranging from 70 mm to 110 mm increments with jaw angulations ranging from straight, 5° to 45° up and down and 5° to 30° left and right in 5° increments. Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.

This document describes the premarket notification (510(k)) for the Aesculap Slim Clip Applier, a device used for opening, closing, and applying Aesculap YASARGIL aneurysm clips. The submission aims to add new lengths and jaw angulations, as well as an optional latch feature, to existing cleared appliers.

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 specific sample sizes used for each test (e.g., number of appliers, number of clips, number of simulated craniotomies). It generally refers to "all required testing" being completed. The tests are bench tests, meaning they were conducted in a laboratory setting, not with human subjects. Thus, data provenance in terms of country of origin or retrospective/prospective medical data is not applicable here as the test data is generated in a controlled environment.

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

This information is not provided in the document. The tests performed are primarily functional and mechanical, suggesting that the "ground truth" is defined by engineering specifications and performance standards rather than expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the bench testing (Pass/Fail results against predefined criteria), formal adjudication by multiple parties for each test outcome is unlikely to have been a primary method.

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

No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (aneurysm clip applier), and the studies described are bench tests to confirm its mechanical and functional equivalence to predicate devices, not studies involving human readers interpreting imaging data or clinical outcomes. Therefore, an effect size of human readers improving with or without AI assistance is not applicable.

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

This question is not applicable to the Aesculap Slim Clip Applier. This device is a manual surgical instrument, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

The ground truth for the acceptance criteria and testing appears to be based on:

• Engineering Specifications: The required interface and opening width of the aneurysm clip, and the ability to release the clip successfully.
• Functional Performance Standards: The successful performance of the clip applier with the aneurysm clip, and latch functionality.
• Usability Requirements: Ensuring proper identification features, legibility, visualization of the surgical site, and the ability to grasp, hold, and apply the clip.

These are primarily objective, measurable criteria related to the device's design and intended function.

8. The Sample Size for the Training Set

This is not applicable. The Aesculap Slim Clip Applier is a mechanical medical device, not a machine learning or AI algorithm that requires training data.

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

This is not applicable, as there is no training set for a mechanical device.

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The Aesculap Slim Clip Applier forceps are used for opening, closing, and applying Aesculap YASARGIL aneurysm clips.

The Aesculap Slim Clip Applier forceps are manufactured from stainless steel (body & jaw). The appliers are available in lengths ranging from 50 mm to 110 mm. In addition to the straight jaw configuration, the Clip Appliers are available with jaws angled up & down, left & right.

Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, identification plugs to easily identify each clip designation are placed in the handles.

The Aesculap Slim Clip Applier is a medical device for opening, closing, and applying Aesculap YASARGIL aneurysm clips.

Here's an analysis of its acceptance criteria and the study proving it meets these criteria:

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 numerical sample size for the test set. It mentions "Bench testing results" and describes the types of tests performed. The data provenance is not explicitly mentioned (e.g., country of origin). The testing described is prospective bench testing focused on the mechanical and functional aspects of the device, rather than patient data.

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

The document does not mention the use of experts to establish ground truth for the test set. The tests described are objective performance and usability assessments.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the tests appear to be objective performance evaluations rather than subjective assessments requiring expert consensus.

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

An MRMC study was not conducted as this device is a mechanical instrument (aneurysm clip applier) rather than an AI-powered diagnostic tool or image interpretation system. Therefore, there is no effect size reported for human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A "standalone" study in the context of an algorithm is not applicable here, as this is a physical medical device. The "standalone" performance would be analogous to the "Benchmark Functional Test" and "Predicate/Subject Device Comparison Test" which assess the device's inherent functional capabilities without direct human interaction beyond its intended use.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on engineering specifications and functional requirements for aneurysm clip appliers, ensuring they correctly interface, open, close, and release aneurysm clips as intended, and meet usability standards.

8. The Sample Size for the Training Set

A "training set" is not applicable as this is a mechanical device, not an AI or machine learning model.

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

As there is no training set for an AI/ML model, this question is not applicable.

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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.

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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.

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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.

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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.

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The Aesculap AVM Microclips are intended for intracranial vascular occlusion (permanent or temporary) of small vessels.

The Aesculap AVM Microclip Applier is intended for holding and applying intracranial AVM Microclips.

The Aesculap AVM Microclips are designed for temporary or permanent occlusion of small vessels during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are available with either straight or curved blades. The AVM Microclip Applier is constructed from Titanium Alloy per ISO 5832/3 with Phynox jaws.

The provided text describes the 510(k) summary for the "Aesculap AVM Microclips and Applier." It states that the device received FDA clearance (K024349) in 2003.

However, the document does not contain the information requested in the prompt regarding a study that proves the device meets specific acceptance criteria.

The section titled "PERFORMANCE DATA" only states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Aesculap AVM Microclips were completed. Biomechanical testing results demonstrate the Aesculap AVM Microclips and Applier are substantially equivalent to other AVM Microclips and Appliers currently on the market."

This indicates that internal biomechanical testing was performed to demonstrate substantial equivalence to existing predicate devices, which is a regulatory pathway for clearance, but it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size for test set or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results (effect size).
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on regulatory compliance and substantial equivalence, not on a detailed clinical or performance study as might be expected for an AI-powered device or one with specific performance acceptance criteria measured in a clinical context.

Therefore, I cannot fulfill your request for items 1-9 based on the provided text. The device described (AVM Microclips) is a physical surgical instrument, not an AI/software device that would typically involve the types of studies mentioned in your prompt (e.g., MRMC, standalone algorithm performance, ground truth establishment with experts for image analysis).

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