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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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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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Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during intracranial aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the intracranial aneurysm.

The Spetzler™ Round-Handled Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.

There are two types of Spetzler™ Round Handle Appliers; Stainless Steel with Titanium Jaws and Pads and completely Titanium. Each type applier has two styles; straight and bayonet.

The provided text is a 510(k) Pre-Market Notification for a medical device called the "Spetzler™ Round Handle Aneurysm Clip Appliers". This type of document is generally about demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative acceptance criteria through a formal study with detailed statistical analysis as might be done for a novel device. Therefore, much of the requested information (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not typically found in such a submission because these types of studies are not usually required for a 510(k) clearance based on substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and related information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "No applicable performance standards have been promulgated under Section 514 of the FD&C Act for these devices." Instead, the device's "performance" is assessed against its conformity to established material and instrument standards, and its substantial equivalence to predicate devices. The "acceptance criteria" here are qualitative and relate to design, material composition, function, and intended use as compared to existing, cleared devices.

• Elekta Clip Appliers (K955064)
• Aesculap Axial Clip Appliers (K984109)
• Yasargil, Caspar, Vario Clip Appliers (K940970)
• Sundt Slim-Line Aneurysm Clip Applier (K982379) |
  | Device Description & Intended Use | "hold and sufficiently open the aneurysm clip for application during aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the aneurysm." (The device also states it is designed for use only with Spetzler™ Titanium Aneurysm Clips). |
  | Technological Characteristics | "The new Spetzler™ round Handle Appliers do not impart any new technological feature in design or manufacturing. It is the same as to function and intended use when compared to the predicates. The Spetzler™ Clip Appliers is different in that its spring loaded squeeze mechanism is more compact than the "box" style. Therefore latch engagement and disengagement requires less travel." |

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

Not applicable in this context. A 510(k) submission generally relies on performance testing (e.g., mechanical, material) to demonstrate compliance with standards and equivalence, rather than a clinical "test set" of patient data. The provided document details compliance with industrial standards (ASTM, ISO) for materials and handling, not clinical data sets. The equivalence is demonstrated through comparison of technical characteristics to already-clezed devices.

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 type of submission is typically based on established engineering principles, material science, and the performance history of predicate devices, rather than expert interpretation of clinical data in a test set.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

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 instrument (aneurysm clip applier), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are irrelevant.

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

Not applicable. This is a manual surgical instrument, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this submission is the established performance and safety profiles of the predicate devices and the compliance with recognized industry standards for materials and surgical instruments. It's built upon:

• Engineering specifications and material properties.
• Functional design comparisons.
• Intended use equivalence to devices already cleared by the FDA.

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 for the same reason as point 8.

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The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.

There are twelve Axial clip appliers; each with complete material and design compatibility with Aesculap's existing Yasargil titanium and phynox aneurysm clip patterns. The new Axial clip appliers are available in three lengths (70mm, 90mm, 110mm), two jaw sizes (mini and standard), and two jaw materials (phynox and titanium).

The provided 510(k) summary for the Aesculap Axial Clip Appliers does not include specific acceptance criteria or details of a study that proves the device meets such criteria.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices already on the market. Here's a breakdown of the information available and what is missing:

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

• Acceptance Criteria: Not explicitly stated. The document mentions adherence to ASTM Standards F700-93 and Proposed ASTM Standard 1B. These standards likely contain performance requirements, but the specific metrics and targets considered "acceptance criteria" for this submission are not enumerated.
• Reported Device Performance: No specific performance metrics (e.g., clip retention force, applier tip strength, number of application cycles without failure) are reported. The submission states, "The new Axial clip appliers do not impart any new technological features or characteristics from Aesculap's current aneurysm clip appliers... These minor modifications, however, do not affect the safety and effectiveness of the new Axial clip appliers, as demonstrated by the information submitted in this premarket notification." This implies that the performance is considered similar to the predicate devices, but no comparative data is presented.

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified.

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

• This information is not applicable as there is no mention of a study involving expert assessment or ground truth establishment for a test set.

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

• Not applicable; no test set involving expert adjudication is mentioned.

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 instrument (clip applier), not an AI-powered diagnostic tool. MRMC studies are not relevant to its evaluation.

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

• Not applicable. This device is a manual surgical instrument; there is no algorithm or AI component.

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

• Not applicable. There is no mention of a ground truth in the context of device performance in this submission. The "ground truth" for substantial equivalence is the safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."

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

• Not applicable.

Summary of the Study (as described in the document):

The document states, "The new Axial clip appliers do not impart any new technological features or characteristics from Aesculap's current aneurysm clip appliers (Yasargil, Caspar and Vario) other than the slightly modified jaw design and the take-apart shaft. These minor modifications, however, do not affect the safety and effectiveness of the new Axial clip appliers, as demonstrated by the information submitted in this premarket notification."

This indicates that the "study" or evidence provided is primarily a justification of substantial equivalence based on design similarities and adherence to existing industry standards (ASTM F700-93 and Proposed ASTM Standard 1B), rather than a detailed performance study with explicit acceptance criteria and corresponding results. The submission implies that because the changes are minor and the device conforms to relevant standards, its safety and effectiveness are considered equivalent to the predicate devices. No specific quantitative performance data or clinical study results are presented in this 510(k) summary.

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The Sundt Slim-Line Aneurysm Clip Applier is designed for use only with Sundt Slim-Line Aneurysm Clips.

The subject Sundt Slim-Line Aneurysm Clip Applier is a stainless steel reusable hand-held instrument that is available in two configurations a fixed tip applier and a hinged tip applier. All three appliers consist of a handle grip with serrations, a two-piece spring, a shaft, and a v-grooved shape tip for grasping the aneurysm clip. The fixed tip Sundt Slim-Line Aneurysm Clip Applier and the Sugita appliers are designed with shaft that angles down and a thin tip profile to provide the surgeon a greater field of view during clip placement.

The provided document, a 510(k) summary for the Sundt Slim-Line Aneurysm Clip Applier, primarily focuses on demonstrating substantial equivalence to previously marketed devices. It does not contain information about specific acceptance criteria for performance, a study proving those criteria were met, or any of the detailed aspects of a performance study (like sample sizes, ground truth establishment, or expert involvement) as typically required for AI/software-as-a-medical-device (SaMD) clearances today.

This submission is from 1998, a period predating widespread AI in medical devices and the current rigorous expectations for demonstrating AI/ML device performance. Devices like aneurysm clip appliers are mechanical instruments, and their clearance process historically relies on demonstrating substantial equivalence in design, materials, and intended use to predicate devices, rather than clinical performance metrics in the way AI algorithms are evaluated.

Therefore, most of the requested information cannot be extracted from this document. I will answer based on what is available in the document and state when information is not present.

1. Table of acceptance criteria and the reported device performance

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

This information is not provided in the document. The clearance was based on substantial equivalence to predicate devices, not on a performance study with a test set.

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

This information is not provided in the document. No "ground truth" was established in the context of a performance study for this device's clearance.

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

This information is not provided in the document. No test set or adjudication method was described as part of this 510(k) submission for the device itself.

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 and not provided in the document. The device is a mechanical surgical instrument (aneurysm clip applier), not an AI-based diagnostic or assistive tool that would involve human readers or AI assistance.

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

This information is not applicable and not provided in the document. The device is a mechanical surgical instrument, not an algorithm.

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

This information is not provided in the document. No "ground truth" as typically understood in performance studies was used for the clearance of this mechanical device.

8. The sample size for the training set

This information is not applicable and not provided in the document. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided in the document. This device is not an AI/ML algorithm.

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