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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 Spetzler Ti 100 Aneurysm Clips are intended for:

• . Temporary occlusion of intracranial blood vessels/aneurysms
• Permanent placement in the brain for occlusion of intracranial aneurysms .

Spetzler Ti 100 Aneurysm Clips are manufactured from titanium--Certified ASTM F67-89, "Unalloyed Titanium for Surgical Implant Applications, Grade IV" (see ASTM F67-89 specifications). This grade of titanium is often referred to as "Commercially Pure Titanium," or "C. P. Titanium." The basic models are distinguished by their surface finish: natural metallic color for clips intended for permanent implantation, and blue for temporary clips.

Aneurysm Clips, whether those proposed by Elekta or those manufactured or distributed by the sponsors of the predicate devices, are available in a wide variety of styles and sizes in order that all of the sizes and shapes of aneurysms can be treated. The clips are available for both temporary and permanent placement in the brain.

Spetzler Ti 100 Aneurysm Clips are applied with the Elekta Titanium Nitride Coated Clip Appliers to avoid foreign metal transfer. Clips are sterilized in the Elekta Sterilization Tray.

The provided text describes the Spetzler Ti 100 Titanium Aneurysm Clip. The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, particularly concerning its use of titanium. This is not a device that relies on algorithms or AI; therefore, many of the requested categories for AI/algorithm-based devices (like sample size for test/training set, number of experts, adjudication methods, MRMC studies) are not applicable.

However, I can extract information related to the acceptance criteria and the studies performed to demonstrate the device meets these criteria in a general sense, focusing on mechanical, biocompatibility, and imaging compatibility aspects.

Here's a summary of the information the document does provide, tailored to the requested format where possible, and noting when a category is not applicable.

Device Name: Spetzler Ti 100 Aneurysm Clip

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a mechanical medical device with no AI component, the "acceptance criteria" are generally derived from demonstrating equivalence to predicate devices and meeting established engineering and biological standards. Performance is reported relative to these standards and comparisons.

• Literature review and commissioned studies indicated titanium's excellent compatibility, lack of inflammatory potential, non-immunotoxicity, non-mutagenicity, non-genotoxicity, non-carcinogenicity, and absence of adverse systemic effects. |
  | MR Safety | - Significantly lower interaction with magnetic fields than predicate devices. | - Magnetic susceptibility 5.2x, 17.2x, and 15.7x lower than Codman (MP35N), Aesculap (Phynox), and Sugita (Elgiloy) clips, respectively. Magnetic force 14x, 35x, 36x lower compared to these in a 2T field.
• No detectable ferromagnetism (only paramagnetism) shown by shallow straight hysteresis loop.
• Negligible deflection in 1.5T and 2.0T fields; superior to Sugita and Aesculap clips in higher fields (7.0T). |
  | Image Artifact (MR) | - Reduced image artifact in MR imaging compared to predicate devices. | - Artifact (signal void with hyperintensity rim) found 7.5 times smaller than Elgiloy and 6 times smaller than Phynox.
• In dog model, MR artifact dimensions were 0.4-1.2 cm² for titanium vs. 1.0-3.6 cm² for conventional clips.
• "Slight" artifact with almost no degradation compared to significant artifacts for Sugita and Aesculap clips. |
  | Image Artifact (CT) | - Reduced image artifact in CT imaging compared to predicate devices. | - Artifact (streak/starburst) relative size 1 (Elekta) vs. 3 (Phynox) vs. 4 (Elgiloy).
• In dog model, CT artifact radius 1 cm for titanium vs. 3 cm for conventional clip.
• "No image degradation" noted for titanium clip compared to 300-400% greater artifact for Sugita and Aesculap clips. |

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

• Mechanical/Metallurgical Tests: "statistically determined number of clips" (specific number not given, but refers to destructive testing by an independent lab).
• Mechanical Performance in Simulated Use: Not explicitly stated, but "Clips placed on tubing..." implies a small number for this specific accelerated aging test.
• Biocompatibility (Intracranial Implant Study): 30 rabbits (12 with titanium clips, 12 with Yasargil Phynox clips, 6 non-implanted controls).
• MR Safety/Compatibility: Various studies cited; often comparing Elekta clips to predicate clips, but specific 'test set' sizes (number of clips tested per study) are not consistently given. For the magnetic susceptibility/force study, it states "characterization, mechanical testing and magnetic evaluation of the Elekta titanium, Codman, Aesculap and Sugita clips," implying at least one of each.
• Image Artifact (MR and CT): Studies often involved comparing a small number of each clip type or using a dog model (one dog used to compare clips).
• Data Provenance: Studies were commissioned by Elekta and conducted at universities (e.g., for MR safety and image artifact), independent metallurgical laboratories (for structural testing), and St. Vincent's Hospital in Dublin, Ireland (for MR artifact observations). The rabbit study was a pre-clinical implant study. Literature reviews also cited. This indicates a mix of in-house testing, external lab testing, and animal studies.

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

This is Not Applicable as the device is a mechanical aneurysm clip, not an AI diagnostic tool. Ground truth (e.g., successful occlusion, biocompatibility, magnetic interaction) is established through physical measurements, direct observation, and histological examination, not expert consensus on interpretations of images or data.

4. Adjudication Method for the Test Set

This is Not Applicable for the same reasons as #3. Physical measurements and objective evaluations are used. For the mechanical performance study, it mentions "changes in closing forces measured (double blind)," indicating a blinding method for that specific measurement.

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

This is Not Applicable. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with or without AI assistance. The Spetzler Ti 100 Aneurysm Clip is a physical implantable device.

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

This is Not Applicable. The device is not an algorithm.

7. The Type of Ground Truth Used

• Mechanical/Metallurgical: Objective physical measurements, destructive testing results, microscopic examination, calibrated force measurements, and corrosion tests.
• Biocompatibility: Histopathological examination (absence of tissue reaction, gliosis), EEG recordings, daily observations of animal behavior, and time-to-induced-seizure measurements in the rabbit study. Supported by extensive literature review on titanium's biological properties.
• MR Safety/Compatibility: Direct magnetic susceptibility measurements, magnetic force measurements in varying magnetic fields, observation of deflection, and direct measurement of artifact dimensions/radii in controlled MRI/CT scans.

8. The Sample Size for the Training Set

This is Not Applicable as the device is a mechanical medical device, not an AI/algorithmic system that requires a "training set."

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

This is Not Applicable for the same reasons as #8.

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