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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 intended use of Störk Instrumente GmbH's Bone Wires is the fixation of bone fractures and / or to guide other implants during insertion to the skeletal system.

Due to their design and used materials, which is either Stainless Steel acc. ASTM F 138 / 139 (316 L) or Titanium Alloy acc. to ASTM F 136, Grade 5, these devices can be used as implants.

Störk Instrumente GmbH delivers all Bone Wires in Non-Sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.

Störk Instrumente GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle of 134°C / 270°F, 3 bar, for 10 minutes.

Trade Name: Bone Wire Common Name: Kirschner Wire (K wire), Steinmann Wire, Bonell Wire (Pin), Cerclage Wire

The provided text is a 510(k) Summary for a medical device (Bone Wires), which primarily focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain information about specific acceptance criteria, performance studies against those criteria, or clinical evaluation data that would typically be found in an AI/ML medical device submission.

Therefore, I cannot populate the requested table or answer most of the questions, as this document type does not involve such studies for this class of device.

Here's what I can extract based on the provided text, and what is missing:

Acceptance Criteria and Device Performance Table:

Detailed Response to Individual Questions:

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

   • See the table above. The "acceptance criteria" for a traditional 510(k) for a device like this are primarily based on material standards and substantial equivalence to legally marketed predicate devices, rather than a quantifiable performance metric derived from a specific study.

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

   • N/A. This document does not describe a "test set" in the context of performance testing or clinical studies. Substantial equivalence for this type of device is typically established through material property comparisons, design similarities, and intended use comparison with predicate devices, rather than a clinical 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)

   • N/A. There is no "ground truth" establishment described in this document, as it's not a study evaluating diagnostic accuracy or clinical outcomes.

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

   • N/A. 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

   • N/A. This device (Bone Wire) is a physical implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance is relevant.

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

   • N/A. This is not an algorithm or software device.

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

   • N/A. No ground truth is established as there is no performance study of this nature. The "truth" for this submission is adherence to material standards and functional equivalence to predicate devices.

8. The sample size for the training set

   • N/A. There is no "training set" as this is not an AI/ML device requiring training data.

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

   • N/A. No training set or ground truth for it is relevant or described.

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