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The Precise™ Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.

The Precise™ Treatment Table is an enhancement to the previously reported EOS RAM and Pedestal devices that have been cleared for commercial distribution. These devices have established and proven track records for safety. This enhancement offers improved directional accuracy and repeatability to provide for easier and more efficient patient set up. The Precise™ Treatment Table is further considered as an enhancement to the RAM and Pedestal devices.

The provided text is a summary of safety and effectiveness information for the Elekta Oncology Systems Precise™ Treatment Table, not a study that proves a device meets acceptance criteria. It primarily focuses on regulatory compliance, quality management, and the device's substantial equivalence to previously cleared devices.

Therefore, the requested information cannot be extracted from the provided text as it does not contain details about:

• Specific acceptance criteria metrics for performance.
• A study design, sample sizes for test or training sets.
• Data provenance, expert qualifications, or adjudication methods.
• MRMC comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used or how it was established.

The text emphasizes that the Precise™ Treatment Table is an "enhancement" to existing devices with established safety records and that it meets international safety standards and quality system requirements (IEC 60601-1, IEC 60601-2-1, ISO 9001, EN 46001, Medical Device Directive 93/42/EEC Annex II, and 21 CFR 820). It also states that the device offers "improved directional accuracy and repeatability," but it does not provide quantitative metrics or the study results to back up this claim.

In summary, the provided document is a regulatory submission for premarket notification (510(k)) and not a detailed study report. It confirms the device's regulatory compliance and safety profile based on its design, quality system, and substantial equivalence to predicate devices, rather than presenting the results of a performance study with specific acceptance criteria.

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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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