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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 Sugita AVM Microclips are designed for occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures.

Sugita AVM Microclips are not intended as a replacement for bipolar electrocoagulation of smaller vessels nor do they negate the need for immediate post-operative angiography following arteriovenous malformation surgery.

The Sugita AVM Microclips were cleared by the FDA through 510(k) K960037. The Sugita AVM Microclips are manufactured from Elgiloy, a cobalt-chromiummolybdenum alloy. They are designed for the occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures. The Sugita AVM Microclips are available in the following sizes: 2mm, 3mm, 4mm and 5mm. Other than the modifications identified above, there have been no other changes to the Sugita AVM Microclips.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided text does not specify exact sample sizes for each MRI compatibility test beyond implying "Sugita AVM Microclips" were used for testing. For the Spatial Gradient Magnetic Field testing, it mentions "5mm Sugita AVM Microclips" were attached to "a porcine blood vessel." The provenance of this data is not explicitly stated as retrospective or prospective, nor is the country of origin. It can be inferred that these are prospective in-vitro tests conducted specifically for this submission.

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

Not applicable. The tests performed are engineering-based performance tests (MRI compatibility, sterilization validation) and do not involve human expert interpretation or ground truth establishment in the traditional clinical sense. These tests rely on established scientific and engineering standards (e.g., ASTM, ISO).

4. Adjudication Method for the Test Set

Not applicable. As the tests are objective engineering measurements against predefined standards, there is no need for an adjudication method by human experts.

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 physical medical implant (microclips), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is irrelevant.

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 device.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests relies on established engineering and scientific standards and measurements as defined by:

• ASTM F2503-13 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment)
• Guidance for Industry and Food and Drug Administration Staff (Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, document issued on May 20, 2021)
• ASTM F2052-15 (Standard Test Method for Measurement of Magnetically Induced Translational Force on Medical Devices in the Magnetic Resonance Environment)
• ASTM F2213-17 (Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment)
• ASTM F2182-19 (Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging)
• ASTM F2119-2013 (Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants)
• ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices)

8. The Sample Size for the Training Set

Not applicable. This device undergoes physical performance testing, not machine learning model training.

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

Not applicable. There is no training set for this type of device.

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The Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion of cerebral blood vessels.

The Sugita Titanium Aneurysm Clip is made from the titanium alloy Ti6AI4V. This alloy was chosen for the new clip because of its excellent compatibility with magnetic resonance imaging (MRI) devices. Titanium and its alloys cause much less artifact and are subject to much smaller magnetomechanical effects than other clips materials such as the cobalt-chrome alloys or stainless steel. Ti6Al4V also has excellent mechanical properties. The Sugita Titanium Aneurysm Clips are available in 55 models of various shapes and sizes. These shapes and sizes are identical to the corresponding models of the Sugita Elgiloy clips.

The provided document is a 510(k) summary for the Sugita Titanium Aneurysm Clip, detailing its substantial equivalence to previously marketed devices. It focuses on mechanical properties and MRI compatibility. The document does not contain information about a study involving human readers, AI assistance, or expert consensus for establishing ground truth in the context of image analysis or diagnostic performance. Therefore, I cannot fully complete the table and answer all points as some of the requested information is not present in the provided text.

Here's the information that can be extracted and a clear indication of what is missing:

Acceptance Criteria and Device Performance for Sugita Titanium Aneurysm Clip

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)

• Sample Size for test set: Not specified in terms of number of clips tested, but implicitly involves various models from the 55 available clips.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is presented as "laboratory data" and "testing."

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)

• Not Applicable. The ground truth for this device is based on physical and mechanical measurements (e.g., closing force, MRI artifact evaluation), not human expert interpretation of images or clinical outcomes.

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

• Not Applicable. As per point 3, this is not a study involving human readers or interpretation requiring adjudication.

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

• No. This document describes a medical device (aneurysm clip) and its mechanical/material properties, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance evaluation was conducted or reported.

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

• No. This is not an algorithmic device.

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

• Mechanical and Physical Properties Measurement: The ground truth for the evaluation was based on objective laboratory measurements for mechanical properties (e.g., closing force using the ASTM measurement technique) and physical characteristics (e.g., MRI safety, artifact extent on MR and CT images).

8. The sample size for the training set

• Not Applicable. This is not a study involving a "training set" for an algorithm or a diagnostic model.

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

• Not Applicable. As per point 8, there is no training set in this context.

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Occlusion of small vessels as a compliment to bipolar coagulation.

These devices are miniaturized versions of the currently marketed Sugita Aneurysm Clip. They are used to occlude small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.

The provided text describes a 510(k) summary for the Sugita AVM Microclip, focusing on its design, intended use, and a summary of test data. However, it does not contain the level of detail regarding acceptance criteria and the comprehensive study methodology typically found in regulatory submissions for AI/ML-driven devices.

The information provided is more akin to validation testing for a medical device that does not involve algorithmic performance or human-AI interaction. Therefore, I cannot fully answer all aspects of your request as the input document does not contain the necessary information.

Based on the provided text, here's what can be extracted and inferred:

Acceptance Criteria and Device Performance

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Clamping of a patient's head and neck in a particular position during surgical procedures.

The device uses a four (4) point system to clamp a patient's head during surgical procedures. The material used was selected to reduce or eliminate interference normally associated with all metal skull clamps should x-rays or similar diagnostic activity be utilized during the procedure.

The provided text describes a medical device, the Mizuho Radiolucent Head Frame, and its testing. However, it does not contain the specific information required to complete the detailed acceptance criteria and study description as outlined in your request. The document is a 510(k) summary for a medical device and focuses on establishing substantial equivalence to legally marketed devices.

Here's why the requested information cannot be fully provided from the given text:

• No explicit "Acceptance Criteria" table: The document describes tests performed (Deflection Under Load, Durability of Reusable Skull Pins, Radiolucence) and their results, but it doesn't present them in a structured "acceptance criteria vs. reported performance" table format with numerical targets.
• No detailed information on "Study" for device performance: The tests mentioned are more akin to engineering verification tests rather than a clinical study evaluating diagnostic accuracy or effectiveness in a human-in-the-loop scenario.
  • Sample size and data provenance: Not applicable in the context of the described engineering tests.
  • Experts for ground truth / adjudication: This is irrelevant for the material property and deflection tests conducted.
  • MRMC study: No indication of any multi-reader multi-case study, as the device is a mechanical head frame, not an AI diagnostic tool.
  • Standalone performance: The concept of "standalone performance" as it relates to AI algorithms is not relevant here.
  • Type of ground truth: The "ground truth" for the tests mentioned would be established engineering standards or direct measurements, not clinical outcomes or expert consensus.
  • Training set size/ground truth for training set: These concepts are applicable to machine learning models, not to a physical medical device like a skull clamp.

Based on the provided text, here is what can be inferred and what cannot be provided:

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

2. Sample sized used for the test set and the data provenance:

• Sample Size:
  • Deflection Under Load: Not specified (refers to "The device" and "The metal device," implying one of each type for testing).
  • Durability of Reusable Skull Pins: "sample skull pins" were tested, but the exact number is not specified. They were tested at 5, 10, 20, and 40 cycles.
  • Radiolucence: Not specified (refers to "Representative x-rays").
• Data Provenance: Not specified, but implied to be laboratory/engineering testing performed during the device development process. This is not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable to the engineering verification tests described. Ground truth for these tests would be based on physical measurements and material science standards, not expert medical opinion.

4. Adjudication method for the test set:

• This information is not applicable to the engineering verification tests described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document describes engineering tests, not a clinical study involving human readers or AI assistance.

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

• No. This term is specific to AI algorithms and is not applicable to this mechanical device.

7. The type of ground truth used:

• Deflection Under Load: Direct physical measurement against a control (metal device).
• Durability of Reusable Skull Pins: Destructive testing and comparison to unprocessed pins; physical measurement of break load.
• Radiolucence: Visual assessment of x-ray interference.

8. The sample size for the training set:

• This information is not applicable as the device is a physical product, not an AI model requiring a "training set."

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

• This information is not applicable as there is no training set for this device.

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