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The DORO LUCENT® Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging.

The DORO LUCENT® Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.

The DORO LUCENT® Skull Clamp ensures an adequate positioning of a patient's head and provides rigid fixation for neurosurgery. The device is suitable for intra-operative X-ray and CT based imaging procedures.

The DORO LUCENT® Skull Clamp consists of a fixed arm, an adjustable arm and modular pin holders. Thus, using the DORO LUCENT® Skull Clamp Pediatric Set, the skull clamp can be configured as three-pin or four-pin pediatric set up.

The provided text describes the 510(k) clearance for the DORO LUCENT® Skull Clamp and DORO LUCENT® Skull Clamp Pediatric Set. However, it does not contain information about a study based on AI/ML or any performance testing related to software or AI. The tests mentioned are for mechanical performance, usability, and reprocessing of the physical device.

Therefore, for aspects related to AI/ML device performance, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, the information is not available in the provided document.

Here's a breakdown of what is available based on the mechanical device performance testing:

Device: DORO LUCENT® Skull Clamp (1101.001) and DORO LUCENT® Skull Clamp Pediatric Set (1101.040)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. For mechanical/physical performance tests, the "sample size" typically refers to the number of units tested. The document indicates "Tests were performed and the results are shown in the table below," implying a sufficient number of tests were conducted to confirm performance.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective for these physical device tests. These are likely internal laboratory tests conducted by the manufacturer.

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

• Not applicable. This device is a mechanical skull clamp, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these tests is the physical measurement and observation of the device's performance against defined engineering and safety standards.

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is relevant for AI/ML diagnostic tools being compared to human performance, which is not the case for this mechanical device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. There is no algorithm or software for standalone performance in this mechanical device.

7. Type of Ground Truth Used:

• Engineering and Safety Standards/Specifications: The ground truth for these tests is established by the device's design specifications and compliance with relevant industry standards (e.g., for mechanical strength, CT compatibility, and reprocessing).

8. Sample Size for the Training Set:

• Not applicable. This is a mechanical device, not an AI/ML product developed through a training process with a data set.

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

• Not applicable. See point 8.

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The DORO QR3 Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.

DORO® QR3 Headrest System consists of 3 components: 1. Skull clamp, 2. Swivel Adapter, 3. Adjustable Base Unit. DORO® QR3 Headrest System (Aluminum) is a cranial stabilization device, designed to provide rigid skeletal fixation. The DORO Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The Swivel Adaptor connects the Base Unit (by means of the Transitional Member) with the Skull Clamp. The Swivel Adaptor provides 360 degrees rotation. This allows a fully flexible adjustment of the DORO® Headrest System to the patient's position. The Base Unit is designed for patient positioning in prone or supine, lateral and sitting positions.

The provided document is a 510(k) premarket notification for a medical device called the DORO QR3 Headrest System (Aluminum). This document primarily focuses on establishing substantial equivalence to a predicate device and outlines performance testing for safety and effectiveness, rather than detailing clinical study results for an AI/algorithm-based device.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission.

Here's the information that can be extracted relevant to acceptance criteria and device performance based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Pass" results of the performance tests, indicating that the device met the established benchmarks for each test. The study performed is a series of engineering and usability tests.

Additional Information:

1. Sample size used for the test set and the data provenance: Not applicable. These were engineering performance tests of the physical device, not a test set of medical data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for engineering tests is typically based on established physical standards and measurements, not expert human interpretation.
3. Adjudication method for the test set: Not applicable.
4. 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 document is for a physical medical device, not an AI/algorithm.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used:
   • For engineering tests (Load, Torque, Creep, System Tests): The ground truth is the performance specified by the referenced ASTM and DIN EN standards. The "Pass" results indicate the device met these engineering specifications.
   • For Usability Test: The ground truth would be adherence to the usability requirements outlined in IEC 62366 and FDA-2011-D-0469.
   • For Cleaning and Disinfection Test: The ground truth is compliance with the referenced ISO, RKI, AAMI, and DGKH/DGSV/AKI guidelines for reprocessing medical devices.
7. The sample size for the training set: Not applicable. This is for a physical device, not an AI/algorithm.
8. How the ground truth for the training set was established: Not applicable.

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Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

DORO® Sterile Disposable Skull Pins are a disposable device. These are delivered sterile (gamma-sterilization), ready for use, and are intended to be disposed after one use. DORO® Sterile Disposable Skull Pins are available in 2 different types (Stainless steel & Titanium) and 2 different sizes (Adult & Pediatric). DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest Systems, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one single skull pin is inserted in the opposite side. DORO® Sterile Disposable Skull Pins (Titanium) are used when Intra-Operative X-Ray-, CTor MR Imaging of the patient is used.

The provided document is a 510(k) premarket notification for the DORO® Sterile Disposable Skull Pins. This document asserts the substantial equivalence of the new device to legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I describe an MRMC comparative effectiveness study or details about the training set.

The document focuses on demonstrating substantial equivalence for a physical medical device (skull pins) by comparing its technological characteristics and performance testing results to those of predicate devices. It does not involve AI/ML components or studies of human reader performance.

However, I can extract information related to the performance data provided for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance (as listed in the document for the physical device):

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

The document describes performance testing of physical properties of the skull pins (e.g., axial load, shear, sterility, biocompatibility) and packaging, not a study involving a "test set" of medical images or patient data in the typical sense of AI/ML evaluation. The specific sample sizes for these engineering and material tests are not detailed in this 510(k) summary, beyond indicating that "worst-case product" was utilized for some tests. The data provenance is from the manufacturer's internal testing (Pro Med Instruments GmbH, Germany). The tests are not clinical studies, so terms like "retrospective or prospective" do not apply.

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

This is not applicable to the type of device and testing described. Ground truth for a physical device's performance tests would typically involve established engineering standards, material specifications, and validated laboratory procedures, not expert consensus on medical images.

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

Not applicable. This is not a study involving human interpretation or adjudication of medical data.

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 document is for a physical medical device (skull pins), not an AI/ML diagnostic or assistive device. Thus, there is no mention of MRMC studies or AI assistance.

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

Not applicable. This device is not an algorithm.

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

For the physical device, the "ground truth" for the performance tests would be defined by engineering specifications, material standards (e.g., ISO, ASTM), and validated test methodologies. For example, for the "Axial Load and Creep Test," the ground truth is the specified load and deformation limits that the device must withstand. For "Biocompatibility," the ground truth is the absence of cytotoxicity or harmful chemical substances as per established biocompatibility standards.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML model.

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

Not applicable. This device is not an AI/ML model.

In summary, the provided document is a regulatory submission for a physical medical device focusing on substantial equivalence based on material properties, design, and mechanical performance testing, rather than an AI/ML device requiring clinical validation or human reader studies.

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The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used.

The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used.

The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.

The DORO LUCENT® iXI and iMRI Headrest System ensures an adequate positioning of a patient's head for neurosurgery. Additional intra-operative imaging can be performed.

The DORO LUCENT® iXI and iMRI Headrest System consists of the following: Skull Clamp, Skull Pins, Parallelogram Adaptor and Headplate. The Parallelogram Adaptor is used to connect the Skull Clamp (including Skull Pins) or the Headplate to the OR-Table/ Transfer Board.

Additional accessories like the Adjusting wrench and Transfer Collision Indicator supports the performance of the Headrest System.

These special Headrest Systems are developed for selected OR-Table/ MRI scanner combinations. They are separated in following sets:

• . 4003.200 DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems
• 4003.300 DORO LUCENT® iMRI Headrest System MAQUET for SIEMENS/PHILIPS/GE ●
• . 4003.500 DORO LUCENT® iXI Headrest System

By the use of the Navigation Adaptors the performance of the Headrest System is supplemented. The intra-operative navigation is feasible because of the provided interface to the navigation device.

The provided FDA 510(k) summary describes a medical device, the DORO LUCENT® iXI and iMRI Headrest System. This document focuses on the substantial equivalence of the new device to a predicate device rather than presenting a clinical study to evaluate diagnostic performance with a human-in-the-loop or standalone algorithm. Therefore, many of the requested criteria related to AI/algorithm performance and clinical study details are not applicable or not present in this submission.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated through "Pass" results in various performance tests.

2. Sample size used for the test set and the data provenance

This is a physical medical device (headrest system), not an AI/software device. The "test set" here refers to the physical units of the device and its components undergoing engineering and materials testing. The document does not specify the exact number of units or components tested for each criterion. The provenance of the data is from pro med instruments GmbH, the manufacturer, and the tests were likely conducted internally or by accredited third-party labs. The study is a prospective testing of manufactured devices against pre-defined engineering and safety standards.

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

Not applicable. Ground truth for a physical device's performance often relates to instrumented measurements (e.g., force, torque, imaging artifacts) and material properties, not expert consensus as would be used for diagnostic imaging algorithms.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies for diagnostic accuracy, where expert opinions need to be reconciled. For device performance testing, results are quantitative or pass/fail based on pre-defined specifications.

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 not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

The ground truth for this device's performance is based on engineering specifications, material science, sterility standards, and regulatory requirements (e.g., MRI compatibility standards). For example, "MR-Compatibility" is verified against established standards for how metallic or non-metallic objects interact with MRI fields. "Static load" is verified against a specified weight with a safety factor.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI/machine learning training sets.

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

Not applicable. As there is no training set for an AI algorithm, no ground truth needs to be established for it.

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The Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

The Arcus Head Fixation Frame is a re-usable, non-sterile device designed to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets. It consists of a Ring that secures the patient's skull with skull pins, a Base that secures the Ring, and Posts that hold Fixation Screws. The device is secured to the scanner table. It is designed for use with specific Siemens MRI Scanners. The device is MR Conditional and contains brass inserts and titanium pin tips.

This document describes a 510(k) premarket notification for the Arcus Head Fixation Frame. It does not contain information about the acceptance criteria and study designs that are typically associated with artificial intelligence/machine learning (AI/ML) powered medical devices. The device described in this document is a physical medical device (neurosurgical head holder/skull clamp), not an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this text.

However, I can extract the relevant performance data and comparisons for the physical device as presented in the document:

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

The document does not explicitly present "acceptance criteria" in a tabular format as would be seen for an AI/ML device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, it states that "Testing confirmed the Arcus HFF met the Product Specification Requirements." The performance data is primarily focused on demonstrating equivalence to a predicate device and confirming basic functionalities and safety for an MRI environment.

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 applicable and therefore not provided in the document, as it pertains to a physical device evaluation through bench testing, not an AI/ML algorithm trained and tested on data.

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 this is a physical device submission without data-driven ground truth. The "ground truth" for this device would be its physical properties and performance under specific test conditions, established through engineering and safety standards.

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

This information is not applicable as it is a physical device evaluation, not a clinical study involving reader performance or expert 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

This information is not applicable as the device is a physical head fixation frame, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable as the device is a physical head fixation frame, not a standalone AI algorithm.

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

For this physical device, the "ground truth" is established through:

• Engineering specifications and design: The device is designed to meet certain physical and mechanical criteria.
• Regulatory standards: Adherence to recognized consensus standards like ISO 10993-1, ASTM F2052, and ASTM F2119-07, which define acceptable physical and biological performance.
• Bench testing: Direct experimental verification of physical properties (e.g., securing head, MR safety properties).
• Predicate device comparison: The performance and safety of the device are judged largely against the established performance and safety of a legally marketed predicate device.

8. The sample size for the training set

This information is not applicable as the device is a physical head fixation frame, not an AI/ML algorithm that undergoes training.

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

This information is not applicable for the same reason as above.

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The DORO® QR3 XTom Headholder System is a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging with a CT-Scanner is used.

The DORO® QR3 XTom Headholder System ensures an adequate positioning of a patient's head for neurosurgery. Due to the utilized material the device can be used for intraoperative CT imaging procedures. The DORO® QR3 XTom Headholder System consists of the following: Skull Clamp, Skull Pins, Base Unit, Torque Screw Driver and U-Belt. The Base Unit is used to connect the Skull Clamp (including Skull Pins) to the OR-Table. Additional components like the Torque Screw Driver and U-Belt supports the performance of the Headholder System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DORO® QR3 XTom Headholder System.

It's important to note that the provided text is an FDA 510(k) summary for a mechanical support system (Neurosurgical Head Holder/Skull Clamp) and not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects like training data, expert consensus for ground truth, MRMC studies, and various performance metrics like sensitivity, specificity, AUC are not applicable to this type of device. The acceptance criteria and performance are based on mechanical and usability testing.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of units tested. It states "The devices have been tested as a system and single device," implying that at least one of each (system, skull clamp, U-Belt) was subjected to testing. For mechanical tests, the sample size might be small, typically 1 to 3 units, as per engineering testing standards, unless statistical significance for variability is a concern.
• Data Provenance: The manufacturer is "pro med instruments GmbH" located in "Freiburg im Breisgau, Germany." This suggests the testing and data likely originated from Germany. The document indicates these were direct performance tests on the physical device, not retrospective or prospective patient data studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable (N/A). As this is a mechanical device, ground truth for its performance is established through objective physical measurements and engineering standards, not through expert human interpretation or consensus like in AI/ML image analysis.

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (like radiology reads) to resolve disagreements or establish consensus. For mechanical performance tests, the results are quantitative and objective, not subject to human interpretation disagreement in the same way.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This type of study is relevant for diagnostic imaging AI/ML devices to assess the impact on human reader performance. This device is a mechanical support system, not an imaging interpretation aid.
• Effect Size: N/A, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• N/A. This is a mechanical device, not an algorithm or software. Its performance is inherent to its physical design, materials, and manufacturing, not dictated by an algorithm.

7. The Type of Ground Truth Used

• Objective Mechanical Measurements and Engineering Standards: The "ground truth" for this device's performance is derived from its ability to meet predefined physical requirements (e.g., load bearing, torque resistance, force accuracy, maintaining clamping force over time) as measured by calibrated testing equipment and adherence to established engineering principles and safety margins. The "Pass" results confirm it met these criteria.

8. The Sample Size for the Training Set

• N/A. This device does not involve machine learning; therefore, there is no "training set."

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

• N/A. Since there is no training set, this question is not applicable.

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The TZ Medical skull pin is placed in a clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

The TZ Skull Pin is a sterile cervical traction skull pin manufactured from implant grade 316L stainless steel alloy. The TZ Skull Pin is used during neurosurgical procedures to immobilize the head in reference to the torso and to provide cervical immobilization.

Here's a breakdown of the acceptance criteria and study information for the TZ Skull Pin Adult device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes (number of pins or animals) for each specific test in the "Summary of Performance Testing" section. It refers to testing being conducted but provides general results rather than specific numerical data for each test condition. The studies are laboratory-based and use animal models for biocompatibility tests (guinea pigs, rabbits, mice) and mechanical testing of the pins. Data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission.

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 and not provided in the document. The tests performed are primarily mechanical and biological (biocompatibility) evaluations based on established international standards (ASTM and ISO), not human reader evaluations or clinical trials. The "ground truth" for these tests is defined by the specific parameters and outcomes outlined in the referenced standards (e.g., absence of cell lysis, holding a load without failure).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies to establish a consensus ground truth. The tests described are objective, laboratory-based evaluations against predetermined criteria.

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. The TZ Skull Pin is a physical medical device (neurosurgical skull pin), not an AI algorithm or an imaging device to be read by human experts. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant to this device's submission.

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

This information is not applicable. As explained above, this device is a physical skull pin, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests (Skull Pin System Testing, Max Load Test, Creep Test) is defined by the pass/fail criteria of established engineering standards, specifically ASTM F1831-97 (implicitly referenced for performance) and the general requirement that the device performs safely and effectively without material failure or slipping.

For the biocompatibility studies (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity), the ground truth is defined by the objective criteria and endpoints specified in the relevant international ISO standards (ISO 10993-5, ISO 10993-10, ISO 10993-11), such as the absence of cell lysis, dermal contact sensitization, irritation, or systemic toxicity.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this physical medical device. Training sets are relevant for machine learning algorithms.

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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The MAYFIELD Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.

The MAYFIELD Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation. The MAYFIELD Skull Clamp supports a 2-pin rocker arm, which allows for 360° rotation under full impingement force. The device has the means for skull pin force

The provided text describes the MAYFIELD Skull Clamp, its indications for use, and nonclinical tests conducted to demonstrate its performance. However, it does not contain information about an AI-powered device, acceptance criteria or a study proving its performance for such a tool.

Therefore, the following information cannot be extracted from the given text:

• A table of acceptance criteria and the reported device performance (for an AI device).
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document is a 510(k) summary for a medical device that is a neurosurgical head holder (skull clamp), not an AI diagnostic or treatment device. The tests discussed are physical performance tests for a mechanical device.

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The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

The IMRIS Head Fixation Device System (HFD100) Rocker Arm Accessory is an MR compatible mechanical support system intended to use in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

The HFD100 and its accessories are designed to immobilize the head during surgical procedures and support patient in the prone, supine or lateral positions. The HFD100 system is comprised of the table adapter, linkage system, one or two rocker arm skull clamps, and skull pins. The HFD100 system can be used with either the operating room table or the angiography room table. The table adaptor is used to mount HFD100 on the table. The linkage system is used to mount the Skull Clamp (including 3 or 4 skull pins) to the table Adapter.

The Skull Clamp requires the use of three (3) or four (4) Skull Pins. IMRIS is using MAYFIELD® Disposable and Reusable Titanium Skull Pins manufactured by Integra LifeSciences Corporation and cleared by FDA K072208. The MAYFIELD® Disposable and Reusable Titanium Skull Pins are used in surgical procedures when rigid fixation is desired and Intra-Operative MR imaging is used.

IMRIS 3-pin and 4-pin HFD100 attached to the OR table assembly is part of the IMRISneuro system. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. The HFD100 can be used individually or with the IMRIS Flexible Intra-operative Head Coils and third party accessories, such as retractor systems and navigation mounts. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images.

The IMRISneuro 1.5T/3T Systems (Neuro III-SV) are traditional MRI units that have been suspended on an overhead rail system to facilitate intra-operative, interventional and diagnostic use. The main components of the IMRISneuro systems are the MRI system, the magnet mover system, the OR Table assembly, the Intra-operative Coil and the Head Fixation Device. The IMRISneuro intraoperative imaging systems are tools for radiologists and surgeons, used to acquire images for diagnosis and surgical planning and monitoring during surgery. When images are requested by the surgeon, the magnet is brought into the operating room or Angiography room moving on a pair of overhead rails. The patient remains stationary throughout the procedure and the magnet moves into the room and over the patient for imaging. The magnet can be moved into and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. The surgeon has access to updated MR images in the surgical field, but does not have to change the surgery would typically be performed. Obtaining images intra-operatively allows surgeons to verify the absence of surgical complications before releasing the patient from the operating room.

The provided text describes a 510(k) premarket notification for a medical device, the IMRIS Head Fixation Device (HFD100) Rocker Arm Accessory. This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to a previously cleared predicate device.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific quantitative acceptance criteria (e.g., "withstanding X N of force," "maintaining Y mm of displacement"). Instead, the main "acceptance criterion" for this 510(k) submission is that the HFD100 Rocker Arm Accessory, which enables a 4-pin configuration, maintains the performance and safety equivalency of the previously cleared 3-pin HFD100 system.

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

The document does not specify a sample size for a test set in terms of patients or independent cases. The "study" mentioned is described as "verification and validation testing." For a mechanical device like this, verification and validation typically involve engineering tests on the device itself, rather than clinical data from a "test set" of patients.

• Sample Size: Not applicable in the context of clinical data. It would refer to the number of devices or components tested, which is not specified.
• Data Provenance: Not applicable in the context of clinical data (e.g., country of origin, retrospective/prospective). The data would be from engineering tests conducted by IMRIS.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and submission. The ground truth for a mechanical fixation device's performance would be established through engineering specifications, standards adherence (though none are referenced in this submission), and physical testing, not expert clinical consensus on images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a "test set" in the context of clinical data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is typically done for diagnostic imaging or AI algorithms where human interpretation is involved. This submission is for a mechanical fixation device, not an imaging or AI interpretation product.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not an algorithm or AI product.

7. Type of Ground Truth Used

The "ground truth" for this device's performance would be based on engineering specifications, physical measurements, and mechanical testing results (e.g., stability under load, material properties, MRI compatibility through phantom testing). The document does not detail these specific technical ground truths but implies they were met through "verification and validation testing."

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

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

Not applicable.

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Sterile Radiolucent Skull Pins are designed for the fixation of a compatible head-holder unit to the patient's skull. This allows the fixation of the head and neck during craniotomy and subsequent neurosurgical procedures. These pins reduce the incidence of artifacts in images acquired intra- operatively using CT, MR (Conditional) or fluoroscopy

The Sterile Radiolucent Skull Pins are part of a fixation system which provides rigid immobilization of the patient's skull during surgery. The Pins are the components which get in direct contact with the patient and are made of Carbon-Fiber Reinforced PEEK. The Pins are designed to penetrate the skull tabula externa to provide rigid fixation to compatible head-holder units while significantly reducing imaging artifacts.
The Sterile Radiolucent Skull Pins are intended for use by physicians or their assistants in a hospital environment only. The product may not be used repeatedly and is a single-use device accordingly. A compatible head- holder unit is required for the safe and effective use of the device.
The use scenario is primarily rigid fixation of the patient's skull during surgery e.g. percutaneous craniotomy. The device requires the same user actions as the listed predicate device, namely insertion and removal from the head-holder unit. A valid fixation setup with a compatible head- holder unit consists of exactly three sterile pins.

Here's a breakdown of the acceptance criteria and the study information for the Sterile Radiolucent Skull Pins, based on the provided text:

Acceptance Criteria and Device Performance

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