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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 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 DORO Radiolucent Headrest System is used in open and percutaneous craniotomies and spinal surgeries for rigid cranial fixation and when intraoperative CT imaging is used.

The DORO® J-ARM Retractor Accessory is used to fix tissue retractor during neurosurgical procedures.

The DORO® Radiolucent Headrest System is a device system used as a support during head and neck surgery. It is composed of several components which are fabricated of materials that allow it to be radiolucent on x-ray. These components are:

• 1. the adjustable Base Unit,
• 2. the Skull Clamp, and
• 3. the Swivel Adaptor,
• 4. Horseshoe Headrest Adult and Children

It is suitable for use in adults and children when the appropriate components are selected.

The DORO System uses a three-point fixation of the head during surgery in the prone, supine, lateral, and sitting positions. The double clamping of the Adjustable Base unit provides simultaneous fixation of the lateral and vertical positions. The Crossbar is used for connection to the side rails of standard operating tables for fixation in a sitting position. The Swivel Adaptor is used in the base unit to provide 360 degree rotation.

The DORO Headrest System, except for the disposable Skull Pins, is sold non-sterile. The Base Unit, Swivel Adaptor and Skull Clamp are intended to be cleaned by the user between uses. It is intended to be used with Disposable, Skull Pins which were cleared with the DORO Headrest System (K001808).

The components of the DORO Headrest System are made of the following materials:

Skull Clamp is made of NOVOTEX laminated fabric with phenolic resin (GRP) colored with BASANTOL black X82 liqu1d and POM (Delrin), PEEK and Polyurethan.

The Swivel Adaptor and the Horseshoe Headrest in adult and pediatric versions, made of Novotex, PEEK and POM

The Base is made of Novotex, PEEK, POM and aluminum.

The J-Arm Retractor System is made of aluminum alloy and is not radiolucent.

The DORO Radiolucent Headrest System can also be used with accessories from the predicate DORO Headrest System (K001808) with Elastic Pads for adults, Headrest supports with one or two Elastic Pads, single Pin Holders, dual Pin Holders for adults, dual Pin Holders for children, a Multi-Purpose Skull Clamp with six Pin fixation or three Elastic Pads).

The DORO Radiolucent Headrest System can also be used with the J-Arm Retractor and Halo Retractor Assembly (K001808) which allows for use as a support and retraction device during neurosurgical procedures where retraction of the brain tissue and handrest are needed.

The provided 510(k) summary for the DORO® Radiolucent Headrest System does not contain information about specific acceptance criteria, device performance metrics, or any detailed studies demonstrating the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, construction, intended use, and performance characteristics, as required for a 510(k) submission. It briefly mentions materials and intended use but does not present quantitative performance data or a study design.

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

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are listed. The submission asserts "similar performance characteristics" to predicate devices without providing explicit data.
2. Sample size used for the test set and the data provenance: No test set is described, and thus no sample size or data provenance is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set 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: Not applicable. The device is a physical medical instrument (surgical head holder), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no ground truth is discussed for a study.
8. The sample size for the training set: Not applicable as there is no training set for a study of this nature.
9. How the ground truth for the training set was established: Not applicable.

The document states that "Performance standards for sheath introducers have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." This implies that the submission relies on substantial equivalence rather than meeting specific pre-defined performance standards or conducting extensive performance studies beyond what's needed for safety and equivalence claims.

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