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The SURGIVISIO medical device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis or articulation structures are visualized.

The Surgivisio system is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures.
The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls.
The mobile C-arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal ends of the 'C'.
The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling.
The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.

The provided text describes the performance data for the Surgivisio system in relation to its substantial equivalence to a predicate device, the Arcadis Orbic. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested, particularly concerning AI/algorithm performance and human reader improvement.

Instead, the performance data section focuses on:

• Nonclinical tests: Primarily on compliance with various IEC standards for medical electrical equipment safety, radiation protection, and imaging quality assessment using phantoms. This includes 2D image quality assessment, basic CBCT bench testing, distortion phantom studies, 3D reconstruction algorithm characterization, and 3D image quality assessment with breathing simulation.
• Clinical images: Evaluation by a qualified expert to support the intended use of 2D and 3D imaging features.
• Radiation doses: Comparison to literature.
• Software Verification: Testing to ensure software requirements perform as intended.

The document explicitly states: "Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence." This means there was no multi-reader multi-case (MRMC) comparative effectiveness study, nor a standalone algorithm performance study involving human-in-the-loop performance or the improvement of human readers with AI assistance. The "qualified expert" reviewing clinical images is not described in a way that allows for the detailed breakdown of ground truth establishment, sample size for the test set, number and qualifications of experts, or adjudication methods as requested for an AI/algorithm-focused study.

Therefore, I cannot provide the information in the requested format as the provided text does not contain the specific details regarding AI performance, human reader improvement, or the rigorous ground truth establishment methodology that would typically be associated with an AI/ML device approval study. The device, an X-ray imaging system, is cleared based on demonstrating substantial equivalence in its technical characteristics and image quality/safety, not on an AI/ML algorithm's diagnostic performance improving human readers.

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The MR Compatible Ventricular Cannula is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. The device is intended for "single patient use only."

The Cannula has a stepped distal tip with a 30 cm rigid ceramic stylet protecting the fluid lumen while providing rigidity to the distal portion of the device. Soft this in areets the lumen in the center portion and at the distal end where it terminates at a female luer fitting. The fluid containing central lumen is manufactured from non-reactive silica. The cannula will be marketed in the following sizes: 16 ga Ventricular Cannula, .008" ID x 4ft; 16 ga Ventricular Cannula. .008" ID x 10ft; 14 ga Ventricular Cannula, .021" ID x 4ft; 14 ga Ventricular Cannula, .021" ID x 10ft.

The provided text describes the SurgiVision MR Compatible Ventricular Cannula and its substantial equivalence to a predicate device (Adson Cannula), but it does not contain information about the acceptance criteria or a study designed to prove the device meets those criteria in the context of typical AI/ML device evaluations. This document describes a traditional medical device submission (a cannula), not a diagnostic AI/ML device.

Therefore, many of the requested details about acceptance criteria, specific performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert consensus, MRMC studies, or standalone performance are not present because they are not applicable to this type of device submission.

However, I can extract the information relevant to the device's technical validation and comparison to the predicate device.

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

The document doesn't explicitly state "acceptance criteria" for performance metrics like those seen in AI/ML diagnostic devices (e.g., sensitivity, specificity). Instead, it describes performance and material characteristics that are either equivalent to the predicate or designed for specific needs (like MR compatibility). The "reported device performance" is essentially that it functions as intended and is safe and effective.

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

This information is not provided in the document. The testing described is bench testing, not a clinical study on human subjects where patient data provenance would be relevant.

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. This is a medical device, not an AI/ML diagnostic algorithm requiring expert-established ground truth from images or data.

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

Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.

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 is a medical device, not an AI/ML diagnostic algorithm.

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

Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.

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

For this type of device, "ground truth" is established through engineering and materials testing, demonstrating that the device physically performs as intended and meets safety standards. For example:

• Biocompatibility: In vitro and in vivo (animal) studies to confirm material safety, assessed against ISO 10993 standards.
• Performance (flow rates, rigidity): Bench testing using simulated conditions and fluids (e.g., Cytarabine, primate CSF).
• MR Compatibility: Physical testing of the device in an MRI environment to confirm safety (e.g., no excessive heating, no significant image artifact).

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.

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

Not applicable. This is a medical device, not an AI/ML diagnostic algorithm.

Summary of the Study/Testing that Proves the Device Meets Acceptance Criteria:

The document describes several types of testing performed to demonstrate the device's safety, effectiveness, and substantial equivalence to the predicate device:

• Sterilization and Shelf Life Testing: Validation using the VDmax25 procedure of ISO 11137-2 to ensure the device remains sterile and functional over its shelf life.
• Biocompatibility Testing: Conducted per ISO 10993 (Biological Evaluation of Medical Devices), including cytotoxicity, material mediated pyrogen, ISO maximization study, intracutaneous toxicity, and systemic toxicity. All tests yielded acceptable results.
• Performance Testing Bench:
  • Design verification testing.
  • Comparison testing with the predicate Adson Cannula.
  • Pressure withstand testing.
  • Injection/aspiration testing.
  • Lateral tip deflection testing.
  • Transit testing in conformance to D4169.
  • Accelerated aging testing.
• Cytarabine Injection and Primate CSF Aspiration Testing: Completed with acceptable results, validating the device's intended use with specific fluids.
• MR Compatibility Testing: The device is stated to be "Safe in a 1.5T MRI environment" and "MRI Safe. All brain contacting components tested safe in a 1.5T environment."

The conclusion from these tests was that the "MR Compatible Ventricular Cannula functions as intended and is substantially equivalent to legally marketed predicate device." The differences in design (e.g., single-patient use, MR compatibility, different materials, longer rigid section, no stylet, integral extension) are noted to "meet the needs of the MR work environment and do not represent changes that effect the safety or effectiveness of the device."

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The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion. The System is intended for use only with 1.5 Tesla MRI scanners.

The ClearPoint System is comprised of a workstation laptop with workstation software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame Accessory Kit, the SMARTFrame Handcontroller, and the MR Neuro Procedure Drape. The MR Neuro Procedure Drape was cleared for market via a separate 510(k) notice (K091343).

The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the burr hole as called out in the trajectory planning software. The SMARTFrame is an adjustable trajectory frame that provides the guidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the MR images, makes changes, and confirms with subsequent MR images.

The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) that meet the physician's desired imaging quality.

Here's a breakdown of the acceptance criteria and study information for the ClearPoint System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • MRI Test Device Accuracy Testing: Not explicitly stated, but implies multiple tests were conducted with a "Test Device representative of the devices to be used."
  • System Accuracy Comparison in a Skull Phantom: Not explicitly stated, but involved the ClearPoint System and the predicate Navigus II MR/NeXframe MR.
  • System Accuracy Comparison in a Cadaver: One cadaver was used.
• Data Provenance: The studies were internal validation studies conducted by SurgiVision, Inc., using phantoms and a cadaver. No information is provided regarding country of origin or whether it was retrospective or prospective in the context of clinical patient data, as these were pre-clinical validation studies.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. The studies described are technical performance assessments against pre-defined targets (phantoms) or comparisons to a predicate device in a cadaver, rather than diagnostic assessments requiring expert interpretation.

4. Adjudication Method (Test Set)

The document does not describe a formal adjudication method for ground truth in the test set. For the phantom studies, the ground truth was presumably the known pre-determined target or the expected performance based on the predicate device. For the cadaver study, it involved comparing the ClearPoint System's performance against the predicate Navigus II MR, likely using objective measurements.

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

No. The provided text refers to comparative effectiveness studies against a predicate device (Navigus II MR) and its performance, and user ratings on procedure-related assessments by a user, but not an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance assessment was conducted for the device's accuracy and functionality. The "ClearPoint System Accuracy Testing" and "System Accuracy Comparison in a Skull Phantom" sections describe tests of the system's ability to precisely position instruments and achieve targeting accuracy. These tests are focused on the device's inherent mechanical and software performance.

7. Type of Ground Truth Used

• For Accuracy Testing:
  • MRI Test Device Accuracy Testing: A "known pre-determined target in a phantom."
  • System Accuracy Comparison in a Skull Phantom: Comparison against data previously obtained for the predicate Navigus II MR/NeXframe MR using the same model system. The predicate device's performance would serve as a de-facto ground truth or benchmark, assuming its accuracy had been previously established.
  • System Accuracy Comparison in a Cadaver: Comparison against the predicate Navigus II MR/NeXframe MR's performance in accessing targets in a cadaver head.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for a "training set." The studies described are validation studies for the device's performance against established benchmarks or a predicate, not studies involving an AI or machine learning model that requires a dedicated training set.

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

Not applicable, as no training set for an AI or machine learning model is mentioned in the provided text. The device is a "Neurological Stereotaxic Instrument" with associated software, not explicitly an AI-driven diagnostic or treatment planning system that would typically have a training set.

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The MRI Neuro Surgical Drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MRI imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.

The MRI Procedure Drape is composed of urethane film, polyethylene EVA copolymer film and polypropylene nonwoven material, creating a sterile barrier for a surgical procedure. The construction includes a suspension system that allows the clear film area to move with the patient as they are moved in and out of the MRI scanner bore.

The provided text describes a 510(k) submission for the "SurgiVision MRI Neuro Surgical Drape and accessories." This submission focuses on establishing substantial equivalence to a predicate device for a medical drape, not an AI/ML-driven diagnostic or assistive device. Therefore, many of the requested categories related to AI performance, ground truth, expert opinions, and comparative effectiveness studies are not applicable to this document.

However, I can extract the information that is relevant to the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.

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

Explanation: The document states, "Testing to applicable Standards has been completed with positive outcomes." The listed "Top level of testing performed" defines the performance characteristics that were evaluated and met. The "Description of Device" and "Intended Use Statement" also imply the requirement for a sterile barrier and MRI safety, both of which are addressed.

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

The document does not specify sample sizes for the performance tests (tensile, tear, flammability, etc.) or provide details on the data provenance (e.g., country of origin, retrospective/prospective). These are typically contained within the full test reports, which are not included in this summary.

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

Not applicable. This device is a surgical drape, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. Performance testing for drapes typically involves laboratory measurements against established standards.

4. Adjudication method for the test set

Not applicable. As noted above, this involves laboratory performance testing, not subjective 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

Not applicable. This device is a surgical drape, 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 device is a surgical drape, not an algorithm.

7. The type of ground truth used

For the performance characteristics (sterilization, shelf life, tensile, tear, penetration, flammability), the "ground truth" would be the objective measurements against established performance standards for surgical drapes and materials. For "MRI Safe," the ground truth would be testing confirming compatibility with MRI environments.

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning algorithm requiring a training set.

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

Not applicable. This device is a physical product, not a machine learning algorithm.

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The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.

The Head Fixation Arc and Table Base is designed to immobilize the patients head during the surqical procedure. It has secondary design intent to provide mounting method for the headcoil and optional camera system. The patient's head is positioned inside the headcoil and attached rigidly to the Head Fixation Arc. The patients head never touches the head coil.

This is a 510(k) submission for a physical medical device, not an AI/ML powered device. As such, many of the requested categories (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable.

Here's the available information presented according to your request:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. This device is a physical head fixation system, not an AI/ML device that processes data. Testing was likely bench-top performance testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance is not relevant here. Device performance was likely assessed against engineering specifications and industry standards during bench testing.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The nature of the testing described (bench testing for a physical device) does not typically involve human adjudication in the way AI/ML studies do.
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 is a physical device, not an AI system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, "ground truth" would likely refer to objective engineering measurements and the ability to maintain specified physical parameters (e.g., stability, secure fixation, MRI compatibility) under controlled conditions, as determined by bench testing against established performance standards. The submission implies compliance with these standards and equivalence to predicate devices.
7. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML powered device, so there is no training set in the AI/ML sense.
8. 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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