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The Spine Navigation system is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to CT imagery of the anatomy.

This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the sacro-lumbar region.

The headset of the Spine Navigation system displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The Medivis Spine Navigation System is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately during spinal surgery. The Medivis Spine Navigation System is comprised of software, a head-mounted display (HMD), passive reflective markers and reusable components. The device provides various image display options and manipulation features, primarily controlled through the touchscreen monitor. An HMD serves as an adjunct display and functions as an optical 3D tracking component for patient and surgical tool localization. The device registers patient data to the surgical environment through IR tracking.

This FDA 510(k) clearance letter for the Medivis Spine Navigation System does not contain the detailed study information required to fully answer your request.

The document primarily focuses on establishing substantial equivalence to a predicate device (Augmedics Ltd. xvision spine system (XVS) K190929) based on similar intended use and technological features. While it states that the device is intended for precisely locating anatomical structures, it does not provide any performance metrics, acceptance criteria, or details of a specific study proving the device meets these criteria.

Here's a breakdown of what can and cannot be extracted from the provided text:

Information that CANNOT be extracted from the document:

• 1. A table of acceptance criteria and the reported device performance: This document does not list any specific performance criteria (e.g., accuracy in mm) or the reported performance outcomes of the Medivis Spine Navigation System.
• 2. Sample size used for the test set and the data provenance: No information on any test set, its size, or where the data came from (country, retrospective/prospective) is provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set study is detailed, this information is absent.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is mentioned.
• 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: There is no mention of an MRMC study or any comparison of human performance with and without AI assistance.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No standalone performance study is detailed.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): With no study described, the type of ground truth is not specified.
• 8. The sample size for the training set: There's no mention of a training set or its size.
• 9. How the ground truth for the training set was established: No information provided.

What the document DOES provide, relevant to your questions:

• Device Name: Medivis Spine Navigation System
• Intended Use: The Spine Navigation system is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures, including Posterior Pedicle Screw Placement in the sacro-lumbar region. It aims to correlate tracked instrument location to registered patient imagery and display virtual instrument location relative to virtual anatomy for percutaneous visualization and trajectory planning.
• Key Technology: Uses a head-mounted display (HMD) (specifically Microsoft HoloLens 2), passive reflective markers, IR tracking for patient and surgical tool localization, and augments reality with overlaid navigation information (2D and stereoscopic 3D images from DICOM data).
• Predicate Device: Augmedics Ltd. xvision spine system (XVS) K190929. The substantial equivalence is based on similar intended use and technological features.

Conclusion:

The provided FDA 510(k) clearance letter indicates that the Medivis Spine Navigation System has been found substantially equivalent to a predicate device. However, it does not include the specific performance data, acceptance criteria, study methodologies (like sample size, ground truth establishment, expert qualifications, or adjudication methods), or details of clinical validation studies usually found in a comprehensive technical report or clinical study summary. These details would typically be part of the larger 510(k) submission, not necessarily summarized in the public clearance letter. You would need to access the full 510(k) summary or a separate clinical study report for such information.

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SurgicalAR is a software device for display of medical images and other healthcare data. It includes functions for image review image manipulation, basic measurements and 3D visualizations and 3D volume rendering).

Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.

Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.

SurgicalAR software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians and technologists.

When accessing SurgicalAR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

SurgicalAR is a software platform to be used by clinicians for the visualization of medical images in 3D to allow for surgical planning activities. The device takes pre-acquired 2D medical images and reconstructs 3D models that a clinician can then view on a stereoscopic, holographic display.

The software application is used to:

• Load patient CT/MR DICOM data

• View DICOM data using a traditional computer monitor or in Augmented Reality (AR) using a head-mounted display, HMD.

The provided document K190764 for the device SurgicalAR is a 510(k) premarket notification and details the device's substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in clinical validation studies.

The document primarily focuses on demonstrating that SurgicalAR has the same intended use and similar technological characteristics to its predicate device (VitreaView K163232). It highlights differences in features that do not introduce new safety or effectiveness concerns.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, MRMC study, etc.) from the provided text, as this type of information is generally part of a separate clinical validation study report, not a 510(k) summary demonstrating substantial equivalence.

The "Tests conducted" Section 5.9 mentions "design verification" and "design validation, including human factors and usability engineering." However, it only provides high-level statements about their success ("met the design input requirements," "met all predetermined acceptance criteria") without detailing specific performance metrics or the methodology of the validation studies in a way that would address your questions.

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