The Neo ADVISE™ System is indicated to calculate the relative positions and distances between implanted Neo Pedicle Screw System™ screws, as estimated by visually identifying screw guides, to estimate rod length, visualize rod positioning, and create a rod template that can be used to visually guide the manually creation a contoured rod by the surgeon, with a mechanical rod bender. The Neo ADVISE™ System can be used in posterior open or percutaneous spine surgery in the thoracic, lumbar, and/or sacral spine when using the Neo Pedicle Screw System™.

Device Description

The Neo ADVISE system is a tool that supports the surgeon in open and percutaneous spinal surgeries performed with the Neo Medical Pedicle Screw System (K222256). After the placement of the pedicle screws, the software scans the the screw head positions and shows them in Augmented Reality (AR) on an iPad. Based on the scanned screw positions, the software displays the distance between the screw heads and calculates the minimum rod length. The surgeon can select any of the pre-bent or straight rods of the Neo PSS and check the placement of the rod in the patient's body without touching the body or taking X-Ray images. The software calculates the distance between the screw head and the rod in the coronal and sagittal plane for the selected rod, indicating possible screw head adjustments.

Again, based on the scanned screw position, the software can generate a custom bent rod template that follows the path through all screw heads. This provides the surgeon with a rod template that assists the surgeon in rod bending. The rod template is displayed in a 1-1 scale on the device in the sagittal and coronal plane, allowing the surgeon to copy the rod shape according to the template.

The scanning of the screw heads can be performed using two distinct scanning methods, 3D scanning and Marker detection. 3D Scanning does not require any additional hardware. The surgeon scans each guide separately by overlaying the physical guide with a virtual guide in AR. 3D Scanning of the guides is limited to 10 guides. The Marker Detection scanning method allows the scanning of up to 20 guides. This is achieved by the use of the Neo Markers and the Neo Marker Base. The Neo Markers are attached to each guide, providing the software with a defined pattern, similar to QR codes, that can be recognized by the software.

The Neo ADVISE System consists of several components. The software runs on an Apple iPad, which is put into a sterile bag to allow use in the sterile environment of the patient's area. The Neo Markers and the Neo Marker Base are needed to allow the scanning of the guides using the Marker Detection scanning method.

AI/ML Overview

The provided documentation is a 510(k) summary for the Neo ADVISE System. It describes the device, its intended use, and the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and performance study results typically found in a full submission. Based on the provided text, I can infer some aspects and highlight what information is missing.

Here's an attempt to answer your request based solely on the provided text, noting limitations:

Device: Neo ADVISE System

The Neo ADVISE System is a software tool intended for use in posterior open or percutaneous spine surgery in the thoracic, lumbar, and/or sacral spine when using the Neo Pedicle Screw System™. Its functions include:

Calculating relative positions and distances between implanted Neo Pedicle Screw System™ screws.
Estimating rod length.
Visualizing rod positioning.
Creating a rod template to visually guide the manual creation of a contoured rod by the surgeon with a mechanical rod bender.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or a table of performance metrics. The performance data presented is qualitative and focuses on the efficacy and usability of the system in cadaveric studies, rather than precise accuracy metrics against a predefined acceptance threshold.

Inferred Performance/Acceptance based on study description:

Acceptance Criteria (Inferred)	Reported Device Performance (from text)
Accuracy of Screw Head Position/Distance Calculation	The first cadaver study involved inserting 6 polyaxial pedicle screws (Neo Pedicle Screw System™) percutaneously at levels L1-S1 on one side of the spine. The software calculates distances and positions based on scanned screw heads. No specific quantitative accuracy metric (e.g., in mm) is provided.
Effectiveness in Rod Length Estimation/Rod Positioning Visualization	The second cadaver study aimed to assess the "accuracy and effectiveness of the Neo ADVISE™ System in assembling and fixing posterior screw-rod constructions." It also looked at "translation of screw heads along sagittal and transverse axes, as well as angular change (Cobb angle) along sagittal and coronal planes." No specific quantitative thresholds or results are provided.
Effectiveness in Rod Template Generation guidance	The system generates a custom bent rod template. The document states a study demonstrating "AR-guided surgery maintained anatomy during rod placement and fixation." No quantitative data on the precision of the generated template or resulting rod contour is available.
Usability and Human Factors	"The usability studies... focused on identifying preventable errors attributable to device design or labeling and affirmed the usability of the Neo ADVISE™ system." No specific usability metrics (e.g., task completion rates, error rates) are provided.

Study Details:

Sample sizes used for the test set and the data provenance:
- Test Sets:
  - Cadaver Study 1: Single human cadaveric spine specimen. (Specific number of "cases" or distinct surgical scenarios not explicitly detailed beyond 6 screws across 5 levels).
  - Cadaver Study 2: Number of cadaveric specimens not explicitly stated, but implies multiple procedures to assess "assembling and fixing posterior screw-rod constructions."
  - Usability Studies: Not specified, but described as a "usability study including a follow-up study."
- Data Provenance: The cadaver studies were conducted in Germany ("11 German orthopedic and trauma surgeons," "Four German spine surgeons"). The studies appear to be prospective, laboratory-based evaluations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cadaver Study 1: 11 German orthopedic and trauma surgeons. Qualifications: No further detail beyond "orthopedic and trauma surgeons."
- Cadaver Study 2: 4 German spine surgeons. Qualifications: No further detail beyond "spine surgeons."
- Ground Truth Establishment: The document does not describe a formal consensus-based ground truth establishment process by these experts for the system's output accuracy. Instead, the experts used the device and their observations/measurements (e.g., CBCT scans for screw head translation and Cobb angle in Cadaver Study 2) served as a basis for assessing the system's performance. For usability, the experts were the users being observed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any formal adjudication method for establishing ground truth or resolving discrepancies in performance measurements. The studies appear to be observational with metrics derived from post-procedure assessments (e.g., CBCT).
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 MRMC study described for comparative effectiveness with vs. without AI assistance. The studies focus on evaluating the Neo ADVISE system itself, not a direct comparison of human performance with and without its aid. The design is more akin to a device validation study where the device functionality is assessed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is intended as an intraoperative tool to assist the surgeon ("supports the surgeon," "assists the surgeon"). The performance data described is based on studies where the device is used by surgeons in a human-in-the-loop scenario.
- While the software performs calculations (e.g., rod length, template generation) on its own, the overall system's performance naturally includes the human interaction (scanning screw guides, interpreting AR display). There's no explicit mention of a "standalone" algorithmic performance evaluation separate from human interaction, which would be difficult given its indicated use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cadaver Studies: The primary ground truth for measuring accuracy (e.g., screw head position, rod fit) during the cadaver studies appears to be derived from CBCT (Cone-beam computed tomography systems) scans. This is an anatomical imaging-based ground truth.
- Usability Studies: Ground truth for usability would typically come from observed user interactions, error logging, and user feedback, evaluated against pre-defined usability goals.
The sample size for the training set:
- Not provided. The document describes non-clinical testing data, but provides no information about the development or training of the AI algorithms (if any, beyond general "proprietary algorithms" mentioned in comparison to the predicate). It's possible the algorithms are rule-based or derived from geometric principles rather than machine learning models requiring large training sets.
How the ground truth for the training set was established:
- Not provided. As the training set size and specifics of the AI/algorithms are not disclosed, neither is the method for establishing their ground truth (if applicable).

Overall Limitation: The provided FDA 510(k) summary is a high-level overview. It typically minimizes detailed performance statistics and focuses on demonstrating substantial equivalence. For a comprehensive understanding of acceptance criteria and detailed study results, one would need to review the full 510(k) submission, which is not publicly available in this snippet.

Summary

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March 8, 2024

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized image of a human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Comerge AG % Frederike Bruhschwein-Mandic Senior Consultant Confinis Ag Hauptrasse 16 Dudingen, 3186 Switzerland

Re: K230195

Trade/Device Name: Neo ADVISE software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 4, 2024 Received: March 4, 2024

Dear Frederike Bruhschwein-Mandic:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230195

Device Name Neo ADVISE System

Indications for Use (Describe)

The Neo ADVISE™ System is indicated to calculate the relative positions and distances between implanted Neo Pedicle Screw System™ screws, as estimated by visually identifying screw guides, to estimate rod length, visualize rod positioning, and create a rod template that can be used to visually guide the manually creation a contoured rod by the surgeon, with a mechanical rod bender. The Neo ADVISE™ System can be used in posterior open or percutancous spine surgery in the thoracic, lumbar, and/or sacral spine when using the Neo Pedicle Screw System™.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K230195

Neo ADVISE System

I. SUBMITTER

Applicant Name: Comerge AG Applicant Adress: Bubenbergstrasse 1 Zurich 8045 Switzerland Applicant Contact Telephone: +41445525264 Applicant Contact: Mr. Beat Hugi Applicant Contact Email: beat.huqi@comerge.net Correspondent Name: confinis ag Correspondent Address: Hauptstrasse 16 Dudingen 3186 Switzerland Correspondent Contact Telephone: +4915201892430 Correspondent Contact: Mrs. Frederike Brühschwein-Mandic Correspondent Contact Email: frederike.bruehschwein@confinis.com Date prepared: March 07, 2024

II. DEVICE

Device Trade Name: Neo ADIVSE system Common Name: Stereotaxic instrument Classification Name Orthopedic Stereotaxic Instrument Regulation Number: 882.4560 Product Code: OLO

III. PREDICATE DEVICE

Predicate #: K122742

Predicate Trade Name: NuVasive Bendini Product Code: OLO

IV. DEVICE DESCRIPTION

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Augmented Reality (AR) on an iPad. Based on the scanned screw positions, the software displays the distance between the screw heads and calculates the minimum rod length. The surgeon can select any of the pre-bent or straight rods of the Neo PSS and check the placement of the rod in the patient's body without touching the body or taking X-Ray images. The software calculates the distance between the screw head and the rod in the coronal and sagittal plane for the selected rod, indicating possible screw head adjustments.

V. INDICATIONS FOR USE

The Neo ADVISE™ System is indicated to calculate the relative positions and distances between implanted Neo Pedicle Screw System™ screws, as estimated by visually identifying screw quides, to estimate rod length, visualize rod positioning, and create a rod template that can be used to visually quide the manually creation a contoured rod by the surqeon, with a mechanical rod bender. The Neo ADVISE™ System can be used in posterior open or percutaneous spine surgery in the thoracic, lumbar, and/or sacral spine when using the Neo Pedicle Screw System™.

VI. INDICATIONS FOR USE COMPARISON

Both the Neo ADVISE System and the predicate Bendini Spinal Rod Bending System are used to locate the screw position during spinal surgery and relative to the identified positions, generate bend instructions to shape a spinal rod.

The Neo ADVISE System is intended to be used with off-the-shelf rod benders while the Bendini system has a dedicated rod bending instrument.

The Bendini system can be used with any pedicle screw system while the Neo ADVISE System is dedicated for use with the Neo Pedicle Screw System (K222256) only.

Like the NuVasive Bendini Spinal Rod Bending System the Neo ADVISE System is intraoperatively digitizing the relative location of anatomical landmarks (i.e. the position of the pedicle screws), through the use of a camera and markers that are pre-fixed on the screw guides (same as the pointer stylus with NuVasive Bendini).

The differences in the indications for use are not critical to the intended surgical use of the devices as in both cases, a final intra-operative X-ray must be taken to confirm the spinal rod placement at the end of the procedure.

VII. TECHNOLOGICAL COMPARISON

Augmented reality and optical/electromagnetic localizer systems share similarities in their use during orthopedic surgery. The Neo ADVISE System's software utilizes the augmented reality functionality of an Apple iPad to scan the position of guides and pedicle screws, without the need for traditional tracking arrays or pre-operative data planning. Instead, markers may be used to

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enhance object recognition. The Apple iPad's camera and sensors provide the interface for communication between the user and the software.

Similarly, the predicate device cleared under K122742 also uses a localized pointer or stylus to intraoperatively digitize the relative location of anatomical landmarks, which are then interpreted by proprietary algorithms, in place of the stereotaxic principle.

VIII. PERFORMANCE DATA

Non-clinical testing included two cadaver studies to evaluate the Neo ADVISE System, a usability study including a follow-up study to evaluate the human factors/usability aspects of the Neo ADVISE System, and bench testing.

The first cadaver study, conducted by 11 German orthopedic and trauma surgeons, utilized a biomechanical pilot study design with a single human cadayeric spine specimen. One investigator inserted 6 polyaxial pedicle screws (Neo Pedicle Screw SystemTM) percutaneously at levels L1-S1 on one side of the spine, resulting in instrumentation across 5 levels for fusion.

The second cadaver study aimed to assess the accuracy and effectiveness of the Neo ADVISE™ System in assembling and fixing posterior screw-rod constructions in thoraco-lumbo-sacral spine fusion surgery. Using CBCT (Cone-beam computed tomography systems) scans, primary endpoints measured translation of screw heads along sagittal and transverse axes, as well as angular change (Cobb angle) along sagittal and coronal planes. Four German spine surgeons conducted the study, demonstrating that AR-guided surgery maintained anatomy during rod placement and fixation.

The usability studies of the Neo ADVISE System's device-user interface, focused on identifying preventable errors attributable to device design or labeling and affirmed the usability of the Neo ADVISE™ system.

No clinical tests have been submitted.

IX. CONCLUSION

Based on equivalence of indications for use, technology characteristics and operational principle the substantial equivalence between the new and the predicate device has been demonstrated. The Neo ADVISE System, is at least as safe and effective as the legally marketed predicate Nuvasive Bendini Spinal Rod Bending System.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).