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The KBA3D v2.0.0 is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.

The patient population targeted with the use of the KBA3D v2.0.0 software includes patients with mature skeletons requiring imaging measurements and planning of surgical procedures. The Bending algorithm is intended for patients older than 22 years old.

The subject device KBA3D v2.0.0 is a SaaS software solution developed by S.M.A.I.O for the medical community; it is a second, independent version of the original KBA3D cleared by FDA in K213975. The current version of the KBA3D software is v.2.0.0. The user needs and requirements of the subject device were jointly defined by S.M.A.I.O and NuVasive. The software is intended to view images, perform spine related measurements, and plan surgical procedures such as osteotomies of the spine and templating of implants (screws, cages, rods).

KBA3D V2.0.0 software can be used by health professionals (orthopedic surgeons, radiologists, neurosurgeons) and service providers (imaging technicians, clinical study technicians) who are trained in spine imaging and pathologies. The KBA3D V2.0.0 software is intended for patients requiring measurements and planning of surgical procedures. KBA3D v2.0.0 aims to achieve three objectives:

• 1. From two perpendicular patient's standing x-rays including patient's spine and pelvis from the femoral heads to the cervical levels, provide 3D scaled representation of the femoral heads, sacral plate, and vertebral bodies. Provide related shape and positioning parameters measurements (disc/vertebra/height/angulation), main curvatures description and global balance assessment.
• 2. Simulate potential effects of a spine surgery on spinopelvic alignment and provide related shape and positioning parameters calculation.
• 3. Visualize scaled representation of implant range (pedicle screws, interbody cages, union rods) relative to spinopelvic representation (pre-op versus realigned) to establish possible implant selection scenarios.

The software is not intended to predict the results of surgery as S.M.A.I.O does not provide tools to carry out planning. Therefore, regarding implant sizing, positioning, and correction impacts, accuracy levels provided by S.M.A.I.O are solely based on theoretical calculations that are not correlated to the output of surgery. KBA3D V2.0.0 provides scaled and simplified representations of the screws and cages relative to the patient's spine and pelvis.

Bendini service (part of NuVasive Pulse System, K210574, reference device):

• The first request from the software to the Bendini system enables the software to retrieve the most up-to-date benders/rods configuration file.
• A second request from the software to the Bendini system enables the software to obtain specific bending instructions for the rod.

Note: The Bendini Rod Bending algorithm is intended for patients older than 22 years old. The NuVasive Bendini Web App service is comprised of an API REST web service that facilities outside clients to utilize the NuVasive Bending algorithm. This algorithm is identical to the Bendini algorithm in K210574 for the NuVasive Pulse System and is hosted using the Microsoft Azure App Service. The KEOPS database manages connection to the software, patient data, and storage of data (X-rays and simulations).

Here's a breakdown of the acceptance criteria and study information for the KBA3D v2.0.0 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The surgical instruments are specifically designed for use with the Pulse System, which enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate.

When used with a Pulse Navigation system, the patient reference hardware is intended to provide a reference to a rigid anatomical structure that can be identified relative to the acquired image of the anatomy.

The subject NuVasive Rod Registration Frame is introducing modifications based on the design of existing patient reference hardware, the Spinous Process Clamp (Pulse System K210574). The Rod Registration Frame was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option for attaching the existing Patient Reference Array to the patient. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device Rod Registration Frame is substantially equivalent to the predicate as demonstrated by verification and validation testing performed using well established and previously cleared test methods.

The NuVasive Rod Registration Frame is a surgical instrument designed for use with the Pulse System, enabling computer-assisted navigation for spinal surgical procedures. The device provides a reference to a rigid anatomical structure that can be identified relative to an acquired image of the anatomy when used with a Pulse Navigation system. The device is a modification of an existing patient reference hardware (Spinous Process Clamp, K210574), with updated distal and proximal connection features and removal of radiographic markers (as it is used only for non-fiducial registration).

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes non-clinical testing to demonstrate substantial equivalence, rather than a direct table of specific numerical acceptance criteria and performance for a new, independent claim of efficacy. The core acceptance criterion is that the Rod Registration Frame performs equivalently to its predicate device (Spinous Process Clamp K210574).

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

• The document states that "non-clinical testing was performed." However, it does not specify the sample size for the test sets used in System Level Accuracy Testing, Cadaver Verification, Design Validation, Tolerance Analysis, or Usability Validation.
• The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated in this summary. Given that it's non-clinical testing for a U.S. FDA submission, it's highly probable the testing was conducted in a controlled lab environment and likely within the U.S. or by a recognized testing facility.

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

• This information is not provided in the summary. For non-clinical performance testing of a medical device, ground truth is typically established through engineering measurements, biomechanical modeling, and cadaveric studies where anatomical landmarks might serve as a reference. The "design validation" and "cadaver verification" sections imply that expert evaluation (e.g., of surgical applicability) would have been involved, but details on their number or qualifications are not given.

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

• This information is not provided as the testing described is non-clinical performance and validation testing, not a clinical study involving human reader assessments 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:

• No MRMC study was done. The device (Rod Registration Frame) is a physical surgical instrument used for navigation, not an AI or imaging diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not applicable. The document explicitly states: "No clinical studies were conducted."

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

• This question is not applicable as the device is a physical surgical instrument, not an algorithm or AI system.

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

• For the performance data mentioned (System Level Accuracy, Design Validation, Tolerance Analysis), the ground truth would be based on engineering specifications, physical measurements, and established performance criteria for navigation devices.
• For Cadaver Verification, the ground truth would involve anatomical landmarks and verified instrument placement/registration accuracy against known anatomical points. This would likely involve precise measurement tools and potentially expert anatomical assessment.

8. The sample size for the training set:

• This question is not applicable as the device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI algorithms.

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

• This question is not applicable for the same reason as point 8.

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