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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

Important Note Regarding Typos: The reported performance for "Screw Positioning (Entry Point Deviation)" and "Cage Positioning (Angulation Deviation)" (< 10-12 mm and < 10-12° respectively) appears to conflict significantly with the acceptance criteria (< 0.5 mm and < 0.5°). It is highly probable these are typos in the provided document and likely intended to report performance within the acceptance criteria (e.g., < 0.01-0.02 mm or similar for the screws and cages). For accurate reporting, clarification from the original submission would be needed.

2. Sample Size Used for the Test Set and Data Provenance

• 3D algorithm reconstruction: Not explicitly stated, but refers to "Vertebral body dimensions... from CT-Scan."
• Surgical Simulation: 12 patients (for comparison with post-op images).
• Other tests (anatomical measurements, uncertainty, screw/cage positioning): Sample sizes are not explicitly provided in the document.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Surgical Simulation: "by a spine surgeon." The exact number (implied one or more), and detailed qualifications are not specified beyond "spine surgeon."
• Other tests: The document does not explicitly state the number or qualifications of experts used for establishing ground truth for other tests.

4. Adjudication Method

The document does not explicitly describe an adjudication method (like 2+1, 3+1). For the surgical simulation, it mentions comparison "by a spine surgeon," implying assessment by an expert.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance is not mentioned or described in the provided text. The device is referred to as "assisting healthcare professionals," but no study on the effectiveness of this assistance on human reader performance is detailed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance assessment of the algorithm was conducted for various parameters:

• Anatomical parameters measurements: Verified via mathematical calculations (Excel vs. KBA3D v2.0.0).
• 3D algorithm reconstruction: Verified by comparison of Vertebral body dimensions from 3D reconstructions using the Balance Analyzer and 3D reconstructions from CT-Scan.
• Uncertainty testing studies: Comparing original coordinates and "worst case variation" coordinates.
• Performance of the algorithm to position the screws: Verified.
• Performance of the algorithm to position the cage: Verified.

7. Type of Ground Truth Used

• Anatomical parameters measurements: Mathematical calculations (Excel).
• 3D algorithm reconstruction: 3D reconstructions from CT-Scan.
• Surgical Simulation: Post-treatment radiographs (post-op images) and assessment by a spine surgeon.
• Screw & Cage Positioning: Theoretical calculations/references (implied by "performance of the algorithm to position the screws/cage was verified").

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established.

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The KHEIRON System, including patient specific K-ROD, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to fusion to treat progresive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

The system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

K-RODs are titanium alloys bent rods, available in diameters 5.5mm and 6mm, which shape is a 3D spline designed to meet the need of specific correction of a patient.

K-RODs are to be used as a part of the KHEIRON® Spinal Fixation System (K201659) to reach intended use. KHEIRON® Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The KHEIRON® Spinal Fixation System may be used for a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the spinal fixation system offers an excellent mean of stabilizing of a specific spinal segment. KHEIRON® Spinal Fixation System includes screws, rods and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailormade. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.

The K-ROD patient specific devices are available in Ø5.5 and Ø6mm.

This document is a 510(k) Premarket Notification for a medical device called the KHEIRON® Spinal Fixation System, specifically an extension for patient-specific bent rods called K-RODs.

Based on the provided text, the device in question is a spinal fixation system component (K-ROD), not an AI/software medical device. As such, the typical acceptance criteria and study designs applicable to AI/software performance evaluations (which involve metrics like sensitivity, specificity, AUC, MRMC studies, and ground truth establishment from expert reads or pathology) are not relevant to this submission.

This 510(k) submission focuses on demonstrating substantial equivalence of the new K-ROD (a physical implant) to existing predicate devices. The "acceptance criteria" here refer to mechanical and material performance standards for orthopedic implants, not diagnostic accuracy or clinical effectiveness in the way an AI algorithm would be evaluated.

Therefore, I cannot extract the information required in your request about AI/software performance studies, ground truth, expert consensus, MRMC studies, or training/test set sample sizes, because this type of study was not performed or described in this document.

Here's what can be extracted, based on the document's content, explaining why the requested information regarding AI/software performance is not applicable:

Non-Applicability of AI/Software Performance Criteria:

The KHEIRON® Spinal Fixation System and its K-ROD component are physical medical devices (implants), not software or AI-based diagnostic/assistive tools. The FDA 510(k) process for such devices primarily evaluates mechanical safety, material compatibility, and substantial equivalence to legally marketed predicate devices, rather than diagnostic accuracy or AI algorithm performance.

Therefore, the following points from your request are not applicable and are not addressed in this 510(k) submission:

• Table of acceptance criteria and reported device performance for AI-specific metrics: Not relevant, as this is a physical implant.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not relevant for physical implant mechanical testing in the context of AI.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant for physical implant mechanical testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not relevant for physical implant mechanical testing.
• 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 relevant, as this is not an AI device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not relevant for physical implant mechanical testing.
• The sample size for the training set: Not relevant, as this is not an AI system that requires a training set.
• How the ground truth for the training set was established: Not relevant, as this is not an AI system.

Information Related to the Actual Device Performance (Mechanical Testing):

While the document doesn't provide the detailed acceptance criteria and results in a table format, it states:

• Acceptance Criteria & Reported Performance (General Statement): "The testing showed that the K-ROD met or exceeded acceptance criteria." (Section 12)
• Sample Size: Not specified for the mechanical tests, but a specific number of samples would have been tested per standard.
• Data Provenance: The tests were non-clinical, likely performed in a lab setting by the manufacturer (S.M.A.I.O.). No country of origin for "data" in the sense of patient data.
• Ground Truth: For a physical device, ground truth relates to meeting established engineering and material standards.
• Training Set/Ground Truth for Training: Not applicable.

Studies Performed (Non-Clinical):

The document lists the following non-clinical tests performed (Section 12):

• "3-point flexion comparison between 90° rods bent with different rod bending processes (KHEIRON curved rod versus K-ROD)"
• "Dynamic axial compression bending and static torsion per ASTM F1717 (K-ROD versus PASS LP patient specific rod comparison)"
• "Literature review to support the addition of the patient-specific K-ROD."

Clinical Studies:

• "No clinical studies were performed." (Section 13) This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicate devices.

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