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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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