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KHEIRON® Spinal Fixation 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 treatment of 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 or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

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

Pediatric pedicle screw fixation is limited to a posterior approach.

Patient specific K-ROD devices are compatible with NuVasive Reline System components and Seaspine Mariner System components that are compatible with ø5.5mm and/or ø6.0mm rods as well as screws ø4.5mm or larger and at least 25mm in length.

S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981, K232650) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is manufactured from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm.

The Seaspine Mariner System is a 510(k) cleared pedicle screw system (K222110) that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The Seaspine Mariner System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. The Seaspine Mariner System is also used to treat severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft.

The purpose of this Special 510(k) Device Modification is to extend indication of S.M.A.I.O.'s patient specific K-ROD (K211981, K232650) for use with the Seaspine Mariner System (K222110).

This FDA 510(k) clearance letter pertains to a spinal fixation system, which is a medical device, not an AI/software device. Therefore, the provided text does not contain the information needed to answer the questions about AI/software device acceptance criteria and study details (such as sample size, ground truth expert qualifications, MRMC studies, standalone performance, training set details, etc.).

The letter explicitly states:
"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...".
It refers to the device as "KHEIRON® Spinal Fixation System, including patient specific K-ROD".

The performance data mentioned (Dynamic compression bending – ASTM F1717, Static torsion – ASTM F1717, Static axial gripping capacity – ASTM F1798, Static torsional gripping capacity – ASTM F1798) are mechanical tests performed to verify the physical properties and compatibility of the spinal fixation system components. These are not related to AI model performance or clinical accuracy studies typically seen with software as a medical device (SaMD).

Therefore, I cannot fulfill the request as the provided document does not contain the type of information required for an AI/software device.

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The KHEIRON® Spinal Fixation 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, deformities or curvatures (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 including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis. Additionally, the KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

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

Pediatric pedicle screw fixation is limited to a posterior approach.

Patient specific K-ROD devices are compatible with Nu Vasive Reline System components that are compatible with ø5.5mm and/or ø6.0mm rods as well as screws ø4.5mm or larger and at least 25mm in length.

S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is manufactured from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm.

The NuVasive Reline System is a 510(k) cleared pedicle screw system (K223181) that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The NuVasive Reline System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. The NuVasive Reline System is also used to treat severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft.

The purpose of this Special 510(k) Device Modification is to extend indication of S.M.A.I.O.'s patient specific K-ROD (K211981) for use with the NuVasive Reline System (K223181).

This FDA 510(k) clearance document is for a medical device modification, not an AI/Software as a Medical Device (SaMD) product. Therefore, many of the requested elements for describing an AI study, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

This submission focuses on demonstrating the substantial equivalence of a physical medical device modification (compatibility of a patient-specific K-ROD with another spinal fixation system) through engineering analysis and mechanical testing.

However, I can extract information related to the "acceptance criteria" and the "study" in the context of this physical device's mechanical performance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as "sample size" in the context of a dataset for AI. For mechanical testing, a "sample size" would refer to the number of physical devices tested. This detail is not provided, but it would have been determined by the specific ASTM standards (F1717, F1798) and internal engineering justifications.
• Data Provenance: This relates to the mechanical testing and engineering analysis performed for the modification. The tests were performed as part of the "V&V activities" (Verification & Validation) by the manufacturer S.M.A.I.O. (France). The data is prospective in the sense that the tests were conducted specifically for this submission.

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

• Not Applicable. This is a physical device modification, not an AI/SaMD. "Ground truth" in this context would refer to established engineering principles, material science data, and the specifications of the predicate devices, which are handled by qualified engineers and technical personnel during the design and testing phases.

4. Adjudication method for the test set:

• Not Applicable. This is a physical device submission. Adjudication methods like 2+1 or 3+1 are used for evaluating discrepancies in human expert interpretation, typically in AI/imaging studies.

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:

• Not Applicable. This is a physical device submission, not an AI/SaMD.

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

• Not Applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• Engineering Standards and Predicate Device Specifications: The "ground truth" for this submission would be the established mechanical and material properties defined by ASTM standards (F136 for material, F1717 and F1798 for mechanical testing) and the known performance and characteristics of the legally marketed predicate devices (KHEIRON® Spinal Fixation System (K211981) and NuVasive Reline System (K223181)). The "acceptability" is based on meeting or demonstrating equivalence to these established benchmarks.

8. The sample size for the training set:

• Not Applicable. This is a physical device submission, not an AI/SaMD. There is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

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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.

Ask a specific question about this device

The KHEIRON Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of 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 or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, 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 progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital 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.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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 pedicle screw offers an excellent means of stabilizing a specific spinal segment. KHEIRON Spinal Fixation System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.

The KHEIRON® Spinal Fixation System is a medical device and the provided document is a 510(k) summary for its premarket notification to the FDA. This summary focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a standalone study of its capabilities in a clinical setting.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly available in the provided text. The document states "No clinical studies were performed."

However, the document does provide information on non-clinical testing to demonstrate the physical performance and safety of the device:

1. A table of acceptance criteria and the reported device performance:

Since no specific numerical acceptance criteria (e.g., minimum strength values) are given, and only a comparative statement is made regarding performance against predicates, a direct table of acceptance criteria and the reported device performance as typically expected for an AI/diagnostic device is not applicable here.

Instead, the non-clinical test summary states:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Test Set Sample Size: Not specified as clinical studies were not performed. For non-clinical tests (mechanical tests), the sample sizes for the devices tested were not provided.
• Data Provenance: Not applicable as no clinical data was used. Mechanical testing is typically done in a laboratory setting. No country of origin for the mechanical test data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable, as no clinical studies requiring expert consensus for ground truth were performed.

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

• Not applicable, as no clinical studies requiring ground truth adjudication were performed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "No clinical studies were performed." This device is a mechanical spinal fixation system, not an AI or diagnostic tool that would typically involve human "readers."

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

• Not applicable. This device is a mechanical implant, not an algorithm.

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

• For the non-clinical mechanical tests, the "ground truth" would be the engineering standards (e.g., ASTM F1717 and ASTM F1798) and the performance characteristics of the predicate devices. The device's strength was directly measured against these established benchmarks.

8. The sample size for the training set:

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device that requires a training set.

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

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device.

Summary of Non-Clinical Testing:

The KHEIRON® Spinal Fixation System underwent the following non-clinical mechanical tests:

• Static and dynamic compression bending (according to ASTM F1717)
• Static torsion (according to ASTM F1717)
• Torsional and axial gripping capacity (according to ASTM F1798)

The results of these evaluations indicated that the KHEIRON Spinal Fixation System is "substantially equivalent to legally marketed predicate devices" and specifically noted that its "strength values" were "greater or equivalent" compared to other cleared devices for thoracolumbosacral spine use.

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