Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device