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510(k) Data Aggregation
(264 days)
DENALI DEFORMITY SYSTEM
The Denali Deformity System is a non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Denali Deformity System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.
The Denali Deformity System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking set screws, offset connectors and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar or sacral spine.
The Denali Deformity System received 510(k) clearance based on substantial equivalence to predicate devices, rather than meeting specific performance criteria through a clinical study. The provided documentation focuses on biomechanical testing against existing devices and a comparison of design features and materials.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this 510(k) submission was substantial equivalence to predicate devices. This means the device's performance, indications for use, and technological characteristics were compared to existing, legally marketed devices.
| Acceptance Criteria (Proxy) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device must perform equally to or better than predicate systems in biomechanical testing. | "The Denali Deformity System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717." |
| Similarity in Design, Function, Material, and Intended Use: Must be substantially the same as predicate devices. | "The design features and sizing of the components were also compared and the Denali Deformity System found to be substantially the same as these systems. It is manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems." |
| No Significant Adverse Differences: Must not have significant differences that would adversely affect product use compared to predicate devices. | "There are no significant differences between the Denali Deformity Spinal System and other systems currently being marketed which would adversely affect the use of the product." |
2. Sample Size for the Test Set and Data Provenance
The provided document does not describe a clinical test set of patients or data in the way a diagnostic AI device would. The "test set" here refers to the biomechanical testing performed on the device itself.
- Sample Size for Test Set: Not specified in terms of number of device units, but refers to "biomechanical testing" and "ASTM testing to F1717." This likely involves multiple iterations and samples of the device components.
- Data Provenance: The testing was done on the manufactured device components. The document doesn't specify a country of origin for the data beyond implying it was part of the K2M, LLC development process. It is not retrospective or prospective patient data.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the clearance was based on substantial equivalence and biomechanical testing, not on comparison to expert-established ground truth from patient data. There were no human experts establishing ground truth for a clinical test set in this context.
4. Adjudication Method for the Test Set
This is not applicable as there was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted or referenced. This type of study is relevant for evaluating the impact of an AI device on human reader performance, which is not the basis for clearance of a spinal implant system.
6. Standalone Performance Study
A standalone (algorithm-only) performance study was not conducted or referenced in the context of an AI device. The "standalone performance" for this device would be its mechanical performance as measured by ASTM standards.
7. Type of Ground Truth Used
The "ground truth" for this submission was based on established engineering standards (ASTM F1717) for spinal implant testing and comparison to the characteristics of predicate devices that have already been deemed safe and effective.
8. Sample Size for the Training Set
This information is not applicable. Medical device clearances based on substantial equivalence and biomechanical testing do not involve "training sets" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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