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510(k) Data Aggregation
(56 days)
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are 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, the Xia® 3 Spinal System 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.
The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are 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, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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Xia® 3 Spinal System
The Xia® 3 Spinal System is comprised of screws, blockers, and hooks that affix rods and connectors to vertebrae of the spinal column for purposes of stabilization, or corrective action through the application of force. -
Xia® 4.5 Spinal System
The Xia® 4.5 Spinal System is comprised of monoaxial and polyaxial bone and reduction screws, hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, and cross connectors to vertebrae of the spinal column.
The provided document is a 510(k) premarket notification for the Stryker Spine Xia® 3 and Xia® 4.5 Spinal Systems. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing or data analysis.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices for an expansion of indications for use.
Here's why and what information is available:
The document explicitly states:
- "This submission seeks to build upon predicate Xia® 3 and Xia® 4.5 Spinal Systems through expansion of indications only. Therefore, no additional performance data is necessary." (Page 6, "Summary of Performance Data")
This means the submission is not presenting new performance studies or acceptance criteria for a novel device or a significantly modified device. Instead, it's arguing that the expanded indications for the Xia® 3 and Xia® 4.5 Spinal Systems are substantially equivalent to the indications already cleared for a primary predicate device (Medtronic Sofamor Danek, CD HORIZON® Spinal System cleared under K140276) and previous versions of the Xia® systems.
Therefore, for the information requested:
- A table of acceptance criteria and the reported device performance: This information is not provided in the document as no new performance data was deemed necessary for this submission. The device is implicitly accepted based on its substantial equivalence to predicate devices, which would have undergone performance testing during their original clearance.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new performance studies were conducted for this 510(k). The document only mentions predicate device clearances.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a spinal fixation system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) relies on the safety and effectiveness demonstrated by its predicate devices for its original indications and argues that the expanded indications are within the scope of what was already established for similar, legally marketed devices. It is a regulatory submission for a spinal implant, which typically doesn't involve the kind of performance studies (e.g., diagnostic accuracy, reader studies) that would generate the detailed data requested in your prompt regarding acceptance criteria, sample sizes, and expert ground truth for an AI/diagnostic device.
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(61 days)
The CD HORIZON® Spinal System without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to following indications: degenerative disc disease (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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI) as an adjunct to fusion in skeletally mature patients. It is intended for plate fration/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.
A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this submission is to modify Medtronic's CD HORIZON Spinal System to add additional components to the system, specifically, modified multi-axial screws.
This document describes a 510(k) premarket notification for the CD HORIZON® Spinal System. It does not contain information about a study with acceptance criteria and reported device performance in the way a typical diagnostic or AI/ML device submission would. This submission is for a medical implant (pedicle screw spinal system), and the evaluation focuses on substantial equivalence to a predicate device rather than performance metrics like sensitivity or specificity.
Therefore, many of the requested elements (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or provided in this type of submission.
However, I can extract information related to the demonstration of equivalence:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a spinal implant, the "acceptance criteria" are typically related to demonstrating substantial equivalence to a legally marketed predicate device, rather than specific performance metrics (like accuracy) for a diagnostic AI. The "reported device performance" in this context refers to the demonstration that the modified device does not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (as per submission) |
|---|---|
| Identical indications for use | The subject CD HORIZON® Spinal System has identical indications for use as the previously FDA cleared predicate, CD HORIZON® Spinal System K091974 (S.E. 09/02/2009). The indications for use are also identical to those cleared most recently in K140276 (S.E. 03/13/2014). |
| Identical intended use | The subject CD HORIZON® Spinal System has identical intended use as the predicate. |
| Identical fundamental scientific technology | The subject CD HORIZON® Spinal System has identical fundamental scientific technology as the predicate. |
| Identical materials | The subject screws are manufactured from medical grade titanium alloy and cobalt chrome, which are the same materials as the predicate CD HORIZON® Spinal System multi-axial screws. |
| Similar design features | The subject device has similar design features to the predicate. Both the predicate and subject devices attach to a 4.75mm diameter rod. The screw diameters of the subject device fall within the range of previously cleared diameters of the predicate device. The submission emphasizes that the modification is to add additional components (modified multi-axial screws) to an existing system. |
| No new issues of safety or effectiveness introduced | A risk analysis was completed and, along with an engineering rationale, demonstrated that the subject CD HORIZON® Spinal System does not introduce new issues of safety or effectiveness. (This is the primary "performance" demonstration for this type of submission – showing that the modification doesn't negatively impact safety or effectiveness relative to the predicate.) |
| Biocompatibility and other regulatory requirements met | (Implied general requirements for medical devices, not specifically detailed as acceptance criteria here, but assumed to be addressed in the broader submission for the predicate and modifications). |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission relies on demonstrating substantial equivalence through comparison of technological characteristics and a risk analysis, not through a "test set" of performance data like a software algorithm.
- Data Provenance: Not applicable for performance testing directly. The "data" here refers to design specifications, material properties, and risk assessments related to the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome. The evaluation is based on engineering and materials comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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. This is a spinal implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a spinal implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable. The basis for approval is substantial equivalence to a predicate, not performance against a "ground truth" derived from patient data in this context. The "truth" considered is the safety and effectiveness profile of the predicate device.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
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