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510(k) Data Aggregation
(101 days)
APEX SPINE SYSTEM W/ COCR RODS
The APEX Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-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 APEX Spine System is also a hook and sacraliliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
The added Ø5.50mm and Ø6.0mm CoCr Spinal Rods are identical to the existing devices of the previously cleared APEX Spine System with recards to indications for use and function. The Ø5.50mm and Ø6.0mm CoCr Rods are available in various lengths and are designed for use with the previously cleared titanium alloy components of the APEX Spine System which can accept a Ø5.50mm and/or Ø6.0mm spinal rod, including monoaxial, polyaxial screws, hooks, and connectors. The Ø5.50mm and Ø6.0mm CoCr Rods will be labelled as components of the APEX Spine System.
The provided text describes a 510(k) submission for the APEX Spine System with CoCr Rods. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study evaluating the performance of an AI model or diagnostic device against acceptance criteria.
Therefore, the input does not contain the information necessary to complete the requested table and details regarding acceptance criteria and studies proving device performance in the context of AI or diagnostic accuracy studies. The document explicitly states:
- "No clinical studies were performed."
- The non-clinical tests were ASTM standards for mechanical properties of spinal implants.
Given this, I cannot fill out the requested table or provide information about:
- Acceptance criteria and reported device performance (in terms of diagnostic accuracy/AI performance): Not applicable, as this is a mechanical spinal implant, not an AI or diagnostic device. Performance is typically assessed through mechanical testing and substantial equivalence, not diagnostic metrics.
- Sample size for the test set and data provenance: No clinical/diagnostic test set was used. Mechanical testing involved specific constructs.
- Number of experts used to establish ground truth: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable in the context of diagnostic performance.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The document is purely about the regulatory clearance of a physical medical device (spinal rods) based on material specifications, intended use, and mechanical testing, demonstrating substantial equivalence to predicates.
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(53 days)
COCR RODS
The REVERE® or BEACON™ Stabilization System, when used as a posterior pedicle screw system, 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 the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the REVERE® or BEACON™ Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used as a posterior non-pedicle screw fixation system, the REVERE® or BEACON™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVERE® or BEACON™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
CoCr Rods consist of 5.5mm and 6.35mm rods manufactured from cobalt chromium molybdenum alloy. REVERE® and BEACON™ Stabilization System implants mate with these 5.5mm and 6.35mm diameter rods. The REVERE® and BEACON™ implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. CoCr Rods are composed of cobalt chromium-molybdenum alloy as specified in F1537.
Here's an analysis of the provided 510(k) summary for the CoCr Rods, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Compression-bending | Tested in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. | The document states testing was conducted in accordance with the guidance, implying the results met the criteria outlined in that guidance. Specific numerical results or pass/fail thresholds are not provided in this summary. |
| Mechanical Performance | Torsion | Tested in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. | Similar to compression-bending, this indicates compliance with the guidance, but specific quantitative results are absent. |
| Material | Biocompatibility | Composed of cobalt chromium-molybdenum alloy as specified in F1537. | This implies adherence to a recognized standard for surgical implant materials, which covers biocompatibility. No separate test results are presented. |
| Substantial Equivalence | Technical Characteristics | Similar to predicate devices. | The submission asserts similarity without specific details. |
| Substantial Equivalence | Material | Similar to predicate devices (CoCr-Mo alloy). | Directly mentioned in the device description. |
| Substantial Equivalence | Performance | Similar to predicate devices (based on mechanical testing). | Implied by the statement of "substantial equivalence" supported by mechanical testing. |
| Substantial Equivalence | Intended Use | Similar to predicate devices. | The stated indications for use are largely consistent with typical spinal stabilization systems. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document describes mechanical testing of the CoCr Rods. For such testing, the "sample size" refers to the number of physical rods and corresponding components subjected to the mechanical tests.
- Sample Size: The document does not explicitly state the number of rods or components used in the compression-bending and torsion tests.
- Data Provenance: The data provenance is pre-clinical mechanical testing, conducted by the manufacturer, Globus Medical Inc. There is no information suggesting external lab testing or geographical origin of the samples beyond the manufacturer's location in Audubon, PA. This is not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this submission. The "ground truth" in this context is established by engineering standards and physical measurements from mechanical stress tests, not by expert clinical consensus. There are no experts involved in establishing a "ground truth" for clinical outcomes in this 510(k) submission.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods are used in clinical studies or expert reviews to resolve discrepancies in observations or diagnoses. Mechanical testing results are objective measurements against predefined engineering standards.
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
This question is not applicable. This 510(k) submission is for a medical device (spinal rods) and not for an AI/CAD (Computer-Aided Detection) system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable, as this is not an AI/CAD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering standards and material specifications.
- For mechanical testing (compression-bending, torsion), the ground truth is defined by the failure criteria outlined in the referenced FDA Guidance document ("Guidance for Spinal System 510(k)s", May 3, 2004), as well as the inherent mechanical properties of the material.
- For material composition, the ground truth is adherence to ASTM F1537 (Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloys for Surgical Implants).
8. The sample size for the training set
This question is not applicable. There is no AI algorithm being trained, so there is no training set.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set.
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