(127 days)
The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is a pedicle screw system 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System are intended for sacral/iliac attachment only. Hooks of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic. Iumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes fixed and polyaxial screws of varying diameters and lengths, and hooks in varying designs in varying designs and lengths. The Shadow™ components are product line additions to complement the Ascend™ system components.
The provided text is a 510(k) summary for the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System. This document describes a medical device submission to the FDA, which primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biomechanical testing, rather than a clinical study evaluating diagnostic performance or comparative effectiveness against human readers. Therefore, many of the requested categories are not directly applicable to this type of submission.
Here's an attempt to answer the questions based only on the provided text, while acknowledging its limitations for certain categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Set by Standard) | Reported Device Performance (Summary) |
|---|---|
| Biomechanical Testing (General): | Demonstrated equivalent mechanical performance compared to predicate devices. |
| ASTM F 1717-96 (Corpectomy Model): | Static compression bending, static torsion, and compression bending fatigue testing. Data compares directly to predicate device testing and meets or exceeds other predicate devices. |
| ASTM F 1798-97 (Interconnection Testing): | Axial gripping capacity of hooks, screws, and rod-to-rod connectors, torsional gripping capacity, and polyaxial screw flexion/extension static and fatigue testing. Data compares directly to predicate device testing and meets or exceeds other predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for specific tests. The text refers to "various system components" being tested.
- Data Provenance: Not specified. This would typically be laboratory-based biomechanical testing, rather than clinical data from human subjects. The country of origin is not 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. This submission details biomechanical testing of a spinal fixation system, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for clinical studies involving human interpretation or challenging diagnoses, not for biomechanical engineering tests.
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 not a study comparing diagnostic performance or human reader improvement with AI assistance. It is an engineering evaluation of a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Standards/Predicate Device Performance: The "ground truth" or reference for performance is established by the specified ASTM standards (F 1717-96 and F 1798-97) and the performance of existing, legally marketed predicate devices. The device's performance is compared against these established benchmarks.
8. The sample size for the training set
- Not Applicable. This involves biomechanical testing, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set mentioned.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.