(82 days)
The components of the Titanium Spinal Rod System are indicated for spinal fixation.
When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine(T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, multi-operated back or revision of previous surgery.
When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-S1.
The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. These device components are for single use. Cementless or cement fixation is not applicable to these components. The components of the Titanium Spinal Rod System are not designed to be used with any other system except the bolts of the UlTium Spinal Plating System. The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V).
Based on the provided text, the "Aurora Titanium Spinal Rod System" is a spinal fixation device. The document is a 510(k) submission to the FDA, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. This type of submission relies on comparison to existing devices rather than new clinical trials with acceptance criteria and performance metrics against ground truth.
Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not applicable to this document as it describes a substantial equivalence determination based on predicate devices, material specifications, and intended use, not a clinical study with detailed performance data, sample sizes, and ground truth adjudication.
However, I can extract information related to the device's intended use and the specific conditions under which its pedicular screw system was deemed substantially equivalent.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: For the pedicular screw system, the FDA's acceptance criteria for substantial equivalence are implicitly linked to the specific indications for use and warnings outlined in the letter. These are not performance metrics in the traditional sense (e.g., sensitivity, specificity) but rather conditions for marketing.
- Reported Device Performance: This document does not contain reported device performance data as would be found in a clinical study (e.g., success rates, complication rates, effectiveness outcomes). The 510(k) process primarily evaluates safety and equivalence, often through bench testing, material specifications, and comparison to predicates, rather than extensive clinical performance data against specific acceptance criteria.
| Feature Area | Implicit Acceptance Criteria (for Pedicular Screw System) | Reported Device Performance |
|---|---|---|
| Legally Marketed | Substantial equivalence to predicate device in terms of safety and effectiveness for specific indications. | The FDA determined the device system is substantially equivalent for the specified indications. |
| Indications for Use (Pedicular Screw System) | Intended only for patients with: (a) severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) receiving fusions using autogenous bone graft only; (c) device fixed to lumbar and sacral spine; and (d) device removed after solid fusion mass develops. | The device's intended use and labeling were reviewed and found to align with these specific conditions for pedicular screw fixation. No performance metrics are reported. |
| Material | Conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V). | The document states the material "conforms to MATERIALS: ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V)". No test results are provided. |
| Compatibility | Not designed to be used with any other system except the bolts of the UlTium Spinal Plating System. | This is a design specification and a warning on use. No testing results are provided. |
No specific study proving the device meets these (implicit) acceptance criteria is described in detail within this document. The FDA's 510(k) clearance is a determination of substantial equivalence based on the submitted information, which typically includes bench testing, material characterization, and comparisons to predicate devices, rather than a prospective clinical trial.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document does not describe a clinical "test set" or clinical study with patient data in the context of evaluation against acceptance criteria. The 510(k) submission relies on demonstrating equivalence to predicate devices, material specifications, and safety. Any testing would typically be bench testing on the device itself, not a patient study with a "test set."
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. No clinical test set with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set with adjudication is described.
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 spinal implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a spinal implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No clinical ground truth data is described in this document. The "ground truth" for the 510(k) submission is the demonstration of equivalence to legally marketed predicate devices, adherence to material standards, and acceptable risk profiles based on design and proposed labeling.
8. The sample size for the training set:
- Not Applicable. No training set for an algorithm is discussed.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth establishment for a training set is discussed.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.