(479 days)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the COLORADO™ II Spinal System Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the COLORADO™ II Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the COLORADO™ II Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The COLORADO™ II Spinal System consists of a variety of rods, hooks, screws, plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The provided text is a 510(k) premarket notification for the COLORADO™ II Spinal System, indicating that the device's substantial equivalence was demonstrated through "Mechanical testing data were provided or referenced to demonstrate substantial equivalence."
This type of submission typically relies on comparing the new device's design and mechanical properties to a legally marketed predicate device, rather than clinical studies involving human subjects in the same way an AI-powered diagnostic device would. Therefore, most of the detailed information requested regarding clinical study design, acceptance criteria, multi-reader multi-case studies, or ground truth establishment is not present or applicable to this type of device submission.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
For a 510(k) submission like this, the "acceptance criteria" are implicitly met if the mechanical testing demonstrates that the new device performs equivalently or better than the predicate device for its intended use. Performance is typically assessed through engineering tests (e.g., strength, fatigue, stiffness) rather than clinical outcomes.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence | "The COLORADO™ II Spinal System is substantially equivalent to other legally marketed devices. Mechanical testing data were provided or referenced to demonstrate substantial equivalence." This implies that the device's mechanical properties, materials, and design are comparable to predicate devices, ensuring similar safety and effectiveness profiles. |
| Intended Use | The device meets the stated indications for use as a pedicle screw fixation system and a posterior, non-cervical, non-pedicle screw fixation system, consistent with predicate devices. |
Study Details (Applicable to Mechanical Testing for Substantial Equivalence):
1. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided text. Mechanical testing would involve a certain number of device components or constructs tested to failure or under specific conditions.
- Data provenance: Not explicitly stated, but mechanical testing data would typically be generated in a lab setting, either by the manufacturer or a third-party testing facility. The country of origin is not specified but based on the company's location (Memphis, TN, USA) it is likely US-based.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of mechanical testing for substantial equivalence. "Ground truth" in this context would refer to established engineering standards or the performance of predicate devices, not expert human interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Mechanical testing results are typically quantitative and objective measurements against established engineering limits or predicate device performance, not subjective interpretations requiring adjudication.
4. 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-powered diagnostic device.
5. 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-powered diagnostic device.
6. The type of ground truth used:
- For mechanical testing, the "ground truth" would be established engineering standards, material properties, and the known performance specifications of predicate devices.
7. The sample size for the training set:
- Not applicable in the context of device approval through substantial equivalence via mechanical testing. There is no "training set" in the machine learning sense.
8. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) seeking approval based on substantial equivalence to predicate devices through mechanical testing. It is fundamentally different from the regulatory pathway for AI/ML-based diagnostic software, which would require extensive clinical validation as detailed in your prompt questions.
§ 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.