(69 days)
The Diamondback™ Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion in skeletally mature patients. The system is intended for posterior, pedicle fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra. In addition, when used as a pedicle screw fixation system of the non-cervical posterior spine (T1 to S2) the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
The Diamondback™ Spinal System consists of rods, monoaxial and polyaxial screws with caps, and cross connectors with lock screws. Rods are available either straight or pre-contoured in a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations.
The Diamondback™ Spinal System is a spinal implant system with acceptance criteria and performance data as follows:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance of worst-case construct must be "as well as or better than" predicate devices according to ASTM F1717 for static compression bending, torsion, and dynamic compression bending. | The mechanical results demonstrated that the Diamondback™ Spinal System performs as well as or better than the predicate devices. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document refers to "worst case Diamondback™ Spinal System construct" for mechanical testing, implying a specific configuration or small set of configurations for testing. A numerical sample size for individual tests (e.g., number of constructs tested) is not explicitly provided in the excerpt.
- Data Provenance: The testing was "performed according to ASTM F1717," indicating laboratory-based mechanical testing. The country of origin for the data is not specified, but the submission is to the US FDA. The nature of the data is retrospective as it refers to performance of the device rather than a clinical trial.
3. Number of Experts and Qualifications
This document describes a premarket notification (510(k)) for a medical device (spinal implant), not an AI/software device. Therefore, the concept of "experts used to establish the ground truth for the test set" in the context of clinical interpretation or image analysis does not apply here. The "experts" involved would be mechanical engineers or testing professionals who conduct and analyze the ASTM F1717 tests. Their qualifications are not explicitly stated.
4. Adjudication Method
Not applicable. This is a mechanical device submission, not a study requiring adjudication of clinical or imaging data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a mechanical device, not an AI or software-assisted diagnostic tool for which MRMC studies would be relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a mechanical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by demonstrating mechanical equivalence or superiority to predicate devices as measured by standardized mechanical testing (ASTM F1717) and by technical characteristics (design, materials, sizes). The predicate devices are legally marketed devices that have a history of safe and effective use.
8. Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI system that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a mechanical device.
§ 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.