(89 days)
The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures.
The FRONTIER Anterior Scoliosis System is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes. Specific indications are:
- Idiopathic scoliosis.
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
- Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
- Neuromuscular scoliosis/kyphoscoliosis.
- Spinal fractures (acute reduction or late deformity).
- Revision surgery.
- Tumor.
The FRONTIER Anterior Scoliosis System can also be used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Indications for these scoliotic uses include:
- Collapsing and unstable paralytic deformity.
- Progressively increasing scoliosis.
- Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
- Inability to maintain sitting balance, necessitating the use of hands.
- Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
The FRONTIER Anterior Scoliosis System consists of spinal rods, spinal screws, spinal staples, and spinal washers. The implants of the FRONTIER Anterior Scoliosis System have been designed for use in either open or thoracoscopic approaches.
The provided 510(k) summary for the FRONTIER Anterior Scoliosis System describes a medical device, which is a physical implant, not a software algorithm or AI device. Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of accuracy, sensitivity, specificity, MRMC studies, standalone performance, and ground truth establishment, are not applicable. These criteria are typically used for evaluating diagnostic software or AI-powered devices that produce an output or make a prediction.
This submission focuses on the mechanical and material equivalence of the FRONTIER Anterior Scoliosis System to predicate devices, and its intended use as a spinal fixation orthosis.
However, I can extract information related to the device description, intended use, and the regulatory process for this physical medical device.
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device (spinal implant) and not a software/AI device, acceptance criteria are generally related to mechanical properties, biocompatibility, and manufacturing quality, rather than performance metrics like sensitivity or AUC. The document states:
- Acceptance Criteria (Implied): Substantial equivalence to predicate devices (MOSS MIAMI Spinal System (K953915), KANEDA™ Anterior Scoliosis System (K974757), CD HORIZON® ECLIPSE™ (K001066)) in terms of design, materials, and intended use. Performance data were "submitted to characterize the FRONTIER Anterior Scoliosis System."
- Reported Device Performance: The document generally states "Performance data were submitted to characterize the FRONTIER Anterior Scoliosis System." However, specific numerical performance results (e.g., in vitro biomechanical test results, fatigue limits, etc.) are not included in this 510(k) summary. The 510(k) summary primarily focuses on demonstrating substantial equivalence rather than presenting detailed performance data.
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 is not a study involving human data or a test set in the context of an AI/software device. The performance data mentioned would likely refer to in-vitro mechanical testing and material characterization, not clinical data sets.
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. Ground truth establishment with experts is relevant for diagnostic accuracy studies, not for the regulatory submission of a physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving diagnostic accuracy or human interpretation of data.
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 or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical spinal implant, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Ground truth is not a concept applied in this context for regulatory approval of a physical implant. Performance data would involve engineering specifications, material properties, and manufacturing standards.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.