(58 days)
The X-Spine ACP System is intended for anterior screw fixation to the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- Spondylolisthesis, .
- Trauma (i.e., fractures or dislocations), ●
- Tumors, ●
- Deformity (defined as kyphosis, lordosis, or scoliosis) .
- Pseudoarthrosis, and/or .
- Failed previous fusions. .
The X-Spine Anterior Compact Plate (ACP) System includes titanium alloy anterior cervical plates and bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The implant components are provided clear and non-sterile.
The provided text is a 510(k) premarket notification summary for the X-Spine Anterior Compact Plate (ACP) System. This document focuses on the regulatory clearance process for a medical device (an orthopedic implant), not a diagnostic algorithm or a device that generates performance data in the typical sense of accuracy, sensitivity, or specificity. Therefore, many of the requested fields related to acceptance criteria, statistical studies, and ground truth for AI algorithms are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as it's a structural implant. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device using performance data that characterizes the device's properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Synthes CSLP System). | Performance data submitted characterized the X-Spine ACP System. (Specific results not detailed in this summary) |
| Device meets the intended use and safety requirements. | FDA determined the device is substantially equivalent for its stated indications for use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is for a mechanical orthopedic implant, not a diagnostic or AI device that typically uses test sets of data. Performance data would likely involve mechanical testing, material characterization, and potentially animal or cadaveric studies, not human clinical test sets in the context of diagnostic performance. The document only states "Performance data were submitted to characterize the X-Spine ACP System." without further detail on the nature or origin of this data.
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 as typically defined for AI algorithms (e.g., expert consensus on images, pathology results) is not relevant for the regulatory clearance of a mechanical orthopedic implant. The "ground truth" for such a device would be its mechanical properties, biocompatibility, and functional performance, evaluated through engineering and materials science methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is for clinical data interpretation or AI output evaluation, not for the submission of performance data for a mechanical implant.
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 study type is specific to diagnostic imaging and AI interpretation, not a mechanical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical, mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a mechanical implant would be its physical and mechanical properties and performance, validated through engineering principles and testing (e.g., fatigue testing, pull-out strength, materials characterization), not expert consensus on images or pathology.
8. The sample size for the training set
Not applicable. This device is an orthopedic implant, not an AI algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.
§ 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.