(10 days)
The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with thefollowing indications:
· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Trauma (including fractures)
· Tumors
· Deformities or curvatures (including kyphosis, lordosis or scoliosis)
- · Pseudoarthrosis
- · Failed previous fusion
· Decompression of the spinal cord following total or partial cervical vertebrectomy.
- · Spondylolisthesis
- · Spinal Stenosis
The Reflex™ Hybrid ACP System includes plates (1level, 2-level, 3-level, and 4-level), 4.0 mm and 4.5mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle self-drilling, and fixed-angle self-tapping), and a locking ring component. This submission adds three new 4-level plate lengths to the Reflex™ Hybrid ACP System.
This document is a 510(k) summary for a line extension to an existing medical device, the Stryker Spine Reflex™ Hybrid ACP System. The submission is for adding three new 4-level plate lengths to the system.
Here's the analysis based on the provided text, addressing your questions:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics in the format you've requested. This document is a 510(k) summary, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed performance data against specific acceptance criteria.
The submission states:
- "The intended use and materials of the subject devices are identical to those of the predicate device system."
- "Engineering analysis demonstrated that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device system."
This indicates that the acceptance criterion is substantial equivalence to the predicate device, demonstrated through engineering analysis. However, the specific metrics or thresholds used in that engineering analysis are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention any test set, sample size, or data provenance because it relies on an "engineering analysis" to demonstrate equivalence rather than clinical or performance testing on a specific "test set" of data or patients. This is typical for a line extension of a device where the core design and materials are unchanged, and the modification (new plate lengths) is assessed through design verification and validation (engineering analysis) rather than new clinical trials or extensive human-data-based testing.
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)
No information about experts, ground truth establishment, or test sets is provided, as the submission relies on engineering analysis for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information about an adjudication method is provided, as no clinical test set or human evaluation 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
No MRMC study was conducted or mentioned. This device is a surgical implant (anterior cervical plate system), not an AI-driven diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No explicit "ground truth" in the clinical or image analysis sense is mentioned. The "ground truth" for demonstrating equivalence would have been the established performance and safety of the predicate device, against which the engineering analysis of the new plate lengths was compared.
8. The sample size for the training set
Not applicable, as this is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
In summary:
This 510(k) summary is for a line extension of an existing, already cleared physical medical device (Reflex™ Hybrid ACP System). The primary method for demonstrating safety and effectiveness for such a submission is to show substantial equivalence to the predicate device through engineering analysis, rather than presenting new clinical study data or performance metrics from human-based testing with ground truth. The change is limited to adding new lengths to existing plates, suggesting that the core performance characteristics are expected to be the same as the predicate devices, as verified by engineering methods.
§ 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.