(386 days)
The Captiva Spine SmartLOX Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion. WARNING: The Captiva Spine SmartLOX Cervical Plate System is not intended for screw attachment or the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Captiva Spine SmartLOX Cervical Plate system is intended for anterior screw fixation of the cervical spine. This system has been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion.
The Captiva Spine SmartLOX Cervical Plate System includes plates, screws, and a screwretaining rail lock. The plates are available in a variety of lengths ranging from 20 to 110mm. Screws are offered in two diameters, a primary screw diameter and a rescue diameter. Primary screws are available in self-drilling, and both screw diameters are available in fixed and variable versions. Screw lengths range from 12 to 18mm in 2mm increments. The rails are assembled with the plate during the manufacturing process and their configuration varies with the plate length.
The Captiva Spine SmartLOX Cervical Plate System is supplied with the instrumentation necessary for implantation of the system. The Captiva Spine SmartLOX Cervical Plate System is for single use only.
This document is a 510(k) summary for the Captiva Spine SmartLOX Cervical Plate System. It details the device, its intended use, and its substantial equivalence to predicate devices, but it does not describe a study that uses acceptance criteria for device performance based on human reader evaluations or AI performance metrics.
Instead, the "acceptance criteria" and "study" described in the document refer to mechanical and material testing performed to demonstrate the device's safety and effectiveness compared to existing, legally marketed predicate devices.
Here's an breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table with acceptance criteria and device performance in the way one might expect for an AI diagnostic device. Instead, it states that the device was evaluated against existing ASTM standards and engineering analyses.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices in static and dynamic loading. | "The worst-case implants were previously tested and performed equally to or better than the predicate devices in static compression, static torsion and dynamic compression in accordance with ASMT F1717." |
| Material corrosion resistance (ASTM F2129-08) | "Corrosion susceptibility was tested per ASTM F2129-08" (No specific performance values provided, but the statement implies it met the standard for acceptance). |
| Galvanic corrosion resistance (ASTM F3044-14) | "Galvanic Corrosion was tested per ASTM F3044-14." (No specific performance values provided, but the statement implies it met the standard for acceptance). |
| Design Failure Modes and Effect Analysis (FMEA) | "Engineering analysis of the proposed design changes included Design Failure Modes and Effect Analysis (FMEA)" (Implies analysis showed acceptable risk and performance for changes compared to predicate). |
| Comparative analysis (product code, indications, materials, dimensions) | "A tabulated comparison between Captiva Spine SmartLOX Cervical Plate System and the predicates. The comparative analysis included product code, indications for use, material and screw/plate dimensions." (Implies no significant differences that would raise new safety concerns). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the "test set" in this context refers to mechanical test samples, not a dataset of patient images or clinical data. The document mentions "worst-case implants" were tested, but not a specific sample size. No country of origin or retrospective/prospective data provenance is relevant here.
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)
This information is not applicable. The ground truth for mechanical testing is established by engineering standards (e.g., ASTM F1717) and physical measurements, not by experts reviewing clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical studies or AI evaluations. For mechanical testing, results are objectively measured against predefined standards.
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, a multi-reader, multi-case comparative effectiveness study was not done. This device is a medical implant (cervical plate system), not a diagnostic AI software. Therefore, there is no concept of human readers or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance evaluation of an algorithm was not done. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on adherence to recognized mechanical and material testing standards (e.g., ASTM F1717, F2129-08, F3044-14) and engineering analyses (FMEA, comparative analysis). These standards define acceptable performance for spinal implant devices.
8. The sample size for the training set
This information is not applicable. There is no "training set" for this type of medical device. The design and manufacturing processes are informed by engineering principles, material science, and prior device designs, not by machine learning training data.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
§ 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.