(42 days)
The ARENAL Anterior Cervical Plate System is intended for fixation and temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions with the following indications:
- Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures)
- Tumors
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- Pseudarthrosis
- Spondylolisthesis
- Spinal stenosis
The ARENAL Anterior Cervical Plate System is interior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths, addressing multiple levels of fixation.
The provided text describes a 510(k) premarket notification for the Arenal Anterior Cervical Plate System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It does not contain information about a study proving device performance against acceptance criteria in the context of AI/software or human readers, as the device is a spinal implant.
Therefore, many of the requested categories are not applicable to the information provided.
However, I can extract information related to the performance of the device based on mechanical testing.
Here's the relevant information derived from the provided text for the mechanical testing of the device:
1. A table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria (from FDA Spinal Plating Systems guidance document) | Reported Device Performance (Arenal Anterior Cervical Plate System) |
|---|---|---|
| Static compression | Not explicitly stated, but implied as a numerical threshold in the guidance document. | Static Compression Bending Yield was in exceptance criteria (likely means acceptance criteria) listed in FDA Spinal Plating Systems guidance document. |
| Static compression | Not explicitly stated, but implied as a numerical threshold in the guidance document. | Static Compression Bending Stiffness was in exceptance criteria (likely means acceptance criteria) listed in FDA Spinal Plating Systems guidance document. |
| Dynamic compression | Not explicitly stated, but implied as a numerical threshold for runout load @ 5M cycles in the guidance document. | Dynamic Compression Bending Runout Load @ 5M cycles was in excess of the acceptance criteria listed in FDA Spinal Plating Systems guidance document. (This indicates better performance than criteria) |
| Static torsion | Not explicitly stated, but implied as a numerical threshold in the guidance document. | Static Torsion Yield was in exceptance criteria (likely means acceptance criteria) listed in FDA Spinal Plating Systems guidance document. |
| Static torsion | Not explicitly stated, but implied as a numerical threshold in the guidance document. | Static Torsion Stiffness was in exceptance criteria (likely means acceptance criteria) listed in FDA Spinal Plating Systems guidance document. |
Study that proves the device meets the acceptance criteria:
The study referenced is a series of non-clinical mechanical tests performed according to ASTM standards for spinal implant constructs. These tests are:
- Static compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Dynamic compression per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static torsion per ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size (number of devices tested) for each test.
- Data Provenance: The tests were performed as part of the 510(k) submission process for a medical device (Arenal Anterior Cervical Plate System). The origin is not specified but is implicitly from testing conducted to support a US FDA submission. It is prospective testing, specifically designed to demonstrate safety and effectiveness for regulatory clearance.
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. The ground truth for mechanical testing is based on physical measurements and engineering principles, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Mechanical test results are quantitative and do not require adjudication.
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 device is a physical spinal implant, not an AI or software-based diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical spinal implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these tests are the defined physical properties and performance characteristics as outlined in the ASTM F1717 standard and the FDA Spinal Plating Systems guidance document. This is based on engineering standards and regulatory requirements for spinal implants.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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.