(106 days)
The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). 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,
- pseudarthrosis, .
- . failed previous fusion,
- spinal stenosis. .
The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The ALTUM anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The ALTUM plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the ALTUM Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.
The provided text is a 510(k) Premarket Notification for the ALTUM Anterior Cervical Plate System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from ASTM F1717-09) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Compression Bending (Strength) | Equal to or higher than predicate systems |
| Mechanical Performance | Static Torsion (Strength) | Equal to or higher than predicate systems |
| Mechanical Performance | Dynamic Compression Bending (Fatigue/Durability) | Equal to or higher than predicate systems |
Note: The document does not specify numerical acceptance criteria from ASTM F1717-09, only that the device's performance was compared to predicate systems.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test, but standard for mechanical testing involves multiple test specimens to ensure statistical validity.
- Data Provenance: The tests are non-clinical (laboratory-based mechanical tests). There is no patient data involved, so country of origin or retrospective/prospective status is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable. For mechanical tests of spinal implants, the "ground truth" is established by the specifications and performance characteristics defined in the ASTM standard (ASTM F1717-09) and the characteristics of the predicate devices. There are no "experts" in the sense of clinical specialists establishing ground truth for individual test outcomes (e.g., diagnosing a condition). The experts involved would be those who developed the ASTM standard and those who critically evaluate the mechanical test methodologies and results.
4. Adjudication Method for the Test Set
This question is not applicable. Mechanical testing does not involve adjudication as seen in clinical studies or image review. The results are quantitative measurements against predefined standards and comparative data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical medical implant (an anterior cervical plate), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence and meeting acceptance criteria for this medical device is based on:
- Standardized Mechanical Test Protocols: Specifically, ASTM F1717-09 outlines the methods for testing spinal implant constructs.
- Performance of Legally Marketed Predicate Devices: The ALTUM system's performance was compared directly to that of the Envision2 Anterior Cervical Plate System (K020649) and Spider Cervical Plating System (K052292). The "ground truth" for acceptable performance is considered to be the performance demonstrated by these existing, equivalent devices.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of device mechanical testing. The device is evaluated based on its physical properties and mechanical performance.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for this type of device evaluation.
§ 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.