(92 days)
The UNIFY® Dynamic Anterior Cervical Plate System and the ASSURE® Anterior Cervical Plate System are intended for anterior screw fixation to the cervical spine (C2-C7) for 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, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
The UNIFY® Dynamic and ASSURE® Anterior Cervical Plate Systems consist of plates and variable or fixed angle screws. The plates attach to the anterior portion of the vertebral body of the cervical spine (C2-C7). The UNIFY® plates allow translation to accommodate bone graft resorption. The UNIFY® additional implants are manufactured from titanium alloy, as specified in ASTM standards F136, F1295 and F1472.
This K133567 510(k) submission describes the UNIFY® Dynamic and ASSURE® Anterior Cervical Plate Systems, specifically requesting clearance for additional UNIFY® screws to be used with ASSURE® and UNIFY® plates, and the use of ASSURE® rigid screws with the UNIFY® plate.
The study presented to establish substantial equivalence is a mechanical testing study.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This device is a physical medical implant, not an AI/software device. Therefore, the "acceptance criteria" are related to mechanical performance, and the "reported device performance" reflects how the implants fared in these tests compared to predicate devices.
| Acceptance Criteria (Performance Measure) | Reported Device Performance (UNIFY® / ASSURE®) |
|---|---|
| Mechanical equivalence to predicate devices for specific screw/plate combinations (as assessed by engineering analysis of design, materials, and dimensions). | The technological characteristics of the UNIFY® additional implants are "similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics." |
| Static cantilever bending strength in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s, May 3, 2004." | Performance data demonstrates "substantial equivalence to the predicate devices." |
| Screw push-out strength in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s, May 3, 2004." | Performance data demonstrates "substantial equivalence to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of samples (e.g., number of screws, plates, or test permutations) used for the mechanical testing. It broadly states "Mechanical testing... was conducted."
- Data Provenance: The study was conducted as mechanical testing/engineering analysis. Therefore, provenance would relate to the testing facility and methodology rather than patient data. The document does not specify the location of the testing. The data is prospective, in the sense that the tests were specifically performed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as this is a mechanical engineering study, not an AI/software study involving clinical image interpretation or diagnosis by experts. The "ground truth" is defined by established engineering standards and physical properties.
4. Adjudication Method for the Test Set
- Not applicable for a mechanical engineering study. Performance is assessed against defined physical and mechanical standards, not through expert adjudication of ambiguous cases.
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. This type of study is relevant to evaluate the impact of AI on human reader performance, typically in diagnostic imaging. This submission deals with the mechanical performance of a spinal implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is not an algorithm or AI device. It's a physical medical implant.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on established engineering principles, ASTM standards (F136, F1295, F1472), and FDA guidance documents ("Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s, May 3, 2004"). The performance of the new implants is compared to the known and accepted performance characteristics of the predicate devices.
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.