(138 days)
The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and The Translation Plate Phase 2 (T-2 plate)) is a temporary implant used for the correction and stabilization of the spine. The system is also intended to help provide temporary stabilization and to help augment the development of a solid spinal fusion. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made from medical grade titanium alloy. Stainless steel and titanium components must not be used together in a construct.
Here is an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K051764) | The modified T-PLATE Anterior Fixation System (T-1 plate and T-2 plate) was determined to be "substantially equivalent" to the predicate device (T-PLATE ANTERIOR PLATE FIXATION SYSTEM, K051764) based on mechanical testing. This implies that its performance met the accepted standards established by the predicate. |
| Maintenance of Spinal Stabilization | The device is intended to "help provide temporary stabilization until a solid spinal fusion develops." The mechanical testing is expected to demonstrate its ability to fulfill this function. |
| Appropriateness for Indicated Use Cases (e.g., Degenerative disc disease, Fracture, Spondylolisthesis) | The substantial equivalence determination, based on mechanical testing, suggests that the device performs adequately across the stated indications. |
| Material Compatibility and Safety (Medical Grade Titanium Alloy) | Implied by the predicate device's prior clearance and the explicit mention of using medical-grade titanium alloy. Mechanical testing would also confirm the structural integrity of this material for the intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Mechanical testing was performed" but does not specify the sample size used for this testing. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective). Given that this is a 510(k) for a mechanical device, the "test set" would refer to the mechanical specimens tested, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. For a mechanical device, "ground truth" is established through engineering standards, test methods, and quantitative measurements of mechanical properties, not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Mechanical testing does not involve adjudication in the way clinical studies or expert reviews do. Standardized test methods (e.g., ASTM, ISO) typically dictate how results are measured and interpreted.
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 comparative effectiveness study was mentioned or performed. This submission is for a physical medical device (an anterior fixation system), not an AI-powered diagnostic or assistive tool. Therefore, the concepts of human readers or AI assistance are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As stated above, this is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on mechanical engineering standards and quantitative measurements of the device's physical properties and performance under various loads and conditions (e.g., fatigue, static strength, stiffness). The comparison is made against the performance of the legally marketed predicate device.
8. The Sample Size for the Training Set
There is no concept of a "training set" in this type of 510(k) submission for a mechanical device. The device is designed, manufactured, and then tested, not "trained."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth established for it.
Summary of Acceptance Criteria and Study for K072231:
The primary acceptance criterion for the T-PLATE Anterior Fixation System in this 510(k) submission (K072231) was demonstrating substantial equivalence to a previously cleared predicate device (K051764).
The study that proves the device meets this acceptance criterion was "mechanical testing." This testing compared the performance of the modified T-PLATE system (T-1 plate and T-2 plate) to the predicate device. The nature of this testing would involve evaluating properties like strength, fatigue resistance, and construct stability, ensuring that the modified device performs comparably to the predicate for its intended use as a spinal fixation system. While specific details of the tests (e.g., specific loads, cycles, failure modes) and the number of samples are not provided in this summary, the FDA's clearance indicates that these mechanical tests were sufficient to demonstrate substantial equivalence, thus meeting the regulatory acceptance criteria for market authorization.
§ 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.