(168 days)
The GraftCage™ TLX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (T1-L5). The GraftCage TLX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage TLX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.
The GraftCage TLX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the GraftCage TLX is optional.
The GraftCage TLX is a device designed to replace a thoracic or lumbar vertebral body and to support axial compression loads following vertebrectomy for the treatment of spinal tumors and in cases of spinal trauma/fracture. The GraftCage TLX is made from implantable PEEK (polyetheretherketone) polymer.
The GraftCage TLX is rectangular -to- oval in shape, with its anterior aspect slightly convex and posterior aspect slight concave. One central (axial) fenestration and two fenestrations on each anterior and posterior aspect provide locations for the addition of bone grafting material. The superior and inferior aspects have ridges that resist expulsion and /or migration after implantation. The device is nonlordotic (0°) i.e., parallel. The lateral aspects are tapered, or bulleted, for ease of insertion.
Two threaded holes, one at each lateral aspect, interface with the insertion tool. The insertion tool is a shaft attached to a handle. The shaft has a threaded end that matches both threaded holes on the GraftCage TLX and allows the surgeon to hold the GraftCage TLX while implanting it into the patient. Each threaded hole is at a different angle relative to the long axis of the implant. The different angles allow the surgeon to choose the best surgical approach depending upon the specific clinical situation.
This is a medical device 510(k) summary, not a study report for an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and training data is not applicable.
A 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of intended use, technological characteristics, and performance data if required for novel features or significant differences.
Here's a breakdown of what can be extracted from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative form, nor does it present specific performance data for the GraftCage™ TLX in a way that would directly correspond to such criteria. The "performance" mentioned is implicitly related to demonstrating substantial equivalence through similar technological characteristics and the belief that it "meets or exceeds functional requirements for a vertebral body replacement device" based on comparison to predicates.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device submission, not a study involving a test set of data in the context of AI/ML.
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. This is a medical device submission, not a study involving ground truth established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 an implantable medical device (vertebral body replacement), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an implantable medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of Applicable Information from the Document:
While the direct questions about AI/ML studies are not applicable, we can infer some details relevant to the device's authorization:
- Acceptance Criteria (Implicit): The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to existing, legally marketed predicate devices. This is achieved by showing that the new device has:
- The same intended use.
- Similar technological characteristics (e.g., material, design, mechanical properties inferred from the comparison).
- No new questions of safety or effectiveness.
- Study That "Proves" Device Meets Criteria: The "study" for a 510(k) is primarily the submission itself, comparing the new device to predicates. The document states:
- "The GraftCage TLX and the predicate devices have the same intended use and similar technological characteristics."
- "Performance data demonstrates that the GraftCage TLX meets or exceeds functional requirements for a vertebral body replacement device." (No specific data is presented in this summary, but it implies mechanical testing or other non-clinical performance data was submitted to the FDA to support this claim).
- Predicate Devices Used for Comparison (Analogous to a "Reference" or "Standard"):
In essence, the "proof" for the GraftCage™ TLX is derived from its similarity to devices already deemed safe and effective by the FDA.
§ 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.