(90 days)
The InterPlate™ C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
In addition, the InterPlate™ C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
WARNING: The InterPlate™ C is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The InterPlate™ C consists of plates, bone screws and screw covers in a variety of sizes. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size. The InterPlate™ C components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.
The provided document is a 510(k) summary for a medical device called InterPlate™ C. It details the device's classification, description, intended use, and substantial equivalence to previously cleared devices. However, this type of document, a 510(k) summary for a Class II medical device, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a specific clinical study with detailed acceptance criteria and performance metrics against those criteria. It does not contain information about:
- Acceptance criteria and reported device performance in a table. The document asserts substantial equivalence, meaning it matches the predicate device’s performance characteristics, but doesn't specify new, quantifiable acceptance criteria or new study results for those criteria.
- Sample sizes for a test set or data provenance. Because it relies on substantial equivalence and mechanical testing, specific patient-based test set details are not included.
- Number of experts or their qualifications for ground truth. This typically pertains to studies involving human interpretation or diagnosis, which isn't the primary focus of this submission.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study. This is relevant for imaging or diagnostic AI devices, not for a spinal implant.
- Standalone (algorithm only) performance. Not applicable to a physical implant.
- Type of ground truth used for a clinical study.
- Sample size for a training set or how ground truth for a training set was established. These are concepts relevant to AI/ML device development, not a spinal implant and its 510(k) submission.
What the document does provide in relation to product performance and evidence is:
- Substantial Equivalence Statement: The primary "proof" is the statement that the InterPlate™ C is "substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, material of manufacture and mechanical performance." This implies that the device meets the same performance expectations as its predicate based on these factors.
- Mechanical Performance: The document explicitly mentions "mechanical performance" as a basis for substantial equivalence. While it doesn't quantify specific acceptance criteria or results here, it means that the device was likely subjected to various mechanical tests (e.g., fatigue, static strength, subsidence) to demonstrate that it performs as safely and effectively as the predicate device mechanically. The specific details of these tests and their criteria would be in the full 510(k) submission, not typically in the public summary.
- Material: Manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136, indicating compliance with recognized material standards.
- Intended Use & Indications: These are detailed, showing the specific clinical context for which the device is approved. The device is for intervertebral body fusion in the cervical spine (C3 to T1) for certain conditions, with specific warnings.
In summary, for this specific K092070 submission:
The "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than establishing new, detailed performance metrics for this specific device in a clinical study as might be done for novel AI or diagnostic technologies. The FDA determined that the device is substantially equivalent, allowing it to be marketed.
§ 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.