(140 days)
The NuVasive CoRoent Thoracolumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent Thoracolumbar System (XL platform) implants are in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The CoRoent Thoracolumbar System (XL and L platforms) implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The CoRoent Thoracolumbar System (XL and L platforms) implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The subject NuVasive CoRoent Thoracolumbar System are interbodies manufactured from PEEK-Optima LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK devices contain titanium alloy radiographic markers conforming to ASTM F136 or ASTM F1472 or tantalum markers conforming to ASTM 560 or ISO 13782. The device's hollow core or graft aperture allows for packing of autograft to help promote a solid fusion. Small spikes or teeth on each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device.
The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
This document (K153419) is a 510(k) premarket notification for a medical device called the NuVasive® CoRoent® Thoracolumbar System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a novel study.
Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria is largely not applicable in the context of this 510(k) submission document. Here's a breakdown of why and what information is available:
1. A table of acceptance criteria and the reported device performance
Not applicable for a 510(k) submission focused on substantial equivalence. The document states: "No new device designs and no new worst case sizes are being introduced to the subject CoRoent Thoracolumbar System. Therefore, no performance testing was performed for this 510(k) submission."
Instead of performance against new acceptance criteria, the device's technological characteristics were compared to predicate devices to demonstrate equivalence.
Here's a table based on the provided information, focusing on the comparisons made:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Intended Use Equivalence: | The NuVasive CoRoent Thoracolumbar System has the same intended use as its predicate devices, indicated for intervertebral body fusion of the spine in skeletally mature patients, with autogenous bone graft and supplemental internal spinal fixation. |
| Material Composition Equivalence: | Manufactured from PEEK-Optima LT-1 (ASTM F2026) or titanium alloy (Ti-6Al-4V) (ASTM F136). PEEK devices contain titanium alloy (ASTM F136 or F1472) or tantalum (ASTM 560 or ISO 13782) radiographic markers. This aligns with predicate device materials. |
| Design Equivalence: | Hollow core/graft aperture allows for autograft packing; small spikes/teeth to resist migration. Available in various sizes and lordotic angles. No new device designs are being introduced. |
| Function Equivalence: | Functions as an intervertebral body fusion device to facilitate fusion and resist migration. Functionally equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new performance testing was conducted for this 510(k) submission. Therefore, there is no test set or related data provenance.
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. No new test set requiring expert ground truth was created for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication was created for this submission.
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 intervertebral body fusion device and is not an AI/software device that would involve human readers or an MRMC study. The document explicitly states: "This device does not contain software or electrical equipment."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth data was generated for this 510(k). The "ground truth" for demonstrating substantial equivalence relies on existing regulatory clearances and performance data for the predicate devices, as well as established material standards (ASTM, ISO).
8. The sample size for the training set
Not applicable. This is a physical implant device, not an AI/software device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/software device.
Summary of what was used to demonstrate equivalence:
The "study" in this case was a comparison to legally marketed predicate devices by analyzing:
- Intended Use: The NuVasive CoRoent Thoracolumbar System shares the same fundamental intended use as its primary predicate, the CoRoent Lumbar System (K151472), and additional predicate, CoRoent Thoracolumbar Implants (K150994).
- Technological Characteristics: This includes material composition (PEEK-Optima LT-1, Ti-6Al-4V, and various radiographic markers conforming to ASTM/ISO standards), design features (hollow core, graft aperture, spikes/teeth, various sizes/lordotic angles), and overall function. The document explicitly states: "The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function."
- No new design or worst-case sizes: This allowed the manufacturer to bypass new performance testing for the mechanical attributes, relying on the already established safety and effectiveness of the predicate devices.
- Clinical Literature Review: A clinical literature review was performed to support the use of the subject device as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis, suggesting a review of existing scientific publications rather than a new primary study.
In essence, for a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through direct comparison of features and intended use, rather than through de novo performance testing against a specific set of new criteria.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.