(123 days)
The NuVasive CoRoent Ti-C System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental 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 Ti-C System (XL platform) is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the CoRoent (XL and L platforms) are intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent Ti-C System (XL and L platforms) are also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.
The NuVasive CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) LT1 conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, Ti-6Al-4V ELI conforming to ASTM F136/1472 or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. The implant contains a hollow core or graft aperture which allows for packing of bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Radiographic pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The purpose of this 510(k) submission is to add a manufacturer.
The provided text is a 510(k) summary for the NuVasive CoRoent Ti-C System, an intervertebral body fusion device. Regulatory documents like this primarily focus on establishing substantial equivalence to previously cleared devices rather than defining new performance criteria or conducting extensive clinical trials for new acceptance criteria.
Therefore, the information required to answer the questions about acceptance criteria and the study that proves the device meets the acceptance criteria is largely not present in the provided text, as this device's approval is based on equivalence to existing devices and non-clinical testing.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
This information is not provided. The document states that the device "meets the requirements as outlined in the Agency's guidance, 'Submission and Review of Sterility Information in Premarket Notification (510(K)) Submissions for Devices Labeled as Sterile'" and that nonclinical testing showed "no new worst-case for performance testing" compared to predicates. Specific numerical acceptance criteria or performance metrics are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions nonclinical testing (mechanical and bacterial endotoxin testing) but does not specify the "sample size" in the context of a test set for human-AI performance or the data provenance. There were no animal or clinical studies.
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)
This information is not applicable/provided. The device is an implant, and its approval is based on physical and material properties, and biological safety. There is no mention of a "test set" requiring expert ground truth in the context of diagnostic or interpretive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the same reasons as point 3.
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
This information is not applicable/provided. This device is not an AI diagnostic or assistive device. It is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device does not contain software or electrical equipment, and therefore, no algorithm-only performance testing would be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical tests mentioned (e.g., tensile strength, wear debris), the "ground truth" would be the established physical and mechanical standards (e.g., ASTM F2077) and biological safety standards (e.g., ANSI/AAMI ST-72:2011). These standards define acceptable ranges for the tested properties. No expert consensus or pathology data is mentioned in relation to the device's performance in this regulatory context.
8. The sample size for the training set
This information is not applicable/provided. The device is a physical implant, not an AI model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reason as point 8.
§ 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.