(241 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 to facilitate fusion.
The CoRoent Ti-C System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 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 lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The NuVasive® CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) 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 implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The provided document is a 510(k) premarket notification for a medical device (CoRoent Ti-C System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical or performance study results for achieving specific acceptance criteria.
Therefore, the document does not contain the information requested for acceptance criteria and the study proving the device meets those criteria, specifically:
- A table of acceptance criteria and the reported device performance: This information is not provided. The document states "no new worst-case for performance testing" but does not detail specific performance thresholds or results against them.
- Sample sized used for the test set and the data provenance: No test set is described in the context of clinical performance.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable as no clinical test set/ground truth is discussed.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states, "No non-clinical or clinical studies were conducted."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not a software/algorithm device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as no training set for an algorithm is described.
- How the ground truth for the training set was established: Not applicable.
The performance data mentioned in the document (Section G, Page 4) is limited to nonclinical testing primarily for demonstrating equivalence to predicate devices:
- Static and dynamic axial compression and compression shear per ASTM F2077
- Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877
The conclusion drawn from this testing is that "the subject CoRoent Ti-C System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate." However, specific acceptance criteria values and the device's numerical performance against those values are not detailed in this submission.
§ 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.