(101 days)
The NuVasive CoRoent Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent Lumbar System (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-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. Additionally, the CoRoent Lumbar System (L and XL platforms) can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The CoRoent Lumbar System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK device contains radiographic markers manufactured from titanium alloy conforming to ASTM F136 or ASTM F1472. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion. 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. The purpose of this 510(k) is to expand the indications for use of previously cleared CoRoent Lumbar implants for use in patients with degenerative scoliosis.
This document is a 510(k) Summary for the NuVasive® CoRoent® Lumbar System. It seeks to expand the indications for use of previously cleared implants. The information provided in the document does not include a study to prove the device meets acceptance criteria, but rather asserts substantial equivalence to existing predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and the reported device performance: This document does not specify any performance-based acceptance criteria or provide performance data for the device. Instead, it relies on substantial equivalence to predicate devices.
- Sample size used for the test set and the data provenance: Since no performance study is described, there's no test set, sample size, or data provenance mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is mentioned.
- Adjudication method for the test set: No adjudication method is mentioned as there is no test set or study described.
- 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: No MRMC study or AI component is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is mentioned.
- The type of ground truth used: No ground truth is mentioned in the context of a performance study.
- The sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: No ground truth for a training set is mentioned.
Key takeaway from the document:
- Substantial Equivalence: The NuVasive CoRoent Lumbar System is deemed substantially equivalent to the primary predicate device, NuVasive CoRoent System (K141896), and additional predicate NuVasive CoRoent System (K141665).
- No Performance Data: The document explicitly states: "No performance data was provided to demonstrate that the subject NuVasive CoRoent Lumbar System is substantially equivalent to the predicate devices."
- Basis of Equivalence: The substantial equivalence is based on technological characteristics and comparison to predicate devices, specifically in areas including design, labeling/intended use, material composition, and function, with an emphasis that "There have been no design changes to the implants previously cleared in the predicate 510(k)s."
- Purpose: The purpose of this 510(k) is to expand the indications for use of previously cleared CoRoent Lumbar implants for use in patients with degenerative scoliosis.
§ 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.