(129 days)
The NuVasive CoRoent 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 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 System (L and XL platforms) can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The CoRoent System implants are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK device contains titanium alloy radiographic markers conforming to ASTM F136/ ASTM F1472 or tantalum markers conforming to ASTM 560/ 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 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 510(k) is to modify the indications for use to include treatment of degenerative scoliosis.
The information provided does not contain acceptance criteria for a device, or a study specifically designed to demonstrate that the device meets acceptance criteria. Instead, the document is a 510(k) summary for the NuVasive CoRoent System, which aims to establish substantial equivalence to predicate devices. This type of submission relies on comparisons to existing legally marketed devices, rather than establishing de novo performance criteria and conducting a study against them.
However, I can extract information related to the performance data and the basis for the assertion of substantial equivalence, which is the closest approximation to what you're asking for based on the provided text:
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1. A table of acceptance criteria and the reported device performance:
Not applicable (N/A). The document does not define specific "acceptance criteria" and "reported device performance" in the context of a de novo study. It asserts substantial equivalence based on a comparison to predicate devices and existing clinical data. -
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document states: "published retrospective clinical data for the CoRoent System as well as devices similar to the subject spinal system were provided in support of this application."- Sample size: Not specified.
- Data provenance: Retrospective clinical data. Country of origin not specified.
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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 (N/A). This information is not provided as the submission relies on existing clinical data and a comparison to predicate devices, rather than a de novo ground truth establishment process for a new test set. Degenerative Disc Disease (DDD) is defined by "history and radiographic studies," which implies expert interpretation, but details on the number or qualifications of these experts are not given. -
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable (N/A). This detail is not provided. -
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 (N/A). The device is an intervertebral body fusion system, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI assistance is mentioned. -
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable (N/A). The device is a physical implant, not an algorithm. -
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the existing clinical data referenced, the "ground truth" for efficacy would generally be outcomes data related to fusion, symptom improvement, and lack of adverse events in patients treated with the CoRoent System and similar devices. The definition of DDD mentions "degeneration of the disc confirmed by history and radiographic studies," which implies expert radiographic interpretation. -
8. The sample size for the training set:
Not applicable (N/A). The device is a physical implant. The concept of a "training set" for an algorithm does not apply. The clinical data mentioned is for performance assessment, not for training a model. -
9. How the ground truth for the training set was established:
Not applicable (N/A). As there is no "training set" in the context of this device, this question is not relevant.
§ 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.