(115 days)
Intervertebral Body Fusion
The NuVasive CoRoent 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 L and XL platforms are 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 CoRoent S platforms are intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from levels C2-C3 to C7- T1. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment. The System is intended to be used with supplemental fixation and autogenous bone graft only to facilitate the fusion.
Partial Vertebral Body Replacement
The NuVasive CoRoent System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
The NuVasive CoRoent System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
This is a spinal implant system (NuVasive CoRoent System), not an AI/ML powered device, so most of the requested information (acceptance criteria, study details, ground truth, training/test sets, expert evaluation, MRMC studies) is not applicable.
However, I can provide the relevant information from the document as it pertains to a traditional medical device submission:
1. A table of acceptance criteria and the reported device performance
For this type of device (spinal implant), acceptance criteria are primarily based on demonstrating substantial equivalence to previously cleared predicate devices in terms of:
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Equivalence in Indications for Use | Claimed to be equivalent |
| Equivalence in Design | Claimed to be equivalent |
| Equivalence in Material | Claimed to be equivalent |
| Equivalence in Function | Claimed to be equivalent |
| Mechanical Testing Performance | Mechanical testing was presented (specific results not detailed in submission summary) |
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. This submission is for a spinal implant system and does not involve AI/ML algorithms or a "test set" in the context of algorithm performance. The evaluation is against predicate devices and mechanical testing.
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. There is no "ground truth" establishment in the context of an AI/ML algorithm for this device. The regulatory review process involves FDA experts evaluating the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See 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
- Not Applicable. This device is a physical spinal implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. There is no "ground truth" as it would apply to an AI/ML algorithm. The "truth" for this submission is established through mechanical testing demonstrating performance characteristics (e.g., strength, durability) and detailed comparison to existing, cleared predicate devices to support substantial equivalence.
8. The sample size for the training set
- Not Applicable. This device does not involve a training set for an AI/ML model.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of Study:
The document states: "Data was provided which demonstrated the NuVasive CoRoent System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function." It also mentions "Mechanical testing was presented."
No clinical tests were applicable or conducted for this 510(k) submission, indicating that the clearance was based on non-clinical data and comparison to predicates.
§ 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.