(101 days)
The NuVasive Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal 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 NuVasive Cohere Thoracolumbar Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12, at the thoracolumbar junction (T12-L1), and in the lumbar spine from L1 to S1 for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy 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 NuVasive Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The NuVasive Cohere Thoracolumbar Interbody System comprises of sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the thoracolumbar spinal column in thoracolumbar intervertebral body fusion procedures.
Each device within the Cohere Thoracolumbar Interbody System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. In addition to PEEK, the device assembly may contain two or more radiolucent markers, depending on footprint, to enable visibility under x-ray in vivo.
The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The provided document is an FDA 510(k) clearance letter for the NuVasive® Cohere® Thoracolumbar Interbody System. This document does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it concerns a physical intervertebral body fusion device.
Therefore, most of the requested information regarding acceptance criteria, study design for a diagnostic device, sample size, experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable (N/A) to this document's content.
However, I can extract information related to the device's performance data and the basis for its clearance, which can be interpreted in the context of "acceptance criteria" for a physical medical device.
Here's what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (based on predicate equivalence and standards) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Demonstrated equivalence to predicate devices in design, intended use, material composition, and function. | "The subject Cohere Thoracolumbar Interbody System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States." |
| Meeting established ASTM standards for intervertebral body fusion devices. | "The results demonstrate that the subject Cohere Thoracolumbar Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate." |
| Static and Dynamic Axial Compression (per ASTM F2077) compliance. | Testing performed, results indicate compliance for substantial equivalence. |
| Static and Dynamic Compression Shear (per ASTM F2077) compliance. | Testing performed, results indicate compliance for substantial equivalence. |
| Compressive and Compressive-Shear Wear Particulate Analysis (ASTM F1877) compliance. | Testing performed, results indicate compliance for substantial equivalence. |
| Subsidence (per ASTM F2267) compliance. | Testing performed, results indicate compliance for substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified as N/A in the context of a physical device. Performance was assessed through non-clinical (mechanical) testing, not patient data.
- Data provenance: N/A. The testing was non-clinical engineering testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: N/A. Ground truth was established through engineering standards (ASTM) and comparison to predicate devices, not expert human evaluation of typical diagnostic outputs.
- Qualifications of experts: N/A.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: N/A. This concept is for clinical or diagnostic studies. The evaluation here was based on specified engineering tests and comparison to a predicate device.
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:
- MRMC study: No. This is a physical device, not an AI/diagnostic software.
- Effect size: N/A.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance: N/A. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: The "ground truth" for this device's performance is adherence to established engineering standards (ASTM) and demonstration of substantial equivalence to already cleared predicate devices based on design, materials, and functional testing.
8. The sample size for the training set:
- Training set sample size: N/A. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Ground truth establishment for training set: N/A.
In summary, the document describes the clearance of a physical medical device based on non-clinical engineering testing and substantial equivalence to predicate devices, rather than a diagnostic AI/ML system. Therefore, many of the questions are not applicable to the content provided.
§ 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.