(85 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. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. 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 anatornical 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 describes the FDA clearance for the NuVasive® Cohere® Thoracolumbar Interbody System, an interbody fusion device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a standalone AI/software device.
Therefore, many of the requested elements for acceptance criteria and a study proving a device meets acceptance criteria (especially for an AI/software device) are not applicable or not present in this document, as it pertains to a physical medical implant.
Here's an attempt to answer the questions based on the provided text, highlighting what is not applicable to a physical device or not present in the document:
1. A table of acceptance criteria and the reported device performance
Since this is a physical implant seeking substantial equivalence to predicate devices, the "acceptance criteria" are primarily related to biomechanical performance and material properties. The document states that the device meets the same criteria as the predicate devices.
| Acceptance Criteria (from "G. Performance Data") | Reported Device Performance (from "G. Performance Data") |
|---|---|
| Biomechanical Testing: | The subject Cohere Thoracolumbar Interbody System meets the same criteria as the predicate devices. |
| - Static and Dynamic Axial Compression (per ASTM F2077) | Performance demonstrated per ASTM F2077 |
| - Static and Dynamic Compression Shear (per ASTM F2077) | Performance demonstrated per ASTM F2077 |
| - Subsidence (per ASTM F2267) | Performance demonstrated per ASTM F2267 |
| Material/Particulate Analysis: | The subject Cohere Thoracolumbar Interbody System meets the same criteria as the predicate devices. |
| - Gravimetric and Particulate analysis (ASTM F1714 and ASTM F1877) | Performance demonstrated per ASTM F1714 and ASTM F1877 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the non-clinical tests (e.g., how many devices were tested for axial compression).
- Data Provenance: Not applicable. The testing is non-clinical, likely conducted in a lab setting, not involving human subjects or data from a specific country of origin in the way clinical studies do. The document does not specify where the testing took place.
- Retrospective/Prospective: Not applicable to non-clinical bench 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. Ground truth, in the context of AI/software devices, refers to expert-validated labels for data. For a physical implant, "ground truth" is typically established by physical measurement against engineering specifications and industry standards. This document does not mention experts establishing ground truth for the performance data, but rather engineers and technicians performing standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling of data, typically in clinical or AI performance studies. This is not mentioned for the non-clinical testing of a physical implant.
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 is a physical, sterile interbody fusion device, not an AI or software device that assists human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not an algorithm or software. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical performance data, the "ground truth" is adherence to established ASTM (American Society for Testing and Materials) standards and engineering specifications for mechanical properties and material characteristics.
8. The sample size for the training set
Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for it.
Summary of what the document does provide regarding "studies":
The document explicitly states that "No clinical studies were conducted." (Page 4, Section G).
The "study" that proves the device meets (or is equivalent to) acceptance criteria is a series of non-clinical bench tests:
- Static and Dynamic Axial Compression (per ASTM F2077)
- Static and Dynamic Compression Shear (per ASTM F2077)
- Gravimetric and Particulate analysis (ASTM F1714 and ASTM F1877)
- Subsidence (per ASTM F2267)
The conclusion (Page 4, Section G and Page 5, Section H) is that "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."
§ 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.