(14 days)
The nvª, nvª, and nv are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.
The nv4, nvP, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 or PEEK Optima HA Enhanced and include tantalum markers per ASTM F560 for radiographic visualization.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.
The provided text describes a medical device, the nvª, nvP, and nvb intervertebral body fusion devices, and their 510(k) premarket notification to the FDA. However, it does not contain information about acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML device testing.
This document pertains to the regulatory clearance of a physical medical implant (intervertebral body fusion device) based on its substantial equivalence to previously cleared predicate devices, primarily through non-clinical engineering analysis of mechanical performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they would apply to an AI/ML device, because this document is about a physical medical device and its mechanical performance, not an AI/ML algorithm.
The document explicitly states:
- "No FDA performance standards have been established for the nv4, nv7, and nv1." (Page 4)
- "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparison of mechanical performance in compression/ compression shear, subsidence, and expulsion (reference ASTM F2077 and F2267). The results of the engineering analysis indicate that the nv3, nvP and nv system is substantially equivalent to the predicate devices." (Page 4)
This indicates that the safety and effectiveness were demonstrated through engineering analysis and comparison to predicate devices, not through a clinical study involving human or AI evaluation with performance metrics like sensitivity, specificity, etc.
§ 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.