(74 days)
The nvª, nvº, and nv are intended for intervertebral body fusion in the lumbar spine 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.
The nv4, nv9, 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 and include tantalum markers per ASTM F560 for radiographic visualization.
The nv4 and nv2 devices have multiple footprints to adapt to the general shape of the vertebral endplates. The nv , nv , and nv are available in multiple heights to accommodate patient variability and have a hollow centre to accommodate bone graft. The devices are implanted via a variety of surgical approaches which include anterior, and transforaminal. There are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.
This document is a 510(k) summary for medical devices (nvª, nvP, and nv*) from Nvision Biomedical Technologies, LLC. It outlines the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner requested (i.e., performance metrics like sensitivity, specificity, accuracy, etc., typically associated with AI/ML devices).
The document focuses on:
- Device Description: Intervertebral body fusion devices made from PEEK Optima® LT1 with tantalum markers.
- Intended Use: Lumbar spinal fusion for degenerative disc disease (DDD) in conjunction with supplemental fixation and autograft.
- Substantial Equivalence: Claims substantial equivalence to listed predicate devices (Genesys Spine ApacheTM System and SeaSpine Spacer System – PacificaTM) in terms of intended use, materials, design, technological characteristics, mechanical safety, and performance.
- Mechanical Testing: Mentions performance testing was conducted according to standardized tests (Static and Dynamic Axial Compression per ASTM F2077, Subsidence per ASTM F2267, Expulsion) and that these results "demonstrate substantial equivalence."
Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving device performance against those criteria, as this document does not contain that type of data. The information provided is primarily for regulatory clearance based on substantial equivalence to existing devices, focusing on design, materials, and mechanical safety, rather than a clinical performance study with specific acceptance criteria that would be relevant for devices like AI/ML products.
§ 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.