(28 days)
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation.
The SeaSpine Ventura NanoMetalene (NM) System is an intervertebral fusion device manufactured from polyetheretherketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy.
This document is a 510(k) premarket notification for the SeaSpine Ventura NanoMetalene System, an intervertebral body fusion device.
Based on the provided text, there is NO information about acceptance criteria or a study proving the device meets acceptance criteria related to a software algorithm or AI performance.
The document explicitly states under "Clinical Testing":
"Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
The "Non-Clinical Testing" section describes tests related to:
- Packaging
- Shipping
- Sterilization
- Bacterial Endotoxin testing (BET)
These tests are for the physical device's sterility and packaging integrity, not for the performance of a diagnostic algorithm or AI system.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them, specifically regarding an AI-driven or diagnostic device performance, because the provided filing pertains to a physical medical implant device (intervertebral body fusion device) and states that clinical performance data was not used for the substantial equivalence determination.
§ 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.