(39 days)
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
The CoAlign Innovations AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL and PL Cages are to be used with autogenous bone graft.
The CoAlign Innovations AccuLIF® TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6A14V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with a delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands.
The AccuLIF TL and PL Cage comes in three sizes which are expandable from 6mm to 9mm, from 8mm to 12mm, and from 10mm to 16mm in 1mm increments . As well each size comes in two shapes, crescent and straight and each shape comes in two different footprints 11mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x 22mm and 11mm x 25mm for the straight shape or a total of 12 models. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.
The provided text describes the CoAlign Innovations AccuLIF® TL and PL Cage, an expandable interbody fusion cage. It details the device's description, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner requested by your prompt (e.g., performance metrics, sample sizes, ground truth establishment, or expert involvement).
The submission focuses on establishing "substantial equivalence" to legally marketed predicate devices, which is a common pathway for 510(k) clearance. This typically involves demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and that any differences do not raise new questions of safety or effectiveness.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study demonstrating device performance against those criteria, as this information is not present in the provided 510(k) summary.
The document states that the following non-clinical tests were conducted to support the claim of substantial equivalence:
- Dynamic compression testing, conducted in accordance with ASTM F2077-03
- Dynamic shear testing, conducted in accordance with ASTM F2077-03
- Static compression testing, conducted in accordance with ASTM F2077-03
- Static shear testing, conducted in accordance with -ASTM F2077-03
- Static Subsidence testing, conducted in accordance with -ASTM F2267-04
- Static Expulsion testing, conducted in accordance with -ASTM Draft Standard F-04.25.02.02
- Surgical technique validation, conducted in the same manner as the predicate surgical technique validation.
The "Conclusions" section states: "The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates." This is a general statement about meeting the requirements for substantial equivalence, not a detailed report of reaching specific acceptance criteria tied to performance metrics.
§ 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.