(30 days)
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF XL Cage is 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 XL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF XL Cage is to be used with autogenous bone graft.
The AccuLIF XL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The Accul.JF XL Cage is manufactured from TI6A14V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, PEEK (Invibio Optima LT1) as per ASTM F2026-07, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with an articulating 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 Imm increments as it expands. The AccuLIF XL Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. The device has fixation ridges on the top and bottom surface. In addition each size comes in 8 foot prints 1) 45mm length x 18mm width, 2) 45mm length x 22mm width, 3) 50mm length x 18mm width, 4) 50mm length x 22mm width. 5) 55mm length x 18mm width, 6) 55mm length x 22mm width 7) 60mm length x 18mm width, and 8) 60mm length x 22mm width. 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 a 510(k) premarket notification for the CoAlign Innovations AccuLIF XL Cage, an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria through new performance data.
Therefore, many of the requested categories related to clinical study design, sample sizes, expert involvement, and ground truth establishment cannot be answered directly from the provided text. The approach taken here is a comparative one based on existing data from predicate devices.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | The device is demonstrated to be substantially equivalent to legally marketed predicate devices. This implies that its safety and effectiveness are considered comparable to those predicates previously cleared by the FDA. The submission argues that "minor differences do not raise any new issues of safety and effectiveness." |
| Technological Characteristics | The AccuLIF XL Cage has "nearly identical technological characteristics" to the predicate devices, including:Indications for UseMaterials of manufacture (Titanium-6AL-4V ELI alloy, PEEK)Expansion mechanismStructural support mechanism |
| Non-Clinical Testing | Surgical technique validation was conducted "in the same manner as the predicate surgical technique validation." This implies that the device performs acceptably within the established surgical technique. |
| Material Compliance | Manufactured from:TI6A14V ELI (as per ASTM F136-08)Stainless Steel (316 LVM) (as per ASTM F138-08)PEEK (Invibio Optima LT1) (as per ASTM F2026-07)Silicone Rubber (MED-4870)These conform to specified ASTM standards. |
2. Sample size used for the test set and the data provenance
- Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study with a distinct test set of patient data. The "testing" mentioned is non-clinical (surgical technique validation), not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No external experts were reported as used to establish ground truth for a test set of patient data. The FDA reviews the submission and determines substantial equivalence based on the provided technical and comparative data.
4. Adjudication method for the test set
- Not applicable. No test set of patient data requiring adjudication is mentioned.
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 document describes a medical implant device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a medical implant device, not an algorithm or AI system.
7. The type of ground truth used
- Implied ground truth for substantial equivalence: For the purpose of this 510(k), the "ground truth" is that the predicate devices (AccuLIF XL Cage K130194 and AccuLIF TL-PEEK Cage K123281) have already been deemed safe and effective by the FDA. The current device's ground truth is its conformance to the performance, design, and material characteristics that made the predicates safe and effective.
8. The sample size for the training set
- Not applicable. This device is an implant, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
§ 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.