(65 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 SI. 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 AccuLIF XL Cage is manufactured from TI6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, PEEK (Invibio Optima LTI) 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 1mm 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 4 foot prints 1) 45mm length x 18mm width, 2) 45mm length x 22mm width, 3) 60mm length x 18mm width, and 4) 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 Special 510(k) submission for the CoAlign Innovations AccuLIF XL Cage, a medical device for intervertebral body fusion. This document focuses on the mechanical and material performance of the device rather than the performance of a diagnostic or AI-driven system. Therefore, many of the requested points related to AI studies, ground truth establishment, expert review, and sample sizes for training/test sets are not applicable to this type of device submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|---|
| Dynamic Compression | ASTM F2077-03 | Conducted in accordance with ASTM F2077-03 |
| Dynamic Shear | ASTM F2077-03 | Conducted in accordance with ASTM F2077-03 |
| Static Compression | ASTM F2077-03 | Conducted in accordance with ASTM F2077-03 |
| Static Shear | ASTM F2077-03 | Conducted in accordance with ASTM F2077-03 |
| Static Subsidence | ASTM F2267-04 | Conducted in accordance with ASTM F2267-04 |
| Static Expulsion | ASTM Draft Standard F-04.25.02.02 | Conducted in accordance with ASTM Draft Standard F-04.25.02.02 |
| Surgical Technique Validation | Predicate surgical technique validation | Conducted in the same manner as the predicate surgical technique validation. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a physical medical device (intervertebral cage) undergoing mechanical and material testing, not a digital device or AI algorithm with test data. The tests are laboratory-based mechanical evaluations as per ASTM standards, not clinical studies with patient data. The "test set" in this context refers to the physical devices tested, but specific numbers are not provided in the summary. The provenance is the testing laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As this is a mechanical device, "ground truth" is established by adherence to engineering performance standards (ASTM) and comparison to predicate devices, not by expert interpretation of data.
4. Adjudication method for the test set
- Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for this type of mechanical testing. Compliance is determined by whether the device meets the specified criteria in the ASTM standards.
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 is not an AI-driven device, nor is it a diagnostic imaging device typically associated with MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical intervertebral cage, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this medical device submission is adherence to established ASTM (American Society for Testing and Materials) standards for mechanical performance of intervertebral body fusion devices, and demonstration of substantial equivalence to predicate devices in terms of design, function, materials, and intended use. The physical and mechanical properties outlined in these standards serve as the "truth" against which the device's performance is measured.
8. The sample size for the training set
- Not Applicable. There is no "training set" for a physical medical device in this context. The manufacturing process and design principles are based on engineering knowledge, material science, and regulatory requirements, not machine learning training.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study involved a series of non-clinical biomechanical tests conducted on the AccuLIF XL Cage. These tests were performed in accordance with recognized ASTM (American Society for Testing and Materials) standards, specifically:
- Dynamic Compression testing (ASTM F2077-03)
- Dynamic Shear testing (ASTM F2077-03)
- Static Compression testing (ASTM F2077-03)
- Static Shear testing (ASTM F2077-03)
- Static Subsidence testing (ASTM F2267-04)
- Static Expulsion testing (ASTM Draft Standard F-04.25.02.02)
- Surgical technique validation, which was conducted in the same manner as the predicate device's validation.
The conclusion of these tests was that the AccuLIF XL Cage was substantially equivalent to its predicate devices (AccuLIF-PEEK Cage K123281, AccuLIF TL Cage K1216835 and K113465, and the SEC Interbody Fusion Cage K093669). This substantial equivalence was based on shared indications for use, design, function, and materials of manufacture. The submission explicitly states that "the predicate device testing represented a worst case such that any minor differences do not impact device performance as compared to the predicates." This implies that the new device's performance met or exceeded the established safety and effectiveness profile of the already-approved predicate devices under the specified testing conditions.
§ 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.