(93 days)
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL-PEEK 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 spondvlolisthesis 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-PEEK Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL-PEEK Cage is to be used with autogenous bone graft.
The AccuLIF TL-PEEK Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL-PEEK Cage is manufactured from Tl6Al4V 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 1mm increments as it expands. The AccuLIF 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. 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.
This document is a 510(k) Summary for the AccuLIF® TL-PEEK Cage, a spinal intervertebral body fixation orthosis. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on mechanical testing to demonstrate the substantial equivalence of the AccuLIF TL-PEEK Cage to its predicates. The acceptance criteria are implicitly that the subject device's performance is comparable to or better than previously cleared predicate devices per the cited ASTM standards, and that minor differences do not raise new issues of safety and effectiveness.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Comparable to predicate devices in: | Non-clinical tests conducted (standards used for comparison): |
| - Dynamic compression strength | Conducted in accordance with ASTM F2077-03. (The submission states "comparison to the predicates," implying the results met or exceeded the predicates' performance, but specific numerical results for acceptance are not detailed in this summary.) |
| - Dynamic shear strength | Conducted in accordance with ASTM F2077-03. |
| - Static compression strength | Conducted in accordance with ASTM F2077-03. |
| - Static shear strength | Conducted in accordance with ASTM F2077-03. |
| - Static Subsidence resistance | Conducted in accordance with ASTM F2267-04. |
| - Static Expulsion resistance | Conducted in accordance with ASTM Draft Standard F-04.25.02.02. |
| Surgical Technique Validation: | |
| Comparable to predicate surgical technique. | Conducted in the same manner as the predicate surgical technique validation. (Implicitly passed by demonstrating no impact of minor differences on device performance). |
| Material Equivalence: | |
| Materials conform to specified ASTM standards. | AccuLIF TL-PEEK Cages are made from Titanium-6AL-4V ELI alloy (ASTM F136) and PEEK (Invibio Optima LT1) (ASTM F2026-07), which are the same materials as the predicates. |
| Indications for Use: | |
| Same as predicate devices. | The Indications for Use are identical to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size (number of devices tested) for each of the non-clinical mechanical tests. It only lists the types of tests performed.
- Data Provenance: The data is from non-clinical (laboratory/mechanical) testing of the device, performed by the manufacturer, CoAlign Innovations. The provenance is internal testing, not patient-derived data, and therefore the concepts of country of origin or retrospective/prospective do not apply in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The "ground truth" for mechanical testing is established by the defined test standards (e.g., ASTM F2077-03) and the measured physical properties of the device, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to human clinical review processes (e.g., for radiology reads), which are irrelevant for non-clinical mechanical device testing.
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
This section is not applicable. The device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the "test set" (i.e., the non-clinical tests) is based on defined engineering standards (ASTM standards) and the measured physical properties and performance characteristics of the device and its predicate devices. The goal is to demonstrate that the new device meets the performance expectations already established by these standards and by the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This section is not applicable, as there is no "training set" for a physical medical 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.