(28 days)
The CoAlign Innovations AccuLIF TL 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 TL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL Cage is to be used with autogenous bone graft.
The AccuLIF TL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL Cage is manufactured from 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 an articulating delivery handle and expanded insitu 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. Each size also comes in an 11mm x 34mm footprint and a 13mm x 34mm footprint. 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.
In addition, the AccuLIF TL Cage System includes distractor trials to aid in distracting the disc space and in selecting the appropriate size cage to use in the surgical procedure. The set also contains a variety of other instruments to aid in the implantation of the cages.
The provided text describes a 510(k) premarket notification for a medical device, the AccuLIF TL Cage. This submission is for an update to an existing device, specifically adding new instruments (distractor trials) to the system. Therefore, the "study" conducted is primarily focused on demonstrating that these new additions do not negatively impact the safety and effectiveness of the previously cleared device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The addition of distractor trials does not raise any new issues of safety and effectiveness. | "The addition of distractor trials to the system does not raise any new issues of safety and effectiveness." |
| "The non-clinical test results demonstrate that the addition of the distractor trial instruments to the system do not impact device safety and effectiveness or performance as compared to the predicates." | |
| Performance of the subject device (with new instruments) is comparable to predicate devices. | "The subject and predicate devices share the same indications for use, design, function, and materials of manufacture." |
| "The AccuLIF® TL Cages were shown to be substantially equivalent to the AccuLIF® TL Cage (K113465) and CRESCENT® Spinal System Titanium (K110543)." | |
| The device (with new instruments) maintains its intended function as an intervertebral body fusion device. | "Validated through cadaver testing." (Implicitly demonstrates continued functionality and effectiveness in a surgical setting.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated as a number. The text mentions "cadaver testing." For cadaver tests in medical devices, sample sizes can vary, but details like the number of cadavers or test repetitions are not provided.
- Data Provenance: The cadaver testing implies a prospective experimental setup. The country of origin for the cadaver data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. For cadaver testing, it would typically involve surgeons or other medical professionals experienced in spinal procedures, but their specific qualifications (e.g., years of experience, specialization) are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. In cadaver testing, the "adjudication" would typically involve direct observation and assessment by the testing team and/or the participating medical professionals. There's no mention of a formal consensus method like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This submission focuses on the safety and effectiveness of new instruments via cadaver testing, not on comparative effectiveness (e.g., human reader performance with/without AI assistance). The device itself is an implantable surgical device, not a diagnostic or AI-powered system that involves human interpretation of output.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
- Standalone Study: No, a standalone performance study was not done. This is not an AI algorithm or software-only device. The "device" in question is a physical surgical implant system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the cadaver testing would be based on direct observation and surgical assessment of proper instrument function and implantation success within the cadaveric model. This would include evaluating ease of use, ability to distract the disc space, and proper selection of cage size, as intended by the new distractor trials.
8. The Sample Size for the Training Set
- Sample Size for Training Set: This concept is not applicable here as there is no "training set" in the context of this 510(k) submission. This is not an AI/ML device that requires training data. The device's design and mechanical properties are pre-determined.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.
§ 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.