(20 days)
Intervertebral Body Fusion Device: 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 TI6Al4V 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 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 Accul.IF 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
The provided text describes the regulatory submission for a medical device called the AccuLIF® TL Cage, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.
However, based on the discussion of testing section, we can infer the types of acceptance criteria being addressed by the non-clinical tests. The "reported device performance" would be the successful completion of these tests in accordance with the specified ASTM standards and the conclusion of substantial equivalence.
Here's an attempt to structure the information based on your request, with the understanding that direct quantitative acceptance criteria and performance values are not explicitly provided in the document for the device itself, but rather compliance with standards is indicated:
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance: | |
| Dynamic compression strength | Met requirements of ASTM F2077-03 |
| Dynamic shear strength | Met requirements of ASTM F2077-03 |
| Static compression strength | Met requirements of ASTM F2077-03 |
| Static shear strength | Met requirements of ASTM F2077-03 |
| Static Subsidence resistance | Met requirements of ASTM F2267-04 |
| Static Expulsion resistance | Met requirements of ASTM Draft Standard F-04.25.02.02 |
| Surgical Technique Performance: | |
| Surgical technique validation | Validation conducted and shown to be similar to predicate |
Note: The document does not provide specific numerical acceptance thresholds or the raw data for device performance. Instead, it states that tests were "conducted in accordance with" specific ASTM standards, implying successful completion to meet the standards' criteria. The overall conclusion is that these tests demonstrate "any minor differences do not impact device performance as compared to the predicates."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only mentions that non-clinical tests were conducted. Typically, such tests involve a certain number of samples for each test type, but these numbers are not disclosed.
- Data Provenance: Not applicable in the context of clinical data. These are non-clinical (mechanical and surgical technique) tests conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. The study involves non-clinical engineering and mechanical testing, not a clinical study involving experts establishing ground truth for a test set in the conventional sense (e.g., radiologists interpreting images). The "surgical technique validation" would involve skilled personnel, but their number and specific qualifications are not detailed.
4. Adjudication method for the test set
- Not applicable. This is not a clinical study requiring adjudication of expert interpretations.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical spinal implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical spinal implant, not an algorithm. The non-clinical tests performed are inherently "standalone" in the sense that they assess the device's physical properties.
7. The type of ground truth used
- The "ground truth" for the non-clinical tests is based on established engineering principles and the requirements of the specified ASTM international standards (e.g., F2077-03, F2267-04, ASTM Draft Standard F-04.25.02.02). For the surgical technique validation, the "ground truth" would be the successful and safe deployment and function of the device as intended, in a similar manner to the predicate.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI study.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI study.
Summary Explanation:
The provided document is a 510(k) summary for a medical device (AccuLIF® TL Cage), which aims to demonstrate "substantial equivalence" to existing legally marketed predicate devices. The "study" described consists of a series of non-clinical, biomechanical tests and surgical technique validation. The acceptance criteria for these tests are implicitly defined by compliance with the referenced ASTM standards. The reported device performance is that these tests were conducted "in accordance with" these standards and that the device's performance is comparable to the predicates, without explicitly listing raw data or specific numerical thresholds. The submission's goal is to show that the device meets safety and effectiveness requirements by being functionally equivalent to already approved devices, rather than through a novel clinical trial with quantitative performance metrics against a "ground truth" in a human study.
§ 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.