(66 days)
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF 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 device is to be used with supplemental fixation.
Vertebral Body Replacement: When used as a vertebral body replacement, the CoAlign Innovations AccuLIF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The CoAlign Innovations AccuLIF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is always to be used with supplemental internal spinal fixation. Additionally, the device may be used with bone graft.
The AccuLIF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The AccuLIF Cage is manufactured from Ti6Al4V and stainless steel. The AccuLIF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes.
This is a spinal implant (AccuLIF Cage) and not an AI/ML device, therefore, the requested information about acceptance criteria for AI/ML performance, study design with test sets, ground truth establishment, expert reader qualifications, adjudication methods, MRMC studies, and training set details are not applicable.
The document describes the device, its indications for use, and a comparison to a predicate device (SEC IBF Cage - K093669) to establish substantial equivalence. The "study" referenced in this document are non-clinical bench tests focused on the mechanical properties of the implant.
Here's a breakdown of the provided information, framed to address the prompt's structure where applicable, and noting where it's not relevant for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate device | Non-clinical tests showed minor differences do not impact performance. |
| Meet ASTM F2077-03 standards for spinal implants | Tests conducted in accordance with ASTM F2077-03. |
| Maintain proper intervertebral/vertebral body spacing/angulation | Device acts as a spacer to maintain specified spacing and angulation. |
| Restore biomechanical integrity | Designed to restore biomechanical integrity of the spinal column. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not applicable in the context of an AI/ML device. For the non-clinical mechanical tests, the "sample size" would refer to the number of physical devices tested. This specific number is not provided, but it's implied that sufficient samples were tested to meet ASTM standards.
- Data Provenance: Not applicable. The "data" here refers to mechanical test results from laboratory (bench) testing of the physical implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts/Qualifications: Not applicable. For mechanical bench testing, ground truth is established by engineering specifications, material properties, and adherence to established ASTM standards, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations of medical images or data. For mechanical testing, results are objective measurements.
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
- MRMC Study: No, not applicable. This is a spinal implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the non-clinical tests, the "ground truth" is adherence to established engineering specifications and material properties as defined by ASTM F136 (for material) and ASTM F2077-03 (for mechanical testing). The comparison to the predicate device also serves as a benchmark for performance.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a physical device, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable.
§ 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.