(138 days)
The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.
The Vault ALIF System consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from medical grade polyetheretherketone (Peek LTI). The products are supplied clean and "NON-STERILE".
The provided document describes the mechanical testing and substantial equivalence determination for the Vault ALIF System, an intervertebral body fusion device. It does not contain information about an AI device or a study involving human readers or ground truth for AI. Therefore, I will respond to the prompt by extracting the available information related to the device's acceptance criteria and the study (mechanical testing) demonstrating it meets these criteria, while noting the absence of AI-specific details.
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:
The Vault ALIF System, an intervertebral body fusion device, underwent mechanical testing to demonstrate its safety and effectiveness. The acceptance criteria were primarily based on showing substantial equivalence to existing predicate devices in terms of mechanical strength and functional characteristics.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Method) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Static testing in axial compression (load to failure per ASTM F2077) | Vault system's mechanical strength is greater than the predicate. (Specific numerical values for load to failure are not provided in this document, but a comparative statement is made.) |
| Static testing in shear compression (load to failure per ASTM F2077) | Vault system's mechanical strength is greater than the predicate. | |
| Static testing in subsidence (per ASTM F2267) | Included in the test battery. (Specific comparative outcome not detailed beyond overall superior strength.) | |
| Static testing in expulsion | Included in the test battery. (Specific comparative outcome not detailed beyond overall superior strength.) | |
| Cyclical axial compression (to estimate max run out load at 5,000,000 cycles) | Included in the test battery. (Specific comparative outcome not detailed beyond overall superior strength.) | |
| Cyclical shear compression (to estimate max run out load at 5,000,000 cycles) | Included in the test battery. (Specific comparative outcome not detailed beyond overall superior strength.) | |
| Material Equivalence | Materials used in the device | The materials used in the Vault system are the same as used in the predicate systems (medical grade polyetheretherketone (Peek LTI)). |
| Design Equivalence | Design (height, width, length, lordotic angle) | The design of the Vault system is similar to the predicates in height, width, length, and lordotic angle. |
| Functional Equivalence | Bone port opening | The bone port opening of the Vault system is equivalent to its predicates. |
| Intended Use Equivalence | Intended Use | The intended use of the Vault system is the same as the predicates. |
| Indications for Use Equivalence | Indications for Use | The indication for use of the Vault system is the same as the predicates. |
Mechanical Test Conclusion:
The mechanical test results concluded that the Vault system is as safe as the predicates based on its similar design, identical materials, and superior mechanical strength. It is as effective as the predicate due to the same intended use, indications for use, and equivalent bone port opening.
The following information regarding AI device testing is not applicable to the provided document, as it describes a non-AI medical device and its mechanical testing for regulatory clearance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable to this document, as it describes mechanical testing of a physical device, not an AI algorithm evaluated with a dataset.
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)
Not applicable to this document. Ground truth for mechanical testing is based on engineering standards and measurements, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to this document. Adjudication methods are relevant for human interpretation of data, not mechanical properties of a device.
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, as this document pertains to a physical medical device and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable to this document. This refers to AI algorithm performance, which is not described here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be established by the precise measurements and calculations derived from standardized test methods (e.g., ASTM F2077, F2267) and engineering principles, which define what constitutes a "passing" or "equivalent" performance. This is not comparable to expert consensus or pathology data for AI systems.
8. The sample size for the training set
Not applicable to this document, as there is no AI algorithm training described.
9. How the ground truth for the training set was established
Not applicable to this document, as there is no AI algorithm training described.
§ 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.