(147 days)
The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Vault-C implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels. Patients should have at least six weeks of non-operative treatment with an intervertebral fusion device.
The Vault-C consists of a spacer assembly including a PEEK cage with a titanium alloy plate and titanium bone screws for intervertebral body fusion. Screws are available in a variety of diameter-length combinations. The titanium and PEEK spacers are available in a variety of depths, widths and heights. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine.
The provided text describes the Spinal USA Vault-C Standalone Cervical Interbody Fusion System, a medical device, and the testing conducted to support its 510(k) premarket notification. The study described is a non-clinical performance study, not an AI-based study or a clinical trial involving human data analysis. Therefore, many of the requested categories related to AI performance, human readers, sample sizes for training/test sets, and ground truth establishment for AI models are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Mode) | Reported Device Performance (Summary) |
|---|---|
| Static Axial Compression | Strength is sufficient for intended use; substantially equivalent to predicates |
| Static Compression-Shear | Strength is sufficient for intended use; substantially equivalent to predicates |
| Static Torsion | Strength is sufficient for intended use; substantially equivalent to predicates |
| Dynamic Axial Compression | Strength is sufficient for intended use; substantially equivalent to predicates |
| Dynamic Compression-Shear | Strength is sufficient for intended use; substantially equivalent to predicates |
| Dynamic Torsion | Strength is sufficient for intended use; substantially equivalent to predicates |
| Subsidence | Strength is sufficient for intended use; substantially equivalent to predicates |
The acceptance criteria implicitly refer to performance thresholds defined within the ASTM standards (ASTM F-2077 and ASTM F-2267) which the device was tested against and found to meet. The specific quantitative values for these thresholds or the Vault-C's measured performance are not explicitly stated, but the conclusion is that the device's strength is sufficient and comparable to predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. Non-clinical mechanical testing standards typically involve a defined number of samples, but the exact count is not mentioned here.
- Data Provenance: The data is from non-clinical mechanical testing of the device itself. It is not patient data from a specific country, nor is it retrospective or prospective in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a mechanical performance study of a physical device, not an AI or diagnostic study requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. This was a mechanical performance study.
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. This was a non-clinical mechanical performance study of a physical implant. It did not involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical intervertebral fusion system, not an algorithm.
7. The type of ground truth used
For this type of study, the "ground truth" is established by the specified ASTM standards (ASTM F-2077 and ASTM F-2267). The device's mechanical properties are measured and compared against the requirements and, implicitly, the performance of predicate devices as defined by these industry-recognized test methods.
8. The sample size for the training set
Not applicable. This is not an AI study, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of non-clinical mechanical performance 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.