(248 days)
The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device must be used with supplement fixation.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy.
The provided text describes a medical device, the Cervical Spine Truss System (CSTS) Interbody Fusion Device, and its 510(k) premarket notification to the FDA. This submission is for an updated version of an already cleared device, intended to introduce design changes to the interbody devices.
However, the document focuses on mechanical performance testing using engineering standards (like ASTM F2077, F2267-04, F2119, F2182, F2213, F2052) to demonstrate the device's strength and substantial equivalence to predicate devices. It does not present any clinical study data or involve acceptance criteria related to a device's diagnostic or therapeutic performance in the context of human-machine interaction or AI performance.
Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them (such as human reader improvement with AI assistance, expert consensus for ground truth, sample sizes for training/test sets for an algorithm, etc.) are not applicable to this document.
The document primarily demonstrates the structural and material integrity of the medical implant through non-clinical testing.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, the acceptance criteria are not in the form of specific performance metrics for an AI/diagnostic device, but rather compliance with established engineering standards for interbody fusion devices.
| Acceptance Criteria (from Performance Standards) | Reported Device Performance |
|---|---|
| Static and dynamic axial compression per ASTM F2077 | Demonstrated sufficient strength and substantial equivalence to predicate devices. |
| Static and dynamic axial compression shear per ASTM F2077 | Demonstrated sufficient strength and substantial equivalence to predicate devices. |
| Static and dynamic torsion per ASTM F2077 | Demonstrated sufficient strength and substantial equivalence to predicate devices. |
| Subsidence Testing per ASTM F2267-04 | Demonstrated sufficient strength and substantial equivalence to predicate devices. |
| Expulsion testing | Demonstrated sufficient strength and substantial equivalence to predicate devices. |
| MR image artifact per ASTM F2119 | Demonstrated substantial equivalence to predicate devices. |
| RF induced heating per ASTM F2182 | Demonstrated substantial equivalence to predicate devices. |
| MR induced torque per ASTM F2213 | Demonstrated substantial equivalence to predicate devices. |
| MR induced displacement force per ASTM F2052 | Demonstrated substantial equivalence to predicate devices. |
| No new worst-case compared to previously cleared devices for mechanical performance (via validated finite element analysis) | Achieved; design changes do not introduce a new worst-case. |
2. Sample size used for the test set and the data provenance: Not applicable. This involves mechanical testing of physical devices or simulations, not a test set of data like in an AI/diagnostic study. The "test set" here refers to the physical devices manufactured for testing. Data provenance is not relevant in the context of mechanical engineering tests on manufactured components.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for mechanical properties is established by the rigorous application of testing standards and physical measurements, not by human experts adjudicating images or clinical data.
4. Adjudication method for the test set: Not applicable for mechanical or simulation testing.
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: Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used: For the mechanical properties, the "ground truth" is derived from the physical laws governing material science and mechanics, validated through standardized testing methods (e.g., ASTM standards) and finite element analysis.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of validating a mechanical implant through performance testing. Finite element analysis (FEA) models are "trained" or developed based on material properties and engineering principles, but not in the same sense as an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. See point 8.
§ 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.