(55 days)
The Nutech Spine and Biologics Anterior Cervical Plate System is interior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
The Anterior Cervical Plate System consists of single level titanium bone plates of various sizes and titanium bone screws in various diameters and lengths to allow for patient specific configurations. The triangular shape of the plate allows for adjacent level fusion without removal of prior Nutech Cervical Plates. Implants are made from Ti 6AI4V ELI, per ATSM F136. The instrumentation allows for simple preparation and placement of the implant construct.
The provided FDA document describes the Nutech Spine and Biologics Anterior Cervical Plate System, which is an implantable medical device, not an AI/ML powered device. Therefore, the information regarding AI/ML device specific acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable.
The document generally outlines the regulatory process for this type of device and refers to performance testing that confirms its structural integrity and mechanical properties.
Here's an interpretation of the available information regarding acceptance criteria and the study that proves the device meets them, tailored to the context of a non-AI medical device:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from FDA Review) | Reported Device Performance (from Summary) |
|---|---|---|
| Intended Use Equivalence | Device's intended use must be substantially equivalent to a predicate device. | The subject device is intended for anterior screw fixation to the cervical spine (C2-T1) for specific conditions, matching the predicate. |
| Indications for Use Equivalence | Device's indications for use must be substantially equivalent to a predicate device. | Indications include degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis, matching the predicate. |
| Technological Characteristics Equivalence | Device materials, design, and other technological characteristics must be substantially equivalent to a predicate. | The device consists of titanium bone plates and screws made from Ti 6AI4V ELI, similar to the predicate. Documentation confirms substantial equivalence in these aspects. |
| Performance (Mechanical) | Device must meet established performance standards for static and dynamic mechanical integrity. | Static Compression Bending, Static Torsion, Static Tension Bending, and Dynamic Compression Bending testing (per ASTM F1717-18) confirmed that the Subject device performed as intended. |
Study Details (as inferable for a non-AI implantable device)
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Sample size used for the test set and the data provenance: Not applicable in the context of clinical data for an AI/ML device. For this implantable device, "test set" refers to the physical devices manufactured and tested for mechanical properties. The document doesn't specify the exact number of physical devices tested but states that testing was performed per ASTM F1717-18 standards. The "provenance" would be the manufacturing lot and controlled laboratory conditions where the mechanical tests were conducted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing of an implantable device, "ground truth" is established by engineering specifications and industry standards (like ASTM F1717-18). The "experts" would be engineering and quality control professionals overseeing the testing, but their specific number and qualifications are not typically detailed in a 510(k) summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials for diagnostic devices or AI systems where human interpretation is involved. For mechanical testing, the results are quantitative measurements against predetermined pass/fail criteria according to ASTM standards.
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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 non-AI implantable device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a non-AI implantable device.
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The type of ground truth used: For this device, the "ground truth" for performance is based on engineering specifications and established mechanical test standards (ASTM F1717-18) to ensure the device can withstand the forces it will encounter in the body. For safety and substantial equivalence, the primary ground truth is comparison to the legally marketed predicate device.
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The sample size for the training set: Not applicable. This is a non-AI implantable device, so there is no training set as understood in AI/ML.
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How the ground truth for the training set was established: Not applicable.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.