(108 days)
The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion (C2-C7). The GSO ACP1 Anterior Cervical Plate System is intended for single use only.
The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions.
The ACPI Anterior Cervical Plate System consists of a variety of anterior cervical spinal bone plates and self-drilling / self-tapping bone screws for fixation of the vertebral body(s) of the cervical spine, using an anterior approach for the development of a cervical spinal fusion (C2-C7), and associated instruments. The bone screws form an interlocked construct on the vertebral bodies. The spinal bone plates include an integrated bone screw locking mechanism consisting of an integrated tab retained by a captive locking screw, covering a portion of the underlying bone screw head to prevent bone screw back-out. The bone screws are self-drilling / self-tapping, in various diameters and lengths, and are available in variable angle and fixed angle configurations. All implant components are ASTM standard, medical implant grade titanium alloy (Ti 6Al-4V ELI). The ACP1 system was designed to be compatible with common surgical instruments available in operating rooms equipped for spine surgery. The device specific instruments are considered to be Class II. The instruments are medical grade stainless steel, some have silicone rubber handles, and they are provided non-sterile. Stainless steel and titanium implant components must not be used together in a construct.
The provided text describes a medical device, the GSO ACP1 Anterior Cervical Plate System, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific acceptance criteria, study details, and performance metrics—such as sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies—are not applicable to this document.
The "acceptance criteria" for this device are demonstrated through non-clinical testing against established ASTM standards and a comparison to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Method) | Performance Goal (Basis) | Reported Device Performance |
|---|---|---|
| Static Compressive Bending | Equivalent to predicate devices (ASTM F1717) | Mechanical testing conducted according to ASTM F1717. (Results implied to meet equivalence) |
| Static Torsional Stiffness | Equivalent to predicate devices (ASTM F1717) | Mechanical testing conducted according to ASTM F1717. (Results implied to meet equivalence) |
| Dynamic Axial Compression Bending | Equivalent to predicate devices (ASTM F1717) | Mechanical testing conducted according to ASTM F1717. (Results implied to meet equivalence) |
| Material Safety | Use of ASTM standard, medical implant grade titanium alloy (Ti 6Al-4V ELI) | All implant components are ASTM standard, medical implant grade titanium alloy (Ti 6Al-4V ELI). |
| Design and Functionality | Substantially equivalent in indications for use, design, and materials to predicate devices (Multiple 510(k) cleared devices) | Demonstrated substantial equivalence to multiple predicate devices (listed in section 8). |
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. This device's acceptance was based on non-clinical mechanical testing and comparison to predicate devices, not on a clinical test set with data provenance.
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. Ground truth for mechanical testing is established by engineering standards (e.g., ASTM F1717) and direct measurement, not by expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not used for mechanical 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 not an AI-powered device, so MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on:
- Adherence to ASTM F1717 standard for mechanical testing.
- Conformity to material specifications (ASTM standard, medical implant grade titanium alloy).
- Demonstrated substantial equivalence in indications for use, design, mechanical testing, and materials to previously cleared predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI-powered device, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI-powered device, there is no training set or ground truth associated with it in that context.
§ 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.