(14 days)
The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the OPTIMA™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis such as scoliosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts. In case of spinal deformities, OPTIMAT® may be used, with posterior hook.
The OPTIMA™ Spinal System is a top-loading multiple component, anterior / posterior Spinal System which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.
The OPTIMA™ Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote fusion. The implants are sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) supplied from stock that conforms to AOTM 1-100. Various sizes of these implants are available.
Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system
Here's a breakdown of the acceptance criteria and the study details for the OPTIMA™ Spinal System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal as Performed Testing) | Reported Device Performance (Testing Standard Met) |
|---|---|
| Mechanical testing to validate intended use, operating principle, materials, shelf life, packaging materials and process. | Mechanical testing carried out according to ASTM F1717-01 & ASTM F1798-97. The testing demonstrated substantial equivalence to the predicate device. |
Note: The provided document is a 510(k) summary for a spinal system, which is a medical device. For such devices, "acceptance criteria" are typically met by demonstrating substantial equivalence to a predicate device through engineering and mechanical testing, rather than clinical performance metrics often seen with diagnostic software. The "reported device performance" is the successful completion of these standard mechanical tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The "test set" in this context refers to the physical samples of the OPTIMA™ Spinal System components used for mechanical testing, not a dataset of patient images or clinical data. The quantity of implants tested is not specified, but it would have been sufficient to meet the requirements of the ASTM standards.
- Data Provenance: Not applicable. The testing described is mechanical, conducted in a lab environment to assess the physical properties and performance of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable for this type of device and study. "Ground truth" in this context usually refers to a definitive diagnosis or condition established by medical experts for evaluating the accuracy of a diagnostic device. For the OPTIMA™ Spinal System, the "ground truth" for its performance is its physical integrity and mechanical properties as demonstrated by standardized engineering tests.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing according to ASTM standards does not involve adjudication by experts in the way clinical diagnostic studies do. The results are objective measurements against defined criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices to evaluate human reader performance with and without AI assistance. The OPTIMA™ Spinal System is a surgical implant, not a diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The OPTIMA™ Spinal System is a physical medical implant, not an algorithm or software requiring standalone performance testing.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance (demonstrating substantial equivalence) was compliance with established engineering standards (ASTM F1717-01 & ASTM F1798-97) through mechanical testing. This verifies the physical and mechanical properties of the device are equivalent to, or better than, the predicate device.
8. The Sample Size for the Training Set
Not applicable. The device is a surgical implant, not an AI or machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.