(90 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, spinal deformities such as scollosis, kyphosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
The OPTIMA™ Spinal System is a top-loading multiple component, anterior / posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism.
The OPTIMA™ system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium allov (Ti-6AI-4V ELI) that conforms to ASTM F 136. 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
The provided text describes a 510(k) summary for the OPTIMA™ Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of design, materials, and intended use, along with basic bench testing to show functional equivalence.
Therefore, the study described is not a clinical study involving human participants or AI for diagnostic purposes. It is a bench test evaluating the mechanical performance of a spinal implant system. As such, many of the requested categories are not applicable or cannot be answered from the provided text.
Here's the breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Equivalence to predicate devices (K020279, K002059, K001319) in accordance with ASTM F1717 standard for static and fatigue testing of spinal implant constructs. | "Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." (Specific quantitative results or detailed criteria are not provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for the bench testing. The ASTM F1717 standard would outline the minimum number of samples required for various tests (e.g., static compression, static torsion, fatigue).
- Data Provenance: Not explicitly stated, but bench testing typically occurs in a controlled laboratory environment. It is not patient data (retrospective or prospective) from a country of origin in the traditional sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For mechanical bench testing of an orthopedic implant, "ground truth" is established by adherence to a recognized international standard (ASTM F1717) and engineering principles, rather than expert clinical consensus.
4. Adjudication method for the test set
- Not applicable. Mechanical tests are objective measurements, not subjective evaluations requiring adjudication.
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 device is a physical spinal implant, not an AI-powered diagnostic tool requiring human reader performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device, the "ground truth" for demonstrating performance is adherence to validated mechanical testing standards (ASTM F1717) and demonstrating mechanical equivalence to predicate devices. This indicates that the device can withstand the expected physiological loads without premature failure, similar to existing approved devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.