(143 days)
The FOREX Corporation, 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 or a posterior hook and sacral/iliac 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 scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.
The OPTIMATM 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 alloy (Ti-6Al-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 information provided describes the FOREX Corporation OPTIMA™ Spinal System, a medical device. The document primarily focuses on its 510(k) submission for market clearance, establishing substantial equivalence to predicate devices, and thus does not directly address typical acceptance criteria and performance studies commonly seen in AI/ML device submissions.
Instead, the "acceptance criteria" for this device are met through demonstrating substantial equivalence to already legally marketed predicate devices, and the "study" proving this involves bench testing.
Here's how to frame the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (Bench Testing Result) |
|---|---|
| Equivalence in materials to predicate devices | Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices. |
| Equivalence in design to predicate devices | Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices. |
| Equivalence in operational principles to predicate devices | Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices. |
| Equivalence in indications for use to predicate devices | Bench testing in accordance with ASTM F1717 demonstrates equivalence to predicate devices. |
Study Details
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Sample size used for the test set and the data provenance:
- The document states "Bench testing as listed in Section XII". Section XII is not provided, so the specific sample size for the bench tests is not specified in the given text.
- The data provenance is from bench testing, meaning in-vitro mechanical and material tests, not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. Bench testing for mechanical properties does not typically involve human expert adjudication for ground truth. The "ground truth" for these tests would be the measured physical properties compared against established engineering standards (ASTM F1717) and the properties of predicate devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Bench testing results are typically objectively measured and do not require adjudication by experts in the same way clinical or imaging studies might.
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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:
- No, an MRMC comparative effectiveness study was not done. This is a spinal implant system, not an AI or imaging device that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the bench testing was established by standardized mechanical testing protocols (ASTM F1717) and engineering specifications. The performance was compared to that of legally marketed predicate devices.
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The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- This is not applicable as there is no training set for a physical implant 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.