(158 days)
Orthros Posterior Stabilization System 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 thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, Orthros Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
Orthros Posterior Stabilization System consist of a variety of shapes and sizes of rods, monoaxial screws, polyaxial screws, locking caps and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws are intended for posterior and anterior use. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps and locking set screws are used to connect screws to the rod. The rods are composed of titanium alloy, as specified in ASTM F136. All other implants are composed of titanium alloy, as specified in ASTM F136.
The provided text describes the Orthros Posterior Stabilization System, a medical device for spinal stabilization. The information primarily focuses on non-clinical testing for substantial equivalence, and therefore many of the requested details concerning software performance, AI algorithms, and human reader studies are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Axial Compression Bend Test (per ASTM F1717-13) | Met the acceptance criteria for static axial compression bend testing. | The results of these studies showed that the Orthros Posterior Stabilization System met the acceptance criteria. (Specific values not provided) |
| Static Axial Torsion Test (per ASTM F1717-13) | Met the acceptance criteria for static axial torsion testing. | The results of these studies showed that the Orthros Posterior Stabilization System met the acceptance criteria. (Specific values not provided) |
| Dynamic Axial Compression Bend Test (per ASTM F1717-13) | Met the acceptance criteria for dynamic axial compression bend testing. | The results of these studies showed that the Orthros Posterior Stabilization System met the acceptance criteria. (Specific values not provided) |
| Screw Pullout Testing (per ASTM F543-07) | Met the acceptance criteria for screw pullout testing. | The results of these studies showed that the Orthros Posterior Stabilization System met the acceptance criteria. (Specific values not provided) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states "The following tests were performed," implying laboratory testing of device components, not patient data.
- Data Provenance: Not applicable, as no patient data was used. The tests were performed on the device components themselves in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for non-clinical, mechanical tests is established by the specifications defined in the ASTM standards (F1717-13 and F543-07). No human expert consensus was needed.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) and not for objective 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
- No MRMC comparative effectiveness study was done. The device is a physical spinal implant system, not an AI software or imaging interpretation tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
- Ground Truth: Engineering specifications and performance thresholds defined by established ASTM (American Society for Testing and Materials) standards: ASTM F1717-13 (Standard Test Methods for Static and Fatigue Bending Properties of a Spinal Implant Construct) and ASTM F543-07 (Standard Specification for Metallic Medical Bone Screws).
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI or machine learning model 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 type of 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.