(220 days)
The Orthopeasia Spinal Fixation System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities:
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Degenerative disc disease (defied as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies):
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Degenerative spondylolisthesis with objective evidence of neurologic impairment;
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Trauma (i.e., fracture or dislocation);
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Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis);
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Tumor;
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Stenosis;
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Failed previous fusion (pseudarthrosis)
The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.
The Orthopeasia Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screw fixation to the non-cervical spine. The system consists of a variety of shapes and sizes of screws, rods, crosslinks and connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.
The Orthopeasia Spinal Fixation System is this submission comprises of the following components,
A. Pedicle screws (Mono-axial and Poly-axial), standard, cannulated, with:
- a. Monoaxial screw diameters from 5.5mm to 8.5mm
- b. Polyaxial screw diameters from 5.5mm to 8.5mm
- c. Monoaxial length range from 20mm to 55mm
- d. Polyaxial length range from 20mm to 100mm
- e. Made up of titanium alloy (ASTM F136).
- B. Straight rods of diameter of 5.0 mm made up of cobalt chrome alloy (ASTM F1537)
- C. Crosslinks and connectors made up of titanium alloy (ASTM F136).
The provided FDA 510(k) summary for the Orthopeasia Spinal Fixation System does not contain information about the acceptance criteria and study details for an AI/ML powered device. The document describes a spinal fixation system, which is a physical implant, not a software device that utilizes AI/ML.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these are typically applicable to AI/ML device submissions and are not present in this document.
The document focuses on the substantial equivalence of the spinal fixation system to predicate devices based on its mechanical properties, intended use, materials, and components.
However, I can extract the performance testing and results that are present for this physical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Implied by context of "passed" and "within range") | Reported Device Performance |
|---|---|---|
| Static and Dynamic Compression Bending (ASTM F1717) | Performance above the range reached by implants of the additional predicate (lumbar polyaxial device). | The results were above the range reached by implants of the additional predicate (lumbar polyaxial device). |
| Static Axial and Torsion Grip Test (ASTM F1798) | Performance within the range reached by predicate devices. | The results were within the range reached by predicate devices. Therefore, the results passed. |
2. Sample size used for the test set and the data provenance: Not applicable to this physical device. The testing described is mechanical performance testing on physical components, not a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this physical device. Ground truth and expert review are not relevant for the mechanical testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to this physical device.
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 to this physical device. This is relevant for AI/ML diagnostic or assistive devices, not physical implants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable to this physical device. This is relevant for AI/ML devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this physical device. The "ground truth" for mechanical testing is based on established engineering standards (ASTM F1717, ASTM F1798) and comparison to predicate device performance.
8. The sample size for the training set: Not applicable to this physical device. This is relevant for AI/ML devices.
9. How the ground truth for the training set was established: Not applicable to this physical device. This is relevant for AI/ML devices.
§ 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.