(55 days)
The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The device is intended to be used with autograft and/or allograft.
The OP Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
This document describes the OrthoPediatrics (OP) Spine System, a spinal fixation device intended for pediatric patients. It's a Special 510(k) submission, which means it's claiming substantial equivalence to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device) | Reported Device Performance (OP Spine System) |
|---|---|
| Torsional grip performance (based on ASTM F1798) | Demonstrated equivalence to the predicate device. |
| Dynamic compression bending performance (based on ASTM F1717) | Demonstrated equivalence to the predicate device. |
Note: Since this is a Special 510(k) claiming substantial equivalence to an existing device (OP Spine System [K120291]), the acceptance criteria for the new device are directly tied to demonstrating performance equivalent to the predicate. The document states that the fundamental scientific principles, technological characteristics, intended use, material, general design, and sizes are the same as the predicate device.
2. Sample Size and Data Provenance
The document does not specify the sample size used for the performance tests.
The data provenance is not explicitly stated. However, given that it's a submission to the FDA for a US medical device, the testing would typically be conducted according to internationally recognized standards (ASTM in this case), and the results presented to the FDA. The nature of the tests (mechanical testing) suggests a laboratory setting, not patient data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission concerns mechanical performance testing of a physical device, not an AI or imaging system requiring expert interpretation or ground truth establishment by medical professionals.
4. Adjudication Method
Not applicable. Mechanical testing does not involve adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic or therapeutic device that would involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (spine system), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the established mechanical testing standards (ASTM F1798 and ASTM F1717) and the performance characteristics of the predicate device. The performance of the new device is compared directly to these established benchmarks.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that involves training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.