(165 days)
The ArcTecTM Semi-Rigid Plating System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the ArcTec™ Semi-Rigid Plating System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.
The ArcTec™ Semi-Rigid Plating System includes plates, bolts, washers and locking nuts in addition to standard surgical instrumentation. The semi-rigid low profile plate has a low stiffness and is easy to contour. The patent pending washer design incorporates a unique polyaxial bandclamp feature that allows unlimited range of placement on the plate and screw angulation of up to 10 degrees in any plane. The system combines the simplicity of a plate with the adaptability of a polyaxial screw connection.
The provided text describes a 510(k) premarket notification for the ArcTec™ Semi-Rigid Plating System. This is a medical device for spinal fixation, not an AI/ML-based device. Therefore, many of the requested criteria related to AI/ML device performance and testing (such as effect size of human readers with AI, standalone algorithm performance, training set details, and ground truth establishment for AI models) are not applicable to this document.
However, I can extract information regarding the device's performance justification based on the mechanical testing described.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical performance | Mechanical testing in accordance with ASTM F1717 was conducted. |
| Substantial equivalence | Sufficient information is included to reach a determination of substantial equivalence to predicate devices based on intended use, function, design, material, and mechanical performance. |
2. Sample size used for the test set and the data provenance
- Test set: Not applicable in the context of an AI/ML device. For this mechanical device, the "test set" refers to the physical devices subjected to mechanical testing. The document does not specify the number of samples used for ASTM F1717 testing.
- Data provenance: Not applicable. The testing is described as mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: Not applicable. This device is evaluated through mechanical testing, not by human experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set
- Adjudication method: Not applicable. This concept is relevant for reconciling expert disagreements in diagnostic studies, which is not the case here.
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
- MRMC study: No. This is a mechanical spinal implant, not an AI-assisted diagnostic tool for which MRMC studies would be conducted.
- Effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This device does not have an "algorithm only" component.
7. The type of ground truth used
- Ground truth: For mechanical performance, the "ground truth" is defined by the standards and metrics outlined in ASTM F1717 for spinal implant testing. The document does not specify which particular aspects of ASTM F1717 were evaluated (e.g., static compression, fatigue, etc.), but it refers to the standard generally.
8. The sample size for the training set
- Training set sample size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
Summary of Device Performance Justification:
The ArcTec™ Semi-Rigid Plating System demonstrates its performance and safety through mechanical testing in accordance with ASTM F1717. This testing serves as the basis for establishing substantial equivalence to legally marketed predicate devices, considering its intended use, function, design, material, and overall mechanical performance. The FDA reviewed this information and found the device substantially equivalent.
§ 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.