(110 days)
The Single Planar Multi Axial (SPMA) Pedicle Screw 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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal turnor, pseudoarthrosis, and failed previous fusion.
The SPMA Pedicle Screw System is an internal fixation device for spinal surgery consisting of rods and pedicle screw assemblies (screw, saddle, axle, locking washer and set screw). The axle that connects the screw to the saddle allows the saddle to be adjusted in a single plane to any angle, up to 60 ° from the midline. Grooves in the head of the screw and in the inferior face of the locking washer interdigitate with the splined surface of the rod to allow the assembly to be rigidly fixed in place when tightened.
This document describes a 510(k) premarket notification for the Trinity Orthopedics, LLC Single Planar Multi Axial (SPMA) Pedicle Screw System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo clinical study with specific acceptance criteria and performance data for the device itself.
Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and detailed performance metrics are not applicable to this type of regulatory submission as they are typically found in clinical trials or performance studies for novel devices or those seeking a higher level of evidence.
Here's a breakdown of the information that can be extracted or that is not present in the provided text:
1. A table of acceptance criteria and the reported device performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Equivalence to legally marketed predicate devices. | "Mechanical testing performed on the SPMA Pedicle Screw System using titanium rods demonstrated equivalence of the device to legally marketed predicate devices." (Specific quantitative performance targets or results are not provided in this summary.) |
| Intended Use Equivalence | Same intended use as predicate devices. | The SPMA Pedicle Screw System states the same intended use as its predicates: "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 spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion." |
| Design Equivalence | Same operating principle and basic design as predicates. | The SPMA Pedicle Screw System "uses the same operating principle" and "incorporates the same basic design" as predicate devices (e.g., rods, pedicle screw assemblies including screw, saddle, axle, locking washer, and set screw; features like multi-axial adjustability in a single plane, interdigitating surfaces for fixation). |
| Material Equivalence | Same materials as predicate devices. | The SPMA Pedicle Screw System uses "the same materials" as predicate devices. Specifically, rods are titanium alloy and Co-Cr-Mo alloy, and pedicle screw assemblies are cannulated titanium alloy. |
| Substantial Equivalence | Determination of substantial equivalence to predicates. | FDA reviewed the 510(k) and determined the device is "substantially equivalent... to legally marketed predicate devices" for the stated indications for use, thereby permitting the device to proceed to market. This is the overarching "acceptance criteria" for a 510(k) submission. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a 510(k) premarket notification for a medical device (pedicle screw system), which primarily relies on demonstrating substantial equivalence to existing predicate devices through design, material, and mechanical testing, rather than a clinical "test set" of patient data. The "testing" referred to is mechanical performance testing of the device itself.
- The provenance of data for mechanical testing would typically be from the manufacturer's internal testing facilities, but this is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This submission does not involve a clinical test set requiring expert-established ground truth. The "ground truth", in a regulatory sense, is the performance of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no clinical test set for diagnostic or interpretative performance is described, no adjudication method is relevant.
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. This is not a study assessing AI assistance or human reader performance. It is a submission for a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Refer to Predicate Device Performance. For this 510(k) submission, the "ground truth" equivalent is the established safety and effectiveness of the legally marketed predicate devices. The new device is deemed acceptable if it can demonstrate substantial equivalence to these predicates through its design, materials, and mechanical performance.
8. The sample size for the training set
- Not Applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for this 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.