(200 days)
The PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.
The PSG 5.5mm Cannulated Pedicle Screw System is a non-cervical spinal fixation system. Pedicle screw fixation is limited to skeletally mature patients.
The PSG 5.5mm Cannulated Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.
The provided document is a 510(k) premarket notification for a medical device called the "PSG 5.5mm Cannulated Pedicle Screw System." This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance rather than clinical efficacy studies in the context of AI/software-as-a-medical-device (SaMD). Therefore, many of the requested details about acceptance criteria, clinical study design, and AI performance metrics are not applicable or available in this submission.
However, I can extract the information relevant to the device's mechanical performance and what the submission provides in place of clinical study details.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices such as pedicle screw systems, "acceptance criteria" and "reported device performance" are typically defined by engineering standards to ensure mechanical integrity and safety. In this context, the device's performance is compared against these standards and to predicate devices.
| Acceptance Criteria (Standard) | Reported Device Performance (Summary) |
|---|---|
| Static axial compression bending (per ASTM F1717-13) | Sufficient for intended use; substantially equivalent to predicates. |
| Static torsion (per ASTM F1717-13) | Sufficient for intended use; substantially equivalent to predicates. |
| Dynamic axial compression bending fatigue (per ASTM F1717-13) | Sufficient for intended use; substantially equivalent to predicates. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of devices or test repetitions) used for the mechanical tests. It only states that the device "has been tested" according to the ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a mechanical implant, not an AI/SaMD that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM F1717-13).
4. Adjudication method for the test set
Not applicable. Mechanical testing is objective and relies on measurements and adherence to specified test protocols, not human adjudication of results.
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 device is a pedicle screw system, not an AI/SaMD for diagnostic imaging or decision support. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this type of device is defined by engineering standards and established mechanical performance characteristics relevant to spinal implants. Specifically, the ASTM F1717-13 standard dictates the methodologies and expected performance metrics for static and dynamic mechanical integrity. Comparison to legally marketed predicate devices also serves as a benchmark for "ground truth" in terms of acceptable clinical performance and safety.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a mechanical device, not a machine learning algorithm.
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.