(96 days)
The PressON Pro Spinal Fixation System is a posterior, non-cervical pedicle screw system 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: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation scoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The PressON Pro Spinal Fixation System is composed of pedicle screws and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. Components are made from Ti-6A1-4V ELI (ASTM F-136).
Here's an analysis of the provided text regarding the acceptance criteria and study for the PressON Pro Spinal Fixation System.
It's important to note that the provided document is a 510(k) summary for a spinal fixation system, which is a medical device. Unlike software algorithms, this document does not contain information about AI algorithm performance metrics, expert consensus for ground truth, or MRMC studies. The "acceptance criteria" discussed here refer to the mechanical performance standards for the physical device.
Description of Acceptance Criteria and Study for the PressON Pro Spinal Fixation System
The PressON Pro Spinal Fixation System is a physical medical device (pedicle screw system), not a software algorithm. Therefore, the "acceptance criteria" and "study" described in the provided 510(k) summary are related to its mechanical performance and substantial equivalence to legally marketed predicate devices, not to diagnostic accuracy or AI model performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Verification Activities) |
|---|---|
| Axial load per ASTM F1798-13 | Mechanical testing performed |
| A/P load per ASTM F1798-13 | Mechanical testing performed |
| Axial torsion per ASTM F1798-13 | Mechanical testing performed |
| Flexion/extension load per ASTM F1798-13 | Mechanical testing performed |
| Static torsion per ASTM F1717-14 | Mechanical testing performed |
| Static compression bending per ASTM F1717-14 | Mechanical testing performed |
| Dynamic compression bending per ASTM F1717-14 | Mechanical testing performed |
| Substantially equivalent in terms of materials, design, indications for use, and operational principles to predicate devices. | Documentation provided demonstrates substantial equivalence. |
Note: The document confirms that testing was performed according to these standards, implying that the device met the requirements of these standards. Specific numerical performance values are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided in the 510(k) summary. The "test set" in this context refers to physical device samples undergoing mechanical testing, not a dataset for an algorithm. Mechanical testing would involve a sufficient number of samples to demonstrate statistical confidence in meeting the ASTM standards, but exact numbers are not detailed here. Data provenance (country of origin, retrospective/prospective) is not relevant for mechanical testing of a physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable. For a physical device like a spinal fixation system, "ground truth" is established by adherence to recognized engineering and material standards (e.g., ASTM F1798, ASTM F1717) and successful completion of mechanical tests, not by expert review of data or images.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" refers to mechanical samples, not data requiring adjudication. Adjudication methods like "2+1" typically apply to expert reviews for image or data interpretation.
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
This information is not applicable. The device is a physical spinal fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established engineering and material standards (ASTM F1798-13, ASTM F1717-14) that define acceptable mechanical properties and performance for spinal implant components. Compliance with these standards, demonstrated through mechanical testing, serves as the "ground truth" for the device's physical integrity and functionality.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" applies to machine learning algorithms, not to the development or testing of a physical medical device. Device development involves engineering design, material selection, and iterative physical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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.