(128 days)
The Vertebron PSS Pedicle Screw System is intended for non pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (2.0. , fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The Vertebron PSS Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The device consists of a system of implantable rods, screw and hooks for the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the rod system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.
The provided text does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the way typically found for AI/ML-based medical devices.
The document K033352 is a 510(k) summary for a non-AI/ML medical device, specifically a Spinal Rod System (Vertebron PSS Pedicle Screw System). This device is a traditional hardware implant for spinal fusion.
Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth establishment for AI, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and are not present in the provided submission.
Here's a breakdown of the information that is available based on the request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The submission states that the device was tested "in accordance with the requirements prescribed in ASTM F1717." ASTM F1717 is a standard specification for spinal implant constructs in a vertebrectomy model, which outlines mechanical testing protocols (e.g., static and dynamic compression bending, torsion). The specific quantitative acceptance criteria (e.g., maximum deflection, fatigue cycles survived, failure load) are not detailed in this summary.
- Reported Device Performance: "The device was found to perform comparably to other spinal rod systems." This is a qualitative statement of performance relative to predicate devices, but specific quantitative results against the ASTM F1717 criteria are not provided in this summary.
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 / Not provided. For a physical implant, testing involves mechanical samples of the device itself, not patient data in the typical sense of an AI/ML ground truth test set. The number of physical units tested is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement instruments, not by medical experts interpreting data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This relates to human interpretation of data, which is not relevant for mechanical device testing.
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 study design is specifically for evaluating the impact of AI on human interpretation of medical images/data. This device is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. There is no algorithm; this is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be its mechanical properties and performance as defined by the ASTM F1717 standard. This is based on engineering specifications and physical measurements, not clinical or pathology data.
8. The sample size for the training set
- Not applicable. There is no "training set" for physical mechanical testing.
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.