(270 days)
The icotec Pedicle System is intended to provide immobilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The icotec Pedicle System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for fixation of the non-cervical spine. The icotec Pedicle System is comprised of monoaxial and polyaxial pedicle screws and curved and straight rods. The icotec Pedicle System can be used for single or multiple level fixations.
This document is a 510(k) premarket notification for the icotec Pedicle System, a medical device. It describes the device, its intended use, and its substantial equivalence to previously marketed predicate devices.
Here's an analysis of the provided text in the context of the requested information about acceptance criteria and evidence of meeting them:
Critically, this document is a 510(k) submission for a pedicle screw spinal system, a physical medical device (implant). It is not a document describing an AI/ML medical device submission. Therefore, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" as they apply to software performance (e.g., sensitivity, specificity, AUC) are not directly applicable in the way your prompt expects for an AI/ML device.
This 510(k) demonstrates substantial equivalence primarily through:
- Intended Use, Material, Geometry, Method of Fixation, and Mechanical Properties comparison with predicate devices.
- Mechanical Testing (non-clinical) to show that the device performs equivalently to previously cleared devices under simulated physiological conditions.
Given this, I will interpret your questions in the context of a physical medical device's submission dossier.
1. A table of acceptance criteria and the reported device performance
For a physical device like a pedicle screw system, acceptance criteria are generally related to mechanical performance, material properties, and design specifications. The document states that the device meets these through comparison to predicates and non-clinical testing.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical Properties | Demonstrated substantial equivalence to previously cleared devices per ASTM F1717 (static compression bending, static torsion, and dynamic compression bending testing). This implies that the device performs within the expected range for pedicle screw systems, comparable to the predicate devices under these test conditions. |
| Material | Manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136), which is a common and accepted material for such implants. Stated as substantially equivalent to predicate devices in material. |
| Geometry | Comprised of monoaxial and polyaxial pedicle screws and curved and straight rods. Stated as substantially equivalent to predicate devices in geometry. |
| Method of Fixation | Posterior pedicle screw system. Stated as substantially equivalent to predicate devices in method of fixation. |
| Intended Use | Matches the indications for use of the predicate devices. |
2. Sample size used for the test set and the data provenance
For physical device mechanical testing (preclinical testing), "sample size" refers to the number of devices or test specimens used in the mechanical tests (e.g., number of screws tested for bending strength). This information is not provided in this summary. Such details would typically be in the full test reports submitted to the FDA, not in the 510(k) summary.
Data provenance: The mechanical tests were performed by "the company" (icotec AG). The tests are "non-clinical," implying laboratory-based testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to a physical device's mechanical or material testing. There isn't "ground truth" derived from expert consensus for device mechanical properties in the way there is for image interpretation in an AI/ML study. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F1717) and the physical measurements themselves.
4. Adjudication method for the test set
Not applicable for mechanical testing of a physical device.
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 a 510(k) for a physical implant, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) for a physical implant, not an AI/ML algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering standards (ASTM F1717) and the measured mechanical properties of the device components, demonstrating equivalence to the predicate devices. There is no biological/clinical "ground truth" from patients or pathology in this specific context of demonstrating substantial equivalence via preclinical testing.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a traditional 510(k) for a physical medical device. The device design and manufacturing process are established, and then the product is tested against established standards and predicates.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.