(209 days)
The SpineFrontier® PedFuse® 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
The SpineFrontier® PedFuse® Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system consists of longitudinal rods, polyaxial screws, and cross connector. Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods are added to the System in this submission.
The provided text describes a 510(k) premarket notification for a medical device, the SpineFrontier® PedFuse® Pedicle Screw System. This specific submission focuses on modifications to an already cleared device, adding hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods.
Therefore, the performance data presented is for the mechanical substantial equivalence of these new materials and components to previously cleared versions and predicate devices, rather than a usability or clinical effectiveness study of the entire system as an AI device or a novel medical device establishing its own set of acceptance criteria.
The document does not describe the use of AI in this device, nor does it detail a study involving human readers, test sets, ground truth establishment, or training sets in the context of AI performance. The study mentioned is purely mechanical testing of the physical components.
However, I can extract information related to the mechanical performance testing conducted to demonstrate substantial equivalence, framed in the context of acceptance criteria if we interpret "acceptance criteria" as meeting the performance standards of the predicate devices.
Description of Acceptance Criteria and Study for SpineFrontier® PedFuse® Pedicle Screw System (Mechanical Performance)
This 510(k) submission (K133153) describes an update to the SpineFrontier® PedFuse® Pedicle Screw System, specifically adding Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods. The study presented is a mechanical performance testing summary to demonstrate that these modifications maintain adequate and substantially equivalent mechanical strength compared to previously cleared versions and predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like pedicle screw systems, "acceptance criteria" for mechanical testing typically involve meeting or exceeding the performance established by recognized ASTM standards or demonstrating equivalence to predicate devices under those standards. The document states the purpose of the testing is to "demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use." While explicit numerical acceptance criteria are not provided in this summary, the implicit acceptance criterion is that the modified device's performance is comparable to or better than previously cleared devices and predicate devices when tested under specified ASTM standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength (Static Axial Compression Bending): Must meet or exceed performance of previously cleared PedFuse® system and predicate devices (e.g., Medtronic TSRH® Spinal System, Pioneer Quantum Spinal System, Globus Transition™ Stabilization System) as per ASTM F1717-13. | The submission states that "The PedFuse Pedicle Screw System was tested in the following modes: Static Axial Compression Bending (ASTM F1717-13)" and concludes that "The overall technology characteristics and mechanical performance data lead to the conclusion that the PedFuse® System is substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.) |
| Mechanical Strength (Static Torsion): Must meet or exceed performance of previously cleared PedFuse® system and predicate devices as per ASTM F1717-13. | "Static Torsion (ASTM F1717-13)" was performed. Conclusion: "substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.) |
| Mechanical Strength (Cyclic Axial Compression Bending): Must meet or exceed performance of previously cleared PedFuse® system and predicate devices as per ASTM F1717-13. | "Cyclic Axial Compression Bending (ASTM F1717-13)" was performed. Conclusion: "substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.) |
| Custom Instrument Testing: Must demonstrate adequate performance. | "Custom Instrument Testing" was performed. Conclusion: "substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of devices or test repetitions) used for each mechanical test. Mechanical testing, especially for medical devices, typically involves multiple samples to ensure statistical validity, but the specific number is not disclosed in this summary.
- Data Provenance: The testing was conducted by SpineFrontier, Inc. in support of their 510(k) submission. This is internal testing performed by the manufacturer, likely in the USA where the company is based. It is a prospective generation of data specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the described study is mechanical performance testing of physical components, not a study involving human interpretation of data where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This information is not applicable as the described study is mechanical performance testing and does not involve human readers or adjudication processes.
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. This submission concerns mechanical properties of spinal implants, not an AI device or a study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This submission concerns mechanical properties of spinal implants, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established mechanical performance benchmarks set by:
- ASTM standards (specifically ASTM F1717-13).
- The known performance of the previously cleared SpineFrontier® PedFuse® Pedicle Screw System (K123164, K092420).
- The known performance of predicate devices (Medtronic TSRH® Spinal System K091797, Pioneer Quantum Spinal System K101790, Globus Transition™ Stabilization System K073439).
The aim of the study was to demonstrate that the modified device's mechanical properties met or were equivalent to these established benchmarks.
8. The Sample Size for the Training Set
This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.
§ 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.