(73 days)
The CapLOX II Spinal System is a posterior. non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal seements 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
The CapLOX II Pedicle Screw System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-55mm. Rods are available in 5.5mm diameter, as either straight rods available in lengths from 30-500mm or precurved rods available in lengths from 30-120mm. The system includes a set screw, tulip heads, a cap and cross connectors to complete the assembly.
1. Acceptance Criteria and Device Performance
The provided document, K120292 for the CapLOX II Pedicle Screw System, describes a Special 510(k) submission for minor changes to an already cleared device. As such, the performance testing focuses on demonstrating that the mechanical characteristics of the modified device are not altered compared to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical characteristics not altered by design changes. | Test results confirm that the changes did not alter the mechanical characteristics of the system. |
| Compliance with ASTM F1798 standard. | New performance testing per ASTM F1798 was completed. |
| Substantial Equivalence to predicate device (K111115). | Concludes that the changes to the system do not introduce any new risks and therefore, the system is Substantially Equivalent to the predicate device. |
2. Sample Size for Test Set and Data Provenance
The document states: "New performance testing per ASTM F1798 was completed at an independent laboratory." However, the specific sample size used for this mechanical testing is not explicitly stated within the provided text.
The data provenance is from mechanical testing performed at an independent laboratory, rather than from patient data. Therefore, the concepts of "country of origin of the data" and "retrospective or prospective" do not directly apply in the context of this mechanical performance study.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable to this submission. The ground truth for this device's performance is established through mechanical testing per a recognized standard (ASTM F1798), not through expert review of clinical cases or data.
4. Adjudication Method for the Test Set
This information is not applicable. Mechanical testing results are objective measurements against a standard, not subject to adjudication by multiple parties in the way clinical data might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device and submission. This device is a pedicle screw system, and the submission addresses mechanical characteristics, not diagnostic or interpretive tasks where human readers' performance with/without AI assistance would be relevant.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the device's mechanical performance was evaluated independently against the ASTM F1798 standard. This was an "algorithm only" (or rather, "device only") performance evaluation, without human interpretation in the loop.
7. Type of Ground Truth Used
The ground truth used was compliance with the mechanical testing standard ASTM F1798. This standard sets specific methodologies and acceptance criteria for evaluating the mechanical properties of pedicle screw systems.
8. Sample Size for the Training Set
This information is not applicable. This submission is for a physical medical device (pedicle screw system), not a machine learning or AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for a physical medical device.
§ 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.