(119 days)
The LDR Spine USA Easyspine System is a posterior, non-cervical, pedicle 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: spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis (with objective evidence of neurologic impairment), trauma (i. e., fracture or dislocation), spinal stenosis, deformities or curvatures (i. e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Easyspine implants are single use devices for mono-and multi-segmental stabilization of the lumbar and thoracic vertebrae to promote fusion. The Easyspine System consists of sacral and pedicle screws, cross-connections, and rods of different rigidities. Specialized associated instrumentation is designed for implantation of these devices and for the distraction, compression or reduction of the lumbar and thoracic spine. The implants are made of surgical titanium alloy Ti6AI4V (ASTM F-136-92). Instruments used to implant Easyspine® are made of medical grade stainless steel. Both the Easyspine LP and Easyspine LP Multiaxial designs consist of various screws, rods, and connectors which are intended to provide temporary stabilization following surgery to fuse the thoraco-lumbar spine. The systems include side-loading screws which are offset as compared to the standard configuration. This offset allows separate rod tightening and polyaxiality locking. Additionally, the system facilitates conducting spondylolisthesis reduction by allowing bone screwing after rod tightening. The lateral offset loading feature incorporated into the designs has not altered the fundamental technology of the predicate Easyspine pedicle screw system. Operatively inserted implants serve to support the normal healing process. They are not intended to replace normal body structures, nor in cases of incomplete healing, to withstand the continually applied loading conditions.
The Easyspine® System, specifically the 6 mm and 7 mm diameter LP and LP Multiaxial pedicle screws, underwent non-clinical performance testing to demonstrate substantial equivalence to a predicate device (K043094 - LDR Spine USA Easyspine System).
Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Reference Standard: K043094) |
|---|---|
| Mechanical Performance | Tested in accordance with ASTM 1717-04. The new device showed performance comparable to the predicate device, indicating substantial equivalence. |
| Indications for Use | Same as predicate device. |
| Design | Posterior - pedicle screw/rod spine system, same as predicate device. |
| Sterility | Implants supplied sterile, instruments non-sterile, same as predicate device. |
| Implant Sterilization Methods | Gamma radiation, same as predicate device. |
| Implant Shelf Life | Five Years, same as predicate device. |
| Rod Diameter | 6 mm, same as predicate device. |
| Material | Titanium Alloy Ti6Al4V, same as predicate device. |
| Screw Sizes | 6 and 7 mm Diameters, same as predicate device. |
| Manufacturer | LDR Spine Medical, same as predicate device. |
| Product Code | MNI, MNH, same as predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The study was a non-clinical performance study and involved mechanical testing in accordance with ASTM 1717-04. Therefore, it did not involve human patients or clinical data for a "test set" in the traditional sense of a clinical trial.
- Sample Size: Not explicitly stated in terms of a number of "samples" but implied to be sufficient for testing according to ASTM 1717-04. This would typically involve multiple test specimens of the screws and associated components to ensure statistical validity.
- Data Provenance: The data is from laboratory testing (mechanical performance testing) of the device. There is no country of origin for human data, as no human data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This was a non-clinical, mechanical performance study. "Ground truth" was established by the ASTM 1717-04 standard, which defines the testing methodology and performance parameters for spinal implant constructs. No human experts were required to establish ground truth for this type of testing.
4. Adjudication Method for the Test Set:
Not applicable. As a non-clinical mechanical performance study, there was no need for adjudication by multiple experts. The results were based on objective measurements against the specified ASTM standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This submission is for a medical device (pedicle screw system), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance was involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used was mechanical performance data comparison against a legally marketed predicate device (K043094) and compliance with the ASTM 1717-04 standard. This standard serves as the established "ground truth" for evaluating the mechanical integrity and performance of spinal implant constructs.
8. The Sample Size for the Training Set:
Not applicable. As this is a non-clinical performance study for a physical device, there is no "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There was no training set involved in this non-clinical performance study.
§ 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.