(94 days)
The LDR Easyspine System is a posterior, noncervical, 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 at L5-S1 or 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.
The LDR Easyspine® System consists of various screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the thoraco-lumbar spine. This system includes side-loading polyaxial screws, which allow the surgeon to easily insert the spinal rod using a posterior-lateral loading technique into the fixation components. The rod opening of the screw heads can be positioned medially or laterally. The polyaxial locking mechanism of the standard screws allows a 20 degree angulation in all directions. The dual-polyaxial α-screw (alpha screw) provides an additional 5 degrees of angulation to facilitate loading of the rod, even when the difference in pedicular screw angulation is significant relative to the next screw. Crosslinks (transverse connectors) are provided to increase rotational stiffness of a given construct as desired by the clinician. Rods consist of a single diameter (6.0mm) yet offer variable stiffness. Multiple lengths of spinal rods are included with this system as is typical for essentially all competitive systems. The variable stiffness/rigidity of the various rod offerings is accomplished by fabricating the rods with a machined flat surface on the rod, from one end to the other, following the longitudinal axis of each rod. Thus, the cross section of the rods (as measured at the flattened area), provide comparable strength and stiffness to other rods available in approved systems.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Easyspine System (K043094):
It's important to note that this document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and efficacy through extensive clinical trials for a novel device. Therefore, the "study" described is primarily engineering testing to show equivalence in performance.
Acceptance Criteria and Device Performance for the Easyspine System (K043094)
The acceptance criteria for the Easyspine System, as presented in this 510(k) submission, are primarily established by demonstrating substantial equivalence to a predicate device (Orthopedic Alliance Spine System, K033826) and compliance with relevant material and mechanical testing standards for pedicle screw spinal systems.
Given the nature of a 510(k) submission for a Class II device, the "acceptance criteria" are not explicitly stated as quantitative thresholds for clinical outcomes but rather as meeting established engineering benchmarks and showing comparable performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion / Standard | Easyspine System Reported Performance |
|---|---|---|
| INDICATIONS FOR USE | Equivalent to predicate device for specific spinal conditions (degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion). | "YES" - Identical indications for use reported. |
| DESIGN | Posterior - pedicle screw/rod spine system, equivalent to predicate. | "YES" - Identical design reported. |
| STERILITY | Acceptable sterility status (implants sterile, instruments nonsterile). | "YES" - Implants supplied sterile, instruments nonsterile. (Predicate: Both nonsterile. This is considered acceptable as it's more sterile, not less). |
| ROD DIAMETER | Acceptable rod diameter. | "NO/YES" - 6mm. (Predicate: 4mm. The difference is acknowledged but likely deemed acceptable due to testing and material properties). |
| MATERIAL | Biocompatible and strong materials, equivalent to predicate. | "YES" - Titanium Alloy. (Predicate: CP titanium & titanium alloy. This is substantially equivalent and compliant with material standards). |
| SCREW SIZES | Acceptable range of screw sizes. | "YES" - 6 & 7mm. (Predicate: 5, 6 & 7mm. The Easyspine has a slightly reduced range, but still considered acceptable). |
| MANUFACTURER | Stated manufacturer. | "YES" - LDR Spine USA. |
| PRODUCT CODE | Applicable FDA product codes. | "YES" - MNI, MNH. (Predicate: MNI. The addition of MNH is relevant to the device's classification). |
| MECHANICAL TESTING | Compliance with mechanical testing standards (fatigue and static testing) for pedicle screw spinal systems as per 21 CFR 888.3070. | "Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device." |
| BIOCOMPATIBILITY | Compliance with biocompatibility standards as per 21 CFR 888.3070. | Mentioned as a special control. Implied compliance through material selection (Titanium Alloy) and substantial equivalence. Specific test results not detailed in provided text. |
| MATERIAL STANDARDS | Compliance with material standards as per 21 CFR 888.3070. | Mentioned as a special control. Implied compliance through material selection (Titanium Alloy) and substantial equivalence. Specific test results not detailed in provided text. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is primarily an engineering performance study comprising static and fatigue testing, as well as a direct comparison of features to a predicate device.
- Description of the Study:
"Testing Summary: Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device."
This statement indicates that the Easyspine System underwent in-vitro mechanical testing to simulate the stresses it would experience in the body. The goal was to show that its mechanical performance (strength, durability under cyclic loading) was comparable or superior to the predicate device, thereby fulfilling the special control requirements for mechanical testing. The Feature Comparison Table further serves as a "study" element, demonstrating equivalency in design, materials, and intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The sample size for the fatigue and static testing is not specified in the provided text. Typically, these types of tests involve a statistically significant number of constructs to ensure reliable results, often dictated by ISO or ASTM standards for implant testing.
- Data Provenance: The data provenance is in-vitro engineering testing performed by the manufacturer (LDR Spine USA). The text does not mention human patient data or a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable (N/A). For this type of 510(k) submission, the "ground truth" is established by adherence to recognized engineering standards for materials and mechanical performance, and by demonstrating substantial equivalence to a legally marketed device. There is no biological "ground truth" established by human experts in the context of this engineering performance study.
4. Adjudication Method for the Test Set
- Not applicable (N/A). Adjudication methods are typically relevant for clinical studies or image-based diagnostic device evaluations where expert consensus is needed to determine a true clinical state. This submission focuses on engineering benchmarks and equivalence, not clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. Not mentioned or performed. This type of study assesses human reader performance (e.g., radiologists interpreting images) with and without AI assistance. The Easyspine System is a surgical implant, not a diagnostic imaging AI device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Yes, in the context of mechanical performance. The fatigue and static testing evaluates the standalone performance of the device's mechanical integrity without human interaction during the test itself (though humans design, conduct, and interpret the tests). There is no "algorithm" in the sense of software performance being evaluated here.
7. Type of Ground Truth Used
- The "ground truth" for this submission is established through:
- Engineering Standards: Compliance with accepted engineering and scientific principles for mechanical testing (fatigue and static).
- Predicate Device Performance: The demonstrated performance of the legally marketed predicate device (Orthopedic Alliance Spine System, K033826) serves as a benchmark for substantial equivalence.
8. Sample Size for the Training Set
- Not applicable (N/A). In the context of a mechanical implant, there is no "training set" in the machine learning sense. The design and manufacturing processes are refined through engineering principles, material science, and prior knowledge from similar devices, rather than iterative learning from a data set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (N/A). As there is no "training set" for this device in the machine learning sense, the concept of establishing ground truth for it does not apply. The device's design is based on established biomechanical principles and material science.
§ 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.