(57 days)
The Response Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.
The Response Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes, including fixed angled screws, to accommodate differing anatomic requirements.
The OrthoPediatrics Response Spine System (K130655) relies on substantial equivalence to predicate devices rather than a standalone clinical study to demonstrate its safety and effectiveness. The acceptance criteria and the "study" proving it meets those criteria are articulated through mechanical testing designed to show equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ASTM F1717 Standard and Equivalence to Predicates) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Mechanical Performance: |
- Static Compression Bending
- Dynamic Compression Bending
- Static Torsion
(Demonstrates that the device's mechanical strength and durability are comparable to predicate devices and meet established standards for spinal implant constructs.) | "Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated the device to be substantially equivalent to the predicate devices." |
Note: The specific numerical acceptance values for these tests are not provided in the summary but would be detailed in the full test report, confirming that the Response Spine System's results fell within acceptable ranges or were comparable to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as the evaluation focuses on mechanical testing of devices rather than patient data. The "sample" here refers to the number of devices (rods, screws, hooks, connectors) tested under various mechanical loads.
- Data Provenance: Not applicable in the traditional sense of patient data. The testing would have been conducted in a laboratory setting, likely in the US, by the manufacturer or a contracted testing facility. This is a retrospective comparison to existing predicate device data and established ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable in the context of mechanical testing. "Ground truth" for mechanical testing is established by the ASTM F1717 standard itself, which is developed by a consensus of engineering and medical experts in the field of spinal implants. The results are physical measurements.
- Qualifications of Experts: The "experts" in this context are the engineers and material scientists who designed and conducted the tests, and those who developed the ASTM F1717 standard.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Mechanical testing results are objective measurements against a standard. There is no human adjudication of "truth" in the way there is for clinical interpretations. The results either meet the standard/equivalence or they don't.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This device is a surgical implant undergoing mechanical performance testing, not an imaging or diagnostic device requiring human interpretation of results. Therefore, an MRMC study is not relevant.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm. Its "performance" is its mechanical integrity under specified loads, which is evaluated directly in a lab.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this evaluation is based on:
- Established ASTM F1717 Standard: This standard dictates the methodology and acceptable criteria for static and dynamic testing of spinal implant constructs.
- Performance of Predicate Devices: The measured mechanical properties (e.g., stiffness, fatigue life) of the Response Spine System are compared to those of the legally marketed predicate devices (OrthoPediatrics' OP Spine System and Medtronic CD Horizon) to establish substantial equivalence.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical device being evaluated for mechanical equivalence, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device evaluation.
§ 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.