(248 days)
The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of dicogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), turnor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RESPONSE 4.5/6.0 Spine System and the RESPONSE 5.5/6.0 Cannulated Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. The RESPONSE 4.5/5.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The RESPONSE 5.5/6.0 Cannulated Screw System is a cannulated screw spinal implant system consisting of anchors (screws) that attach to the longitudinal members (rods) and interconnection components (connectors) previously cleared in the RESPONSE 5.5/6.0 Spine System see K193100. Pedicle screws are placed in the spine that attach to rods that allow immobilization and stabilization of the spine. The RESPONSE 5.5/6.0 Cannulated Screws are cannulated screws that are passed over a guidewire to achieve insertion. The RESPONSE 5.5/6.0 Cannulated Screws are available in a 6mm to 9mm diameter range by 40mm to 100mm lengths. All implant components are manufactured from titanium alloy, cobalt chrome, and commercially pure titanium. All components are supplied non-sterile. The screws, which have a Ø1.750 mm cannulation, are available in the following diameters and lengths: Ø6.0 - 40-80mm Ø6.5 - 40-90mm Ø7.0 - 40-100mm Ø8.0 - 40-100mm Ø9.0 - 40-100mm. All screws are double lead with a 2.750 mm thread pitch which is identical to the predicate screws. For the subject screws, the minor diameter, neck diameter and thread runout length were increased and the hexalobe feature and root radius were modified from the predicate pedicle screw design to accommodate the cannulation. The subject drivers are cannulated with features to interface with the screw hexalobe.
The provided text is a 510(k) summary for the OrthoPediatrics RESPONSE 5.5/6.0 Cannulated Screw System, a medical device for spinal fixation. This document primarily focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing. It does not describe a study involving human readers or AI performance in diagnostic or clinical tasks.
Therefore, the requested information regarding AI performance, human reader studies, ground truth establishment for AI, and related metrics cannot be extracted from this document, as it is not relevant to the type of device review described.
Below is the information that can be extracted, primarily related to the mechanical performance testing of the device for its substantial equivalence determination.
Acceptance Criteria and Reported Device Performance
The document describes various performance tests conducted to support substantial equivalence. The acceptance criteria themselves are not explicitly detailed as numerical thresholds in this summary, but rather implied as meeting the standards set by the predicate device and relevant ASTM standards. The "reported device performance" is that the device "supports the differences between the subject and predicate devices" and "is substantially equivalent."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet ASTM F1717-21 for dynamic compression bend testing | Testing performed per ASTM F1717-21 |
| Meet ASTM F1717-21 for static compression bend testing | Testing performed per ASTM F1717-21 |
| Meet ASTM F1798-21 for static and dynamic flexion/extension testing | Testing performed per ASTM F1798-21 |
| Meet ASTM F543-17 for screw pullout strength | Testing performed per ASTM F543-17 |
| User validation | User validation studies performed |
| Functional relationship | Functional relationship analysis performed |
| MR compatibility per ASTM F2052-21, F2119-07, F2182-19, F2213-17 | Testing performed per specified ASTM standards |
| Meet ASTM F1798-21 for axial and rotational grip | Information leveraged from K193100 |
| Meet AAMI ST79:17 for sterilization | Information leveraged from K193100 |
| Meet ISO 10993-1 for biocompatibility | Information leveraged from K193100 |
| Demonstrate substantial equivalence to predicate device | Concluded to be substantially equivalent to predicate device |
Information Not Applicable to this Device/Study:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is a mechanical device, and the "tests" refer to laboratory-based mechanical and material performance evaluations, not diagnostic image analysis or clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical testing is defined by engineering specifications and material properties, assessed in a lab, not by expert human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for clinical or diagnostic studies involving human assessment, not for mechanical testing.
- 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: Not applicable. There is no AI component in this device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no AI component.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical tests, the ground truth is based on physical scientific principles, engineering standards (ASTM), and direct measurement of material and structural performance, not expert consensus or clinical pathology.
- The sample size for the training set: Not applicable. Pertains to AI model development.
- How the ground truth for the training set was established: Not applicable. Pertains to AI model development.
§ 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.