(69 days)
To facilitate the placement of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Adaptor and the RemB Corded Driver. When the adaptors are attached, the RemB Corded Driver provides power to rotate screw drivers for inserting of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature non-cervical spine using powered instrumentation. The systems include the family of Xia Spinal Systems (Xia Stainless Steel, Xia II, Xia Anterior, and Xia Precision), Xia 3 Spinal System, Xia 4.5 Spinal System, Radius Spinal System and Mantis Spinal Systems.
The Xia® Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The XIA® 4.5. XIA® 3. Radius® Spinal Systems are intended for use in the noncervical spine. When used as an anterior/anteral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative disc disease (DDD) (defined as back pain of discogenic 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, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion.
The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic 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, and/or lordosis); tumor; Pseudoarthrosis; and failed previous fusion.
The line extension, which is the subject of this 510(k), consists of the addition of a power adaptor instrument accessory. This adaptor instrument is intended to facilitate the insertion of pedicle screws using powered instrumentation. This 510(k) supports a labeling update to include the option for pedicle screw insertion using powered instrumentation (in addition to the existing manual insertion technique). To facilitate the insertion of pedicle screws using the power technique, the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Adaptor and the RemB Corded Driver. The adaptors serve as a mechanical interface between the power driver and screwdriver instrument. When the adaptors are attached, the RemB Corded Driver provides appropriate power to rotate screw drivers for the insertion of pedicle screws.
The provided text describes a special 510(k) premarket notification for a line extension to Stryker Spine Thoracolumbar Spinal Systems: the inclusion of a Power Adaptor Instrument Accessory. This accessory is intended to facilitate the insertion of pedicle screws using powered instrumentation.
1. Table of Acceptance Criteria and Reported Device Performance
The submission outlines a risk assessment that led to an appropriate testing plan, focusing on the mechanical and functional compatibility of the power adaptor.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Withstand screw loading during normal use | Bench testing results demonstrated that the subject instrument can withstand screw loading during normal use without loss of function. |
| Withstand screw insertion during normal use | Bench testing results demonstrated that the subject instrument can withstand screw insertion during normal use without loss of function. |
| Compatibility with existing screwdriver instruments | Bench testing results also demonstrated that the power adaptor instrument is compatible with existing screwdriver instruments. |
| Quality/accuracy of screw placement with power technique | Tested under simulated use conditions to evaluate the quality/accuracy of screw placement. (No specific quantitative results are provided in the summary, but the implication is that it met acceptable standards for safe use, allowing for substantial equivalence determination). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact numerical sample sizes for the "fatigue and functional compatibility testing" or the "simulated use conditions" testing. It broadly states that testing was performed "over a simulated usage period."
- Data Provenance: The studies were bench tests and simulated use conditions, conducted by Stryker Spine. The provenance is internal to the manufacturer, likely conducted in the US (as Stryker is a US-based company and the submission is to the FDA). The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since this involves bench testing and simulated use, rather than clinical data requiring expert review for ground truth, the concept of "experts" for establishing ground truth as typically understood in AI/clinical studies (e.g., radiologists interpreting images) does not directly apply here. The "ground truth" was established by engineering specifications and performance standards for spinal instrumentation. The individuals conducting and reporting the tests would be qualified engineers and technicians.
4. Adjudication Method for the Test Set
Not applicable in the context of mechanical bench testing and simulated use. Performance was measured against pre-defined engineering and functional criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a mechanical instrument accessory, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no "human readers improve with AI vs without AI assistance" to evaluate.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This is not an algorithm, but a mechanical device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance evaluated was of the device itself (power adaptor) and its compatibility with other instruments.
7. Type of Ground Truth Used
The ground truth for the device's performance was based on:
- Engineering specifications for mechanical strength, fatigue, and functional compatibility.
- Pre-defined criteria for adequate screw loading, screw insertion, and compatibility with existing instruments.
- Safety and functional requirements for surgical instruments.
8. Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a mechanical 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.