(24 days)
To facilitate the placement of pedicle screws using the power technique (corded and cordless). the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached. the CD3 Cordless Driver 3 and RemB Univer provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the skeletally mature non-cervical spine using powered (corded and cordless) instrumentation. The systems included are 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/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients as an adjunct to fusion 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; curvature (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The XIA 4.5. Xia 3. Radius Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3, XIA 4.5, Xia 3, and Radius Spinal Systems are 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, 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, kyphosis, 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. The power adaptor is intended to facilitate the insertion of pedicle screws using the CD3 Cordless Driver 3 powered instrument. The STRYKER Spine Power Adaptor instrument, currently used with the RemB Universal Driver (corded), Power Adaptor (K111478) has the same design and function, differ only with respect to the power source used to operate (4 volt battery vs. Controller interface). Verification activities for fatigue insertion, interface and functional compatibility and comparison testing for profile and weight using the RemB Universal Driver, Power Adaptor (K111478) were found to be equivalent, all test reports are found in Section 18.3. This 510(k) supports a labeling update to include the option for pedicle screw insertion using cordless powered instrumentation (in addition to the existing manual and corded power 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 Reamer and the CD3 Cordless Driver 3, identical to the RemB Univer (corded) Power Adaptor (K111478). The adaptors serve as a mechanical interface between the power driver and screwdriver instrument. When the adaptors are attached, the CD3 Cordless Driver 3 provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems: Xia Spinal System (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 System. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.
The provided text describes a 510(k) premarket notification for a power adaptor instrument accessory. This device is an accessory to a spinal fixation system, intended to facilitate the insertion of pedicle screws using powered techniques (corded and cordless). The submission focuses on demonstrating substantial equivalence to a predicate device (RemB Universal Driver, Power Adaptor, K111478).
Here's an analysis of the acceptance criteria and study information, based solely on the provided text. It's important to note that this document is a summary and details of the actual test reports (TRP000002163 and DSGN-fm-5303) are not fully provided, only referenced.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes verification activities rather than explicit quantified acceptance criteria in the typical sense of a diagnostic device's sensitivity, specificity, or similar metrics. The primary acceptance criterion appears to be demonstrating equivalence and adequate performance compared to the predicate device and existing manual techniques through various bench tests.
| Acceptance Criteria (Implied/Inferred) | Reported Device Performance |
|---|---|
| Fatigue Insertion (Simulated 3-year usage) | "Test results demonstrated that the subject device can withstand screw loading and screw insertion during normal use without loss of function." (Referencing TRP000002163 and DSGN-fm-5303 reports) |
| Interface and Functional Compatibility (with existing screwdrivers) | "Additionally, bench testing results confirmed that the CD3 Cordless Driver 3Power Adaptor device is compatible with existing screwdriver instruments." |
| Usability and Ergonomics (Surgeon Interface) | "No significant differences were observed concerning the surgeon interface for usability and ergonomics between the two hand pieces [new device vs. predicate]." |
| Safety Evaluation (Screw Placement Quality/Accuracy) | "safety evaluation testing of the CD3 Cordless Driver 3 Power Adaptor pedicle screw insertion technique under simulated use conditions presented no quality/accuracy issues for screw placement." |
| Profile and Weight (Comparison to Predicate) | "Additionally, the weight differences were considered modest and both size and shape were of similar design." |
| Equivalence in Design and Performance to Predicate | "The Stryker Spine CD3 Cordless Driver 3 Power Adaptor and RemB Universal Driver Power Adaptor (K1114780) are identical in design and performance and differ only with respect to the power source used for operation." (This is a conclusion from the testing and comparison; the performance aspect is supported by the other tests mentioned). |
| Maintain existing Indications for Use | The submission asserts: "No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems... The indications for use of each spinal system remain consistent with their most recent 510(k) clearance." This means the new accessory does not broaden or alter the clinical applications or patient populations for the spinal systems it's used with, and the testing supports that the device doesn't negatively impact the ability to meet these existing indications. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical "sample size" in terms of patient data or clinical cases. The testing described is bench testing using simulated conditions and materials. For "fatigue insertion over a simulated three year usage period," this implies a duration of testing rather than a discrete number of samples in the typical sense. It refers to "screw loading and screw insertion" events as part of the fatigue test, but no specific count is given.
- Data Provenance: The data provenance is from bench testing conducted by the manufacturer (Stryker Spine). It is not patient data, so concepts like "country of origin of the data" (for patients) or "retrospective/prospective" (for clinical studies) do not directly apply here. The testing is laboratory-based verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Experts: The document mentions "safety evaluation testing... under simulated use conditions presented no quality/accuracy issues for screw placement." It also states "No significant differences were observed concerning the surgeon interface for usability and ergonomics between the two hand pieces." While these evaluations likely involved ergonomic assessment by individuals with surgical or engineering expertise, the document does not specify the number or qualifications of any "experts" used to establish a ground truth. The evaluations appear to be internal engineering and usability assessments rather than formal expert consensus panels.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This is not a study requiring adjudication of expert opinions or interpretations, as it is bench testing and engineering verification.
5. 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:
- MRMC Study: No. This is not a diagnostic device based on interpretation by human readers (e.g., AI in radiology). It is a surgical instrument accessory. Therefore, an MRMC comparative effectiveness study involving human "readers" or "AI assistance" is not relevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: Not applicable. This device is a mechanical instrument accessory, not a software algorithm that performs diagnostic or analytical tasks. It is inherently used "human-in-the-loop" as a surgical tool.
7. The Type of Ground Truth Used:
- Ground Truth: The "ground truth" for this device's performance is established by engineering specifications, material properties, and functional performance benchmarks as demonstrated through bench testing. For example, "withstanding screw loading and screw insertion without loss of function" is verified against a predefined functional standard. "Compatibility with existing screwdriver instruments" is verified through direct operational testing. The "ground truth" is adherence to design and performance requirements.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set." The development and verification rely on engineering design, materials science, and physical testing, not data training.
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.
§ 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.