(55 days)
The MESA and DENALI Spinal Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:
Posterior non-cervical fixation 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; pseudoarthosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.
Except for the ARI staples, the MESA, DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
This traditional 510(k) premarket notification is to introduce the Cannulated Power Driver Attachment instrument for use with Stryker Power Systems.
The Cannulated Power Driver Attachment is an accessory to the Everest and Range (Mesa and Denali) pedicle screw systems intended to facilitate the insertion of pedicle screws using powered instrumentation. The Cannulated Power Driver Attachment, also referred to as the power adaptor or subject device, serves as a mechanical interface between the power driver and screwdriver instrument. When the adaptor is attached, the driver (corded and cordless) 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 Everest and Range (Mesa and Denali) Spinal Systems. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.
The provided text is a 510(k) summary for the "Cannulated Power Driver Attachment". This document is for a medical device that assists in the surgical insertion of pedicle screws, not an AI/ML-driven device for diagnosis or prediction. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable.
However, I can extract information related to the acceptance criteria and how the device met them.
1. A table of acceptance criteria and the reported device performance
The document states that the "Cannulated Power Driver Attachment Instrument has demonstrated substantial equivalence to the predicate device." It further states: "The performance of the Cannulated Power Driver Attachment has met all acceptance criteria."
While specific numerical acceptance criteria (e.g., torque values, cycles to failure) are not provided in this summary, the general acceptance criteria can be inferred from the context of "substantial equivalence" and "verification and validation activities."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated substantial equivalence to the predicate device (K200666 and others). |
| Compatibility with Stryker Power Drivers | Connection to various Stryker Power Drivers does not represent a new worst case for powered pedicle screw insertion. |
| Functionality for Pedicle Screw Insertion | Aids in the rotation of the bone screw to facilitate insertion (when used with Stryker Power Drivers). |
| Mechanical Integrity/Performance | Met all acceptance criteria through Verification and Validation activities. (Specific criteria, e.g., torque, fatigue, not detailed in summary). |
| Material and Design Equivalence | Has equivalent materials, fundamental scientific technologies, and design compared with the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device is a mechanical instrument. Testing would involve engineering evaluations (e.g., mechanical stress tests, fatigue tests) rather than data from human subjects or medical images. Therefore, the concepts of "test set sample size" and "data provenance" as typically applied to AI/ML systems are not relevant here. The "test set" would be the manufactured Cannulated Power Driver Attachment instruments subjected to various non-clinical performance evaluations. The number of units tested is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a mechanical instrument. Ground truth in this context would be defined by engineering standards and specifications, not expert medical opinion on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a mechanical device.
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
Not applicable as this is a mechanical medical instrument, not an AI/ML diagnostic or predictive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is a mechanical medical instrument, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a mechanical device would be established by engineering specifications, validated test methods, and performance benchmarks against predicate devices. The summary indicates that "Verification and validation activities" were conducted to demonstrate that the device "met all acceptance criteria" and "does not represent a new worst case for powered pedicle screw insertion," implying a comparison to established performance characteristics of the predicate device.
8. The sample size for the training set
Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable as this is not an AI/ML 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.