(89 days)
PathFinder - Mini-Open Posterior Approach
When intended for pedicle screw fixation from L1-S1, the indications include 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking info consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
The Abbott Spine, Inc. PathFinder® system is a pedicle screw fixation system designed to allow for use of an open or mini open surgical technique. The approved Pathfinder® system consists of various screws and rods and is intended to provide temporary stabilization following surgery to fuse the spine.
The subject device is the result of modifications to the existing PathFinder® 6.5mm polyaxial pedicle screws resulted in the inclusion of a 4.5mm polyaxial pedicle screw to the Pathfinder System. The subject device shares the same intended use and fundamental scientific technology as the predicate device.
The Abbott Spine PathFinder® System is a spinal fixation system. The submission K071174 specifically concerns modifications to the existing PathFinder® 6.5mm polyaxial pedicle screws to include a 4.5mm polyaxial pedicle screw.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device | Laboratory and bench testing results demonstrate substantial equivalence to the predicate device. |
Study Details
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Acceptance Criteria and Reported Device Performance: See table above.
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The submission states "NONCLINICAL PERFORMANCE AND CONCLUSION: Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device. CLINICAL PERFORMANCE AND CONCLUSIONS: Clinical data and conclusions were not needed for this device." The evaluation relied on nonclinical (laboratory and bench) testing.
- Data Provenance: Not applicable, as no clinical data was required or provided. The nonclinical testing would have been conducted in a laboratory setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical ground truth was established. The device's performance was evaluated through nonclinical laboratory and bench testing against the predicate device.
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Adjudication method for the test set: Not applicable, as no clinical ground truth requiring adjudication was established.
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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. This device is a mechanical spinal fixation system, not an AI-assisted diagnostic or therapeutic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a mechanical implant, not an algorithm.
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The type of ground truth used: Not applicable for clinical ground truth. For the nonclinical evaluation, the "ground truth" was the
performance characteristics and regulatory standards applied to the predicate device (PathFinder® System K030625). The new device's
performance in laboratory and bench tests was compared to these established characteristics to demonstrate substantial equivalence. -
The sample size for the training set: Not applicable, as no clinical trials or machine learning models were involved.
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How the ground truth for the training set was established: Not applicable, as no clinical trials or machine learning models were involved.
§ 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.