(349 days)
The ISOBAR Spinal System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion.
As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of solid fusion.
The Semi-Rigid Rod and Dual Dampener Rod should only be used at levels (one and two levels, respectively) that will be fused.
The ISOBAR Spinal System consists of pedicle screws, rigid rods and crosslink members (K990118, K013444, K020245, K031290 and K051063), semi-rigid rods (K991326) and hooks (K013440 & 013447). The Isobar Semi-rigid Dual Dampener Rod is an addition to the ISOBAR Spinal System family. The semi-rigid rod allows a very small amount of compression, torsion and bending. The components in this submission are fabricated from Ti6A14V alloy, conforming to ASTM F136 and ISO 5832-3, which is known to be biocompatible.
The provided text is a 510(k) summary for the "ISOBAR Spinal System." It details the device's indications for use, description, and states its substantial equivalence to predicate devices. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, or grand truth establishment for performance evaluation.
Here's an explanation of why the requested information is not present in the given document:
- Acceptance Criteria and Reported Device Performance: The document only states that "Testing performed indicates the ISOBAR Spinal System is substantially equivalent to predicate devices." It does not provide specific acceptance criteria (e.g., specific thresholds for mechanical strength, fatigue life) or the quantitative results of the tests performed against such criteria.
- Sample Size for Test Set and Data Provenance: This document is a regulatory submission for a spinal implant system. Performance testing for such devices typically involves benchtop mechanical testing (e.g., fatigue, static strength), not studies on human data or medical images. Therefore, concepts like "test set," "data provenance," or "country of origin of the data" in the context of medical imaging or clinical study data do not apply here. The "sample size" would refer to the number of devices or components tested mechanically, which is not disclosed.
- Number of Experts and Qualifications: As the evaluation is based on mechanical performance and substantial equivalence to predicate devices, there isn't a need for medical experts to establish "ground truth" or to adjudicate observations in the way they would for, say, an AI-powered diagnostic device analyzing medical images.
- Adjudication Method: Not applicable for a mechanical device substantial equivalence submission.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is used for diagnostic devices, particularly those involving human interpretation of medical data, to assess how a new technology (like AI) affects reader performance.
- Standalone Performance: While the device is "standalone" in the sense that it's an implantable device, the concept of "algorithm only without human-in-the-loop performance" is typically relevant to AI/ML software devices.
- Type of Ground Truth: The "ground truth" for a spinal implant system's performance would generally be established by adherence to recognized ASTM or ISO standards for mechanical testing (e.g., fatigue strength, pull-out strength). The document only mentions conformity to ASTM F136 and ISO 5832-3 for material properties, but not specific performance test standards or their results.
- Sample Size for Training Set: Not applicable. This pertains to AI/ML models.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document is a 510(k) summary primarily focused on demonstrating substantial equivalence to predicate devices based on indications for use, design, function, and materials, rather than detailed performance study results against specific acceptance criteria. For mechanical devices like spinal implants, "performance standards" typically refer to adherence to recognized test methods and successful completion of those tests, rather than clinical studies with human participants. The document indicates that testing was performed to show substantial equivalence, but it does not elaborate on the specific tests, their results, or the acceptance criteria used.
§ 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.