(69 days)
The EBI® Array™ Spinal Fixation System is a non-cervical spinal fixation device intended for use as an anterolateral pedicle screw fixation system, a posterior hook and sacral/iliac screw fixations ystem, or as an anterplated for pedicle screw fixation system, a posterior november patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographie studiosis, spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, spondylorisations) and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.
The EBI® VuePASS™ Portal Access System when used with the EBI® Array™ Spinal Firation System is I he EDI Vuel ABS
The EBI® SpineLink II Spinal Fixation System is a non-cervical spinal fixation device intended for use as an anagerolateral The EBT Spinellilik II Spillar I Ration System.
Pedicle screw fixation system, a posterior hook and sacrabiliates. The device is indicated for pedicle screw fixation system, a posterior nosition. In the patientive disactive is indicated for all of the following indications regardess of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studiosis discogenic back pain with defencialism or me
spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, spondylonstrations) in the many psuedoarthrosis, and failed previous fusion.
The EBI® VuePASS™ Portal Access System when used with the EBI® Spinal Fixation The EBI * VuePASS * * Foral 766655 byers.
System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The EBI® Array™ Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, and hooks. The EBT® VuePASS™ Portal Access Surgical System is a retractor system for a minimally invasive approach for posterior spinal surgery. The system includes a series of stainless steel sequential dilators and various sized reusable radiolucent oval cannulas and circular tubes. When used with the EBI® Array™ Spinal Fixation System, the use of the EBI® VuePASS™ Portal Access Surgical System is limited to the implant of a rod length of 50mm or less and excludes the use of system cross connectors or hooks.
The EBI® SpineLink® II Spinal Fixation System is a fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties. The EBI® VuePASS™ Portal Access Surgical System is a retractor system for a minimally invasive approach for posterior spinal surgery. The system includes a series of stainless steel sequential dilators and various sized reusable radiolucent oval cannulas and circular tubes. When used with the EBI® SpineLink® II Spinal Fixation System, the use of the EBI® VuePASS™ Portal Access Surgical System is limited to the implant of link lengths of 36mm or less and excludes the use of system cross links.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EBI® Array™ Spinal Fixation System with the EBI® VuePASS™ Portal Access Surgical System, and the EBI® SpineLink® II Spinal Fixation System with the EBI® VuePASS™ Portal Access Surgical System:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the submission focuses on demonstrating substantial equivalence to existing predicate devices rather than defining specific performance acceptance criteria with numerical targets. The "acceptance criteria" here is implicitly defined as successful implantation demonstrating substantial equivalence in design, intended use, and materials.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| EBI® Array™ System: Substantial equivalence in design, intended use, and materials to the predicate EBI® Array™ Spinal Fixation System (K033312) when utilizing the EBI® VuePASS™ Portal Access Surgical System. | "Verification testing demonstrated successful implantation of the EBI® Array™ Spinal Fixation System utilizing the EBI® VuePASS™ Portal Access Surgical System. It is substantially equivalent to the predicate device in regards to design, intended use, and materials." (For EBI® Array™ System) "The EBI® Array™ Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion." (Intended Use from K042772) |
| EBI® SpineLink® II System: Substantial equivalence in design, intended use, and materials to the predicate EBI® SpineLink® II Spinal Fixation System (K012516, K031355) when utilizing the EBI® VuePASS™ Portal Access Surgical System. | "Verification testing demonstrated successful implantation of the EBI® SpineLink® II Spinal Fixation System utilizing the EBI® VuePASS™ Portal Access Surgical System. It is substantially equivalent to the predicate device in regards to design, intended use, and materials." (For EBI® SpineLink® II System) "The EBI® SpineLink® II Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion." (Intended Use from K042772) |
2. Sample Size Used for the Test Set and Data Provenance
The document only generically refers to "Verification testing". It does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective). This type of information is typically detailed in a separate test report referenced in a 510(k) summary, but not explicitly provided in this summary itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention human experts being used to establish a "ground truth" for a test set. The term "verification testing" implies engineering or mechanical performance testing, not a clinical study involving expert assessment of outcomes or images.
4. Adjudication Method for the Test Set
As there's no mention of a test set requiring expert ground truth or assessment, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This type of study would typically involve human readers (e.g., surgeons) evaluating cases with and without AI assistance, and measuring the effect size of the AI's improvement. The device in question (spinal fixation system and portal access system) is a physical surgical device, not a diagnostic AI system, making an MRMC study irrelevant in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone algorithm performance study was done or reported. The devices are physical surgical tools, not algorithms. The "verification testing" would assess the mechanical integrity and functional performance of the surgical tools themselves, likely through bench testing.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic AI (e.g., pathology, outcomes data) is not directly applicable here. The "ground truth" in this context would be the successful mechanical and functional performance of the medical devices as designed, verified through engineering tests matching established predicate device performance and safety standards. This is likely based on engineering specifications and test results.
8. Sample Size for the Training Set
The document does not specify a training set size. This is a physical device, not an AI algorithm that requires a training set in the conventional sense. If any form of "training" or development involved iterative testing, those details are not provided.
9. How the Ground Truth for the Training Set Was Established
As this is a physical device submission and not an AI submission, the concept of a "training set" and associated "ground truth" as used in AI development does not apply. The design and development of such devices are guided by engineering principles, biomechanical requirements, materials science, and conformity to established standards for medical implants. "Ground truth" for development would be the known and desired mechanical properties and biological compatibility standards.
§ 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.