(77 days)
The EBI® SpineLink® 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 or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The transverse connector is not intended for anterior/anterolateral fixation.
The EBI® SpineLink® Spinal Fixation System is a spinal fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties. This submission is for a modification to the Indications for Use to include degenerative disc disease (ddd).
The provided text describes a 510(k) Summary for the EBI® SpineLink® Spinal Fixation System, which is a spinal fixation device. This document is a pre-market notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the sense of a clinical trial or performance study determining diagnostic accuracy or similar statistical measures.
Therefore, many of the requested categories for a study proving acceptance criteria are not applicable in this context. The "acceptance criteria" here refer to the regulatory requirement of demonstrating substantial equivalence to predicate devices, primarily through comparison of intended use, materials, and function, supported by mechanical testing.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Device intended use aligns with predicate devices. | The EBI® SpineLink® Spinal Fixation System's intended use, including the expanded indication for degenerative disc disease, is compared to predicate devices: Spinal Concepts BacFix Spinal Fixation System, Sofamor Danek CD Spinal System, and Sofamor Danek Townley Pedicle Screw Plating System. The document states: "It is substantially equivalent to the predicate devices in regards to intended use." |
| Materials Equivalence: Device materials are equivalent to predicate devices. | Components are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The document states: "It is substantially equivalent to the predicate devices in regards to...materials." |
| Functional Equivalence/Performance: Device functions similarly and meets applicable standards, comparable to predicate devices. | Mechanical testing was performed comparing the EBI® SpineLink® Spinal Fixation System to two predicate systems. The document states: "Mechanical testing comparing the System to two predicate systems demonstrates that the device complies with applicable standards and meets all of its functional requirements." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "mechanical testing" but does not specify the sample size of tested devices or the details of the test set. Given this is a device for human implantation, the "test set" would refer to the physical devices undergoing mechanical tests, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided and is generally not applicable to the type of regulatory submission described. Mechanical testing typically involves engineers and lab technicians applying standardized tests, not medical experts establishing "ground truth" on cases.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable. Mechanical testing results are typically objectively measured against pre-defined engineering and material standards, not adjudicated by experts in the context of diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI devices where human readers interpret medical images. The EBI® SpineLink® Spinal Fixation System is a physical medical device (spinal implant), and MRMC studies are not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study (in the context of an algorithm's performance) was not done. This is not an AI/algorithm-based device. The "performance" assessment here refers to the physical device's mechanical integrity as determined by testing.
7. Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence and functional requirements in this context is based on:
- Established engineering and material standards: ASTM F136 for titanium alloy.
- Mechanical test results: Comparing the device's performance against industry standards and the performance of similar predicate devices.
- Regulatory definitions: Such as the definition of degenerative disc disease for the expanded indication.
8. Sample Size for the Training Set
This information is not applicable and not provided. As this is a physical medical device and not an AI or machine learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as #8.
§ 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.