(84 days)
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 or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The transverse connector is not intended for anterior/anterolateral fixation.
The EBT® SpineLink® II 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.
The provided text describes a 510(k) summary for a medical device called the EBI® SpineLink® - II Spinal Fixation System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the way an AI/ML device would. Therefore, most of the information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for training) is not applicable to this type of device submission as described.
Here's an analysis based on the available information:
Description of the Device and its Assessment:
The EBI® SpineLink® - II Spinal Fixation System is a spinal fixation device used for various spinal conditions. Its 510(k) submission, K031355, asserts substantial equivalence to existing legally marketed predicate devices. This means the device's safety and effectiveness are established by showing it is as safe and effective as a device already on the market.
1. Table of Acceptance Criteria and Reported Device Performance:
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Acceptance Criteria for Spinal Fixation Systems (Inferred from 510(k) principles): For a device like the EBI® SpineLink® - II Spinal Fixation System, the "acceptance criteria" are not typically expressed as specific performance metrics like sensitivity or specificity for diagnosis. Instead, they center around:
- Substantial Equivalence: The primary criterion is demonstrating that the device is as safe and effective as legally marketed predicate devices. This is achieved by comparing its technological characteristics (intended use, materials, function) and through mechanical testing.
- Compliance with Applicable Standards: The device must comply with relevant industry standards for spinal implants (e.g., ASTM F136 for materials).
- Meeting Functional Requirements: The device must perform its intended mechanical functions reliably.
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Reported Device Performance (from the document):
| Acceptance Criteria Category (Inferred) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Substantial Equivalence | "There are no significant differences between the EBI® SpineLink® - II Spinal Fixation System and other legally marketed spinal systems. It is substantially equivalent to the predicate devices in regards to intended use, materials, and function." |
| Compliance with Standards | "The components of the System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136." |
| Meeting Functional Requirements | "Mechanical testing comparing the System to 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 the data provenance:
- Not Applicable. This is a mechanical device, not an AI/ML diagnostic tool. Its performance is demonstrated through mechanical testing against predicate devices and adherence to material standards, not through analysis of data from a training/test set of patient images or other data. The "test set" in this context would refer to the physical devices undergoing mechanical tests, not a dataset. The document does not specify the number of devices tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the sense of expert consensus on patient data or pathology, is not relevant for demonstrating the substantial equivalence of a mechanical spinal fixation system.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation or uncertain outcomes, which is not the case for this type of 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. MRMC studies are specific to evaluating the impact of AI on human readers (e.g., radiologists interpreting images). This device is a surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (in the conventional sense). For this medical device, the "ground truth" for its safety and effectiveness is established by:
- Mechanical Test Results: Demonstrating that its physical performance (strength, durability, etc.) is comparable to or better than predicate devices and meets relevant standards.
- Material Specifications: Conformance to established material standards (e.g., ASTM F136 for titanium alloy).
- Comparison to Predicate Devices: Showing that its design, intended use, and functional principles are substantially equivalent to devices already proven safe and effective.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for a mechanical device like this.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.