(83 days)
The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.
When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.
When used as an anterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.
The EBI SpineLink™ System with Link Tie is a spinal fixation device for the interconnection of two links.
The provided text describes a 510(k) premarket notification for a medical device (EBI SpineLink™ System with Link Tie), not a study analyzing device performance against acceptance criteria. A 510(k) is a submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process does not typically involve detailed studies with acceptance criteria in the manner requested for a new device's efficacy or accuracy.
Therefore, most of the requested information (such as acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from the provided document. The document focuses on establishing substantial equivalence through comparison of technological characteristics, intended use, and materials, rather than presenting a performance study with detailed statistical outcomes.
Here's what can be gathered from the text, indicating the type of assessment rather than the specifics of a performance study:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial equivalence to predicate devices regarding intended use, materials, and function. | "Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements." |
Explanation: The "acceptance criteria" here are not numerical performance thresholds but rather the regulatory requirement of demonstrating substantial equivalence to predicate devices, supported by bench testing results that show compliance with standards and functional requirements. Specific numerical performance metrics are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable/Not mentioned. The document refers to "bench testing," which typically involves mechanical testing of device components, not a clinical "test set" in the context of diagnostic or AI performance evaluation.
- Data Provenance: Not applicable/Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Number of Experts: Not applicable/Not mentioned. This type of information is pertinent to studies involving human interpretation or clinical data, which is not the subject of this 510(k) summary.
- Qualifications of Experts: Not applicable/Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/Not mentioned.
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:
- MRMC Study: No, an MRMC study was not done. This is a medical device for spinal fixation, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable. The "bench testing" mentioned compares the device to a predicate system against "applicable standards" and "functional requirements," indicating objective engineering and material property measurements rather than clinical "ground truth."
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/Not mentioned. This pertains to machine learning models, not mechanical devices.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable/Not mentioned.
Summary:
The provided text is a 510(k) submission for a physical spinal fixation device. Its purpose is to demonstrate substantial equivalence to existing devices through comparison of intended use, materials, and general function, supported by "bench testing." It does not contain the detailed performance study information typically requested for AI-enabled diagnostic devices or software, such as clinical test sets, expert ground truth, or statistical performance metrics.
§ 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.