(184 days)
The 5.5 Helical Flange Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion 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 and for use with autograft. The device is indicated for all the following indications: 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), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
The 5.5 Helical Flange Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The Percutaneous instruments when used with the Percutaneous cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: 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), deformity or curvature (i.e., scoliosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.
The 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications: 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), deformity or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft.
This submission is a line extension to the EB1 5.5 Helical Flange Spinal System to add new 5.5 Polaris components, which may be used with the other 5.5mm components in order to build various types of spinal constructs. The new components include another style of screws in the larger diameters and a smaller diameter screw.
The provided document is a 510(k) summary for a medical device called the "EBI 5.5 Helical Flange Spinal System." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device's efficacy through clinical studies with acceptance criteria in the same way one might for a novel diagnostic AI.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. This document describes a traditional medical device (spinal fixation system) and its mechanical characteristics, not an AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth.
However, I can extract information related to the demonstration of "substantial equivalence" which is the core of this type of submission.
Here's a breakdown of what can be extracted and what is not applicable based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material composition | The technological characteristics (material) of the 5.5 components are the same as, or similar to, the predicate devices. |
| Design | The technological characteristics (design) of the 5.5 components are the same as, or similar to, the predicate devices. |
| Sizing | The technological characteristics (sizing) of the 5.5 components are the same as, or similar to, the predicate devices. |
| Intended Use | The 5.5 Helical Flange Spinal System is substantially equivalent to its predicate devices with respect to intended use. It is a non-cervical fixation device intended for immobilization and stabilization as an adjunct to fusion for a range of conditions (e.g., degenerative disc disease, spondylolisthesis, trauma, deformity, tumor, stenosis, pseudarthrosis, failed previous fusion). |
| Indications for Use | The 5.5 Helical Flange Spinal System is substantially equivalent to its predicate devices with respect to indications. The specific indications listed are comprehensive and match those of the predicate devices for pedicle screw fixation, posterior hook and sacral/iliac screw fixation, and anterolateral fixation. |
| Technological Characteristics | The 5.5 Helical Flange Spinal System is substantially equivalent to its predicate devices with respect to technological characteristics. Key characteristics like materials, design, and sizing are stated as "same as, or similar to." |
| Principles of Operation | The 5.5 Helical Flange Spinal System is substantially equivalent to its predicate devices with respect to principles of operation. |
| Safety and Effectiveness (No New Issues) | The device "do[es] not present any new issues of safety or effectiveness" compared to the predicate devices. |
| Mechanical Testing Performance | Based upon "mechanical testing," the 5.5 Helical Flange Spinal System is substantially equivalent for its intended use to other spinal systems currently on the market. (Specific performance values or acceptance thresholds for mechanical testing are not detailed in this summary, but are implied to be met to demonstrate equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a mechanical device, not a diagnostic algorithm. The "test set" in this context would refer to mechanical testing (e.g., fatigue testing, static strength testing of the implants), not a clinical data set. The document states "Based upon the mechanical testing," but does not provide details on the sample size, specific tests, or provenance of the data.
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)
- Not Applicable. Ground truth in the context of diagnostic AI refers to a definitive correct answer for a medical condition. For a spinal implant, "ground truth" would relate to the mechanical integrity and biocompatibility, which are verified through engineering tests and material science, not by expert medical interpretation of images or patient outcomes in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used in studies involving subjective interpretation, often by multiple readers, to establish a consensus ground truth. This is not relevant for the type of mechanical testing described in this 510(k) summary.
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 diagnostic performance, often for AI-assisted workflows. This document is for a spinal fixation system, not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a medical implant like this is typically established through adherence to recognized industry standards for mechanical testing (e.g., ASTM standards for spinal implants) and biocompatibility testing (though not explicitly detailed in this summary, it's a prerequisite for such devices). The summary mentions "mechanical testing" as the basis for substantial equivalence, implying these standards were met. There is no expert consensus, pathology, or outcomes data used to establish "ground truth" in the way it would be for an AI diagnostic.
8. The sample size for the training set
- Not Applicable. This device is a mechanical implant, not an AI. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for a mechanical implant, 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.