(226 days)
The Micomed Posterior Doublerod System is a pedicle screw system indicated for treatment of severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Micomed Posterior Doublerod System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic, or kyphotic deformities such as scollosis, Scheuermann's disease); degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.
The Micomed Posterior Doublerod System is a low profile, top-loading spinal fixation system available in titanium. The system consists of pedicle screws of varying lengths and diameters, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod System.
The acceptance criteria and device performance for the Micomed Posterior Doublerod System are primarily based on biomechanical equivalence to predicate devices, as detailed in the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biomechanical behavior comparable to legally marketed predicate spinal fixation systems. | The Micomed Posterior Doublerod System has been shown to have acceptable biomechanical behavior when compared to TSRH (Sofamor Danek), VSP (AcroMed), ISOLA (AcroMed), AcroMed Pedicle Screw (AcroMed), Dyna-Lok (Danek), and Miami Moss (DePuy Motech). |
| Substantial equivalence to legally marketed predicate spinal fixation systems regarding design, materials, and intended use. | The Micomed Posterior Doublerod System is substantially equivalent to TSRH (Sofamor Danek), VSP (AcroMed), ISOLA (AcroMed), AcroMed Pedicle Screw (AcroMed), Dyna-Lok (Danek), and Miami Moss (DePuy Motech). |
| Compliance with material specifications for implantable medical devices. | The components of the Micomed Posterior Doublerod System are manufactured from titanium in conformance with ASTM F136. |
| Indicated uses are consistent with those of predicate devices. | The indications for use for the Micomed Posterior Doublerod System (treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities, and non-pedicle screw fixation system for scoliotic, lordotic, or kyphotic deformities) are deemed substantially equivalent to those of the predicate devices. |
Study Details:
The provided document describes a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with strict acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.
Therefore, many of the typical data points required for AI/diagnostic device studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance studies, and training set details) are not applicable or not explicitly reported in this type of submission.
Here's a breakdown of the requested information:
2. Sample size used for the test set and the data provenance:
- Not applicable/Not reported. This 510(k) relies on a comparative biomechanical assessment and substantial equivalence argument, not a diagnostic accuracy study with a test set of patient data. The "test set" here refers to biomechanical testing of the device itself. The document states "acceptable biomechanical behavior when compared to" several predicate devices, implying in-vitro mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not reported. Ground truth in this context would likely refer to established biomechanical standards and engineering principles, not expert interpretations of patient data.
4. Adjudication method for the test set:
- Not applicable/Not reported. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not the primary focus of 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. This device is a mechanical spinal fixation system, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical spinal fixation system, not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" implicitly used for this type of submission is:
- Biomechanical performance standards and data established for similar spinal fixation systems (predicate devices).
- Material specifications (ASTM F136 for titanium).
- Clinical experience and regulatory history of the predicate devices for establishing appropriate indications for use.
8. The sample size for the training set:
- Not applicable/Not reported. There is no "training set" in the context of an AI device. For a traditional mechanical device, "training" might informally refer to iterative design and testing, but not in the sense of machine learning.
9. How the ground truth for the training set was established:
- Not applicable/Not reported. As there is no training set as understood in AI, this question does not apply.
In summary, the Micomed Posterior Doublerod System gained acceptance based on demonstrating substantial equivalence to numerous established predicate spinal fixation systems, primarily through biomechanical comparison studies and conformance to material standards (ASTM F136). The focus of this 510(k) was to show that the new device performs acceptably and is as safe and effective as devices already on the market, rather than to prove superior clinical efficacy or diagnostic accuracy through extensive clinical trials or AI performance evaluations.
§ 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.