(87 days)
The Micomed Posterior Doublerod System is a pedicle screw system indicated for the treatment of severe spondyloisthesis (Grades 3 and 4) at the L5-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 of deformities of the thoracic, lumbar, and sacral spine: degenerative spondyloisthesis 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 deformities such as scoliosis, Scheuermann's disease, degernerative disk disease defined as back pain of discogenic origin with degeneration of the disk 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 and stainless steel. The system consists of pedicle screws, polyaxial screws*, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod System. * polyaxial screws are only available in titanium
The provided text describes a 510(k) submission for a medical device, specifically the Micomed Posterior Doublerod System. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and performance.
However, the document primarily outlines the regulatory approval process and device specifications, and does not contain detailed information about a study proving the device meets specific acceptance criteria in the way a clinical or even a detailed standalone performance study would. The "Testing and Performance" section is brief and refers to biomechanical performance as per an ASTM standard, rather than a comprehensive study with specific acceptance criteria that one would typically associate with AI/software performance.
Therefore, many of the requested elements for describing an acceptance criteria study, especially those related to AI/software performance (e.g., sample sizes for test sets, expert ground truth, MRMC studies, training sets), cannot be extracted from the provided text.
Here is the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical performance per ASTM F1717-96 | The polyaxial screw has been shown to have acceptable biomechanical performance per ASTM F 1717-96 and to function in an equivalent manner to predicate polyaxial screws. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to biomechanical testing, which typically involves a set number of test specimens (e.g., screws, rods) rather than patient data.
- Data Provenance: Not specified, but given the nature of biomechanical testing, it would involve engineered test samples rather than patient data. The company is based in Germany, so if there were any clinical aspects not detailed, it might have European origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Biomechanical testing adherence to ASTM standards does not involve expert-established ground truth in the way clinical or image-based AI studies do. The "ground truth" is typically defined by the test parameters and failure modes according to the ASTM standard.
4. Adjudication method for the test set
- Not applicable. Biomechanical testing results are typically objective measurements against a standard, not subject to adjudication by multiple human experts.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/software in diagnostic or interpretive tasks, not for physical medical devices undergoing biomechanical testing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical spinal fixation system, not an algorithm. The reported "standalone" performance is the biomechanical performance of the device's components.
7. The type of ground truth used
- Ground Truth: Adherence to defined biomechanical performance standards and metrics outlined in ASTM F1717-96.
8. The sample size for the training set
- Not applicable. This device is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. This device is a physical medical device, not a machine learning algorithm.
§ 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.