(65 days)
The Erisma® LP MIS components are intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:
- Degenerative disc disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- Degenerative spondylolisthesis with objective evidence of neurologic impairment,
- Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint,
- Fracture,
- Dislocation,
- Scoliosis,
- Kyphosis,
- Spinal tumor,
- Failed previous fusion (pseudarthrosis).
The Erisma® LP MIS device is intended to be used for the surgical treatment of spinal pathologies by percutaneous access. The treatment consists of the stabilization of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.
The Erisma® LP MIS consists of cannulated extended pedicle screws and straight or pre-bent rods that can be used via posterior percutaneous surgical approach to provide the immobilization and the stabilization of spinal segments in mature patients as an adjunct to fusion in the treatment of instabilities or deformities of the thoracic, lumbar and sacral spine.
The components are available in a variety of diameters and lengths to accommodate patient anatomy and are made from ISO 5832-3 or ASTM F136 medical grade Titanium alloy.
The Erisma® LP MIS also contains surgical instruments common for posterior percutaneous spinal fixation approach. The primary purpose of this submission is to extend the breakoff tabs of the pedicle screws to allow for minimally invasive surgery.
The provided document is a 510(k) premarket notification decision letter from the FDA for the Erisma® LP MIS device. This type of submission is for medical devices and their physical performance characteristics and safety, not for AI-powered diagnostic tools or software as a medical device (SaMD) that typically have acceptance criteria focused on diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).
Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, F1 score).
Instead, the "Performance Data" section mentions:
- Bench Testing: This refers to physical and mechanical testing of the device.
- Dynamic ASTM F1717 testing: This is a standard for spinal implant constructs in a simulated in-vivo environment to assess their mechanical integrity and fatigue life. The acceptance criteria would be defined by the stress and cycle limits set in the standard for equivalence to the predicate device.
- Sterilization validation: This ensures the device can be properly sterilized, meeting specific sterility assurance levels, which are critical for patient safety.
- Substantial Equivalence: The primary "proof" is that the device is substantially equivalent to legally marketed predicate devices in terms of material, design, and indications for use, and that the minor change (extended breakoff tabs for MIS insertion) does not raise new safety or effectiveness questions.
In summary, the document does not provide the type of information requested for an AI/diagnostic device, such as acceptance criteria for diagnostic performance, sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies. The "study" referenced is bench testing to demonstrate mechanical and sterilization equivalence to predicate devices, which is typical for physical medical implants.
§ 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.