(253 days)
The MIS Spinal Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The MIS Spinal System can be used in an open approach and a percutaneous approach.
The MIS Spinal System is intended for the following indications:
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture or dislocation), Spinal stenosis, Curvatures (i.e., scoliosis, kyphosis, lordosis), Tumor, Pseudarthrosis, Failed previous fusion.
The MIS spinal system consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537).
The provided text is a 510(k) summary for a spinal system, not a summary of an AI/ML-driven medical device study. Therefore, the information required to answer the prompt regarding acceptance criteria and performance studies for an AI/ML device is not present in the input.
Specifically, the document focuses on demonstrating substantial equivalence of a physical medical device (spinal screws and rods) to previously cleared predicate devices based on design, materials, manufacturing process, and mechanical performance testing. It does not mention any AI/ML components, software, or algorithms.
Therefore, I cannot extract the following information from the provided text:
- Table of acceptance criteria and reported device performance: This document reports mechanical testing data (substituted from predicate devices), not performance metrics for an AI/ML algorithm (e.g., accuracy, sensitivity, specificity).
- Sample size used for the test set and data provenance: There is no mention of a test set for an AI/ML algorithm. The "testing" referred to is mechanical reliability testing of the physical hardware.
- Number of experts used to establish ground truth and qualifications: Ground truth for AI/ML models is typically established by experts (e.g., radiologists, pathologists). This is not applicable here as there is no AI/ML component.
- Adjudication method for the test set: Not applicable for mechanical hardware testing.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is for evaluating the impact of AI assistance on human readers, which is not relevant to a spinal implant.
- Standalone (algorithm only) performance: There is no algorithm.
- Type of ground truth used: No AI/ML ground truth is involved.
- Sample size for the training set: Not applicable as there is no AI/ML model to train.
- How ground truth for the training set was established: Not applicable.
In conclusion, the provided text does not contain the necessary information to describe the acceptance criteria and study proving an AI/ML device meets them, as it pertains to a physical medical device (spinal system hardware).
§ 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.