(116 days)
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:
Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of 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.
Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disease (DDD) (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; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Mesa Spinal System is a top-loading, multiple component, spinal fixation system. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from titanium and cobalt chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to provide immobilization and stabilization of spinal segments of the thoracic, lumbar and / or sacral spine.
The provided text pertains to a 510(k) summary for the "Mesa Spinal System" and its substantial equivalence to predicate devices. It describes the device, its intended use, and a comparison to other legally marketed systems, primarily focusing on mechanical testing against ASTM F1717 standards.
However, the document does not contain information about acceptance criteria, a specific study used to prove the device meets those criteria, or details regarding ground truth, expert consensus, or clinical performance data that would typically be found in a study demonstrating effectiveness for a diagnostic or AI-driven device.
This document is for a spinal fixation system, which is a mechanical implant, not a diagnostic or AI device. Therefore, the questions posed (related to AI performance, expert ground truth, multi-reader studies, etc.) are not applicable to this type of medical device submission.
The "study" referenced in the document is mechanical testing to ASTM F1717.
Here's how to address the prompt based on the provided text, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from text) | Reported Device Performance (from text) |
|---|---|
| Performance equal to or better than predicate and currently marketed systems in ASTM F1717 testing. | "The Mesa Spinal System was mechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717." |
| Substantial equivalence in design features, sizing, materials, and intended use as predicate devices. | "The design features and sizing of the components were also compared and the Range Spinal System was found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems." |
| No significant differences that would adversely affect use compared to currently marketed systems. | "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in terms of patient data. The "test set" here refers to the components of the Mesa Spinal System subjected to mechanical testing. The number of components tested for ASTM F1717 is not detailed.
- Data Provenance: Not applicable in the context of patient data for a mechanical fixation device. The testing is performance-based for the device itself.
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. This document describes a mechanical device, not a diagnostic or AI system requiring expert-established ground truth from medical images or clinical outcomes. The "ground truth" for the mechanical testing is defined by the ASTM F1717 standard itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for clinical studies involving human interpretation or uncertain outcomes. This document details mechanical testing against a standard.
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. This is a mechanical spinal fixation system, not a diagnostic or AI device. An MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the ASTM F1717 standard for mechanical testing of spinal implant constructs. The device's performance is compared against the requirements and performance characteristics of legally marketed predicate devices as measured under this standard.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As a mechanical device, a training set and its associated ground truth are not relevant concepts for this submission.
§ 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.