(365 days)
Non-cervical spinal fixation devices intended for posterior, non-pedicle fixation for the following indications: degenerative disc 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.
Non-cervical pedicle screw fixation 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-S 1 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 Mesa Spinal System is a top-loading, multiple component, posterior system which consists of pedicle screws, rods, hooks, and transverse connectors. 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 Ti6Al-4V ELI alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of spinal segments of the thoracic, lumbar and / or sacral spine.
This request is about a medical device, the Mesa Spinal System, specifically the 4.0mm Screw component, and not about an AI/ML powered device. Therefore, many of the typical acceptance criteria and study design elements expected for an AI/ML device (like sample size for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable here.
The provided text describes a 510(k) submission for the Mesa Spinal System, which is a spinal fixation device. For such devices, the "acceptance criteria" and "study" typically revolve around demonstrating substantial equivalence to a legally marketed predicate device through engineering and biocompatibility testing, material characterization, and comparison of design features and intended use.
Here's an analysis based on the provided text, addressing the relevant points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical Performance (ASTM F1717) | "The Mesa Spinal System was biomechanically 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." |
| Material Composition (ASTM & ISO Standards) | "The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards." "It is manufactured from the same FDA recognized materials..." |
| Design Features and Sizing | "...the design features and sizing of the components were also compared and the Mesa System found to be substantially the same as these systems." |
| Intended Use | "is indicated for the same intended uses as these systems." (The specific indications are listed in the 'Intended Use' and 'Indications for Use' sections of the document). |
| No Adverse Effects | "There are no significant differences between the Mesa Spinal Systems currently being marketed which would adversely affect the use of the product." |
| Substantial Equivalence | "It is substantially equivalent to these other devices in design, function, material and intended use." (This is the overarching acceptance criterion for a 510(k) submission). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This is not applicable in the context of this 510(k) submission. "Test set" typically refers to data used to evaluate an AI/ML model's performance on unseen data. For a spinal fixation device, performance is evaluated through material testing and biomechanical testing on representative samples of the device components, not a "test set" of patient data. The text indicates that the device was "biomechanically tested," which implies a certain number of physical samples were subjected to various tests, but the exact count is not provided.
- Data Provenance: Not applicable in the AI/ML sense. The "data" here would be the results of laboratory biomechanical and material tests. The document does not specify the location where these tests were performed or if they were retrospective or prospective, as these terms are generally used for clinical studies or data collection for AI.
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. "Ground truth" and "experts" in this context are not relevant for demonstrating substantial equivalence for a spinal fixation device. Performance is determined by objective engineering and material standards (e.g., ASTM F1717).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses, which is not part of a spinal fixation device's 510(k) submission.
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 is for AI-assisted image interpretation or diagnostic tools. The Mesa Spinal System is a physical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This concept pertains to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. "Ground truth" as an expert-derived label or outcome is not used here. Instead, the "truth" or standard for performance is defined by established engineering and material standards (e.g., ASTM F1717 for biomechanical testing) and comparison to the predicate device's characteristics.
8. The sample size for the training set
- Not applicable. There is no "training set" for physical medical devices in this context.
9. How the ground truth for the training set was established
- Not applicable. As there's no training set, there's no ground truth to establish for it.
§ 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.