(98 days)
The Mesa Spinal System is a non-cervical spinal fixation device 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.
The Mesa Spinal System is also intended for 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 'pondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by utogenous 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 Spine System is a top-loading, multiple component, posterior spinal fixation 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 of spinal segments of the thoracic, lumbar and / or sacral spine.
The provided document is a 510(k) Summary for the Mesa Spinal System, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. It describes the device's intended use, materials, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of clinical or diagnostic efficacy.
Instead, the document primarily focuses on biomechanical testing to demonstrate equivalence to predicate devices, which is typical for spinal fixation systems. Here's a breakdown of why the requested information cannot be fully provided from the given text:
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Acceptance criteria and reported device performance (Table 1): The document states: "The Mesa Spine 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." This indicates a type of performance standard (ASTM F1717) was used, and the device met or exceeded it. However, specific numerical acceptance criteria (e.g., "must withstand X N of force," "fatigue life must exceed Y cycles") and the exact reported performance values are not detailed in this summary. The table below reflects the limited information available.
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Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and ground truth establishment for a clinical/diagnostic study: These questions are entirely not applicable to the type of information presented in this 510(k) summary. The document describes a biomechanical study, not a clinical study involving human patients, image analysis, or diagnostic accuracy where such details would be relevant.
Therefore, most of the requested fields cannot be filled based on the provided text.
Here's the closest possible answer based only on the provided text, with explanations where information is absent:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biomechanical Performance: Equal to or better than predicate devices in ASTM F1717 testing. | Performed equal to or better than predicate systems and other currently marketed systems in ASTM testing to F1717. |
Explanation: The document explicitly states that the device was biomechanically tested against the ASTM F1717 standard and compared to predicate devices. The acceptance criterion was implicitly defined as performing "equal to or better than" these established systems. Specific numerical thresholds for this ASTM standard and the exact results are not provided in this 510(k) summary.
Details of the Study
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. (This likely refers to the number of devices or components tested in the biomechanical study).
- Data Provenance: Not applicable, as this was a biomechanical study, not a clinical data collection from patients or specific countries.
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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 was a biomechanical test of physical properties, not a study requiring expert clinical "ground truth" establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. (Again, this pertains to clinical/diagnostic studies, not biomechanical tests).
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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 study was not done. This device is a spinal fixation system, not a diagnostic AI tool, so this type of study is irrelevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for a biomechanical study would typically be the physical properties and performance standards defined by the ASTM F1717 standard and the performance of the predicate devices.
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The sample size for the training set:
- Not Applicable. This device is hardware; there is no "training set" in the machine learning sense.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for this type of device and study.
§ 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.