(129 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 LS-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 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. scolosis; and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion.
The Range Spinal System is a top-loading, multiple component, spinal fixation system which consists of pedicle screws, rods, hooks, connectors, staples and washers. 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 Range Spinal System, Staples and Washers. This type of document is for a medical device seeking clearance from the FDA, and it focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through mechanical testing and comparison of design features and materials. It does not typically involve clinical studies with human participants or AI performance evaluation that would require the detailed acceptance criteria and study information you've requested.
Therefore, many of your requested points are not applicable to the content of this document. I will fill in what information is available and indicate where information is not present in the provided text.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission for the Range Spinal System primarily relies on mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies involving human patients or complex algorithm performance evaluations. The key acceptance criteria are related to the mechanical performance and design characteristics of the device.
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria Reported Device Performance Mechanical Performance:
- Static Torsion Strength
- Dynamic Compression Strength | The Range Spinal System performed equal to or better than predicate systems and other currently marketed systems in static torsion and dynamic compression in accordance with ASTM F1717. |
| Design Features and Sizing: - Substantial similarity to predicate devices | The design features and sizing of the components were compared and the Range Spinal System was found to be substantially the same as predicate systems. |
| Material: - Use of appropriate, biocompatible materials consistent with predicate devices | The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards, which is the same material as other marketed systems. |
| Intended Use: - Consistent indications for use with predicate devices | The Range Spinal System is indicated for the same intended uses as predicate systems (e.g., as an adjunct to fusion for indications like trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion, and severe spondylolisthesis in L5-S1). |
| Overall Substantial Equivalence: - No significant differences adversely affecting product use | "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." (Page 2 of 510(k) Summary) |
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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: The document does not specify the exact number of device samples (screws, rods, hooks, connectors, staples, washers) tested for static torsion and dynamic compression. However, mechanical testing typically involves a sufficient number of samples to generate statistically meaningful data according to the relevant ASTM standards.
- Data Provenance: The data is from mechanical testing, not human patient data. No country of origin for the testing itself is specified, but the submitter (K2M, Inc.) is based in Leesburg, VA, USA. The testing would be prospective in the sense that the device was specifically manufactured and tested for this submission.
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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 submission relies on mechanical testing against established ASTM standards, not a ground truth established by medical experts for diagnostic or clinical performance. The "ground truth" here is the performance required by the ASTM F1717 standard and comparison to predicate device performance benchmarks.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in clinical or image-based studies. Mechanical testing results are objective measurements.
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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
- Not Applicable. This is a traditional medical device (spinal fixation system) submission, not an AI software/device. No MRMC study was performed, and thus no effect size related to AI assistance is provided.
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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 a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical testing, the "ground truth" is defined by ASTM F1717 standards for static torsion and dynamic compression, and the established performance and design characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's mechanical properties and design are equivalent or superior within the context of these standards and predicate devices.
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The sample size for the training set
- Not Applicable. There is no "training set" as this is a physical medical device being evaluated through mechanical testing for substantial equivalence, not an AI or machine learning model.
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How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided document.
§ 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.