(33 days)
The LDR Easyspine System is a posterior, noncervical, pedicle system 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: spondylolisthesis (grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Modifications to the Easyspine System that are the submission are confined solely to the addition of 5 mm diameter screws, 8 mm diameter screws, and washers (also referred to as spacers.) No components of the predicate (unmodified) system have been modified or deleted.
The provided document is a 510(k) summary for a medical device called the Easyspine® System, specifically for modifications including the addition of 5mm and 8mm diameter screws and washers. This document details the regulatory nature of the device and its equivalence to previously cleared predicates, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, or reader improvement.
The 510(k) process for devices like the Easyspine System (a pedicle screw spinal system) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves showing that the device has the same intended use, technological characteristics, and similar or identical materials and operating principles, and that any differences do not raise new questions of safety or effectiveness. Performance for such devices is usually assessed through mechanical testing (e.g., fatigue strength, torsional strength) rather than clinical studies that would generate the kind of performance metrics you've asked for.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria/Performance Data: The document does not specify quantitative acceptance criteria for device performance (e.g., in terms of clinical outcomes, diagnostic accuracy, or reader performance) nor does it report the device's performance against such criteria. The "performance" discussed pertains to material properties and mechanical integrity rather than analytical or clinical efficacy metrics.
- No Clinical Study for AI/Diagnostic Performance: This device is a surgical implant, not a diagnostic AI tool or a device that would typically undergo studies to assess human reader improvement or standalone diagnostic performance. The 510(k) largely focuses on mechanical and material equivalence.
Given this, I will answer each numbered point based on the information available in the document, noting when the information is not present.
Here's the breakdown based on the provided text:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this 510(k) appear to be demonstrating "substantial equivalence" to predicate devices, including having the same intended use, operating principle, basic design, materials, and packaging/sterilization processes.
- Reported Device Performance:
- Material Composition: Made of titanium alloy conforming to ASTM F 136, "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications."
- Biocompatibility: Titanium material is described as "biocompatible, corrosion-resistant, and not toxic in a biologic environment."
- Imaging Compatibility: Allows for "artifact-free x-ray imaging, computed tomography (CT) and Magnetic Resonance Imaging (MRI)."
- Equivalence to Marketed Product: The modified system shares the same intended use, operating principle, basic design, materials, and packaging/sterilization processes as the predicate Easyspine System.
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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)
- This information is not provided in the document. The filing is for a modified spinal implant, and the assessment of "performance" typically involves bench testing (mechanical and material analyses) rather than clinical data sets in the diagnostic sense.
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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)
- This information is not applicable/provided. The device is a surgical implant, not one that requires establishing ground truth by expert interpretation of images or clinical data for performance assessment in the manner of AI/diagnostic devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/provided for the same reasons as point 3.
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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
- This information is not applicable/provided. This device is a spinal implant, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable/provided. This device is a spinal implant, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this type of device (spinal implant), "ground truth" would typically relate to the material specifications and mechanical testing standards (e.g., ASTM standards for titanium alloy, validated mechanical testing protocols to ensure strength and durability). The document indicates compliance with ASTM F 136 for material composition. No clinical "ground truth" in terms of patient outcomes or pathology is referenced in this summary.
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The sample size for the training set
- This information is not applicable/provided. This device is a spinal implant being evaluated for substantial equivalence, not an AI model requiring a training set.
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How the ground truth for the training set was established
- This information is not applicable/provided for the same reasons as point 8.
§ 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.