Search Results

The LDR Easyspine System is a posterior, noncervical pedicle and non-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:

• Degenerative disc disease (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
• Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

Easyspine® implants are single use devices for mono-and multi-segmental stabilization of the lumbar and thoracic vertebrae to promote fusion. Easyspine® consists of sacral and pedicle screws, transverse connectors, hooks, and rods of different rigidities. Specialized associated instrumentation is designed for implantation of these devices and for the distraction, compression or reduction of the lumbar and thoracic spine.

The provided text describes a 510(k) summary for the LDR Spine USA Easyspine System. However, it does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Identification of the device: Trade Name, Common Name, Classification, Owner, Contact Person.
• Date of submission.
• Description of the device: Components and purpose.
• Intended Use: Specific spinal conditions it's designed to treat.
• Legally Marketed Equivalent Predicate Device: LDR Spine Easyspine System (K043094).
• Non-Clinical Performance Data: A statement that mechanical test results demonstrated substantial equivalence of a modified transverse connector design to the predicate device, and that the fundamental scientific technology remains unchanged.
• FDA's clearance letter: Confirming substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Ask a specific question about this device

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:

1. 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.

2. 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.

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)

   • 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.

4. 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.

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

   • This information is not applicable/provided. This device is a spinal implant, not an AI-assisted diagnostic tool.

6. 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.

7. 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.

8. 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.

9. How the ground truth for the training set was established

   • This information is not applicable/provided for the same reasons as point 8.

Ask a specific question about this device