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The Easyspine® Posterior Spinal System is a posterior, non-cervical 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 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 ●

The Easyspine Spinal System is a side-loading posterior spinal pedicle fixation system consisting of various implant components. The 4.25 mm pedicle screws and curved rods represent a line extension to the previously cleared Easyspine Spinal System (K043094, K063794, and K082592). The subject devices are identical to their predicates with respect to general technological characteristics and intended use.

The provided document describes the LDR Spine Easyspine Posterior Spinal System, a medical device for spinal fixation. However, the document does NOT contain information about acceptance criteria for device performance, nor does it detail a study proving the device meets such criteria in terms of clinical or algorithm performance.

Instead, the document focuses on:

• Device Description: The Easyspine Spinal System is a side-loading posterior spinal pedicle fixation system. The K123134 submission is for a line extension of 4.25 mm pedicle screws and curved rods to an existing system.
• Indications for Use: The system is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for various spinal instabilities.
• Non-Clinical Testing: This section states that non-clinical testing was performed on the proposed 4.25 mm pedicle screws in accordance with ASTM standards (F-1717 and F-1798) for static and dynamic axial compression, static torsion, axial gripping capacity, and flexion-extension cantilever.
• Conclusion: The non-clinical testing results demonstrate that the performance of the proposed LDR Spine Easyspine implants is "substantially equivalent" to their legally marketed predicates. This is the basis for the FDA's 510(k) clearance, which is a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria for device performance and a study proving those criteria are met for a clinical or software-based outcome. The document describes a non-clinical (benchtop) study designed to demonstrate substantial equivalence to predicate devices based on mechanical performance standards, not a study evaluating human-in-the-loop performance, standalone algorithm performance, or using human expert ground truth.

If this were a submission for a software-as-a-medical-device (SaMD) or AI-based device, the requested information would be pertinent. However, for this spinal implant submission, the "study" is the non-clinical mechanical testing, and the "acceptance criteria" are implicitly defined by the chosen ASTM standards and the demonstration of substantial equivalence to predicate devices, rather than a quantifiable clinical performance metric.

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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.

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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.

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The LDR Spine USA Easyspine System is a posterior, non-cervical, 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) of the L5-S1 vertebra, 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.

Easyspine implants are single use devices for mono-and multi-segmental stabilization of the lumbar and thoracic vertebrae to promote fusion. The Easyspine System consists of sacral and pedicle screws, cross-connections, 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 implants are made of surgical titanium alloy Ti6AI4V (ASTM F-136-92). Instruments used to implant Easyspine® are made of medical grade stainless steel. Both the Easyspine LP and Easyspine LP Multiaxial designs consist of various screws, rods, and connectors which are intended to provide temporary stabilization following surgery to fuse the thoraco-lumbar spine. The systems include side-loading screws which are offset as compared to the standard configuration. This offset allows separate rod tightening and polyaxiality locking. Additionally, the system facilitates conducting spondylolisthesis reduction by allowing bone screwing after rod tightening. The lateral offset loading feature incorporated into the designs has not altered the fundamental technology of the predicate Easyspine pedicle screw system. Operatively inserted implants serve to support the normal healing process. They are not intended to replace normal body structures, nor in cases of incomplete healing, to withstand the continually applied loading conditions.

The Easyspine® System, specifically the 6 mm and 7 mm diameter LP and LP Multiaxial pedicle screws, underwent non-clinical performance testing to demonstrate substantial equivalence to a predicate device (K043094 - LDR Spine USA Easyspine System).

Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The study was a non-clinical performance study and involved mechanical testing in accordance with ASTM 1717-04. Therefore, it did not involve human patients or clinical data for a "test set" in the traditional sense of a clinical trial.

• Sample Size: Not explicitly stated in terms of a number of "samples" but implied to be sufficient for testing according to ASTM 1717-04. This would typically involve multiple test specimens of the screws and associated components to ensure statistical validity.
• Data Provenance: The data is from laboratory testing (mechanical performance testing) of the device. There is no country of origin for human data, as no human data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. This was a non-clinical, mechanical performance study. "Ground truth" was established by the ASTM 1717-04 standard, which defines the testing methodology and performance parameters for spinal implant constructs. No human experts were required to establish ground truth for this type of testing.

4. Adjudication Method for the Test Set:

Not applicable. As a non-clinical mechanical performance study, there was no need for adjudication by multiple experts. The results were based on objective measurements against the specified ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This submission is for a medical device (pedicle screw system), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance was involved.

6. 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.

7. The Type of Ground Truth Used:

The ground truth used was mechanical performance data comparison against a legally marketed predicate device (K043094) and compliance with the ASTM 1717-04 standard. This standard serves as the established "ground truth" for evaluating the mechanical integrity and performance of spinal implant constructs.

8. The Sample Size for the Training Set:

Not applicable. As this is a non-clinical performance study for a physical device, there is no "training set" in the context of machine learning or AI models.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There was no training set involved in this non-clinical performance study.

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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.

The LDR Easyspine® System consists of various screws, rods and connectors and is intended to provide temporary stabilization following surgery to fuse the thoraco-lumbar spine. This system includes side-loading polyaxial screws, which allow the surgeon to easily insert the spinal rod using a posterior-lateral loading technique into the fixation components. The rod opening of the screw heads can be positioned medially or laterally. The polyaxial locking mechanism of the standard screws allows a 20 degree angulation in all directions. The dual-polyaxial α-screw (alpha screw) provides an additional 5 degrees of angulation to facilitate loading of the rod, even when the difference in pedicular screw angulation is significant relative to the next screw. Crosslinks (transverse connectors) are provided to increase rotational stiffness of a given construct as desired by the clinician. Rods consist of a single diameter (6.0mm) yet offer variable stiffness. Multiple lengths of spinal rods are included with this system as is typical for essentially all competitive systems. The variable stiffness/rigidity of the various rod offerings is accomplished by fabricating the rods with a machined flat surface on the rod, from one end to the other, following the longitudinal axis of each rod. Thus, the cross section of the rods (as measured at the flattened area), provide comparable strength and stiffness to other rods available in approved systems.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Easyspine System (K043094):

It's important to note that this document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and efficacy through extensive clinical trials for a novel device. Therefore, the "study" described is primarily engineering testing to show equivalence in performance.

Acceptance Criteria and Device Performance for the Easyspine System (K043094)

The acceptance criteria for the Easyspine System, as presented in this 510(k) submission, are primarily established by demonstrating substantial equivalence to a predicate device (Orthopedic Alliance Spine System, K033826) and compliance with relevant material and mechanical testing standards for pedicle screw spinal systems.

Given the nature of a 510(k) submission for a Class II device, the "acceptance criteria" are not explicitly stated as quantitative thresholds for clinical outcomes but rather as meeting established engineering benchmarks and showing comparable performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily an engineering performance study comprising static and fatigue testing, as well as a direct comparison of features to a predicate device.

• Description of the Study:
  "Testing Summary: Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device."
  This statement indicates that the Easyspine System underwent in-vitro mechanical testing to simulate the stresses it would experience in the body. The goal was to show that its mechanical performance (strength, durability under cyclic loading) was comparable or superior to the predicate device, thereby fulfilling the special control requirements for mechanical testing. The Feature Comparison Table further serves as a "study" element, demonstrating equivalency in design, materials, and intended use.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The sample size for the fatigue and static testing is not specified in the provided text. Typically, these types of tests involve a statistically significant number of constructs to ensure reliable results, often dictated by ISO or ASTM standards for implant testing.
• Data Provenance: The data provenance is in-vitro engineering testing performed by the manufacturer (LDR Spine USA). The text does not mention human patient data or a clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable (N/A). For this type of 510(k) submission, the "ground truth" is established by adherence to recognized engineering standards for materials and mechanical performance, and by demonstrating substantial equivalence to a legally marketed device. There is no biological "ground truth" established by human experts in the context of this engineering performance study.

4. Adjudication Method for the Test Set

• Not applicable (N/A). Adjudication methods are typically relevant for clinical studies or image-based diagnostic device evaluations where expert consensus is needed to determine a true clinical state. This submission focuses on engineering benchmarks and equivalence, not clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. Not mentioned or performed. This type of study assesses human reader performance (e.g., radiologists interpreting images) with and without AI assistance. The Easyspine System is a surgical implant, not a diagnostic imaging AI device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Yes, in the context of mechanical performance. The fatigue and static testing evaluates the standalone performance of the device's mechanical integrity without human interaction during the test itself (though humans design, conduct, and interpret the tests). There is no "algorithm" in the sense of software performance being evaluated here.

7. Type of Ground Truth Used

• The "ground truth" for this submission is established through:
  • Engineering Standards: Compliance with accepted engineering and scientific principles for mechanical testing (fatigue and static).
  • Predicate Device Performance: The demonstrated performance of the legally marketed predicate device (Orthopedic Alliance Spine System, K033826) serves as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

• Not applicable (N/A). In the context of a mechanical implant, there is no "training set" in the machine learning sense. The design and manufacturing processes are refined through engineering principles, material science, and prior knowledge from similar devices, rather than iterative learning from a data set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable (N/A). As there is no "training set" for this device in the machine learning sense, the concept of establishing ground truth for it does not apply. The device's design is based on established biomechanical principles and material science.

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