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When used as a pedicle screw fixation system, the NuVasive® 4.5-5.0 System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis) The NuVasive Reline 4.5-5.0 System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline 4.5-5.0 System is also intended for the following indications: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Spinal stenosis 3. Spondylolisthesis 4. Spinal deformities 5. Fracture 6. Pseudoarthosis 7. Tumor resection and/or 8. Failed previous fusion When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline 4.5-5.0 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline 4.5-5.0 System is intended to treat pediatic patients diagnosed with the following conditions: spondylolysis, and fracture caused by turnor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Reline System.

The NuVasive Reline 4.5-5.0 System is a pedicle screw system that consists of a varietv screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

This document is a 510(k) premarket notification for the NuVasive Reline 4.5-5.0 System, a pedicle screw system. It states that the device is substantially equivalent to legally marketed predicate devices. The information provided focuses on demonstrating this equivalence through non-clinical performance testing rather than clinical studies or AI-driven performance.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document confirms that "demonstrate that the subject NuVasive Reline 4.5-5.0 System is substantially equivalent to the predicate device." However, it does not provide specific numerical values for the acceptance criteria (e.g., minimum bending strength in Nm) or the numerical performance results of the NuVasive Reline 4.5-5.0 System or its predicate for direct comparison. It only states that the results show substantial equivalence.

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

The study described is non-clinical performance testing of a physical medical device (pedicle screw system), not an AI/software device involving data sets, patients, or human readers. Therefore:

• Sample Size for Test Set: This information is not provided as the tests are for mechanical properties of the device components. The ASTM standards typically specify the number of samples required for each test.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this involves mechanical testing of physical implants, not patient data.

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

Not applicable. Ground truth, in the context of expert consensus, is relevant for AI/diagnostic devices interpreting medical images or patient data. This is a physical device subject to mechanical engineering standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are used to resolve disagreements among human experts in clinical studies, not for non-clinical mechanical testing.

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

No, an MRMC comparative effectiveness study was not done. This document describes the testing of a physical medical implant (pedicle screw system), not an AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This document focuses on the mechanical properties and substantial equivalence of a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this type of device is defined by the ASTM standards (ASTM F1717 and ASTM F1798) themselves, which specify the test methodologies and, implicitly, the expected performance characteristics for pedicle screw systems. Substantial equivalence is determined by comparing the new device's performance to that of a legally marketed predicate device under these standardized test conditions.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical medical device.

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

Not applicable. As there's no training set, there's no ground truth for it to be established.

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When used as a pedicle screw fixation system, the NuVasive GSB Global Spinal Balance System is 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 posterior thoracic, lumbar, and sacral spine:

• I. Degenerative disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
• 3. Fracture
• 4. Dislocation
• 5. Scoliosis
• 6. Kyphosis
• 7. Spinal tumor and/or
• 8. Failed previous fusion (pseudoarthrosis)

The NuVasive GSB Global Spinal Balance System is also indivated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum). with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine. the NuVasive GSB Global Spinal Balance System is also intended for the following indications:

• 1.Degenerative disease (as defined by back pain of discogenic origin with deveneration of the disc confirmed by patient history and radiographic studies)
• 2. Spinal stenosis
• 3. Spondvlolisthesis
• 4. Spinal deformities
• 5.Fracture
• 6. Pseudoarthosis
• 7. Tumor resection and/or
• 8. Failed previous fusion

The NuVasive GSB Global Spinal Balance System (hereto referenced as the GSB System) is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different contigurations to suit the individual pathology and anatomical conditions of the patient.

The provided 510(k) summary for the NuVasive® GSB Global Spinal Balance System ([K132014](https://510k.innolitics.com/search/K132014)) describes a medical device with mechanical performance requirements, not an AI/ML powered device. As such, the typical acceptance criteria and study designs found in AI/ML performance evaluations (e.g., sample size for test/training sets, ground truth by expert consensus, MRMC studies) are not applicable here.

Instead, the acceptance criteria and study details provided relate to non-clinical mechanical and material testing to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study that proves the device meets the acceptance criteria:

The study performed was nonclinical testing described in section G. "Performance Data." The objective was to demonstrate substantial equivalence to predicate devices by comparing the mechanical properties of the NuVasive GSB Global Balance System to established performance benchmarks for such devices, as defined by ASTM F1717 and a "Tulip pull-off" test. The summary states that "The results demonstrate that the subject NuVasive GSB Global Balance System is substantially equivalent to the predicate."

Regarding the AI/ML-specific questions (2-9), this information is NOT applicable or available for this type of medical device submission:

2. Sample sized used for the test set and the data provenance: Not applicable. The tests are mechanical, not data-driven for AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered specifications and test results against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Mechanical test results are objective measurements.
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: Not applicable. This is a spinal implant system, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device refers to physical properties meeting mechanical specifications and safety standards.
8. The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable. There is no training set for an AI/ML algorithm.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: 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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.

The CD HORIZON SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.

In order to achieve additional levels of fixation as an adjunct to fusion, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY®rods and screws: DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors: and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 03.5mm, 04.5mm, 05.5mm rods or 06.35mm rods, while other components can connect to both Ø5.5mm rods and Ø6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The provided document is a 510(k) summary for the
CD HORIZON® Spinal System. This type of regulatory submission is for a medical device and is not a study that proves a device meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study.

Instead, the document focuses on demonstrating substantial equivalence to previously approved predicate devices, which is the primary requirement for 510(k) clearance. Substantial equivalence means the new device is as safe and effective as a legally marketed device (predicate device).

Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not directly applicable to this type of document because it is not a clinical study or an AI/algorithm performance study.

However, I can extract information related to the demonstration of substantial equivalence, which serves a similar purpose in the regulatory context of this device.

Here's a breakdown of the available information in the context of your request:

I. Acceptance Criteria and Device Performance

The "acceptance criteria" in this context are not quantitative performance metrics as in a clinical trial. Instead, the acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has "similar technological characteristics" and is "as safe and effective" as the predicate.

The "reported device performance" is not given as numerical results from a clinical study, but rather implied through mechanical testing and risk analysis compared to predicate devices.

II. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. This document refers to mechanical testing and risk analysis, not a clinical "test set" of patients or data in the way an AI algorithm study would. The focus is on the new components themselves.
• Data Provenance: The document does not specify country of origin for the mechanical test data. It is a regulatory submission to the US FDA. The "study" is a collection of engineering tests and a risk analysis, not a clinical data study. It is retrospective in the sense that it evaluates new components against established predicate devices and materials.

III. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. This is not a study requiring expert clinical review to establish ground truth. Substantial equivalence is determined by regulatory bodies (FDA) based on submitted engineering data and comparison to predicates.
• Qualifications of Experts: N/A.

IV. Adjudication method for the test set

• Adjudication Method: Not applicable. No clinical test set or subjective interpretations requiring adjudication are mentioned.

V. 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

• MRMC Study: Not applicable. This is a spinal implant system, not an AI diagnostic tool.

VI. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm.

VII. The type of ground truth used

• Ground Truth Type: Not applicable in the traditional sense of a clinical study. For a medical device 510(k), the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, biomechanical testing standards, and the history of safe and effective use of the predicate devices.

VIII. The sample size for the training set

• Training Set Sample Size: Not applicable. No training set is relevant for this type of device submission.

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

• Ground Truth Establishment for Training Set: Not applicable.

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