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The 4CIS® Chiron Spinal Fixation 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 thoracic, lumbar and sacral spine:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. Spondylolisthesis
3. Trauma (i.e., fracture or dislocation)
4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
5. Tumor
6. Stenosis
7. Failed previous fusion (pseudoarthrosis).

The 4CIS® Chiron Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery or minimally invasive surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F 136 and Cobalt Alloy (Co-28Cr-6Mo) per ASTM F1537. Also, instruments are available for the application and removal of the Spinal Fixation System.

This document is a 510(k) premarket notification for the "4CIS® Chiron Spinal Fixation System." It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance data. However, it does not include detailed acceptance criteria or extensive study results that would typically be found in a clinical trial report.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document provides summary statements about performance data but does not explicitly list acceptance criteria or specific numerical results in a table format. It states:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Mechanical testing was performed," but does not explicitly state the sample size (e.g., number of spinal fixation systems tested) for this testing. It also doesn't specify the country of origin for the data or whether it was retrospective or prospective. Given it's mechanical testing of a physical device, it's typically performed in a lab setting rather than involving human subjects or real-world data in the same way clinical studies do.

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 question is not applicable to the type of data presented. The "ground truth" for mechanical testing is based on the physical properties and performance of the device under defined conditions, typically measured by engineering standards and equipment, not by expert medical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth for diagnoses or interpretations. Mechanical testing uses objective measurements against predefined standards.

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 such study was mentioned or performed. This document is for a spinal fixation system, which is a physical implant, not an AI software or a device that assists human readers/diagnosticians.

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

This question is not applicable, as this is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance of the 4CIS® Chiron Spinal Fixation System, as described, is based on mechanical testing results against established ASTM standards (ASTM F1717 and ASTM F1798) and comparison to the performance of predicate devices. This is an engineering-based ground truth.

8. The sample size for the training set

This question is not applicable. The device is a physical implant. The concept of a "training set" is relevant for machine learning models, not for mechanical testing of a spinal fixation system.

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

This question is not applicable, as there is no training set for this type of device and testing.

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The 4CIS® Chiron spinal fixation 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 thoracic, lumbar and sacral spine:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies):
2. Spondylolisthesis;
3. Trauma (i.e., fracture or dislocation);
4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
5. Tumor;
6. Stenosis:
7. Failed previous fusion (pseudoarthrosis).

The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery or minimally invasive surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136 and Cobalt Alloy (Co-28Cr-6Mo) per ASTM F1537. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.

The provided document is a 510(k) Premarket Notification for a spinal fixation system (4CIS® Chiron Spinal Fixation System). It focuses on demonstrating substantial equivalence to previously marketed devices through mechanical testing and comparison of design features and indications for use.

Crucially, this document does NOT contain information about an AI/ML-driven medical device or any study involving human readers, ground truth establishment by experts, or performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves a device meets them for an AI/ML product based on this document. The document describes a traditional medical device (implantable hardware) and its clearance pathway, which relies on engineering and mechanical testing, not software performance studies.

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The 4CIS SARA Spine System and 4CIS VERTU Spine System is a pedicle screw system indicated for the weathern of severe Spondylolisthesis (Grade 3 and 4) of the L5-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.

In addition, the 4CIS SARA Spine System and 4CIS VERTU Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) and Cobalt Chromium alloy that conforms to ASTM F136 and ASTM F1537 respectively. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.

The provided document is a 510(k) summary for the "4CIS SARA Spine System" and "4CIS VERTU Spine System." It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to a diagnostic or AI-based function.

Instead, the "Performance Data" section states:

"Mechanical testing (static and dynamic compression bending, static tension bending, static torsion) is conducted in accordance with ASTM F1717. Static Tension Test, Static Torsion test, Static Compression test & Dynamic Compression bending test (Fatigue Test) meets performance requirement against predicates."

This indicates that the performance evaluation for this spine system is based on mechanical testing, not on diagnostic accuracy, sensitivity, specificity, or any other metrics typically associated with AI/ML-based medical devices or diagnostic tools. Therefore, the requested information about acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Indications for Use: The devices have the "same or similar indications for use statements."
• Material: Composed of the "same material as the predicate devices" (titanium alloy and cobalt chromium alloy conforming to ASTM F136 and ASTM F1537 respectively).
• Design and Function: "Share similar basic design features and functions as well as their dimensions."
• Mechanical Performance: Demonstrated to meet performance requirements against predicates through mechanical testing according to ASTM F1717.

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The NEX-D2 Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pediatic patients, the NEX-D2 Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft to facilitate fusion.

The Next Orthosurgical NEX-D2 Posterior Fixation System is a non-cervical pedicle screw system that consists of pedicle screws, rods, connectors, and set screws. All components are available in a variety of sizes to match patient anatomy. All components are manufactured from Ti-6AI-4V ELI per ASTM F136, commercially pure titanium per ASTM F67, and cobalt chrome allov per ASTM F1537, These components are supplied either sterile or non-sterile.

The provided document is a 510(k) summary for the NEX-D2 Posterior Fixation System, which is a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through novel acceptance criteria and studies.

Therefore, the information typically requested in your prompt regarding acceptance criteria, device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for a novel AI/medical device with new performance claims is not applicable to this document.

Instead, the document focuses on non-clinical mechanical testing to demonstrate that the new device components are substantially equivalent to existing, cleared devices.

Here's how to interpret the available information in the context of your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document states, "The subject devices met the pre-determined acceptance criteria." It implies these criteria are derived from the performance of the predicate devices according to the listed ASTM standards. However, the specific numerical acceptance criteria (e.g., minimum bending strength, maximum deflection) are not detailed in this summary. They would typically be found in the full 510(k) submission, referencing the specific ASTM standard requirements for such devices.
• Reported Device Performance: The document generally states, "Testing results demonstrate that the NEX-D2 Posterior Fixation System is substantially equivalent to the predicate devices." It does not provide specific numerical performance results for the NEX-D2 system (e.g., exact values for static compression bending strength, fatigue life cycles). This level of detail is also usually present in the full submission, comparing the subject device's performance directly to the predicate or to the ASTM standard's requirements.

2. Sample sized used for the test set and the data provenance

• For the non-clinical mechanical tests, the sample sizes are not specified in this summary. These quantities would be defined by the relevant ASTM standards for the specific tests performed (e.g., a certain number of constructs for fatigue testing).
• Data Provenance: The tests were conducted internally by Next OrthoSurgical or a contracted lab to support the 510(k) submission.

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

• Not Applicable. This is a mechanical device, and "ground truth" in this context refers to the specified performance requirements of industry standards (ASTM) rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

• Not Applicable. Mechanical testing results are objective measurements against established standards, not subject to expert adjudication of subjective assessments.

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 device is a surgical implant (pedicle screw system), not an AI-powered diagnostic or assistive tool. No human reader studies were performed.

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

• Not Applicable. This is a mechanical surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance acceptance is based on adherence to recognized industry standards (ASTM F1717, ASTM F1798, ASTM F543, ANSI/AAMI ST72) and demonstrating performance comparable to previously cleared predicate devices.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not Applicable.

In summary, for the NEX-D2 Posterior Fixation System, the primary "study" is a series of non-clinical mechanical tests demonstrating compliance with recognized ASTM standards and substantial equivalence to predicate devices, rather than a clinical trial or AI performance study with human-in-the-loop assessments.

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The DePuy PULSE Thoracolumbar Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The DePuy PULSE Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation 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, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are pedicle screw systems intended to provide immobilization 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-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.

The ISOLA, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are also a hook and sacral/iliac screw fixation system of the indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The ISOLA, VSP, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The ISOLA and MOSS MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MONARCH Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in posterior spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM, VIPER, VSP, ISOLA, MONARCH, MOSS MIAMI, and TiMX Spine Systems. Please refer to the labeling of the aforementioned spinal systems indications for use.

The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic. Iumbar and sacral spine.

The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended for noncervical pedicle fixation 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, VIPER PRIME is intended for noncervical pedicle fixation and nonpedicle fixation 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); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER 2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, and VIPER PRIME are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM Growing System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM Growing System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM Spine Systems. The EXPEDIUM Growing Spine System is not intended to be used with 4.0mm diameter screws.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with the CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Cross over and E-Z Link Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. The CrossOver and E-Z Link Cross Connectors are indicated as part of the ISOLA Spinal System.

The DePuy PULSE Thoracolumbar Screw System consists of a variety of rods, pedicle screws, connectors, setscrews and other connection components used to build a spinal construct. The DePuy PULSE Thoracolumbar Screw System is offered in titanium material in sizes ranging from 4.35mm to 12.0mm in shank diameter and 20mm to 130mm in length. Screw shanks with 7.0mm and smaller are assembled from the top of the outer head, while screws with 7.5mm and larger are assembled from the bottom using a flex ball. The implant components can be rigidly locked into a variety of configurations, with each construct being made for the individual case.

The EXPEDIUM, VIPER and VIPER PRIME screws with fenestrations are designed with a cortical fix screw shank that is fully cannulated with lateral fenestrations at the distal end and may be used in conjunction with, or without the CONFIDENCE High Viscosity Spinal Cement. The cannulation and fenestrations allow for the injection of bone cement through the screws into the vertebral body in patients with severe osteoporosis or pathological fractures due to osteoporosis and tumor in the thoracic, lumbar and sacral spine.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in constructs comprising spinal instrumentation components. It features an advanced top-loading design and unique snap-fit feature that simplify initial placement and tightening procedures which helps avoid impingement of surrounding anatomy. The EXPEDIUM SFX Cross Connector system incorporates a broad range of implant options in both and adjustable configurations for an optimal balance between dural clearance and implant profile.

The EXPEDIUM VERSE Spine System is designed to provide intraoperative polyaxial to monoaxial conversion. It facilitates easier rod capture and provides a powerful and precise reduction mechanism. EXPEDIUM VERSE is a reduced profile thoracolumbar implant for use for with wide range of patient statures. EXPEDIUM VERSE is a selfcontained, efficient, and intuitive instrument system that is compatible with EXPEDIUM 5.5 rods, hooks and mono screws to enhance versatility.

The ISOLA Spine System is a pedicle screw 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. The ISOLA Spine System consists of connectors, open and closed iliac screws, iliac bolts, and angled closed iliac screws. These components have been designed to allow for rigid fixation of the sacral and pelvic regions of the spine.

The MONARCH Spine System is both a rod-based and plate-based system designed to interface with various spinal anatomies. The plate-based system consists of pedicle screws, spine plates, transverse connectors. J-hooks, washers, nuts and set screws. The rod-based system consists of spinal rods, pedicle screws, set screws, various slotted connectors, and transverse connectors.

The TiMX Low Back System is a construct that consists of pedicle and sacral screws, spine plates, nuts, washers, and transverse connectors. The TiMX Low Back System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of chronic instabilities and deformities of the thoracic, lumber, and sacral spine.

The MOSS MIAMI Spine System is a closure mechanism which secures the rod to the screw in one single, simple step. The unique square threads balance the forces vertically, creating a secure assembly. It consists of anatomic hooks, monoaxial screws, polyaxial screws and a dual closure mechanism.

The VIPER PRIME System is novel technique for percutaneous pedicle screw placement and posterior stabilization. This innovative technique eliminates the need for guidewires, Jamshidi needles and pedicle preparation instruments; utilizing a stylet that is fully controlled by the screwdriver. The VIPER PRIME System enables surgeons to target pedicles and insert the screw, without the need for instrument exchanges or reconfirmation of their trajectory.

The VIPER Sacral-Alar-Iliac Screw is an implant designed for sacropelvic fixation. The VIPER SAI Screw is optimized for Sacral-Alar-Iliac placement vis-à-vis a favored angle polyaxial head, smooth shank and robust drive feature. The in-line nature of this anchor allows not only stabilization but also correction of pelvic sagittal or coronal deformities.

The EXPEDIUM Spine System, VIPER System, and VIPER 2 System are metallic implants intended to provide immobilization and stabilization of spinal segments. They can be used for skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine; or for posterior non-cervical pedicle screw fixation in pediatric patients as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM Spine System consist of longitudinal rods, monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers. The VIPER and VIPER 2 Systems consist of cannulated polyaxial screws, monoaxial screws, uni-planar screws, reduction screws, and rods used in a percutaneous approach.

The VSP Spine System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion. Levels of fixation are for the thoracic, lumbar and sacral spine. The VSP Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion us attained. Levels of fixation are from L3-S1.

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to previously cleared devices. Therefore, the information provided focuses on comparative data rather than a standalone clinical study with acceptance criteria in the same manner as a de novo or PMA submission might require.

However, based on the provided text, we can infer some "acceptance criteria" related to magnetic resonance compatibility and how the study "proves" the device meets them.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are indirectly established by the selection of specific ASTM standards for magnetic resonance compatibility. The study "proves" the device meets these criteria by performing tests according to these standards and reporting that the "results demonstrated compatibility conditions." While the exact quantitative thresholds are not provided in this summary, the FDA's clearance implies that the performance met the requirements set by these recognized standards for MR safety.

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

• Sample Size for Test Set: Not specified. The document states that "non-clinical testing was conducted in alignment with the following standards." This usually means a set of representative devices or components are tested, but the specific number is not provided in this summary.
• Data Provenance: The nature of the tests (magnetic resonance compatibility) indicates laboratory testing of the devices themselves, rather than human subject data. Therefore, "country of origin of the data" and "retrospective or prospective" do not directly apply in the traditional sense of clinical studies. The tests were performed to demonstrate that the device materials and design are safe within an MR environment.

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

This submission is for device clearance based on non-clinical (laboratory) testing for MR compatibility. Therefore, there were no experts used to establish ground truth for a test set in the clinical sense. The "ground truth" is governed by the objective measurements defined by the ASTM standards for MR compatibility.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical laboratory testing, there is no adjudication method involving human interpretation or consensus. The data points are quantitative measurements against predefined ASTM standard limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on diagnostic performance with human readers, which is not the purpose of this submission. This submission is for the clearance of physical medical devices (spinal systems) and their magnetic resonance compatibility labeling.

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

No. A standalone algorithm-only performance study was not done. This submission concerns physical medical devices and their MR compatibility, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was defined by the specifications and limits within the cited ASTM standards (ASTM F2213, ASTM F2052, ASTM F2119, ASTM F2182) for magnetic resonance compatibility. These standards outline methodologies and acceptable thresholds for torque, displacement force, image artifacts, and heating.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission, as it relates to physical device testing for MR compatibility, not machine learning or AI algorithm development.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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The F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior, noncervical pedicle fixation (T1-S1) 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 (Grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal stenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinal tumor, Schuermann's disease, and failed previous fusion.

The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The F1-MPS is also intended for posterior, non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

The F1-Modular Pedicle Screw System is composed of cannulated and non-cannulated pedicle screws which are designed to accept a 5.5mm rod and are available in various sizes. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 or cobalt-chromium-molybdenum per ASTM F1537.

This document is a 510(k) premarket notification for a medical device called the "F1-Modular Pedicle Screw System". It's not a study proving device performance against acceptance criteria in the way you're asking about for an AI/software device. This document is for a mechanical implant, and the "acceptance criteria" and "study" described are for non-clinical mechanical testing to demonstrate substantial equivalence to existing devices.

Therefore, many of your requested points (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the non-clinical performance testing and substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this mechanical device, "acceptance criteria" are typically defined by recognized standards such as ASTM F1717 and ASTM F543, and the performance is demonstrated by meeting or exceeding the performance of predicate devices. Specific quantitative acceptance criteria are not provided in this summary, but the conclusion states the device meets or exceeds the performance of predicate devices.

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

• Sample Size: Not explicitly stated in this summary. For mechanical testing per ASTM standards, specific sample sizes are prescribed, but the exact number of screws/constructs tested is not given here.
• Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical testing.

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 this context refers to established mechanical testing standards and the comparison to predicate devices, not expert human interpretation of data for an AI.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical testing against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/diagnostic imaging device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established ASTM mechanical testing standards (F1717, F543) and the performance of existing, legally marketed predicate devices. The goal is to show substantial equivalence, meaning it performs at least as well as, if not better than, comparable devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this type of mechanical device.

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

Not applicable. There is no "training set."

Summary for this specific document related to your request:

This document describes a non-clinical performance testing study for a mechanical pedicle screw system. The purpose of the study was to demonstrate substantial equivalence to existing predicate devices based on recognized ASTM standards for mechanical testing. The "acceptance criteria" are implied by these standards and the performance of the predicate devices, which the subject device was found to meet or exceed. There are no elements related to AI, software performance, human reader studies, or ground truth derived from expert consensus on clinical data.

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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 Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The Spinal Edge TITAN Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. The Spinal Edge TITAN Pedicle Screw System components are available in titanium alloy conforming to ASTM F-136 specifications.

The provided text describes the regulatory clearance of the Spinal Edge TITAN Pedicle Screw System. Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a table format. Instead, it relies on demonstrating comparable function and performance characteristics to the predicate device as the primary acceptance criterion. The performance is reported in relation to relevant industry standards.

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

• Sample Size: The document mentions "Representative samples of the device" were tested. However, the exact sample size (e.g., number of screws, number of constructs) used for the mechanical testing is not specified.
• Data Provenance: The testing methodology ("ASTM F1717 'Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model'") describes a laboratory-based, ex-vivo (or simulated in-vitro) test. Therefore, it's not applicable to "country of origin of the data" or "retrospective/prospective" in the clinical sense, as it's a mechanical performance study.

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

This information is not applicable to this type of device and study. The "ground truth" here is objective mechanical performance measured against a standard, not expert interpretation of clinical data. The ASTM F1717 standard itself defines the "ground truth" in terms of physical properties and behaviors under specified loads.

4. Adjudication Method for the Test Set:

This information is not applicable. Mechanical testing against a standard does not involve an adjudication method in the way clinical studies or image interpretations do. The results are typically quantitative measurements compared directly to specified limits or benchmarks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is involved. The TITAN Pedicle Screw System is a physical implant, and its performance is assessed through mechanical testing, not through human reading of cases.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. The device is a surgical implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used:

The ground truth used for this study is based on engineering standards and established material science properties. Specifically, the ASTM F1717 standard defines the appropriate testing methodology and expected performance characteristics for spinal implant constructs in a vertebrectomy model. The "ground truth" is therefore objective mechanical strength, stiffness, and fatigue resistance as measured against the parameters defined by this engineering standard.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical implant, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for this type of device.

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The Mercury Spinal System is intended for fusion procedures of the thoracic, lumbar, and sacral spine (T1-S1) of skeletally mature patients This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation 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 (1 e , scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, rods, and staples that are used for attachment to the non-cervical spine (T1-S1) A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with the screws Staples (when used) are placed under the head of the polyaxial or monoaxial screws to help distribute loads placed against the bone

Screws, rods, and staples are made from titanium alloy (Tr-6A1-4V) conforming to ASTM F 136 or ISO 5832-3

The devices of this submission are new screw designs and sizes that are being added to the existing system

The provided text describes a 510(k) premarket notification for the Mercury™ Spinal System, a medical device for spinal fixation. It mentions that "Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use," but it does not provide specific acceptance criteria or details of a study with performance metrics for software or AI components.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth, experts, or AI-related studies. This document pertains to a physical medical device (screws, rods, staples) and its mechanical testing, not a digital health product with AI/ML components.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Cannot provide. The document states "Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use," but it does not specify any quantitative acceptance criteria or detailed performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot provide. This information is typically found in detailed study reports, which are not included in this 510(k) summary.

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):

• Cannot provide. This document is about a physical spinal implant, not a diagnostic or AI device that relies on expert-established ground truth from images or other data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot provide. Not applicable to this type of device and submission.

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:

• Cannot provide. This information is irrelevant as the device in question is a physical spinal implant, not an AI-assisted diagnostic tool.

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

• Cannot provide. Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Cannot provide. Not applicable. The "performance" mentioned is mechanical testing.

8. The sample size for the training set:

• Cannot provide. Not applicable as there is no mention of an algorithm or AI model requiring a training set.

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

• Cannot provide. Not applicable.

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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The Zodiac DynaMo Semi-Rigid Spinal System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
3. In addition, the Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The Zodiac DynaMo Semi-Rigid Spinal System , when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The Zodiac DynaMo Semi-Rigid Spinal System is a top loading anterior/posterior spinal fixation system consisting of various types and sizes of implantable components that are assembled to create a rigid spinal construct.

The Zodiac DynaMo Semi-Rigid Spinal System is a spinal fixation system. The testing performed was to demonstrate the substantial equivalence of its mechanical performance to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates that "Mechanical and dynamic testing" was performed, but does not specify the sample size used for the test set.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as the study involves mechanical testing of the device itself rather than patient data.

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

This question is not applicable as the study involved mechanical testing of a spinal fixation system, not a diagnostic or prognostic device requiring expert-established ground truth from clinical data.

4. Adjudication method for the test set

This question is not applicable as the study involved mechanical testing, not a clinical study requiring adjudication of expert opinions.

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 question is not applicable as this device is a mechanical spinal fixation system, not an AI-assisted diagnostic tool.

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

This question is not applicable as this device is a mechanical spinal fixation system and does not involve an algorithm.

7. The type of ground truth used

The ground truth for this device's performance is established through mechanical and dynamic testing against predefined engineering standards and comparison to a legally marketed predicate device's performance.

8. The sample size for the training set

This question is not applicable as this is a mechanical device, not an AI or machine learning model that requires a training set.

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

This question is not applicable as this is a mechanical device and does not involve a training set.

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