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The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis (Grade 3 and 4) .
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis .
• Spinal deformities (Scoliosis, Kyphosis, Lordosis) .
• Pelvic obliquity ●
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, iliac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.

Perfix™ Iliac Screw System consists of a variety of shapes and size of iliac screws, iliac connectors, iliac screw cap and set screw. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Perfix" Iliac Screw System is intended to provide spinal stability related to the lumbosacral fixation or spinopelvic fixation is provided by iliac screws inserted into the vertebral body of the lumbar spine and sacrum regions using a posterior approach.

The U&I Corporation's Perfix™ Iliac Screw System underwent non-clinical (bench) testing to demonstrate its performance and establish substantial equivalence to predicate devices. The study aimed to show that the device met established acceptance criteria, indicating no new safety or efficiency issues compared to existing, legally marketed spinal fixation systems.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that the mechanical performance of the Perfix™ Iliac Screw System met the acceptance criteria which have been established from the predicate devices. However, the exact numerical acceptance criteria for each test and the specific reported performance values for the Perfix™ system are not detailed in the provided text. The document generally confirms that the tests were performed and the device met the criteria.

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

• Sample Size: The document does not specify the exact number of devices or constructs tested for the "test set" in the performance testing.
• Data Provenance: The study was a non-clinical setting (bench testing). Data provenance is not geographical in this context, but rather refers to the type of experimental setup. It is retrospective in the sense that the acceptance criteria were established from existing predicate devices.

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 to this study. The "ground truth" for this type of mechanical performance testing is defined by established engineering standards (ASTM F1717) and the performance of predicate devices, not by expert medical opinion on individual cases.

4. Adjudication Method for the Test Set

This question is not applicable to this study. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple observers. This study involved mechanical testing against predefined criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focused on the mechanical performance of a medical device, not on the interpretative performance of human readers, with or without AI assistance.

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

N/A. This device is a physical spinal implant system, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant. The performance testing was for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was based on:

• Established industry standards: Specifically, ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model).
• Performance of predicate devices: The Perfix™ Iliac Screw System was compared directly against the mechanical performance of the Synergy™ Spinal System - Synergy VLS Screws (K011437), OPTIMA™ Spinal System (K024096), and Global Spinal Fixation System™ (K001668). The acceptance criteria were derived from these predicate devices.

8. The Sample Size for the Training Set

This question is not applicable to this study. There is no concept of a "training set" in a mechanical bench testing study for a physical device.

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

This question is not applicable as there was no training set.

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The MEGA Spine System is a pedicle screw system indicated for the treatment 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 MEGA Spine 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The MEGA Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking bolt, and a cross(transverse) linking mechanism.

The MEGA Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA Spine System.

The provided document is a 510(k) summary for the MEGA Spine System, a medical device for spinal fixation. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on mechanical testing. However, it does not contain the specific information required to complete the table and answer the study-related questions as it is not a study report on device performance but a premarket notification for regulatory approval.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Mechanical testing as listed in APPENDIX 9 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." However, it does not provide the specific acceptance criteria or the reported device performance metrics. Therefore, this table cannot be filled with the requested level of detail.

Missing Information for Complete Answer:

The following information is not present in the provided 510(k) summary:

2. Sample size used for the test set and the data provenance: This document does not detail specific sample sizes for mechanical testing or the origin of any data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This document is about mechanical testing of a medical device, not a performance study involving human interpretation or ground truth establishment by experts.
4. Adjudication method for the test set: Not applicable for 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: Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for mechanical testing. The "ground truth" would be the ASTM standard and predicate device performance.
8. The sample size for the training set: Not applicable to this type of device and study.
9. How the ground truth for the training set was established: Not applicable to this type of device and study.

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The 4STM SPINAL SYSTEM is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bon 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 4STM SPINAL 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The 4STM SPINAL SYSTEM is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, bolt, and a transverse (cross) linking mechanism. The 4STM SPINAL SYSTEM will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The 4STM SPINAL SYSTEM implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4STM SPINAL SYSTEM.

The provided text describes a 510(k) submission for the 4STM SPINAL SYSTEM, a pedicle screw spinal fixation device. The focus of the performance data in this submission is on mechanical testing rather than AI/software performance. Therefore, many of the requested categories related to AI model evaluation (such as sample size for test/training sets, expert adjudication, MRMC studies, standalone performance with AI, and ground truth establishment) are not applicable to this specific submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The study involved mechanical testing of components, not human subject data.

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

Not applicable. Ground truth was established through mechanical testing standards, not expert clinical assessment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for human interpretation tasks, not 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

Not applicable. This is a medical device for physical implantation, not an AI-assisted diagnostic or interpretative tool.

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

Not applicable. This device does not have an "algorithm only" component in the context of AI performance. The device itself is a standalone physical implant.

7. The Type of Ground Truth Used

The ground truth or performance standard used was established by mechanical testing protocols, specifically ASTM F1717. This standard defines the methods for bending and torsion testing of spinal implant constructs.

8. The Sample Size for the Training Set

Not applicable. There is no AI model or training set described.

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

Not applicable. There is no AI model or training set described.

Summary of the Study:

The study proving the device meets its acceptance criteria is a mechanical testing study. This study was conducted in accordance with ASTM F1717, a standard specification for spinal implant constructs in vitro. The results of this testing demonstrated that the 4STM SPINAL SYSTEM is mechanically equivalent to its legally marketed predicate devices: the Global Spinal Fixation System (K001668) and the OPTIMA™ Spinal System (K031585). The specific number of implants or test specimens used in this mechanical testing is not detailed in the provided text (though typically, ASTM standards require a certain number of samples for statistically valid results). The data provenance is from the manufacturing site in the Republic of Korea.

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The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment 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 GSS Pedicle Screw 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism.

The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System.

The provided text describes the "GSS Pedicle Screw System" and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI device submission would.

Instead, this document focuses on demonstrating substantial equivalence to previously approved predicate devices based on mechanical testing, as is typical for implantable medical devices like pedicle screw systems.

Therefore, many of the requested points are not applicable or cannot be answered based on the provided text.

Here is a breakdown based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable for this type of device submission. The study described is mechanical testing, not a clinical study with a "test set" of patients or data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. Ground truth, in the context described (expert consensus for diagnostic AI), is not relevant for this device's submission. Mechanical testing relies on standardized methodologies, not expert interpretation of patient data.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" of cases/data that would require adjudication in the context of this submission.

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

• No. This type of study is for evaluating diagnostic performance (e.g., how human readers perform with vs. without AI assistance). The "GSS Pedicle Screw System" is an implantable medical device, and its submission relies on mechanical testing, not diagnostic performance studies.

6. Standalone (Algorithm Only) Performance Study

• No. This device is not an algorithm or AI. It is a physical implantable device.

7. Type of Ground Truth Used

• Mechanical Test Standards (ASTM F1717): For this device, the "ground truth" for proving performance is adherence to and successful completion of standardized mechanical tests, showing the device is robust and performs as expected under simulated physiological loads. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic tools, but rather a demonstration of structural integrity and functional capability relative to established standards and predicate devices.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this device is not an AI/algorithm that learns from data.

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

• Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.

Summary of the Device's Approval Approach:

The GSS Pedicle Screw System gained clearance via the 510(k) pathway by demonstrating substantial equivalence to existing legally marketed devices (Global Spinal Fixation System (K001668) and OPTIMA™, Spinal System (K031585)). This equivalence was primarily proven through mechanical testing in accordance with ASTM F1717, which showed that the subject device performs comparably to the predicate devices in terms of its physical and mechanical properties. The focus of this type of submission is on the device's design, materials, and functional performance under simulated conditions, rather than clinical diagnostic accuracy or reader performance.

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The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertehra 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® SOLAR Spine System and 4CIS® APOLLON Spine System are 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System are a toploading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4C1S * SOLAR Spine System and 4CIS * APOLLON Spine System.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the "test set" in the context of clinical data. The primary performance data cited is mechanical testing. For this, the sample size would refer to the number of implants/components tested. The document refers to "APPENDIX 10" for details, which is not provided, so the exact sample size for the mechanical tests is unknown from the given text.

• Data Provenance: Not applicable in the context of mechanical testing. This is a laboratory-based study.

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

Not applicable. This submission relies on mechanical testing against an ASTM standard, not clinical data requiring expert review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or expert adjudication.

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 is a spinal implant system, not an AI-powered diagnostic or assistive 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 is a physical medical device (spinal implant), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance data is predominantly defined by the ASTM F1717 standard for mechanical testing and the definition of substantial equivalence to predicate devices by the FDA. In essence, the ground truth is established engineering and regulatory benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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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 Polyaxial Pedicle Screw 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 Polyaxial Pedicle Screw 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 Polyaxial Pedicle Screw 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 Polyaxial Pedicle Screw 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 Polyaxial Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti6Al-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). The ZODIAC Polyaxial Pedicle Screw System is designed to facilitate optimal screw and rod placement.

The provided text describes a medical device, the ZODIAC Polyaxial Pedicle Screw System, and its clearance through the 510(k) pathway. This pathway establishes substantial equivalence to already marketed predicate devices, primarily through performance data demonstrating comparable safety and effectiveness.

However, the 510(k) summary does not contain the level of detail requested for a typical AI/software device study (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone performance). This is because the ZODIAC system is a mechanical implant, and its performance evaluation relies on different methodologies, primarily mechanical and dynamic testing, rather than clinical efficacy studies with human readers or AI algorithms.

Therefore, many of the specific questions cannot be answered from the provided document. I will extract what information is present and indicate where the requested information is not available.

Acceptance Criteria and Device Performance (Based on Provided Text)

The "acceptance criteria" for a mechanical device like the ZODIAC system are met by demonstrating structural integrity and comparable mechanical performance to predicate devices. The document focuses on demonstrating substantial equivalence rather than listing specific numerical acceptance criteria.

Missing Information: Specific numerical thresholds for mechanical strength, fatigue life, or other mechanical properties that would constitute "acceptance criteria" are not provided in this 510(k) summary. These would typically be found in detailed test reports, not the summary itself.

Study Details (Based on Provided Text)

1. Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing. The "test set" would refer to the number of devices or components tested. This number is not specified in the 510(k) summary. The data provenance would be from laboratory testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing of implantable devices, "ground truth" is established through physical measurement and engineering analysis, not expert interpretation of data relevant to AI performance.

3. Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements and do not typically require adjudication in the way clinical diagnostic interpretations do.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpretation, which is not the function of a pedicle screw system.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not applicable. The device is a mechanical implant, not an algorithm.

6. The type of ground truth used: For mechanical performance, the ground truth is derived from direct physical measurements (e.g., load-to-failure, cycles to fatigue) obtained in laboratory settings according to established industry standards or internal protocols.

7. The sample size for the training set: Not applicable. As a mechanical device, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles and prior device experience, not by a data-driven training set.

8. How the ground truth for the training set was established: Not applicable. See point 7.

Summary of Non-Applicability:

The requested detailed information regarding acceptance criteria, study sample sizes, expert ground truth, and AI-specific study methodologies (MRMC, standalone performance, training sets) is largely not applicable to the ZODIAC Polyaxial Pedicle Screw System as described in this 510(k) summary. This is because it is a physical medical implant, and its regulatory clearance relies on demonstrating substantial equivalence through mechanical and dynamic testing against predicate devices, rather than clinical efficacy studies involving diagnostic interpretations or AI performance. The provided text indicates that mechanical and dynamic testing was performed and that the results demonstrated comparability to predicate devices.

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