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The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:

• 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.

The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws. rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.

The provided document is a 510(k) premarket notification for the CorticaLINK Spinal Fusion Platform. It describes the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices. However, it does not contain acceptance criteria or detailed results of a study demonstrating the device meets specific performance criteria in a clinical context that would require ground truth, human readers, or AI.

This document describes a medical device called the "CorticaLINK Spinal Fusion Platform," which is a system of implants used to stabilize the spine. The performance data provided is for non-clinical mechanical testing of the device's components (screws, rods, and locking caps), not a study involving human or AI performance.

Therefore, I cannot fulfill the request to provide details about acceptance criteria and a study proving the device meets those criteria, as the information required (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training and test sets) is not present in the given text.

The document only states that the device was tested mechanically according to ASTM standards and found to be substantially equivalent to predicate devices for its intended use, indicating sufficient strength.

Here's what I can provide based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions ASTM F1717-14 standards, which are general test methods for spinal implant constructs. However, specific numerical acceptance criteria (e.g., minimum bending strength in Nm) and the corresponding reported device performance values are not detailed in this summary. It only states that the results "show that the strength of the CorticaLINK Spinal Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Missing Information (Not Available in the Document):

2. Sample size used for the test set and the data provenance: Not applicable, as this was mechanical testing, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable, as this was mechanical testing, not a study requiring ground truth for diagnostic or expert agreement.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Gibralt® Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Spine System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Gibralt® Spine System may be connected to the Gibralt® Occipital Spine System with rod-to-rod connectors. The Gibralt® Spine System may also be connected to the Exactech® Proliant® System, Exactech® Silverbolt® and Mainframe® Spinal Screw Systems, or Exactech® Hydralok® Exactech, using rod-to-rod connectors and transitional rods. Refer to the specific system package inserts for a list of their indications for use.

When used with the Gibralt® Spine System, the Gibralt® Occipital Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7), and the thoracic spine from T1 - T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Occipital Spine System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Gibralt® Occipital Spine System may be connected to the Gibralt® Spine System, using rod-to-rod connectors. Refer to the Gibralt® Spine System package insert for a list of the Gibralt® Spine System indications of use.

The Occipital Bone Screws are limited to occipital fixation only.

The line extension and device modifications for the Gibralt® Spine System are intended to provide immobilization and stabilization of spinal segments in the upper thoracic, cervical, and occipital spine. The system components are manufactured from titanium and cobalt chromium. The modifications included in the scope of this submission are: expanded indications for use for both systems, incorporation of design changes, and addition of new components.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Gibralt® Spine System and Gibralt® Occipital Spine System." It is primarily a regulatory approval document and does not contain the detailed study information typically found in a clinical trial report or a comprehensive technical performance study.

Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance of an AI/algorithm-based device cannot be fully provided from this document alone. This document describes a medical device (spinal fixation system) which is a physical implant, not an AI or algorithm-based diagnostic/prognostic device.

However, based on the provided text, I can extract information related to the device's performance data which serves as the "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission, and the "acceptance criteria" can be inferred from the nature of the tests and the conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The document mentions "the Gibralt® Spine System" and "the proposed line extensions and modified Gibralt® Spine System" were tested, implying multiple units or configurations were tested, but an exact number of samples (e.g., number of constructs tested) is not provided.
• Data provenance: Not explicitly stated, but the testing would have been conducted by or for Exactech, Inc. or Empirical Testing Corp. in a laboratory setting. Since it's device testing, it is prospective in the sense that the tests were specifically performed for this submission according to established ASTM standards. It is not clinical data from patients/countries.

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

• Not applicable. This document pertains to mechanical testing of a spinal implant, not the assessment of medical images or patient data that would require expert consensus for ground truth. The "ground truth" here is the physical performance of the device under mechanical load, measured by objective instruments according to specified ASTM standards.

4. Adjudication method for the test set

• Not applicable. See point 3. Mechanical tests follow predefined protocols and 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 device is a physical spinal implant system, not a diagnostic or prognostic AI/algorithm requiring human reader evaluation.

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

• Not applicable. This is a physical device, not an algorithm.

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

• For this type of device, the "ground truth" for the mechanical performance testing is the objective measurement of physical properties and strength when subjected to various loads and cycles, as defined by the ASTM F1717-14 standard. There is no expert consensus, pathology, or outcomes data involved in generating the mechanical performance data in this context.

8. The sample size for the training set

• Not applicable. This document describes the mechanical testing of a physical medical device. There is no "training set" in the context of an AI/algorithm. The device design might be informed by previous designs and engineering principles, but this is not analogous to an AI training set.

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

• Not applicable. See point 8.

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The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (T-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput Systems are also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.

The Aesculap S4 Cervical Spinal and Occiput Systems are implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap S4 Cervical Spinal and Occiput Systems consist of plates, bone screws, rods, hooks, and connectors. This consists of 3.5mm rod, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and cross connectors. The occipital plate is fixed to the occiput with bone screws and the transition by a locking mechanism. The end of the construct is stabilized with polyaxial screws to the upper thoracic spine, as required. The components are available in a variety of lengths in order to accommodate patient anatomy. The Aesculap S4 Cervical Spinal and Occiput Systems are manufactured from Titanium alloy and will be provided non-sterile.

The provided document is a 510(k) summary for the Aesculap S4 Cervical Spinal and Occiput Systems. It describes the device, its indications for use, and a comparison to predicate devices. It also details the performance testing conducted. However, this document does not contain information typically found in a study proving a device meets acceptance criteria for an AI/ML powered device, as the Aesculap S4 Cervical Spinal and Occiput Systems are physical medical implants, not an AI/ML software device.

Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this submission pertains to a physical orthopedic implant system, not a digital health or AI/ML device.

The "Performance Data" section solely refers to non-clinical mechanical testing of the implant system against established ASTM standards to demonstrate substantial equivalence to predicate devices, not clinical performance data or AI/ML specific metrics.

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The LEXUS Cervical Fixation System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and . radiographic studies)
• . Spondylolisthesis
• . Spinal stenosis
• . Fracture/dislocation
• . Failed previous fusion
• . ' Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The LEXUS Cervical Spinal Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, rods, set screws, and hooks.

Materials: All products are made of titanium alloy (Ti-6Al-4V ELI/ in conformance with ASTM F136) approved for medical use.

The LEXUS Cervical Fixation System's performance was evaluated through mechanical testing according to ASTM F1717 standards, which outlines methods for static and dynamic tests of spinal implant constructs in a vertebral body model.

1. Acceptance Criteria and Reported Device Performance:

Note: The provided document states that the device was "tested according to the ASTM F1717", and that it is "considered substantially equivalent to other legally marketed devices" and "expected to be equivalent in safety and effectiveness." This implies that the device met the performance requirements specified in the ASTM F1717 standard, which serve as the acceptance criteria for mechanical performance for such spinal fixation systems. Specific numerical acceptance criteria and actual reported performance values are not detailed in this summary.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not specified in the provided document. As this is mechanical testing, the "sample size" would refer to the number of physical devices or constructs tested for each mechanical test.
• Data Provenance: The testing was conducted by or for L&K BIOMED Co., Ltd., based in the Republic of Korea. The document does not specify the location of the testing laboratory (e.g., in-house, third-party, country). This is a technical performance study, not a clinical study involving human patients.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

• Not applicable. This study focuses on the mechanical performance of the device, not a diagnostic or prognostic assessment requiring expert medical opinion for ground truth.

4. Adjudication Method for Test Set:

• Not applicable. This is a mechanical engineering test, not a clinical study requiring adjudication of expert opinions.

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

• Not applicable. This is a submission for a physical medical device (spinal fixation system) and its mechanical performance, not an AI or imaging-based diagnostic device. Therefore, no MRMC study was performed.

6. Standalone Performance Study:

• Yes, a standalone study was performed in the sense that the device's mechanical performance was tested independently of its clinical implantation or interaction with human readers. The tests (Static/Dynamic Axial Compression, Static Tension, Static Torsion) evaluated the device itself.

7. Type of Ground Truth Used:

• The "ground truth" for this study is defined by the objective physical and mechanical properties and behaviors of the device as measured against the industry standard (ASTM F1717). This includes parameters like strength, stiffness, and fatigue life under specified loading conditions.

8. Sample Size for Training Set:

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

9. How Ground Truth for Training Set was Established:

• Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.

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When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;

• DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed . by patient history and radiographic studies)
• Spondylolisthesis .
• Spinal stenosis .
• Fracture/dislocation .
• Failed previous fusion .
• Tumors .

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 - T3) spine.

The use of the polyaxial screws is limited to placement in T1 – T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

The provided text describes a 510(k) summary for the S4 Spinal System and indicates that the device has undergone performance testing. However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes, or ground truth establishment typically found in a clinical study report.

Instead, it states:

"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where applicable."

This implies that the device met the general requirements outlined in the FDA's guidance documents for spinal systems, which typically include mechanical and biocompatibility testing. It does not provide the specific "acceptance criteria" or the "reported device performance" in a quantitative manner as requested. It also lacks information on clinical study aspects like ground truth, expert opinions, or MRMC studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or clinical study details based on the provided text. The document is a regulatory submission summary rather than a detailed performance study report.

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