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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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When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

The occipital bone screws are limited to occipital fixation only.

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

The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.

The Nextgen Altius OCT System is an occipito-cervico-thoracic spinal fixation system. This submission is a line extension to Altius OCT System to add CoCr rods and alternate styles of rods, and screws, as well as other system components to the system and to update the indications for use for the system as a whole.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

This 510(k) summary is for a spinal fixation system, which falls under the category of a medical device and not an AI/ML algorithm. Therefore, many of the requested points related to AI/ML studies (like MRMC, standalone algorithm performance, AI improvement over human readers, training set details) are not applicable to this document. The study described is a series of mechanical tests to demonstrate substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: This information is not explicitly stated in the summary. For mechanical tests, the "sample size" would refer to the number of constructs tested for each configuration.
• Data Provenance: The data is generated from mechanical laboratory testing of the device components, not from patient data. Therefore, concepts like "country of origin" or "retrospective/prospective" studies are not applicable.

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

• Not Applicable. As this is a mechanical testing study for a physical device, expert-established ground truth (in the clinical sense, e.g., for image interpretation) is not relevant. The "ground truth" here is adherence to established mechanical testing standards (ASTM standards) and the comparison of performance metrics against predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert clinical assessments or diagnostic interpretations. This study involves objective mechanical performance measurements, not subjective expert reviews.

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

• No. An MRMC study is relevant for evaluating the impact of an AI/ML system on human reader performance. This document describes mechanical testing of a spinal fixation device, which does not involve human readers for diagnostic interpretation.

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

• No. This is not an AI/ML algorithm. It is a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth" in this context is based on established mechanical testing standards (ASTM F2706, F1717, F1798) and performance characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's components meet these engineering and regulatory benchmarks, indicating that they are at least as safe and effective as existing devices.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of mechanical testing for a spinal fixation system. This concept applies to the development of AI/ML algorithms.

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

• Not Applicable. As there is no training set, there is no ground truth established for one.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio- graphic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); turnor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CD HORIZON® Pediatric Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CDHORIZON SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor. In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The purpose of this Traditional 510(k) is to add Threaded Rods to the CD HORIZON® Spinal System.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

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

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameters from 3.5mm to 6.35mm), hooks, screws. CROSSLINK® Plates, and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, CD HORIZON® SPIRE spinous process plate devices, Shape Memory Alloy Staples, DYNALOK® bolts, and TSRH® screws and washers. All screws used in pediatic cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium alloy, and medical grade cobalt-chromiummolybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples, washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medironic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 3.5mm, 4.5mm, 5.5mm diameter rods or 6.35mm diameter rods, while other components can connect to both 5.5mm rods and 6.35mm diameter rods. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD HORIZON®4.5mm rods and associated components may be used posteriorly. The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hy-droxyapatite. No warranties expressed or implied are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobaltchromium-molybdenum alloy with stainless steel in the same construct. The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients. PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobalt-chromium-molybdenum alloy implants. CD HORIZON@PEEK Rods are not to be used with CROSSLINK@Plates or in pediatric patients. To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.

The provided document is a 510(k) summary for the CD HORIZON® Spinal System, specifically for the addition of Threaded Rods. It details the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample size (number of constructs tested) for each non-clinical test. However, tests were performed "per ASTM F1717 (2010)," which outlines methodologies for such testing. Adherence to a recognized standard suggests appropriate sample sizes were used for mechanical testing to ensure statistical significance, though the exact numbers are not explicitly stated in this summary.
• Data Provenance: The data is from non-clinical (benchtop) testing of the device components. Therefore, there is no country of origin for patient data, nor is it retrospective or prospective in a clinical sense.

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

This section is not applicable as the study was non-clinical (benchtop mechanical testing) and did not involve human subjects or expert assessment of clinical data. The "ground truth" in this context is the physical performance of the device against predefined mechanical standards and comparison to predicate devices.

4. Adjudication Method for the Test Set:

This section is not applicable as the study was non-clinical (benchtop mechanical testing) and did not involve human experts making judgments on clinical cases. The "adjudication" was based on objective mechanical measurements and comparison against established criteria within the ASTM standard.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study solely involved non-clinical benchtop testing of the device's mechanical properties.

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

This section is not applicable as the device is a medical implant (spinal system components), not an algorithm or software. The "standalone performance" refers to the mechanical performance of the physical device components.

7. The Type of Ground Truth Used:

The "ground truth" used was objective mechanical performance data derived from standardized laboratory tests (ASTM F1717) measuring properties such as static bending, static torsion, and fatigue bending. This data was compared against acceptance criteria presumably established from the performance of legally marketed predicate devices and the requirements of the ASTM standard.

8. The Sample Size for the Training Set:

This section is not applicable. There was no "training set" in the context of machine learning. The device underwent non-clinical mechanical testing.

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

This section is not applicable. There was no "training set" or "ground truth" in the context of an algorithm. The device's performance was evaluated against a recognized industry standard (ASTM F1717) and by comparison to predicate devices; the "ground truth" for the predicate device's performance would have been established similarly through non-clinical mechanical testing at the time of their 510(k) clearances.

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