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The Aversion Pedicle Screw System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion

The Aversion Pedicle Screw System consists of straight and curved rods, polyaxial pedicle screws and crosslink connectors. These are available in a variety of sizes to accommodate differing patient anatomy.

This is a 510(k) premarket notification for a medical device called the "Aversion Pedicle Screw System." It is not an AI/ML device, therefore the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) related to AI/ML device testing is not applicable.

The document describes a traditional medical device, a pedicle screw system, and focuses on demonstrating its substantial equivalence to a legally marketed predicate device based on:

1. Technological characteristics: Basic design (rod-based fixation), material (titanium alloy), anatomic location (non-cervical spine), and sizes.
2. Performance Data: Mechanical testing (static compression bending and torsion, dynamic compression bending, and pullout testing) performed according to ASTM F1717 and ASTM F543 standards. The results demonstrated substantial equivalence in performance to the predicate devices.

Therefore, I cannot fulfill the request for information on acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, or standalone performance as these concepts are specifically relevant to AI/ML device evaluations, which this document does not describe.

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The tangoRS™ is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the tangoRS is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.

The tangoRS™ consists of rods, polyaxial pedicle screws and crosslinks with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Polyaxial screws are available in a variety of diameter-length combinations. Crosslinks are offered in four lengths. The purpose of this submission is to add components (a screw size and crosslink options) and two indications for use.

The provided 510(k) summary for the tangoRS™ multifunctional posterior system describes its performance through mechanical testing. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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 a "sample size" in terms of individual patients or clinical cases for a test set. The performance evaluation is based on mechanical testing of "worst case tangoRS™ constructs." The exact number of constructs tested is not provided, but it would typically involve multiple samples for each test condition to ensure reproducibility.
• Data Provenance: The data is generated from in-vitro (benchtop) mechanical testing, not from patient-derived data. Therefore, there's no country of origin for clinical data, and it is not retrospective or prospective in the clinical sense.

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 submission. Mechanical testing does not involve human experts establishing "ground truth" on patient data. The "ground truth" for mechanical testing is established by the specified ASTM F1717 standard and the performance of predicate devices.

4. Adjudication Method for the Test Set

This is not applicable as the study is mechanical testing, not a clinical study involving human judgment that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission relies on mechanical bench testing, not clinical studies involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical medical implant (pedicle screw system), not an algorithm or software. Therefore, there's no concept of "standalone performance" in the context of an algorithm. The performance described is inherent to the device's physical and mechanical properties.

7. Type of Ground Truth Used

The "ground truth" used for this type of device and submission is based on:

• ASTM F1717 standards: These provide the accepted methodology and criteria for testing spinal implant constructs.
• Performance of predicate devices: The tangoRS™ system is compared against the mechanical performance of previously cleared predicate devices (flamenco™ {K102853}, CD HORIZON® {K031655/K041460}, Expedium {K041119/K062196}, tangoRS™ {K052385}). The implicit "ground truth" is that if the new device performs "as well as or better than" these established devices under standardized testing, it is considered safe and effective.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design of the tangoRS™ system is based on established engineering principles and knowledge gained from predicate devices, but there isn't a "training set" of data in the machine learning sense.

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

This is not applicable as there is no "training set" for this type of device and study. The physical design and materials are chosen based on known biomechanical requirements and historical performance of similar devices.

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The flamenco™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.

When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients.

When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the flamenco™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

The flamenco™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.

The provided text describes the "flamenco™ spinal fixation system," a Class II medical device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for standalone performance or comparative effectiveness with AI.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria are implied to be achieving performance at least on par with the predicate devices under the specified ASTM F1717 mechanical tests.

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

The document reports mechanical performance data, not clinical performance data from a test set of patient cases. Therefore, information regarding "sample size used for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The testing was laboratory-based mechanical testing of "worst case" device constructs.

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

As this is a mechanical testing study, there were no human experts involved in establishing "ground truth" in the clinical sense. The "ground truth" for the mechanical tests would be the physical properties and performance measured by standardized mechanical testing equipment.

4. Adjudication Method for the Test Set:

Not applicable, as this was a mechanical test, not a clinical study requiring adjudication of expert interpretations.

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

No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system, not an AI diagnostic or therapeutic software that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.

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

Yes, in spirit, a standalone performance was done for the device's mechanical properties. The mechanical tests were performed on the device "constructs" themselves, independent of human interaction during the test. This is not "standalone algorithm performance" in the context of AI, but rather standalone performance of the physical device.

7. The Type of Ground Truth Used:

The "ground truth" for the mechanical performance study was physical measurements and adherence to engineering standards (ASTM F1717). The performance was compared against the measured performance of predicate devices.

8. The Sample Size for the Training Set:

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

Summary of Study:

The study described is a mechanical performance study conducted according to ASTM F1717. This standard specifies methods for static and dynamic testing of spinal implant constructs. The "flamenco™" system's "worst case" construct was subjected to static compression bending, torsion, and dynamic compression bending. The objective of the study was to demonstrate that the mechanical performance of the flamenco™ system is equivalent to or superior to that of legally marketed predicate devices. The study concluded that the "flamenco™ performs as well as or better than the predicate devices," thereby meeting the implied acceptance criteria for mechanical equivalence.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I. Acceptance Criteria and Device Performance

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

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

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

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

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

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

IV. Adjudication method for the test set

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

V. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

VII. The type of ground truth used

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

VIII. The sample size for the training set

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

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

• Ground Truth Establishment for Training Set: Not applicable.

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The CD HORIZON® Spinal System is intended for posterior, non-cervical 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; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

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 implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

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

The purpose of this 510(k) submission is to include 5.5mm diameter straight and pre-bent titanium cannulated rods to the CD HORIZON® Spinal System.

This is a 510(k) premarket notification for the CD HORIZON® Spinal System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance studies in the same way a PMA (Premarket Approval) submission would.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study methodologies (like MRMC or standalone performance) is not applicable for this 510(k) summary.

Here's a breakdown of what is available and why other requested details are not present for this type of submission:

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

• Not Applicable. For a 510(k), the "acceptance criteria" is primarily the demonstration of "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. There are no specific quantitative performance metrics or acceptance criteria for device performance laid out in this document as there would be for a novel device undergoing a PMA.

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

• Not Applicable. This document does not detail a "test set" in the context of clinical or performance data collection because it's a 510(k) submission. The substantial equivalence was shown through "Documentation, including a risk analysis, mechanical test reports and a finite element analysis." These are engineering and analytical tests, not clinical performance studies with patient data.

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

• Not Applicable. As no clinical "test set" with ground truth was used for this 510(k) submission, there were no experts establishing ground truth in this context.

4. Adjudication method for the test set

• Not Applicable. No clinical test set requiring adjudication was performed or reported in this 510(k) summary.

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 spinal implant system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is irrelevant.

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

• Not Applicable. As mentioned above, this is a physical medical device, not an algorithm.

7. The type of ground truth used

• Not Applicable. No ground truth in the clinical sense (expert consensus, pathology, outcomes data) was used in this 510(k) submission for performance evaluation. The "truth" established for substantial equivalence was based on engineering analysis and comparison to predicate devices.

8. The sample size for the training set

• Not Applicable. This device is a spinal implant, not a machine learning model, so there is no concept of a "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of Substantial Equivalence (the "Study" for 510(k)):

The "study" in a 510(k) context is the demonstration of substantial equivalence.

• Evidence Provided: "Documentation, including a risk analysis, mechanical test reports and a finite element analysis."
• Predicate Devices: The device was deemed substantially equivalent to similar CD HORIZON® Spinal System components previously cleared in K032265 (SE 8/11/03) and in K031655 (SE 06/27/03).
• Data Provenance: The mechanical test reports and finite element analysis would have been generated internally by the manufacturer (Medtronic Sofamor Danek) during the device development process. This is not patient data.
• Ground Truth: The "ground truth" for showing substantial equivalence essentially relies on established engineering principles and comparison to the safety and effectiveness profile of the predicate devices.

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The CD HORIZON® Spinal System is intended for posterior, non-cervical 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; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

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 implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

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

The purpose of this 510(k) submission is to include additional plates and multi-axial screw components to the CD HORIZON® Spinal System.

The provided text is a 510(k) summary for the CD HORIZON® Spinal System. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving performance is not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not provided. The document focuses on demonstrating substantial equivalence to previously cleared devices (K032265 and K031655) for the purpose of adding new components (plates and multi-axial screws) to an existing system, not on meeting predefined performance criteria through a new study.

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

Not applicable. No new study data is presented. The submission relies on the predicate devices' prior clearances.

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)

Not applicable. No new study data is presented.

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

Not applicable. No new study data is presented.

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-assisted diagnostic or treatment device.

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

Not applicable. This is a spinal implant system, not an algorithm-only device.

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

Not applicable. The "ground truth" in a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device(s) and the demonstration that the new device or components do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary of available information from the document:

The document, K041777, is a 510(k) premarket notification for the CD HORIZON® Spinal System, specifically for the addition of plates and multi-axial screw components.

• Substantial Equivalence: The primary "proof" in this document is the demonstration of substantial equivalence to previously cleared devices: K032265 (cleared 8/11/03) and K031655 (cleared 06/27/03). This means the manufacturer argued that the new components are as safe and effective as the predicate devices, and perform similarly to the previously cleared versions of the CD HORIZON® Spinal System.
• Intended Use/Indications: The document extensively lists the indications for use for the CD HORIZON® Spinal System, including posterior, non-cervical fixation for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. It also specifies indications for percutaneous approaches, anterolateral thoracic/lumbar systems (with ECLIPSE® components), and the CD HORIZON® SPIRE Plate.

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