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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.

Ask a specific question about this device

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation 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); 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.

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.

The CD HORIZON® SPIRE Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S1). 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.

When used as a pedicle screw fixation system in skeletally mature patients, the CD HORLZON® AGILE™ Dynamic Stabilization device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the degenerative spondylolisthesis with objective evidence of neurologic impairment and/or failed previous fusion in the thoracic, lumbar and/or sacral spine. Additionally, when used as a pedicle screw fixation system, the CD HORIZON® AGILE™ Dynamic Stabilization device is indicated for use in patients who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and/or are having the device removed after the development of a solid fusion mass.

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 VERTF.X™ Reconstruction System through a rod connector.

Certain implant components from other Medironic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, stapies 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 CD HORIZON® AGILE™ Dynamic Stabilization device is comprised of four components and is comprised by a combination of materials. The proximal and distal rod components arc manufactured from commercially pure titanium. The cable is fabricated from a 7x7 filament yarn made from titanium alloy, with a cylinder rotary-swaged to the end, made from the same material. The spacer portion of the device is manufactured from Polycarbonate-Urethane.

The purpose of this 510(k) submission is to include additional CD HORIZON® SEXTANT® instruments to the CD HORIZON® Spinal System.

This document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics of the device itself in the way an AI/software device often would.

Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are common for evaluations of AI or diagnostic software, is not present in this regulatory submission for a physical spinal implant system.

This 510(k) focuses on demonstrating that the updated CD HORIZON® Spinal System (specifically the inclusion of additional SEXTANT® instruments) is substantially equivalent to previously cleared predicate devices for the same indications for use.

Here's an explanation of why the requested information isn't available in this document:

• No Acceptance Criteria for Device Performance: For a physical implant like a spinal system, "acceptance criteria" generally relate to manufacturing specifications, material properties, mechanical testing (e.g., fatigue, strength), biocompatibility, and sterilization, rather than diagnostic accuracy metrics. This 510(k) doesn't detail those specific engineering or biological acceptance criteria.
• No "Study" in the AI/Diagnostic Sense: The determination of substantial equivalence relies on comparing the new device's design, materials, indications, and performance to a predicate device that has already been cleared. It doesn't involve a prospective clinical study to prove the device meets specific performance criteria against a clinical ground truth in the way a diagnostic algorithm would.
• No Test Sets, Training Sets, or Ground Truth: These concepts relate to the evaluation of algorithms or diagnostic tools where performance is measured against a known "truth." For a spinal implant, the "performance" is its ability to provide immobilization and stabilization as an adjunct to fusion, and its safety. This is typically assessed through comparison to existing marketed devices with a known safety and efficacy profile, and potentially bench testing.
• No Experts for Ground Truth/Adjudication: The regulatory review for this type of device involves evaluating the design, materials, manufacturing processes, and indications against FDA regulations and known predicate devices. It doesn't involve clinicians establishing a "ground truth" on individual cases to assess the device's diagnostic accuracy.
• No MRMC or Standalone Performance: These are terms used for evaluating diagnostic performance, which is not the primary function of a spinal implant.

What the document does state regarding "performance" and "equivalence" (which is the substitute for a formal "study" in this context):

The document mentions:

• "Documentation, including a risk analysis, was provided which demonstrated the subject instruments to be substantially equivalent to the predicate CD HORIZON® SEXTANT® instruments previously cleared in K051674 (SE 07/21/05) for the same indications." (Page 2, Section VI)
• It also references previous 510(k) clearances for the condensed CD HORIZON® Spinal System indications (K061304) and the CD HORIZON® AGILE™ Dynamic Stabilization device indications (K060615). (Page 2, Section VI)

In summary, this 510(k) submission is for a physical medical device (spinal implant components) and therefore does not contain the types of performance data, study designs, or expert evaluations typically described for AI or diagnostic software. Its clearance is based on demonstrating substantial equivalence to predicate devices, implying similar safety and efficacy profiles.

Ask a specific question about this device

The CD HORIZON® Spinal System with or without SEXTENT® instrumentation 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; 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.

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.

The CD HORIZON® SPIRE Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc discase (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 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 slightly modified staples and screws to the CD HORIZON® Spinal System,

This 510(k) submission (K063083) is for a medical device, the CD HORIZON® Spinal System, and therefore the acceptance criteria and study described will pertain to demonstrating substantial equivalence to a predicate device, rather than explicit performance metrics against a pre-defined acceptance criteria for a new AI/software device.

The provided document describes a spinal implant system, not an AI or software-driven device. Therefore, a table of acceptance criteria and reported device performance related to AI/software, as well as information about sample sizes for test/training sets, experts, adjudication methods, MRMC studies, or standalone performance, are not applicable in this context.

Instead, the "acceptance criteria" for this type of medical device generally revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

Here's an interpretation of the relevant information provided in the document:

Acceptance Criteria (for Substantial Equivalence of a Spinal Implant System):

For a spinal implant system like the CD HORIZON® Spinal System, the primary "acceptance criteria" for 510(k) clearance by the FDA are focused on demonstrating that the new or modified device is substantially equivalent to a predicate device. This typically involves showing that the device:

• Has the same intended use as a predicate device.
• Has the same technological characteristics as a predicate device; OR
• Has different technological characteristics than a predicate device but can demonstrate that the device is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness.

The Study that Proves the Device Meets the Acceptance Criteria (Substantial Equivalence):

The document explicitly states the mechanism used to demonstrate that the modified components of the CD HORIZON® Spinal System meet the acceptance criteria for 510(k) clearance:

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

Information Not Applicable or Not Provided for a Non-AI/Software Device:

As this is a traditional medical device (spinal implant hardware), the following points are not applicable and are not found in the provided documentation:

2. Sample sizes used for the test set and the data provenance: Not applicable to a hardware substantial equivalence submission in the context of AI/software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a hardware device is established through engineering testing, material science, and clinical judgment often based on historical device performance.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device does not involve human readers interpreting output from an AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable, as there is no algorithm or software being assessed.
7. Type of ground truth used: For a hardware implant, "ground truth" would relate to its physical properties, biocompatibility, mechanical strength, and clinical outcomes, not expert consensus on image interpretation or pathology.
8. Sample size for the training set: Not applicable, as there is no machine learning model involved.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The CD HORIZON® Spinal System with or without SEXTENT® instrumentation 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; 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.

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.

The CD HORIZON® SPIRE Plate is a 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 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, 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 add modified screws and lateral connectors to the CD HORIZON® Spinal System.

The provided text is a 510(k) summary for the CD HORIZON® Spinal System. This type of submission is for medical devices seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a traditional clinical study with acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

Instead, the document focuses on:

• Product Description: Details of the components and function of the CD HORIZON® Spinal System.
• Intended Use/Indications: Specifies the medical conditions for which the device is intended.
• Substantial Equivalence: States that documentation (including a Risk Analysis) was provided to demonstrate substantial equivalence of the new components (modified screws and lateral connectors) to previously cleared CD HORIZON® Spinal System components (K042025 and K020709). The labeling is also stated to be identical to a previously cleared system (K060203).

The FDA's letter (pages 2-3) confirms the "substantial equivalence determination" based on the marketing of legally marketed predicate devices, not on a new study showing performance against acceptance criteria.

Ask a specific question about this device

Ask a specific question about this device

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 arc intended for the following indications: ( I ) 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, 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.

The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the derice removed after the development of a solid fusion mass.

When used as a pedicle screw system in skeletally mature patients, the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spinc: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (?) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: ( 1 ) are receiving fusion with autogenous graft only, (2) who are having the device attached to the lumbar or sacral spine, and/or (3) who are having the device removed after the development of a solid fusion mass.

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 comector. 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® bol1s; 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 add TSRH® SiLo components to the CD HORIZON® Spinal System.

The provided documentation is a "Summary of Safety and Effectiveness" for the CD HORIZON® Spinal System, specifically addressing the addition of TSRH® SiLo components. This document is a 510(k) premarket notification for a medical device seeking clearance from the U.S. Food and Drug Administration (FDA).

Crucially, this document is for a 510(k) submission seeking substantial equivalence to previously cleared predicate devices, not for a study demonstrating performance to set acceptance criteria.

Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, etc.) is not present in this document.

Instead, the document focuses on:

• Product Description: Detailing the components and general use of the CD HORIZON® Spinal System.
• Indications for Use: Specifying the medical conditions for which the device is intended.
• Substantial Equivalence: Stating that the new TSRH® SiLo components are substantially equivalent to previously cleared components from other Medtronic Sofamor Danek spinal systems (K052144, K041030, and K042210). This means the company is arguing that its new device is as safe and effective as a legally marketed predicate device, without requiring new clinical trials or extensive performance data.

In summary, this document does not contain the information needed to fill out the requested table and study details because it is a substantial equivalence submission, not a performance study report against pre-defined acceptance criteria.

Ask a specific question about this device

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 cach 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.

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, 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 diseasc - 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.

The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw system in skeletally mature patients, the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: (1) are receiving fusion with autogenous graft only, (2) who are having the device attached to the lumbar or sacral spine, and/or (3) who are having the device removed after the development of a solid fusion mass.

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 cach 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 Medironic Sofamor Danck spinal systems van be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, 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 add sterile PEEK rods to the CD HORIZON® Spinal System.

The provided text is related to a 510(k) submission for the CD HORIZON® Spinal System, specifically for the addition of sterile PEEK rods. This document is a summary of safety and effectiveness, and subsequently, an FDA clearance letter for substantial equivalence.

Crucially, this document does not describe a study that involves an AI/ML device, nor does it provide acceptance criteria or performance metrics in the way one would for such a device.

Instead, it's a submission for a medical device (spinal implant), and the "study" referred to is a demonstration of substantial equivalence to existing predicate devices. This is a very different type of evaluation from what an AI/ML product would undergo.

Therefore, the requested information about acceptance criteria, device performance, sample size, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it pertains to a different type of medical device clearance process.

The document states:

VI. Substantial Equivalence

"Documentation, including a sterilization validation report, was provided which demonstrated the subject rods to be substantially equivalent to predicate CD HORIZON® PEEK components previously cleared in K050809 (SE 06/14/05)."

The core "acceptance criteria" here is that the new PEEK rods are "substantially equivalent" in terms of safety and effectiveness to predicate devices already on the market (K050809). The "study" that proves this is the documentation provided in the 510(k) submission, which for non-AI devices typically includes:

• Comparison to predicate device: Detailing similarities in indications, technological characteristics, and performance.
• Performance testing: This would involve non-clinical (e.g., mechanical, material, biocompatibility) testing to demonstrate that the new device meets established standards and performs comparably to the predicate. The document mentions a "sterilization validation report" as an example.
• Clinical data (if required): For spinal implants, clinical data might be used if there are significant technological differences or new indications that cannot be adequately assessed through non-clinical means. However, for a simple material addition like PEEK rods that are substantially equivalent, extensive clinical trials might not be required for 510(k) clearance.

In summary, as per the provided text, the device is a spinal implant, not an AI/ML algorithm. The "study" involved demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, not a performance study in the context of AI/ML evaluation.

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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.

The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw system in skeletally mature patients, the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: (1) are receiving fusion with autogenous graft only, (2) who are having the device attached to the lumbar or sacral spine, and/or (3) who are having the device removed after the development of a solid fusion mass.

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 Danck 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 modified CD HORIZON® set screws to the CD HORIZON® Spinal System.

The provided text describes a 510(k) premarket notification for the CD HORIZON® Spinal System, focusing on the inclusion of modified set screws. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving device performance against specific acceptance criteria through a clinical study with detailed statistical endpoints.

Based on the provided document, the following points can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for device performance (e.g., strength, durability, biocompatibility in a numerical format). Instead, the primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to existing predicate devices.
• Reported Device Performance: The document states that "Documentation, including a risk analysis, was provided which demonstrated the subject set screws to be substantially equivalent to predicate CD HORIZON® Spinal System set screws previously cleared..."

Essentially, the performance metric being assessed is "substantial equivalence," and the reported device performance is that this equivalence was successfully demonstrated.

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

The document does not describe a clinical "test set" in the context of a prospective human study to evaluate the performance of the modified set screws. The 510(k) process for a device like this often relies on engineering testing (e.g., mechanical tests) and comparison to existing data for predicate devices. Therefore, information on sample size for a clinical test set or data provenance (country, retrospective/prospective) is not applicable here as a standalone performance study as typically understood for new device effectiveness was not conducted.

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

Since a clinical test set with human subject data and corresponding ground truth determination is not described, this section is not applicable.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication is described in the provided text.

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

No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is typically used to assess the impact of an AI algorithm on human readers' performance, which is not relevant to this 510(k) submission for mechanical spinal implants.

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

No, a standalone algorithm performance study was not done. This device is a mechanical spinal implant, not an algorithm.

7. The Type of Ground Truth Used:

For a 510(k) submission based on substantial equivalence for a mechanical device like this, the "ground truth" implicitly refers to the established safety and effectiveness profile of the predicate devices. The demonstration of substantial equivalence relies on comparing the new device's design, materials, and intended use to those of legally marketed predicate devices, supported by engineering tests and risk analysis rather than a "ground truth" derived from patient outcomes in a new study.

8. The Sample Size for the Training Set:

Not applicable, as this is a mechanical device submission, not an AI or algorithm-based device that would require a "training set."

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

Not applicable, for the same reasons as point 8.

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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 SEXT ANT 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 fordosis); 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, 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 modified CD HORIZON® SPIRE plates to the system.

The requested information is not available in the provided document. The document describes a medical device (CD HORIZON® Spinal System) and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets such criteria. There is no mention of a test set, ground truth establishmen, expert radiologists, AI assistance, or related performance metrics. The document confirms the device's "substantial equivalence" to a predicate device, which is a regulatory pathway for medical devices in the US, but this is a different concept from clinical performance studies against specific acceptance criteria.

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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 add modified 5.5mm and 6.35mm diameter cobalt-chromium-molybdenum rods, and set screws to the CD HORIZON® Spinal System.

Here's a breakdown of the acceptance criteria and study information for the CD HORIZON® Spinal System based on the provided text.

This document describes a 510(k) submission for modifications to an existing spinal system, primarily focusing on adding new rod and set screw components. The "study" mentioned here refers to mechanical testing for substantial equivalence, not a clinical trial or algorithm performance study as typically understood for AI/software devices. Therefore, many of the requested points regarding AI/algorithm performance are not applicable.

Acceptance Criteria and Device Performance (Mechanical Testing)

Study Details (Focusing on Mechanical Testing for Substantial Equivalence)

Since this is a submission for a physical medical device (spinal system components) and not an AI/software device, many of the typical AI-related study questions are not applicable.

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

   • Sample Size: Not specified in the provided text. The testing would involve a sufficient number of samples of the newly introduced components (5.5mm and 6.35mm diameter cobalt-chromium-molybdenum rods and set screws) and predicate components to perform comparative mechanical characterization.
   • Data Provenance: The nature of the study (mechanical testing) indicates the "data" would be generated in a lab setting. The company, Medtronic Sofamor Danek, Inc., is based in the USA.

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

   • Not applicable. For mechanical testing, "ground truth" is established by engineering standards and validated testing protocols rather than expert human interpretation. The testing would be conducted by qualified engineers or technicians.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are for expert consensus in clinical contexts. Mechanical test results are quantitative and compared against predefined engineering specifications or predicate device performance.

4. 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 physical device, not an AI or imaging diagnostic tool. An MRMC study is irrelevant here.

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

   • Not applicable. This device does not involve an algorithm.

6. The Type of Ground Truth Used:

   • For mechanical testing, the "ground truth" would be established by engineering specifications, industry standards (e.g., ASTM, ISO for spinal implants), and the established performance characteristics of the predicate devices. The goal is to demonstrate that the new components perform equivalently or better in terms of mechanical properties (e.g., strength, fatigue, stiffness).

7. The Sample Size for the Training Set:

   • Not applicable. This is not a machine learning model. There is no "training set."

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

   • Not applicable. As above, no training set is involved.

Summary of the 510(k) Submission:

The provided document K043488 is for a modification to an existing spinal implant system, the CD HORIZON® Spinal System. The primary purpose of this specific 510(k) was to add modified 5.5mm and 6.35mm diameter cobalt-chromium-molybdenum rods and set screws. The demonstration of safety and effectiveness for such modifications typically relies on mechanical testing to show that the new components are substantially equivalent to previously cleared predicate devices and meet the same performance standards. The FDA's clearance confirms this substantial equivalence.

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