Search Results

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

When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment. (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is 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) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.

The TSRH® 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 TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, 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 TSRH® Spinal System. These components include GDLH® rods, rods, rod/bolt cometions, Variable Angle T-Bolts, set screws and locking screws; DYNALOK® PLUS holts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, as well as CD® HORIZON rods, screws, setscrews and locking screws.

The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® connectors and TSRH-3D® screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Officet Plates may be used anteriorly as well.

The TSRH® Spinal System components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade. tittanium. The TSRH® Spinal System may be sold sterile or non-sterile.

The purpose of this 510(k) submission is to add modified connectors and setscrews to the TSRH® Spinal System. Additionally, the package insert was modified to include references to the ability of certain CD HORIZON® Spinal System components to be used with the TSRH® Spinal System.

This document is a 510(k) summary for the TSRH® Spinal System, specifically an amendment to add modified connectors and setscrews. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study for performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance studies for a device that relies on AI or diagnostic capabilities is not present in this type of submission.

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

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics. The core "acceptance criteria" for a 510(k) submission are demonstration of substantial equivalence to predicate devices. This is achieved through analysis of materials, design principles, and intended use as compared to devices already on the market.
• Reported Device Performance: Not reported in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical test results compared against thresholds). The submission asserts that the modified components are substantially equivalent.

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

• Sample Size: Not applicable. This submission doesn't describe a 'test set' in the context of a performance study with human or image data. It pertains to a physical medical device.
• Data Provenance: Not applicable.

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

• Number of experts/Qualifications: Not applicable. There is no 'ground truth' established by experts in this type of submission. The evaluation is based on regulatory review of design, materials, and intended use.

4. Adjudication method

• Adjudication Method: Not applicable.

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

• MRMC Study/Effect Size: No. This device is a physical spinal implant system, not an AI-powered diagnostic tool.

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

• Standalone Performance: No. This is a physical medical device.

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

• Type of Ground Truth: Not applicable. For this device, the "truth" being established is that the modified components are safe and effective for their intended use and are substantially equivalent to existing predicate devices. This is assessed through engineering analysis and regulatory review, not by establishing 'ground truth' from clinical data in the traditional sense of a diagnostic device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no machine learning "training set" for this physical device.

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

• Ground Truth for Training Set: Not applicable.

Summary of available information from the document:

• Device Type: Spinal System (implants for fixation and stabilization of spinal segments).
• Regulatory Mechanism: 510(k) Premarket Notification, seeking to add modified connectors and setscrews to an existing system.
• Primary "Acceptance Criteria" implicitly met: Substantial Equivalence to legally marketed predicate devices.
• Predicate Devices cited: K030285, K011029, K050282, K982290, K041282, K020699, K022778, K022778, K042025, K052054, and K062807.
• Study Proving Acceptance: The document states: "Documentation, including a risk analysis, was provided which demonstrated the subject rods to be substantially equivalent to predicate TSRH® components previously cleared..." This documentation would typically include engineering analyses, material biocompatibility data, and potentially mechanical testing (though specific results for the modified components against defined thresholds are not in this summary). The "study" here is a regulatory comparison and risk analysis, not a clinical trial or performance study against specific, quantitative acceptance criteria for a diagnostic device.

Ask a specific question about this device