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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys® Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys system 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; .
• Who are having the device removed after the development of a solid fusion . mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer® DTO™ Implant, rodacord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer DTO Implant is a cord-rod combination implant that is assembled intraoperatively by the final tightening of the fastening pin that secures the connection of the cord and the rod. The U & I Corporation OPTIMA ZS Transition Screw is a pedicle screw that is part of the OPTIMA ZS Spinal System. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are implanted on contiguous levels the Zimmer DTO Implant and the OPTIMA ZS Transition Screw are used at the interface of these two systems. The cord portion of the Zimmer DTO Implant interfaces with the Dynesys Spinal System. The rod portion of the Zimmer DTO Implant interfaces with the OPTIMA ZS Transition Screw and with the OPTIMA ZS Spinal System.

The provided text is a 510(k) summary for the Zimmer® DTO™ Implant, a spinal fixation system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, function, and intended use, rather than presenting a detailed clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text. The requested information is simply not present in this regulatory submission.

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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: ( ) ) degenerative disc discase (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.c., 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 (1,3 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: ( i ) 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™ Rcconstruction 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; GDI.H® 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 PEEK rods as well as modified titanium alloy screws to the CD HORIZON® Spinal System.

The provided text describes a 510(k) premarket notification for the CD HORIZON® Spinal System, specifically for the addition of PEEK rods and modified titanium alloy screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a clinical study with detailed performance metrics and acceptance criteria as would be found in a study for a new device requiring extensive clinical validation.

Therefore, the information typically requested in your prompt (e.g., sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth types) is not present in this type of regulatory submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable / Not Provided. This submission relies on engineering and mechanical testing data for substantial equivalence, not clinical test set data from patients.

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

• Not Applicable / Not Provided. Ground truth as a clinical diagnosis from experts is not relevant in an engineering substantial equivalence submission.

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

• Not Applicable / Not Provided.

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 medical device (spinal implant) with no AI component, so MRMC studies are irrelevant.

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

• Not Applicable. This is a medical device (spinal implant) with no AI component.

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

• For the mechanical testing performed, the "ground truth" would be established by engineering standards and specifications for material properties and mechanical performance. This is implied by the "mechanical test reports" mentioned.

8. The sample size for the training set:

• Not Applicable / Not Provided. There is no "training set" in the context of an engineering substantial equivalence assessment for a spinal implant.

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

• Not Applicable / Not Provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is a substantial equivalence demonstration based on mechanical testing and analysis, rather than a clinical trial.

• Objective: To demonstrate that the newly added PEEK rods and modified titanium alloy screws to the CD HORIZON® Spinal System are substantially equivalent to existing, legally marketed predicate devices.
• Methodology:
  • Mechanical Testing: Comprehensive mechanical tests were performed on the PEEK rods and modified titanium alloy screws to characterize their material properties and performance under relevant physiological loads. The specific tests and their outcomes (e.g., fatigue strength, static strength, bending stiffness) are not detailed in this summary but were provided to the FDA.
  • Risk Analysis: A risk analysis was conducted to assess any new or different safety and effectiveness questions raised by the modifications.
  • Comparison to Predicate Devices: The results of the mechanical tests and risk analysis were compared against established data for several predicate CD HORIZON® components (K043488, K041862, K042962, K000094, K042025, K032033, K043151, K021791) and the DYNESYS Spinal System (K031511). The comparison aimed to show that the new components perform at least as well as the predicates in terms of safety and effectiveness for identical indications.
• Conclusion: The documentation provided, including mechanical test reports and risk analysis, demonstrated that the subject rods and screws are substantially equivalent to the identified predicate devices. The FDA concurred with this assessment, leading to the 510(k) clearance.

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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System 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; .
• Who are having the device removed after the development of a solid fusion mass. .

The Dynesys Spinal System is comprised of a variety pedicle screws sizes, tensioning cords and longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws are manufactured from medical grade titanium alloy. The tensioning cords are manufactured from Sulene-PET (polyethylene-terephthalate). The longitudinal spacers are manufactured from Sulene-PCU (polycarbonate-urethane).

The K043565 510(k) submission for the Dynesys® Spinal System describes the device and its intended use, but it does not include acceptance criteria or a study proving that the device meets such criteria in the context of an AI/ML medical device.

This document pertains to a traditional medical device (spinal fixation system) and its substantial equivalence to a predicate device, rather than an AI/ML-driven diagnostic or treatment system. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this submission.

The relevant information from the provided text focuses on the comparison of technological characteristics for additional screw components to the existing Dynesys Spinal System, establishing substantial equivalence based on materials, design, and function.

Table of Acceptance Criteria and Reported Device Performance:

Answers to Specific Questions (based on the provided text for a non-AI/ML device):

1. A table of acceptance criteria and the reported device performance: As shown above, specific performance metrics or acceptance criteria for an AI/ML component are not present. The "performance" described is the finding of substantial equivalence of additional screw components to the predicate device based on material, design, and function.

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. This submission concerns a physical medical device (spinal fixation system), not an AI/ML device requiring a test set of data. The testing mentioned refers to mechanical or physical characteristics of the screw components.

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 "ground truth" in the context of an AI/ML diagnostic or predictive model is established in this submission. The evaluation is based on engineering and design principles, and comparison to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the AI/ML sense to be adjudicated.

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. No AI component is described, so no MRMC study with AI assistance would have been conducted or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm mentioned in this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's substantial equivalence is the existing, legally marketed predicate device, and the engineering principles and standards applied to the new components.

8. The sample size for the training set: Not applicable. There is no AI/ML model that would require a training set.

9. How the ground truth for the training set was established: Not applicable. No training set is associated with this device submission.

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