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The FORTEZZA Spinal Stabilization System is intended for posterior, non-cervical fixation in skeletally mature patients 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: pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the FORTEZZA Spinal Stabilization System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the FORTEZZA Spinal Stabilization System are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The FORTEZZA Spinal Stabilization System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

The FORTEZZA Spine Stabilization System consists of a variety of shapes and sizes of screws and 5.5 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy. Components of the system include straight and pre-bent rods, multi-axial screw.

This document is a 510(k) summary for the FORTEZZA Spinal Stabilization System, a medical device. It does not describe any clinical studies involving humans or AI. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical, bench testing.

Therefore, the requested information elements related to clinical studies, AI performance, ground truth, experts, and sample sizes for training/test sets are not applicable to this document.

Here's an analysis based on the provided text, focusing 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

• Test Set Sample Size: Not explicitly stated as a number of devices/tests, but implicitly refers to the number of samples required by ASTM F1717-14 for mechanical testing.
• Data Provenance: Not applicable for mechanical bench testing. The data is generated in a laboratory setting through controlled experiments.

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

• Not Applicable. No human experts were involved in establishing "ground truth" for these mechanical performance tests. The ground truth is determined by the physical properties and mechanical behavior of the device components under standardized test conditions specified by ASTM F1717-14.

4. Adjudication method for the test set

• Not Applicable. There is no adjudication method in the context of mechanical bench testing. Performance is measured against pre-defined engineering and material standards.

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 document describes a medical device for spinal stabilization, not an AI-powered diagnostic or interpretive tool. No MRMC studies were conducted.

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

• Not Applicable. This document describes a physical medical device, not a software algorithm.

7. The type of ground truth used

• The "ground truth" for the performance testing is based on engineering and material science standards and measurements. Specifically, the device's mechanical properties (static compression bending, static torsion, fatigue compression bending) are measured and compared against the properties of a predicate device, as required by ASTM F1717-14 and FDA guidance.

8. The sample size for the training set

• Not Applicable. There is no training set in the context of this type of medical device submission (mechanical testing for substantial equivalence).

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

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

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The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients 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.

In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The Adena-Zina System consists of a variety of a variety of shapes and sizes of screws and 5.5 and 6.35 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include straight and pre-bent rods, fixed angle reduction screws, multi-axial and multiaxial reduction screws, T-links, domino connectors, and sacro-illiac connectors.

This document describes a 510(k) premarket notification for the Adena-Zina System, a pedicle screw spinal system. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting a novel clinical study with acceptance criteria in the way a new drug or a more complex diagnostic device might.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, specifically regarding device performance and human interpretation, is not applicable in the context of this 510(k) summary for a pedicle screw spinal system. This document primarily describes mechanical performance testing against established standards.

However, I can extract and present the information that is available concerning performance testing and the comparison to a predicate device.

Summary of Device Performance Testing (Not Acceptance Criteria in the context of a clinical study for AI/diagnostic devices):

The Adena-Zina System underwent mechanical performance testing to demonstrate its substantial equivalence to a predicate device.

Regarding the specific questions posed:

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

   • As shown in the table above, the "acceptance criteria" here are defined by meeting or exceeding the performance of the predicate device for specified mechanical tests according to ASTM standards. There are no specific quantitative acceptance criteria listed in this summary, but rather a comparative statement.

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

   • This information is not provided. The testing described is mechanical bench testing of components, not clinical data from patients. The manufacturer is Shanghai Sanyou Medical Company, Limited (China).

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. This is mechanical testing against engineering standards, not expert-based clinical ground truth assessment.

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

   • Not applicable for mechanical bench testing.

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 (implantable system) for spinal fixation, not an AI software or diagnostic imaging device that involves human readers.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • The "ground truth" for this type of submission is adherence to recognized industry standards (ASTM F1717-12, ASTM F1798-13) and comparable performance to a legally marketed predicate device (Medtronic CD Horizon Spinal System, K123809).

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical performance testing for substantial equivalence for this type of device.

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

   • Not applicable.

In conclusion: The provided document is a 510(k) summary for an orthopedic implant. The "performance testing" described refers to mechanical bench testing conducted to demonstrate that the device is substantially equivalent to a predicate device in terms of engineering characteristics. It does not involve clinical studies, human readers, or AI algorithms typically associated with the "acceptance criteria" and "study" questions posed.

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The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; survatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS components are monded for the formities (i.e., scoliosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to when used as a vertebrar body replaceming surgical correction and stabilization of the spine. The be used in corpectonly procedures to the under spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Specifically, BASIS™ Vertebral Body Spacers are to be used with the Medtronic Sofamor Specifically, DASID - Vertenal Booy of lates, Multi-Axial Screws, or Fixed Angle Screws. Dallek DASIS - Amerior Theraceral Body Spacers are intended to be used with bone graft.

Nota Bene: The BASIS™ Vertebral Body Spacers are not intended for cervical or Nota Denc. The Drive - The BASIS™ Anterior Cervical Plates are intended for anterior cervical intervertebral body fusions only. The BASIS™ Anterior Thoracolumbar Plates are intended for screw fixation/attachment to the anterolateral intervertebral bodies only.

The BASISTM Spinal System consists of a variety of shapes and sizes of hooks, screws, bolts, nuts, plates, and vertebral body spacers, as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case.

BASIS™ hooks are intended for posterior use only.

The BASIS™ Spinal System implant components are made from medical grade titanium alloy. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct.

BASIS™ Vertebral Body Spacers must be used with additional anterior and/or posterior spinal instrumentation to augment stability. Specifically, the BASIS™ Anterior Thoracolumbar Plate, the BASIS™ Multi-Axial Screws, or the BASIS™ Fixed Angle Screws must be used with the BASIS™ Vertebral Body Spacers.

To achieve best results, do not use any of the BASIS™ components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic implants, none of the BASIS™ components should ever be reused under any circumstances.

The purpose of this 510(k) submission is to add CROSSLINK® components to the Basis™ Spinal System.

The provided document is a 510(k) summary for the BASIS™ Spinal System - Crosslink® Plates. This type of document is a premarket notification to the FDA for medical devices and typically does not contain detailed study information, acceptance criteria, or performance data in the way a clinical trial report or a comprehensive engineering study would for a new AI/software device.

Instead, 510(k) submissions demonstrate substantial equivalence to a legally marketed predicate device. This usually involves comparing device characteristics and, in some cases, non-clinical bench testing or animal studies, rather than extensive human clinical trials with performance metrics like sensitivity, specificity, or reader studies.

The document states:

• "The purpose of this 510(k) submission is to add CROSSLINK® components to the Basis™ Spinal System."
• "Components to be substantially equivalent to EQUATION™ Fixation System Components previously cleared in K013962."

Therefore, the requested information about acceptance criteria and a study proving device performance in the context of an AI/software device is not available in the provided text.

The document focuses on:

• Product Description: Details of the BASIS™ Spinal System components (hooks, screws, bolts, nuts, plates, vertebral body spacers), materials (medical grade titanium alloy), and general usage guidelines (e.g., prohibition of reuse, not mixing with other systems).
• Indications For Use: Specifies the medical conditions and anatomical regions for which the BASIS™ Spinal System is intended (spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, failed previous fusion, vertebral body replacement).
• Substantial Equivalence: States that the components are substantially equivalent to the EQUATION™ Fixation System Components (K013962). This is the primary "proof" for a 510(k) submission – demonstrating that the new device is as safe and effective as a legally marketed predicate device, not necessarily meeting specific performance criteria that would be established for an AI algorithm.

In summary, this document is for a spinal implant system, not a software/AI device, and therefore does not contain the specific information requested.

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