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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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The BASIS™ anterior cervical plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

The BASIS™ anterior Thoracic and Lumbar plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

When used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS™ components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

The BASIS™ Spinal System components included in this submission consist of screws, bolts, nuts and plates as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The BASIS™ Spinal System implant components are made from titanium alloy.

The provided document is a 510(k) premarket notification for the BASISTM Spinal System. This type of regulatory submission establishes substantial equivalence to a legally marketed predicate device, rather than proving device performance through a standalone study with specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

• No acceptance criteria or reported device performance are presented. The document focuses on regulatory approval based on equivalence.
• No sample size for a test set or data provenance is mentioned.
• No information on experts or ground truth establishment is provided for a performance study.
• No adjudication method is described.
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is discussed.
• No standalone (algorithm only) performance study is mentioned.
• No type of ground truth used for a performance study is specified.
• No sample size for a training set or how ground truth was established for it is provided.

The document indicates that the BASISTM Spinal System was determined to be "substantially equivalent" to several predicate devices, including:

• SYNTHES® Cervical Vertebrae Plates (K792352)
• SYNTHES® Spinal Implant System (K802462)
• ORION® Anterior Cervical Plate System (K973854)
• ZPLATE-ATL™ Anterior Fixation System and ZPLATE-ATL™ Anterior Fixation System ZPLATE-II (K922543 and K990603)
• VANTAGE™ Anterior Fixation System Plate (K023797)

The indications for use for the BASISTM Spinal System are the same as those for the predicate devices, covering various spinal conditions such as spinal stenosis, spondylolisthesis, spinal deformities, fracture, pseudarthrosis, tumor resection, and failed previous fusion.

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BASIS™ Screws and Hooks are intended for posterior, non-cervical fixation for the following indications: spinal stenosis; spondylolisthesis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); trauma (i.e., fracture or dislocation); pseudarthrosis; tumor; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

The BASIS™ Spinal System consists of a variety of shapes and sizes of hooks, screws and rods as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

BASIS™ hooks are intended for posterior use only.

The BASIS™ Spinal System implant components are made from medical grade titanium and titanium alloy.

This document is a 510(k) premarket notification for the BASIS™ Spinal System, which seeks to demonstrate substantial equivalence to previously cleared devices. It is not a study that proves the device meets specific acceptance criteria through performance evaluation. Therefore, most of the requested information regarding acceptance criteria and study design is not present in this document.

Here's what can be extracted based on the provided text:

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

This document does not contain acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity) or reported performance metrics. It's a regulatory submission focused on substantial equivalence based on product description and indications for use.

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 is a 510(k) submission, which typically relies on comparisons to predicate devices and engineering/bench testing, not clinical performance studies with test sets in the manner of an AI/diagnostic device.

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 establishment for a test set is described.

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

Not applicable. No adjudication method for a test set is described.

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

Not applicable. This is a spinal implant system, not a diagnostic AI device.

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), not a standalone algorithm.

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

Not applicable. The concept of "ground truth" in the context of diagnostic or AI performance evaluation is not relevant to this 510(k) submission. The "truth" in this context refers to the safety and effectiveness of the device as established through comparison to legally marketed predicate devices and adherence to regulatory standards for medical implants.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no training set mentioned.

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

Not applicable. As there is no training set, there's no ground truth for it.

Summary of what the document does provide:

• Device Name: BASIS™ Spinal System
• Manufacturer: Medtronic Sofamor Danek, Inc. USA
• Regulatory Status: 510(k) premarket notification (K050484), determined substantially equivalent (May 4, 2005)
• Predicate Devices: CD HORIZON® Spinal System screws, hooks and Rods (K042025, K020709 and K981676)
• Indications for Use (Key "Acceptance Criteria" in the context of 510(k) for equivalence): These are the conditions for which the device is intended to be used, and they must be substantially equivalent to the predicate device.
  • BASIS™ Screws and Hooks (posterior, non-cervical fixation): spinal stenosis; spondylolisthesis; curvatures (scoliosis, kyphosis, lordosis); trauma (fracture or dislocation); pseudarthrosis; tumor; and/or failed previous fusion.
  • BASIS™ Components (except hooks, as anterolateral thoracic/lumbar, or anterior cervical system): spinal stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion.
• Materials: Medical grade titanium and titanium alloy.

The "study that proves the device meets the acceptance criteria" in the context of a 510(k) is the demonstration of substantial equivalence to predicate devices, not a separate clinical performance study with specific metrics like sensitivity or specificity. The entire submission acts as the "proof" that it meets the regulatory "acceptance criteria" for market clearance.

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