Search Results

Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or curvatures (i.e., scollosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)

The Spinal Fixation System is available in various lengths. This system is comprised of screws, set screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 5.5 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

Here's a breakdown of the requested information, based on the provided text:

Important Note: The provided document is a 510(k) summary for a spinal fixation system, which is a medical device. It does not describe an AI/ML-based device or a study involving human readers and AI assistance. Therefore, many of the requested points related to AI/ML device performance, ground truth establishment for AI, and MRMC studies cannot be found in this document and will be explicitly stated as "Not Applicable (N/A)" or "Not mentioned in the provided text."

Device Acceptance Criteria and Performance Study Summary

The device in question is the LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System, which are non-cervical spinal fixation devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are focused on substantial equivalence to existing predicate devices, rather than specific performance metrics like sensitivity, specificity, or accuracy (which would be typical for an AI/ML device). The performance is demonstrated through the equivalence of design, materials, and intended use, along with mechanical testing data, which is here substituted from predicate devices.

• Design
• Materials
• Scientific Technology
• Indications for Use
• Performance (specifically mechanical testing) | The additional components of the LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System are considered substantially equivalent to the predicate devices. The systems have the same design, materials, scientific technology, and indications for use. |
  | Material Composition | Manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) or Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537). This must be the same material used in the predicate devices. | The devices are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) or Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537), which is the same material used in the predicate devices. |
  | Mechanical Performance | The additional components do not require additional mechanical testing if they are not the "worst case" and can substitute mechanical test data from predicate devices. (Implicit criterion is that the mechanical performance is equivalent to cleared predicate devices). | Mechanical test data for the additional components are substituted with data from predicate devices (K120270, K143363, K171813, K183168) because the additional components are not the worst case. The conclusion states they "perform as well as the predicate devices." |
  | Intended Use | Non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). Limited to skeletally mature patients and intended as an adjunct to fusion for: degenerative disc disease, spondylolisthesis, trauma (fracture or dislocation), deformities or curvatures (scoliosis, kyphosis, lordosis), tumor, stenosis, and failed previous fusion (pseudoarthrosis). | The device's indications for use match the specified criteria and are consistent with the predicate devices. |

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

• Sample Size: Not applicable. This submission relies on substituting mechanical testing data from predicate devices and demonstrating material and design equivalence, rather than a new test set of patient data or images for performance evaluation.
• Data Provenance: Not applicable. The "data" here refers to the design, materials, and previous mechanical testing of predicate devices. The country of origin for the predicate device's data is not specified. The nature of the "data" is not retrospective or prospective in the sense of clinical study data for an AI/ML device.

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

• Not Applicable. As established, this is not an AI/ML device performance study requiring expert annotation for ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. No test set requiring adjudication of "ground truth" labels.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, not mentioned. This document does not describe an AI/ML device and therefore no MRMC study was performed or is relevant to this submission.

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

• Not Applicable. This is not an algorithm-based device. Its "performance" is mechanical and related to its physical properties and design.

7. The Type of Ground Truth Used

• Not Applicable. The "ground truth" for this device is effectively the demonstrated safe and effective performance of its predicate devices through their established properties (design, materials, mechanical testing results) that it is substantially equivalent to. There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, and thus there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. No training set exists for this type of device.

Ask a specific question about this device

The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista/Ballista II instruments are intended to be used with Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.

The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

The Polaris Spinal System is a non-cervical spinal fixation device. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This submission is a line extension to Polaris Spinal System to add other styles of multiaxial screw, including a screw with translating feature, and to provide the Polaris Spinal System sterile packed.

The provided document describes a 510(k) summary for the Biomet Spine Polaris Spinal System - Translation Screw, which is a non-cervical spinal fixation device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data for algorithmic performance. The testing performed was mechanical testing of the device hardware.

• Test Set Sample Size: Not applicable in the context of clinical data or algorithm performance.
• Data Provenance: Not applicable. The "data" comes from physical mechanical tests conducted on the device components.

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

Not applicable. Ground truth, in the context of algorithm performance, typically refers to expert-validated clinical diagnoses or outcomes. This submission focuses on mechanical performance data of a physical medical device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions for clinical ground truth. Mechanical testing has well-defined pass/fail criteria per ASTM 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

No, an MRMC comparative effectiveness study was not done. This device is a physical spinal fixation system, not an AI or imaging diagnostic tool.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the mechanical testing was the established pass/fail criteria defined by ASTM 1717-11a standard test methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device.

Ask a specific question about this device

The Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use:

• degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
• spondylolisthesis;
• trauma (i.e. fracture or dislocation);
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• tumor;
• stenosis, and;
• failed previous fusion (pseudoarthrosis)

This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

The provided text describes the "Dali Spinal Fixation System," a Class III medical device for spinal fixation. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

• Static compression bending
• Static torsion
• Dynamic compression bending (in accordance with ASTM F1717-10)
• Gripping-push down (in accordance with ASTM F1798) |
  | Material Equivalence | The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537), which are the same materials used in predicate devices. |
  | Design Equivalence (substantially similar) | The Dali Spinal Fixation System shares technological characteristics similar to the predicate devices, including similar design. |
  | Intended Use / Indications for Use | The device's intended use and indications for use as a non-cervical spinal fixation device (posterior pedicle fixation T1-S2/ilium, or anterolateral fixation T8-L5) for skeletally mature patients as an adjunct to fusion for conditions like degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion are deemed substantially equivalent to legally marketed predicate devices. |
  | Overall Safety and Effectiveness | The Dali Spinal Fixation System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use. |

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

The document explicitly states: "Clinical data and conclusions were not needed for this device." This means there was no clinical test set involving human subjects. The evaluation was based on non-clinical (bench) testing. Therefore, there is no sample size for an clinical test set or data provenance (country of origin, retrospective/prospective clinical data).

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

Not applicable. As no clinical data was required or used, there was no need for experts to establish ground truth for a clinical test set. The acceptance was based on engineering and material equivalence to predicate devices.

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

Not applicable. No clinical test set with human data requiring adjudication was performed.

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 device is a spinal fixation system (physical implant), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not performed.

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

Not applicable. This device is a physical medical implant, not a software algorithm.

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

For the non-clinical performance evaluation, the "ground truth" was established by standardized mechanical testing protocols (e.g., ASTM F1717-10 for dynamic compression bending, and ASTM F1798 for gripping-push down) and material specifications (ASTM F136 for Titanium alloy, ASTM F1537 for CoCrMo alloy). The "truth" was that the device met or exceeded the performance of the predicate devices under these controlled, quantifiable conditions.

8. The sample size for the training set

Not applicable. This device is a physical implant evaluated through bench testing and comparison to predicate devices, not an AI or machine learning model that requires a training set.

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

Not applicable, as there was no training set.

Ask a specific question about this device