Search Results
Found 2 results
510(k) Data Aggregation
(209 days)
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
The SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
The SpineFrontier® PedFuse® Pedicle Screw 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 system consists of longitudinal rods, polyaxial screws, and cross connector. Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods are added to the System in this submission.
The provided text describes a 510(k) premarket notification for a medical device, the SpineFrontier® PedFuse® Pedicle Screw System. This specific submission focuses on modifications to an already cleared device, adding hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods.
Therefore, the performance data presented is for the mechanical substantial equivalence of these new materials and components to previously cleared versions and predicate devices, rather than a usability or clinical effectiveness study of the entire system as an AI device or a novel medical device establishing its own set of acceptance criteria.
The document does not describe the use of AI in this device, nor does it detail a study involving human readers, test sets, ground truth establishment, or training sets in the context of AI performance. The study mentioned is purely mechanical testing of the physical components.
However, I can extract information related to the mechanical performance testing conducted to demonstrate substantial equivalence, framed in the context of acceptance criteria if we interpret "acceptance criteria" as meeting the performance standards of the predicate devices.
Description of Acceptance Criteria and Study for SpineFrontier® PedFuse® Pedicle Screw System (Mechanical Performance)
This 510(k) submission (K133153) describes an update to the SpineFrontier® PedFuse® Pedicle Screw System, specifically adding Hydroxyapatite (HA)-coated titanium alloy screws and Cobalt Chrome (CoCr) alloy rods. The study presented is a mechanical performance testing summary to demonstrate that these modifications maintain adequate and substantially equivalent mechanical strength compared to previously cleared versions and predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like pedicle screw systems, "acceptance criteria" for mechanical testing typically involve meeting or exceeding the performance established by recognized ASTM standards or demonstrating equivalence to predicate devices under those standards. The document states the purpose of the testing is to "demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use." While explicit numerical acceptance criteria are not provided in this summary, the implicit acceptance criterion is that the modified device's performance is comparable to or better than previously cleared devices and predicate devices when tested under specified ASTM standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength (Static Axial Compression Bending): Must meet or exceed performance of previously cleared PedFuse® system and predicate devices (e.g., Medtronic TSRH® Spinal System, Pioneer Quantum Spinal System, Globus Transition™ Stabilization System) as per ASTM F1717-13. | The submission states that "The PedFuse Pedicle Screw System was tested in the following modes: Static Axial Compression Bending (ASTM F1717-13)" and concludes that "The overall technology characteristics and mechanical performance data lead to the conclusion that the PedFuse® System is substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.) |
| Mechanical Strength (Static Torsion): Must meet or exceed performance of previously cleared PedFuse® system and predicate devices as per ASTM F1717-13. | "Static Torsion (ASTM F1717-13)" was performed. Conclusion: "substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.) |
| Mechanical Strength (Cyclic Axial Compression Bending): Must meet or exceed performance of previously cleared PedFuse® system and predicate devices as per ASTM F1717-13. | "Cyclic Axial Compression Bending (ASTM F1717-13)" was performed. Conclusion: "substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.) |
| Custom Instrument Testing: Must demonstrate adequate performance. | "Custom Instrument Testing" was performed. Conclusion: "substantially equivalent to the predicate devices." (Specific numerical results are not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of devices or test repetitions) used for each mechanical test. Mechanical testing, especially for medical devices, typically involves multiple samples to ensure statistical validity, but the specific number is not disclosed in this summary.
- Data Provenance: The testing was conducted by SpineFrontier, Inc. in support of their 510(k) submission. This is internal testing performed by the manufacturer, likely in the USA where the company is based. It is a prospective generation of data specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the described study is mechanical performance testing of physical components, not a study involving human interpretation of data where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This information is not applicable as the described study is mechanical performance testing and does not involve human readers or adjudication processes.
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
This information is not applicable. This submission concerns mechanical properties of spinal implants, not an AI device or a study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This submission concerns mechanical properties of spinal implants, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established mechanical performance benchmarks set by:
- ASTM standards (specifically ASTM F1717-13).
- The known performance of the previously cleared SpineFrontier® PedFuse® Pedicle Screw System (K123164, K092420).
- The known performance of predicate devices (Medtronic TSRH® Spinal System K091797, Pioneer Quantum Spinal System K101790, Globus Transition™ Stabilization System K073439).
The aim of the study was to demonstrate that the modified device's mechanical properties met or were equivalent to these established benchmarks.
8. The Sample Size for the Training Set
This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the described study is mechanical performance testing and does not involve a training set for an algorithm.
Ask a specific question about this device
(129 days)
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
The SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
The SpineFrontier® PedFuse® Pedicle Screw System consists of longitudinal rods, polyaxial screws, tulips, transverse connectors, and instrumentation to facilitate installation of this system.
The PedFuse® Pedicle Screw is offered in multiple screw types, with multiple diameters and lengths to accommodate individual patient needs. PedFuse® Pedicle Screw assemblies consist of the screw, a tulip, and a washer that secures the tulip to the screw and also serves as the saddle for the longitudinal rod. The tulip and screw designs allow the screw to have a polyaxial rotation relative to the tulip. A locking cap is placed on top of the pedicle screw assembly to secure the position of the implant and to retain the longitudinal rod.
The PedFuse® Pedicle Screw assembly serves as the central fixation device to which various rods and cross connectors are secured to provide desired fixation.
Longitudinal rods are provided in two configurations, straight and lordotic, have a fixed diameter (5.5mm), and vary by length.
Cross connector assemblies are provided in multiple configurations, varying by length. Cross connectors are used to provide additional fixation support.
For percutaneous, minimally invasive surgical (MIS) procedure, extended Respond tulips and bulleted rods are introduced. Instruments for the MIS technique are also used.
The SpineFrontier® PedFuse® Pedicle Screw System components are fabricated from medical grade titanium conforming to ASTM F-136 specifications.
The provided text describes the SpineFrontier® PedFuse® Pedicle Screw System, a medical device for spinal fixation. It details the device's technical characteristics, intended use, and substantial equivalence to predicate devices, but it does NOT include information typically associated with acceptance criteria or studies proving performance for an AI/software device. This document is a 510(k) summary for a physical medical implant (pedicle screw system), not an AI algorithm.
Therefore, many of the requested categories for information (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance) are not applicable or cannot be extracted from this document, as they relate to the validation of AI/software rather than a mechanical implant.
However, I can extract the relevant information from the provided text for a physical medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from FDA Guidance and Recognized Test Methods) | Reported Device Performance |
|---|---|
| Mechanical Performance: Adherence to established standards for spinal implant constructs in a vertebrectomy model. | The SpineFrontier® PedFuse® Pedicle Screw System was evaluated in accordance with FDA Document, Guidance for Industry and FDA Staff – Spinal System 510(k)s, May 3, 2004, and has been found to meet criteria defined in the guidance document. Mechanical testing includes performance assessments per ASTM Standard F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". |
| Material Compatibility: Use of medical-grade materials. | Components are fabricated from medical grade titanium conforming to ASTM F-136 specifications. |
| Substantial Equivalence: Comparison of indications for use, function, operating principles, and materials to predicate devices. | The device was shown to be substantially equivalent to predicate devices (K092420, K950099, K992739, K100605, K061591) in terms of indications for use, function, materials, and performance (mechanical testing). |
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 applicable as the device is a physical implant and its performance was evaluated through mechanical testing, not a clinical study involving a "test set" of patient data in the context of an AI/software device. The document states "Clinical data was not required for this 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)
This information is not applicable. Ground truth establishment by experts is relevant for clinical data interpretation or labeling in AI/software validation, not for the mechanical testing of a physical medical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical "test set" requiring adjudication methods was used.
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
This information is not applicable as the device is a physical implant, not an AI-assisted diagnostic or interpretive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" for performance is defined by the established mechanical testing standards (ASTM F1717) and the material specifications (ASTM F-136). The device's substantial equivalence was also based on its alignment with the characteristics of legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable as the device is a physical implant and does not involve AI/machine learning requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical implant and does not involve AI/machine learning requiring a training set or its associated ground truth.
Ask a specific question about this device
Page 1 of 1