Search Results
Found 3 results
510(k) Data Aggregation
(78 days)
Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ Minimally Invasive System is intended for non-cervical pedicle 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior, non-cervical pedicle, and non-pedicle fixation, the Lancer™ Open Pedicle Screw System is indicated for the following: degenerative disc disease (DDD) (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 failed previous fusion. Overall levels of fixation are T1 to the Sacrum/Ilium. When used for fixation to the ilium, the lateral offset connectors on the Lancer™ Open Pedicle Screw System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems include implant components made of implant grade titanium alloy (Ti-6Al-4V ELI; ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo; ASTM F1537). The systems also include instruments made of PEEK (ASTM F2826), Tantalum (ASTM F560), stainless steel (ASTM F899/A564) and aluminum (ASTM B221). These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements.
The components include: polyaxial pedicle screws, set screws, rods, instruments and sterilizer trays. The Lancer™ Open Pedicle Screw System also includes connector and hook components.
The provided text describes a medical device, the Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems, and its substantial equivalence submission to the FDA. It does not describe an AI/ML device or a study comparing its performance against acceptance criteria in the context of AI/ML.
Therefore, I cannot extract the information required to answer your request about acceptance criteria and a study proving a device meets acceptance criteria in an AI/ML context. The document focuses on the mechanical and material equivalence of a surgical implant system to previously cleared predicate devices, as assessed through non-clinical (mechanical) testing.
Here's why the requested information cannot be found in the provided text:
- AI/ML Device: The "Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems" are physical surgical implants (pedicle screws, rods, connectors) used for spinal stabilization. They are not AI/ML devices that perform diagnostic, predictive, or assistive functions involving data analysis.
- Acceptance Criteria (for AI/ML): The document discusses "Substantial Equivalence" based on "intended use/indications for use, materials, design features, operational principles, and levels of attachment" and mentions non-clinical (mechanical) testing. These are not acceptance criteria for an AI/ML model's performance (e.g., sensitivity, specificity, AUC).
- Study Proving Device Meets Acceptance Criteria (for AI/ML): The "Non-Clinical Evaluation" describes mechanical testing (Static Compression-Bending, Dynamic Compression-Bending, and Static Torsion tests per ASTM F1717). This is a purely physical performance evaluation, not a study involving test sets, ground truth, expert readers, or sample sizes relevant to AI/ML performance.
- Other AI/ML related questions: All other points in your request (sample size for test set, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size, training ground truth) are specifically applicable to the evaluation of AI/ML algorithms and are therefore not present or relevant in this document.
In summary, the provided text describes a traditional medical device (spinal implants) and its regulatory clearance process, which relies on demonstrating substantial equivalence to already-cleared predicate devices through mechanical testing, not through AI/ML performance evaluation.
Ask a specific question about this device
(27 days)
The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: desc disease (DDD; 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ Minimally Invasive System is intended for non-cervical pedicle 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, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for hook fixation. The Lancer™ Open Pedicle Screw System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems include implant components made of implant grade titanium alloy (Ti-6AI-4V ELI; ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo; ASTM F1537). The systems also include instruments made of PEEK (ASTM F2826), Tantalum (ASTM F560), stainless steel (ASTM F899/A564) and aluminum (ASTM B221). These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: polyaxial pedicle screws, set screws, rods, instruments and sterilizer trays. The Lancer™ Open Pedicle Screw System also includes cross connector and hook components.
The provided FDA 510(k) clearance letter does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the manner you've outlined for diagnostic AI/CADe systems. This document is for a physical medical device (pedicle screw systems) and focuses on substantial equivalence to predicate devices, primarily through engineering analysis rather than clinical performance metrics typically associated with AI/CADe.
Therefore, many of the requested fields cannot be filled from the provided text. I will indicate where information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (for AI/CADe style clinical performance) | Not Applicable (for AI/CADe style clinical performance) |
| The submission indicates that the "subject implants were demonstrated to not represent a new worst case through engineering analysis." This implies an engineering-based acceptance criterion related to mechanical strength and safety, which was met. The specific engineering acceptance criteria (e.g., specific load thresholds, fatigue limits) are not detailed in this summary. | The engineering analysis concluded that the new sizes of screws do not represent a 'new worst case' compared to the predicate devices. This suggests they met the same structural and safety characteristics as the already cleared devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not Applicable. The evaluation was based on engineering analysis, not a clinical test set with patient data for diagnostic performance.
- Data Provenance: Not Applicable (no patient data used for this type of evaluation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No diagnostic ground truth was established as this was an engineering evaluation of a physical implant.
4. Adjudication method for the test set
- Not Applicable. No test set requiring adjudication 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
- Not Applicable. This is a physical implant device, not an AI/CADe system, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant device, not an algorithm.
7. The type of ground truth used
- For this device, the "ground truth" or basis for evaluation would be established engineering principles, material science specifications (e.g., ASTM standards for implant-grade titanium and cobalt chrome), and potentially a biomechanical comparison to the predicate devices, rather than clinical outcomes or expert consensus on diagnosis.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI/CADe system for this physical implant.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth in the context of an AI/CADe system for this physical implant.
Summary of the document's relevance to your request:
The provided document is an FDA 510(k) clearance letter for a physical medical device (pedicle screw systems) which involves expanding the available sizes of existing cleared devices. The "study" mentioned is an engineering analysis to demonstrate that the new sizes do not represent a "new worst case" compared to the predicate devices and maintain substantial equivalence. This is fundamentally different from the performance evaluation of AI/CADe devices, which involve clinical accuracy metrics, ground truth establishment, and often multi-reader studies.
Ask a specific question about this device
(74 days)
Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD); 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ System is intended for non-cervical pedicle 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for hook fixation. The Lancer™ Open Pedicle Screw System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease(DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems includes components made of implant grade titanium alloy (Ti6Al4V ELI; ASTM F136-02A), cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537, and instrumentation made of PEEK (ASTM F2826) and stainless steel per ASTM F899. These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: pedicle (polyaxial) screws, set screws, rods, hooks, instruments, and sterilizer trays. Additionally, cross connector components are available with the Lancer™ Open Pedicle system.
This document is a 510(k) premarket notification for a medical device, specifically the Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems. It details the device's indications for use, its classification, and asserts substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.
The information provided in the document pertains to a traditional orthopedic implant, a pedicle screw spinal system, and its regulatory clearance process based on substantial equivalence to previously cleared devices. The "Performance Standards: Torsional Grip and Axial Grip per ASTM F1798" listed under the Predicate Devices section relate to mechanical testing for the physical pedicle screws, not to the performance of an AI/ML algorithm.
Therefore, I cannot provide details for the following requested items because they are not present in the provided text:
- A table of acceptance criteria and the reported device performance (for an AI/ML device)
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
Ask a specific question about this device
Page 1 of 1