Search Results

The COLONNADE Posterior Screw Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Fenestrated screws are not intended for use with cement.

The COLONNADE Posterior Screw Fixation System pedicle screw is an internal fixation device for spinal surgery. Various forms and sizes of these implants are available so that constructions can be utilized to account for the unique pathology and anatomy of each patient. The subject pedicle screws and set screw of COLONNADE Posterior Screw Fixation System are manufactured from Ti-6Al-4V ELI as per ASTM F136, and are anodized The subject rods are manufactured from Ti-6Al-4V ELI as per ASTM F136 and Co-28Cr-6Mo as per ASTM F1537.

This document, an FDA 510(k) clearance letter for the "COLONNADE Posterior Screw Fixation System," details the regulatory approval of a medical device intended for spinal surgery. However, it does not contain information about a study proving that an AI/software device meets acceptance criteria.

The 510(k) letter explicitly states, "Clinical Testing: Not Applicable" in the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 6. This indicates that no human clinical study was performed to assess the device's performance in a clinical setting against acceptance criteria for diagnostic or AI-driven tasks.

Instead, the provided text emphasizes the substantial equivalence of the "COLONNADE Posterior Screw Fixation System" to predicate devices based on:

• Identical Indications for Use: The intended applications of the new device are the same as previously cleared devices.
• Similar Technological Characteristics: The design, materials (Ti-6Al-4V ELI, Co-28Cr-6Mo), function, and fundamental technologies are comparable to predicates, with only "slight differences between the length and diameter of screws, and rod length."
• Non-Clinical Testing: Performance was evaluated through mechanical testing standards (ASTM F1717) related to spinal implant constructs (Static Compression Bending, Static Torsion, Dynamic Compression Bending).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/software device meets them, as this information is not present in the provided FDA 510(k) clearance letter.

The letter pertains to a hardware device (a spinal fixation system), not a software or AI device for which performance metrics like those typically associated with diagnostic AI (e.g., sensitivity, specificity, AUC, human reader improvement) would be established and tested in a clinical trial.

Ask a specific question about this device

The Advanced LumFix Spinal Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Advanced Lumfix Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, set screws, rod connectors and a crosslink linking mechanism. The Advanced Lumfix Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Advanced Lumfix Spinal Fixation System components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforming to ISO 5832-3 or ASTM F136, with a cobalt-chromium-molybdenum rod option conforming to ASTM F1537 (Co-28Cr-6Mo). Various sizes of these implants are available.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.

The document is an FDA 510(k) clearance letter for the "Advanced LumFix Spinal Fixation System." It primarily addresses the device's substantial equivalence to previously marketed predicate devices, its indications for use, and general regulatory compliance.

Specifically, the document mentions:

• Device Name: Advanced LumFix Spinal Fixation System
• Regulation Number: 21 CFR 888.3070 (Thoracolumbosacral Pedicle Screw System)
• Regulatory Class: Class II
• Indications for Use: Posterior, noncervical pedicle fixation as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Material: Titanium alloy (Ti-6A1-4V ELI) with a cobalt-chromium-molybdenum rod option.
• Non-clinical testing: Mechanical testing was performed in accordance with ASTM F1798 and ASTM F1717-11/18/21 (Static and Dynamic tests). This testing was to demonstrate equivalence to predicate devices, not to meet specific performance thresholds for a new function or AI component.
• Conclusion: The device is substantially equivalent in design, materials, indications, and performance to predicate devices.

There is no mention of:

• A table of acceptance criteria and reported device performance metrics (e.g., accuracy, sensitivity, specificity).
• Sample sizes for test or training sets for an AI/algorithm study.
• Data provenance.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• MRMC studies, human reader improvement, or effect sizes.
• Stand-alone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth was established for training data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The device described is a physical spinal fixation system, not an AI or software device that would typically have performance metrics and studies as you've outlined.

Ask a specific question about this device

The LumFix Spinal Fixation System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The LumFix Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, set screws, rods and a crosslink linking mechanism.

The LumFix Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. LumFix Spinal Fixation System components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforming to ISO 5832-3 or ASTM F136, with a cobalt-chromium-molybdenum rod option conforming to ASTM F1537 (Co-28Cr-6Mo). Various sizes of these implants are available.

The provided text describes a medical device submission, specifically a 510(k) premarket notification for the "LumFix Spinal Fixation System." This document is focused on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or performance through a clinical study for a novel AI/software device.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

The document discusses:

• Device Name: LumFix Spinal Fixation System
• Regulation Number: 21 CFR 888.3070
• Regulation Name: Pedicle screw spinal system
• Regulatory Class: Class II
• Product Code: MNI, MNH
• Indications for Use: Spinal fusion for various acute and chronic instabilities/deformities of the thoracic, lumbar, and sacral spine in skeletally mature patients.
• Predicate Devices: Zenius™ Spinal System (K093104) and ANAX™ 5.5 Spinal System (K132101).
• Non-clinical testing: Mechanical testing according to ASTM F1717 and ASTM F1798 to demonstrate equivalence. This includes static (tension, compression, torsion) and dynamic (fatigue) tests.

This is a submission for a physical medical device (spinal fixation system) and relies on mechanical testing to prove substantial equivalence to existing devices, not a clinical study to establish performance against acceptance criteria for an AI or software-based medical device.

Ask a specific question about this device