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The SOLACE Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:

• Sacroiliac joint dysfunction including degenerative sacroiliac joint disruptions
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The SOLACE Sacroiliac Fixation System is also indicated for fracture fixation of acute, and nontraumatic fractures involving the sacroiliac joint.

The SOLACE Sacroiliac Fixation System Navigation Instruments are intended to be used with the SOLACE Sacrolliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The SOLACE Sacroiliac Fixation System consists of 3D printed medical grate Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-3001) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.

Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The SOLACE implant surfaces have been engineered with surface features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

This document is a 510(k) summary for the SOLACE Sacroiliac Fixation System, a medical device for sacroiliac joint fusion and fracture fixation. It does not contain information about software or AI. Therefore, I cannot extract information related to acceptance criteria, study details, human-in-the-loop performance, or training/test set specifics for an AI/software device.

The document discusses the substantial equivalence of the device to previously cleared predicate devices, focusing on the addition of nano claims related to the implant's surface. The studies mentioned are primarily related to assessing the nano-surface features and their in vitro biological responses, not related to an AI/software's performance.

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When used as a Lumbar Interbody Fusion device, NeoFuse Ti3D is in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device. The devices must be used with supplemental fixation and must be used with autograft/autologous bone graft to facilitate fusion for each spinal region.

When used as a Cervical Interbody Fusion device. NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment with the device. The devices must be used with supplemental fixation and must be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

The NeoFuse Ti3D PLIF/TLIF/Cervical devices are intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F136. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.

Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody. This document focuses on demonstrating substantial equivalence to predicate devices rather than the performance of a novel AI/software medical device.

Therefore, the document does not contain any information regarding:

• Acceptance criteria for an AI/software device's performance.
• A study proving a device meets AI/software performance acceptance criteria.
• Sample sizes for test sets in an AI/software context.
• Data provenance for AI/software data.
• Number of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI assistance.
• Standalone (algorithm-only) performance studies for AI.
• Type of ground truth used for AI studies.
• Sample size for training sets for AI.
• Ground truth establishment for training sets for AI.

The information provided describes non-clinical testing performed on a physical intervertebral body fusion device to demonstrate its safety and effectiveness, specifically:

• Acceptance Criteria (for the physical device's mechanical properties): The document states that "FDA performance standards have been established" for the device, and the listed tests (Static/dynamic axial compression, torsion, shear, subsidence, expulsion) were performed to demonstrate safety based on "current industry standards." The conclusion is that the device "does not raise new issues of safety or efficacy compared to the predicates," implying it meets these established industry and FDA mechanical performance standards.
• Reported Device Performance: The document only states that "The results of these tests indicated that the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is substantially equivalent to the predicate devices." Specific numerical performance values (e.g., maximum force withstood, specific subsidence depth) are not reported in this summary.
• Sample sizes: Not specified for the mechanical tests, but implied to be sufficient for demonstrating substantial equivalence.
• Data provenance: Not applicable in the context of device mechanical testing.
• Experts/Ground Truth/Adjudication/MRMC/Standalone: These concepts are not applicable as this is a review of a physical medical implant, not an AI/software device.
• Training Set/Ground Truth for training: Not applicable for a physical device.

In summary, the provided text is about a 510(k) submission for a physical intervertebral body fusion device and does not contain the information required to answer the prompt regarding AI/software device acceptance criteria and study details.

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When used as a Lumbar Interbody Fusion device, NeoFuse is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. Lumbar DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device.

The devices must be used with supplemental fixation and must be used with autograft / autologous bone graft to facilitate fusion for each spinal region.

Not Found

This document is an FDA 510(k) clearance letter for a medical device called NeoFuse™ HA Enhanced PLIF/TLIF. It primarily outlines the regulatory approval process and includes the device's indications for use.

Crucially, this document does NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the device's approval is based on demonstrating substantial equivalence to a predicate device, rather than a new clinical study with specific acceptance criteria that are detailed in this document. Often, in 510(k) submissions, performance data is provided to demonstrate this equivalence, but that data and its associated criteria are not part of this output.

Therefore, I cannot provide the requested information based on the text provided.

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When used as a Lumbar Interbody Fusion device, NeoFuse is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. Lumbar DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device.

The devices must be used with supplemental fixation and must be used with autograft / autologous bone graft to facilitate fusion for each spinal region.

The NeoFuse™ HA Enhanced PLIF/TLIF devices are intervertebral body fusion devices made from PEEK-OPTIMA HA Enhanced (HA PEEK). Each device may include an optional Titanium Insert containing through holes to increase graft volume. The implants are available in various heights to accommodate patients' anatomy. The implants are provided non-sterile with surgical instruments to facilitate implantation. Radiographic markers made of tantalum (ASTM F-560), or titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.

This is a notification of intent to market a medical device, specifically an intervertebral body fusion device called NeoFuse™ HA Enhanced PLIF/TLIF. The document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a standalone study with acceptance criteria, human expert validation, or clinical efficacy data on the device's performance in a diagnostic or interpretive task.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in this document.

Here's why and what information is provided:

1. Acceptance Criteria and Reported Device Performance:

   • This document does not specify "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic or interpretive task.
   • The "performance" reported is related to bench testing for mechanical properties.
   • Table of Acceptance Criteria and Reported Device Performance: This cannot be created as such. The document states:
     • "Test results demonstrated that the devices are substantially equivalent to the predicate devices."
     • "Performance bench testing and comparisons have demonstrated NeoFuse is substantially equivalent to the predicate devices in regards to Indications for Use, Dimensions, Function, Materials, Mechanical Testing, and Technology Characteristics."
   • The criteria for "substantial equivalence" are based on comparing the mechanical test results of the NeoFuse to those of the predicate devices, ensuring they perform similarly under test conditions. Specific numerical values for these criteria are not provided in this summary.

2. Sample Size used for the test set and the data provenance:
   This information is not applicable and not provided. The "test set" here refers to the physical devices undergoing mechanical bench testing, not a dataset of patient images or clinical outcomes. The provenance would refer to the testing lab and standards (ASTM F2077 and ASTM F2267).

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 and not provided. "Ground truth" in this context would refer to the true mechanical properties, which are measured directly through standardized testing, not established by human experts.

4. Adjudication method for the test set:
   This information is not applicable and not provided. Mechanical testing results are objective measurements, not subject to human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
   No, an MRMC study was not done. This device is not an AI-powered diagnostic or interpretive tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   No, this device is a physical intervertebral body fusion device, not an algorithm.

7. The type of ground truth used:
   The "ground truth" for the mechanical testing would be the actual physical measurements obtained from the standardized ASTM tests. This is not "expert consensus, pathology, or outcomes data."

8. The sample size for the training set:
   This information is not applicable and not provided. There is no AI algorithm being trained for this device.

9. How the ground truth for the training set was established:
   This information is not applicable and not provided.

In summary, this document is a 510(k) premarket notification for a physical medical device. It demonstrates substantial equivalence through comparisons of materials, design, and mechanical bench testing to legally marketed predicate devices, rather than through clinical studies involving human performance or AI algorithms.

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