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The Sovereign Posterior Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Sovereign Posterior Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Sovereign Posterior Cervical System may be connected to the Xultan 5.5 system using rod-to-rod connectors or transition rods. Please refer to the individual system's Instructions for Use for a list of indications for use for each system.

The Met One Technologies Sovereign Posterior Cervical System is an implant device designed for the posterior stabilization of the cervical and upper thoracic spine. The system includes implants such as polyaxial screws, blocker screws, rods, crosslinks, lateral connectors, and rod to rod connectors to form a unique construct to match patient anatomy.

Polyaxial screws are offered in a range of sizes in both standard and reduction tulips for ease of use. All screws are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

Straight, pre-bent, and transition rods are offered in 3.5mm and 4.0mm diameters and in two different materials, titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt chrome (Co-Cr28-Mo6 per ASTM F1537). Transition rods are fully compatible with Met One Technologies Xultan 5.5 Pedicle Screw System line of implants.

A variety of connectors and crosslinks are offered for surgeons to create the desired construction. Rod to rod crosslinks improve the torsional stability of the construct. Lateral connectors are provided in open and closed configurations, 3.5mm and 4.0mm diameters, and in long and short lengths. Rod to rod connectors are offered in several configurations to join rods together. All connectors are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

I am sorry, but the provided text is an FDA 510(k) clearance letter for a Sovereign Posterior Cervical System, which is a physical medical device (spinal implant system), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/SaMD's performance.
• A study proving the device meets AI/SaMD acceptance criteria.
• A test set (sample size, provenance).
• Experts establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth.
• Training set details.

The non-clinical testing described (ASTM F1717 and ASTM F1798) refers to mechanical testing of the physical implant's strength and durability, not software performance.

As such, I cannot fulfill your request for information related to AI/SaMD acceptance criteria and study details based on the provided input.

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The Kodiak Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the Kodiak Lumbar Spacer System. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the Kodiak Lumbar Spacer System.

The Kodiak Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6A1-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.

The provided text describes the 510(k) premarket notification for the "Kodiak Lumbar Spacer System," an intervertebral body fusion device. This document is a regulatory submission for a medical device that does not involve Artificial Intelligence (AI).

The requested information pertains to studies proving device performance with AI, such as acceptance criteria for AI model performance, sample sizes for AI training and test sets, expert adjudication methods for AI ground truth, and AI-assisted reader studies. Since the Kodiak Lumbar Spacer System is a physical implant and not an AI-powered diagnostic or therapeutic tool, this document does not contain any of the information requested about AI device performance studies.

The "Performance Data" section lists several types of mechanical tests performed on the device in accordance with ASTM standards (e.g., Static Compression, Dynamic Compression, Subsidence, Expulsion). These tests are standard for orthopedic implants to demonstrate their structural integrity and function, but they are not related to AI performance.

Therefore, I cannot provide the requested information because the provided document does not discuss an AI device or its performance studies.

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The Kodiak C Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Kodiak C Cervical Cages are intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Kodiak C Cervical Cages are intended to be used with an FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of nonoperative treatment prior to treatment.

The Kodiak C Corpectomy Cages are indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed, or unstable vertebral body due to trauma/fracture or tumor, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Kodiak C Corpectomy Cages are intended to be used with autograft and/or allograft bone. The Kodiak C Corpectomy Cages are intended to be used with an FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

The Met One Technologies Kodiak C Cervical Cage is a cervical intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The cervical cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are additively manufactured from Ti-6A1-4V ELI and are available in a variety of height, footprints, and lordotic configurations to suit individual patient anatomy.
The Met One Technologies Kodiak C Corpectomy Cage is a thoracolumbar vertebral body replacement device (VBR) that is implanted to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The corpectomy cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.

This document is a 510(k) Summary for the Kodiak C Spinal Implant System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving performance against specific acceptance criteria in the context of AI/ML or diagnostic performance.

Therefore, the information requested regarding acceptance criteria, study details (sample size, data provenance, expert qualification, adjudication, MRMC, standalone performance, ground truth), training set sample size, and ground truth establishment cannot be fully provided from the given document. This document describes mechanical and material testing, not diagnostic or AI performance.

Here's an attempt to answer based on the provided text, highlighting what is present and what is missing:

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

The document lists performance tests conducted, but it does not explicitly state quantitative acceptance criteria or reported numerical performance values for these tests. It only states that the device "demonstrated substantial equivalence" to predicate devices, implying that the results met relevant industry standards (e.g., ASTM standards) but without providing the actual data or specific thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set sample size: Not specified. The document refers to "the following test modes" and implies mechanical testing of devices, not clinical studies with patient data.
• Data provenance: Not applicable in the context of mechanical device testing. The tests are likely performed in a lab setting.

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)

• Not applicable. This is a medical device approval involving mechanical properties and material composition, not diagnostic interpretation by experts. Ground truth in this context would refer to material specifications and engineering standards, not expert medical opinions.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations of data, not for objective mechanical test results.

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. This document does not mention any MRMC study or AI assistance. The device is a physical spinal implant.

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

• No. This document does not pertain to an algorithm or AI.

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

• The "ground truth" for this type of device (spinal implant) would be established by engineering specifications, material standards (e.g., ASTM F3001 for Ti-6Al-4V ELI), and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these known, objective standards to demonstrate substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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

• Not applicable. This document does not describe an AI/ML device.

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The AUDERE Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the AUDERE Lumbar Spacer System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AUDERE Lumbar Spacer System.
The AUDERE Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The AUDERE Lumbar Spacer System consists of implants and trials that are compatible with all previously cleared AUDERE instruments. The AUDERE Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transforaminal (TLIF) approach.

The provided text describes a medical device, the AUDERE Lumbar Spacer System, and its FDA 510(k) clearance (K193457). However, the document does not contain information about acceptance criteria for an AI/algorithm-based device, nor does it detail a study proving device performance in the context of AI.

This document is for a physical implantable medical device (intervertebral body fusion device), not a software or AI-driven diagnostic/treatment device. The performance data section refers to non-clinical mechanical testing (e.g., static axial compression, dynamic axial compression, expulsion, subsidence) demonstrating the physical strength and durability of the implant, not the diagnostic or analytical performance of an algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/algorithm device from the provided text. The questions about sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.

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The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: Degenerative Disc Disease, Trauma, Spinal Stenosis, Cervical myelopathy, Deformities or Curvatures, Tumor, Pseudoarthrosis, and failed previous fusion.

The Met One Czar Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The Met One Czar Anterior Cervical Plate System includes screws, plates, and a set of instruments to insert the implants. Plates are available in a variety of lengths to accommodate fusion procedures from one to four levels of the cervical spine. Fixation is achieved by inserting the screws through the openings in the plate into vertebral bodies of the cervical spine. Met One Czar plates are manufactured from Titanium 6A1-4V ELI per ASTM F136 and Invibio PEEK-OPTIMA™ LT1 per ASTM F2026.

This document describes a spinal intervertebral body fixation orthosis, specifically the Met One Czar Anterior Cervical Plate System. It is a 510(k) premarket notification for a Class II medical device. As such, the information provided focuses on demonstrating substantial equivalence to legally marketed predicate devices through design, material, and functional comparisons, along with mechanical testing. It does not contain the kind of clinical study details, acceptance criteria tables, expert ground truth adjudication, or human-AI reader studies typically found for AI/ML-driven diagnostic devices.

Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/ML performance.

Here's why:

• Device Type: The Met One Czar Anterior Cervical Plate System is a physical implant (spinal plate and screws), not a diagnostic software or AI/ML algorithm.
• Regulatory Pathway (510(k)): For this type of device and regulatory pathway, the primary demonstration of safety and effectiveness relies on showing "substantial equivalence" to existing, legally marketed predicate devices, often supported by bench testing (mechanical, material properties) and design comparisons. It does not typically involve clinical trials with human readers, AI assistance, or complex ground truth establishment in the way an AI diagnostic device would.
• Information Provided: The document details the device description, intended use, technological characteristics, and notes that substantial equivalence is supported by mechanical testing (static and dynamic compression, static torsion per ASTM F1717). There is no mention of an algorithm, image analysis, diagnostic performance, or human-in-the-loop studies.

In summary, the provided document does not contain the information necessary to answer your questions regarding acceptance criteria, AI/ML device performance studies, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies because the device described is a physical implant, not an AI/ML diagnostic tool.

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The Xultan 5.5 Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients. The Xultan 5.5 Pedicle Screw System is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine (T1-S2/ilium); 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; curvature (i.e., scoliosis and/or lordosis); tumor; and failed previous fusion (i.e., pseudoarthrosis).

The Xultan 5.5 Pedicle Screw System is an implant device manufactured from titanium and silicone. The screws are available cannulated or non-cannulated in various diameters and lengths to accommodate various patient anatomies. The system includes straight rods, curved rods, crosslinks, and associated instrumentation.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document describes a 510(k) premarket notification for a medical device called the "Xultan 5.5 Pedicle Screw System," which is a spinal implant.

The document focuses on the substantial equivalence of this device to existing predicate devices based on:

• Indications for Use: The stated medical conditions the device is designed to treat.
• Technological Characteristics: Materials, design, and principles of operation.
• Performance Data: Results of non-clinical mechanical testing (static and dynamic axial compression bending, static torsion) according to ASTM F1717-15 standards.

There is no mention of:

• Any AI/ML component or software.
• Acceptance criteria for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
• Clinical studies involving human-in-the-loop performance or standalone AI performance.
• Details about ground truth establishment, expert adjudication, or sample size for training/test sets related to AI/ML development.
• Any multi-reader multi-case (MRMC) studies.

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

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