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The VyPlate™ Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:

• instability caused by trauma or fracture;
• instability associated with correction of cervical lordosis and kyphosis deformity;
• instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
• instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
• instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.

This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The VyPlate™ Anterior Cervical Plate System is comprised of implant, instrument, and tray components. The implant components, the VyPlate™ device, consists of anterior cervical plates with integrated cover plates and bone screws. The implant components of the VyPlate™ Anterior Cervical Plate System are composed of Titanium alloy 6Al-4V as described in ASTM F-136.

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The ANTERIS Thoracolumbar Plate System Plates are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability, or via the anterior surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Trauma (i.e. fractures, including dislocation and subluxation), tumors, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, deformities (i.e. scoliosis, kyphosis, or lordosis), spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The ANTERIS Thoracolumbar Plate System is an anterior, anterolateral, or lateral plate fixation system intended for use in the thoracic, lumbar, and sacral spine (T1-S1). The plates are pre-contoured to accommodate anatomical alignment and incorporate a central vertical slot to facilitate visualization and graft placement. The ANTERIS plates are offered in standard and optional large versions. Screw back-out is prevented through the use of anti-backout caps. The system is intended to provide temporary stabilization and support to promote the development of a solid spinal fusion.

The ANTERIS Thoracolumbar Plate System consists of plates and bone screws made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

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The PathLoc Lumbar Plate System is indicated for use via the anterior surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion.

This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conformed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

The system consists of plates and fixation screws manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136 standards, and it includes manual surgical instruments commonly used in general surgical procedures.

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The ASTER is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck 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.

The ASTER is an anterior cervical plate system made from titanium alloy in accordance with ASTM F136. The system consists of various plates and screws, and fixation is achieved by inserting bone screws through the plate openings into the cervical vertebral bodies. Each plate includes locking caps designed to prevent screw back-out, and the locking caps are provided pre-assembled to the plate.

A variety of plate lengths and screw configurations are available to accommodate patient anatomy. The product is supplied only in a non-sterile condition, and must be steam sterilized prior to use.

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The Lumbar Spine Truss System Plating Solution (LSTS-PS) non-integrated plate is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The LSTS-PS is designed to provide temporary stability until fusion is achieved. It is intended for lateral, anterolateral, or anterior lumbar (L1-S1) 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The LSTS-PS integrated plate may be attached and remain attached to a Lateral Spine Truss System (LSTS) Interbody Fusion Device or an Anterior Spine Truss System (ASTS) Interbody Fusion Device after implantation. In this configuration the LSTS-PS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The 1-hole 4WEB LSTS-PS integrated plate is intended to be used with supplemental fixation (e.g. posterior fixation).

The Lumbar Spine Truss System Plating Solution (LSTS-PS) is comprised of lumbar plates and screws. The lumbar plates have a rotating locking tab for each screw position to prevent back-out of the screw. The plates are available in 1-hole, 2-hole, and 4-hole integrated configurations and 2-hole and 4-hole non-integrated configurations. Each plate is available in multiple lengths for single level fusion. The screws are available in two diameters and various lengths to accommodate the patient's anatomy.

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The aprevo® cervical plating system is intended for anterior cervical fixation (C2-T1) for the following indications:

• Degenerative disc disease (DDD) (defined as neck 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.

The aprevo® cervical plating system, which is comprised of the aprevo® cervical segmental plating system and the aprevo® cervical multilevel plating system configurations, is intended for anterior fixation of the cervical spine. The system consists of a variety of segmental and multilevel plates that are additively manufactured from titanium alloy (Ti-4Al-6V ELI) per ASTM F3001 as well as a range of fixation screws manufactured from titanium alloy (Ti-4Al-6V ELI) per ASTM F136. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the implants, are manufactured from stainless steel per ASTM A564. The plates, screws, and instruments are provided sterile packaged for single patient use.

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The Proximity Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The Segmental Plating System (SPS) is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The subject Alphatec Plating Systems consists of two anterior cervical plate subsystems, Proximity Anterior Cervical Plate System and Segmental Plating System, intended for anterior fixation to the cervical spine. The Alphatec Plating Systems consist of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136. The systems offer instrumentation for the delivery of the plate and screw constructs. The instruments in this system are intended for use in surgical procedures. The Alphatec Plating Systems implants are provided either terminally sterile or non-sterile to be steam sterilized by the end user.

I apologize, but the provided text from the FDA 510(k) clearance letter for the Alphatec Spine Proximity™ Anterior Cervical Plate System does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria for software-based AI/ML devices.

The document details:

• Device Type: Spinal Intervertebral Body Fixation Orthosis (a physical implantable device, not a software/AI device).
• Regulations: Primarily related to medical devices, specifically orthopedic implants.
• Performance Data: Lists non-clinical (mechanical) testing based on ASTM standards (e.g., Static and Dynamic Compression Bending, Static Screw Push-out) and sterilization/packaging validations.
• Substantial Equivalence: Compares the mechanical design and indications for use of the Proximity™ system to predicate physical spinal fixation devices.

Therefore, I cannot extract the information required by your prompts (acceptance criteria table, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) because these concepts are not applicable to the type of device described in this 510(k) clearance letter. The letter pertains to a traditional, physical Class II medical device, not a software-based or AI/ML-driven diagnostic or therapeutic tool.

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The Resolve Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck 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.

The Resolve Anterior Cervical Plate (ACP) System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments designed to facilitate proper implantation/explantation of the plates and screws.

The provided FDA document, K251436, describes the Resolve Anterior Cervical Plate System, a medical device. The document states that the substantial equivalence of the device was demonstrated through performance criteria identified in the FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway".

While the document confirms that non-clinical mechanical tests were performed and met acceptance criteria, it does not provide the specific numerical acceptance criteria or the reported device performance in a table format. Nor does it detail a clinical study with human readers or specific ground truth methodologies. The information focuses on non-clinical mechanical testing for spinal plating systems.

Therefore, the following information is extracted and inferred based only on the provided document:

Acceptance Criteria and Device Performance Study (as per provided document)

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document states that the device "meets or exceeds the acceptance criteria stated in the 'Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway' guidance document." However, the specific numerical acceptance criteria from this guidance document and the precise numerical results of the Resolve Anterior Cervical Plate System are not provided in this submission.

2. Sample Size for the Test Set and Data Provenance

The document describes non-clinical mechanical testing, not a clinical study involving a test set of human subjects or patient data.

• Sample Size: Not applicable in the context of human data. For mechanical testing, the "worst-case configuration" was tested. The specific number of mechanical test samples is not detailed.
• Data Provenance: Not applicable as it refers to non-clinical, laboratory-based mechanical testing.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" here is adherence to mechanical performance standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader agreement. This describes non-clinical mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document describes non-clinical mechanical tests for a spinal implant, not an AI/imaging device requiring human-in-the-loop evaluation.
• Effect size of human readers with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical spinal implant, not an algorithm or AI software. Therefore, there is no standalone algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by meeting predetermined mechanical performance specifications outlined in the FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway" and relevant ASTM standards (ASTM F1717 for mechanical tests; ASTM F2052, ASTM F2213, ASTM F2182 for MR safety).

8. Sample Size for the Training Set

Not applicable. This refers to non-clinical mechanical testing of a physical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set for an algorithm was involved.

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The Frida™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine in skeletally mature patients, serving as an adjunct to fusion of the cervical spine (C2 - T1). The system is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: 1) degenerative disc disease (as defined as neck pain of discogenic origin and confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) spinal stenosis, 4) trauma, 5) failed previous fusions, 6) tumors, 7) curvature deformities (kyphosis, lordosis, or scoliosis), and/or 8) pseudoarthrosis.

The Frida™ Anterior Cervical Plate System is an anterior cervical plating system that consists of single-use plates and screws, along with manual instruments for implant insertion. The plates are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and come in a variety of lengths to accommodate individual pathology and anatomical conditions of the patient. Plates incorporate a graft window for intraoperative visualization. Screws are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and are available in self-tapping and self-drilling options. Screws are available in a fixed or variable configuration, with a range of sizes to accommodate individual pathology. Plates and screws are available in single-use sterile packaging.

The provided FDA 510(k) clearance letter for the Frida™ Anterior Cervical Plate System does not contain the detailed information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria and study results.

This document is for a traditional medical device (a mechanical implant), not a software-based device. Therefore, the "acceptance criteria" and "study proving the device meets the acceptance criteria" are related to mechanical performance and biocompatibility, not algorithmic performance or clinical effectiveness in a human-computer interaction context.

Here's how to interpret the available information based on your request, and what information is missing due to the nature of this particular device:

Device Type: This is a physical, implantable medical device (Anterior Cervical Plate System), not an AI/SaMD. The "studies" described are primarily mechanical performance tests.

Acceptance Criteria & Device Performance (as much as can be inferred for a mechanical device):

Missing Information (Crucial for an AI/SaMD, but not applicable/provided for this physical device):

The following points are specifically geared towards AI/SaMD and are not found in the provided document because it pertains to a physical, mechanical medical device:

1. Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing mechanical testing, not a dataset of patient information.
2. Number of experts used to establish ground truth: Not applicable. Ground truth for a spinal plate is its mechanical performance and material properties.
3. Adjudication method: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating AI-assisted human performance, not relevant for a physical implant.
5. Standalone (algorithm only) performance: Not applicable.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/SaMD sense. The ground truth here is the objective measurement of mechanical properties compared to established standards and predicate devices.
7. Sample size for the training set: Not applicable. This device does not have a "training set" in the machine learning sense. Its design and manufacturing are based on engineering principles and material science.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

• Study Type: Non-clinical mechanical performance testing.
• Tests Performed:
  • Static compression testing
  • Dynamic compression testing
  • Static torsion testing
• Standards Used: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
• Comparison Basis: The device's performance was compared to "legally marketed predicate devices."
• Conclusion: The tests demonstrated that the "worst-case constructs were substantially equivalent to legally marketed devices." This implies that the Frida™ Anterior Cervical Plate System's mechanical characteristics, such as strength and durability, are comparable to or better than existing devices on the market, thereby demonstrating its safety and effectiveness for its intended use.

In essence, while the prompt asks for information typically found in AI/SaMD submissions, the provided document details the regulatory clearance for a traditional orthopedic implant, focusing on mechanical and material equivalence rather than data-driven algorithmic performance.

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X-PAC® N-GAGE™ 2-Hole and 4-Hole Lumbar Plate System is indicated for temporary stabilization during spinal fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients for the treatment of degenerative disc disease (DDD), spondylolisthesis, spondylolysis, spinal stenosis, pseudoarthrosis, deformity (defined as scoliosis, kyphosis, or lordosis), tumors, trauma (i.e. fractures including dislocation and subluxation), and/or failed previous fusion. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

N-GAGE™ 2-Hole and 4-Hole Plates may be assembled with the X-PAC® LLIF Expandable Cage to create a plate-spacer assembly. When assembled to the X-PAC® LLIF Expandable Cage, the plate-spacer assembly is indicated for standalone use at one or two levels of the lumbosacral spine (L2-S1), as an adjunct to fusion in skeletally mature patient with degenerative disc disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have at least six (6) months of non-operative treatment.

N-GAGE™ 1-Hole Plate is to be assembled with the X-PAC® LLIF Expandable Cages. When assembled, the system is intended to maintain the relative position of X-PAC® LLIF Expandable Cage and intended for use with supplemental fixation (e.g., posterior spinal systems).

X-PAC® N-GAGE™ Lumbar Plate System is a lumbar plate system comprised of implants (plates and screws), couplers, and surgical instruments. The implants are used in a lateral approach interbody fusion and are designed to provide rigid stabilization and support to the spinal column. The plate helps to restrict movement between adjacent vertebrae, preventing further injury and promoting the fusion of the bones over time. During operation, the plate is positioned laterally or anterolaterally, following insertion of a spinal interbody fusion spacer, via a removable inserter and screwdriver. The plate system can be installed either attached to (with a coupler) or floating from the X-PAC® LLIF Cage. The plates are available in multiple sizes and configurations to accommodate all heights of interbody spacing. The plates have a flat, elongated shape that conforms to the curvature of the spine at the required level(s) and have holes to secure the plate to the vertebrae. The fully threaded screws are available in two diameters and multiple lengths to accommodate varying anatomies. The screws are inserted into the vertebral body to hold the plate in place. The system includes a 1-hole, 2-hole, and 4-hole configuration. The screw can be angled up to 20 degrees away from the cage, and 10 degrees towards the cage. Each screw hole has an adjacent tab, which is turned and locked over the screw head once the screw has been inserted. The coupler is used to create a secure connection between the plate and the interbody device. The plates, screws, tabs, and couplers are manufactured from medical grade titanium alloy per ASTM F136.

This document is a 510(k) clearance letter for a medical device called the X-PAC® N-GAGE™ Lumbar Plate System. It is not an AI/ML device, and therefore the request to describe acceptance criteria and associated studies for such a device is not applicable.

The document describes a physical medical implant (a lumbar plate system) and details the non-clinical mechanical tests performed to ensure its safety and effectiveness. It does not mention any artificial intelligence or machine learning components, nor does it refer to acceptance criteria that would typically be associated with AI/ML device performance (e.g., accuracy, sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them, as the provided document does not pertain to an AI/ML device.

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