Search Results

When Used as a Cervical Intervertebral Body Fusion System:

The CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

When Used as a Partial Vertebral Body Replacement (VBR) System:

The CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. Lordotic implants greater than a 5° profile are not to be used for partial vertebral body replacement.

The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR Device is intended to be used with autograft or allograft and supplemental fixation system.

The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.

The CONSTRUX Mini Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini Ti Spacer System is intended for use with autograft comprised of cancellous and/ or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.

The FORZA Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The FORZA Spacer System is intended to be used with supplemental fixation systems. As an example, the supplemental fixation that may be used is the Orthofix Firebird Spinal Fixation System.

The FORZA Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

The FORZA PTC 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). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.

The FORZA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the Firebird Spinal Fixation System.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.

The FORZA Ti 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). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.

The FORZA Ti Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA Ti Spacer System.

The FORZA XP Expandable 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). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA XP Expandable Spacer System.

The LONESTAR Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD), DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The LONESTAR Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the LONESTAR Cervical Stand Alone System in the cervical spine.

The PILLAR PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The PILLAR PEEK Spacer System is intended to be used with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).

The PILLAR PL PEEK Spacer is used singly or in pairs and is implanted using a posterior approach.

The PILLAR TL PEEK Spacer is used singly or in pairs and is implanted using a transforaminal approach.

The PILLAR AL PEEK Spacer is used singly and is implanted using an anterior approach.

The PILLAR XL PEEK Spacer is used singly and is implanted using a lateral approach.

The PILLAR PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

When used as a Partial Vertebral Body Replacement (VBR) Device:

The PILLAR PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of a fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The PILLAR PEEK Spacer System is intended for use with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).

When used as an Intervertebral Body Fusion Device:

The PILLAR SA PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation system that may be used is the Orthofix Firebird Spinal Fixation System.

The PILLAR SA PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

When used as a Partial Vertebral Body Replacement (VBR) Device:

The PILLAR SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the supplemental fixation must be used to augment stability. As an example, the supplemental fixation that may be used is the Orthofix Firebird System.

The PILLAR SA PTC 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). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).

The PILLAR SA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft.

The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws provided with the system. If the physician chooses to use fewer than four of the provided screws then supplemental fixation must be used to augment stability. As an example, a supplemental fixation system that may be used is the Orthofix Firebird® Spinal Fixation System.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the PILLAR SA PTC Spacer System.

When used as an intervertebral body fusion device, the SKYHAWK Lateral Interbody Fusion System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The SKYHAWK Lateral Interbody Fusion System is intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The SKYHAWK Lateral Interbody Fusion System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System – The CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with titanium markets as described by ASTM F67. The implants are available in multiple sizes to accommodate various patient anatomies. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The CONSTRUX Mini PEEK VBR System is intended for vertebral body replacement to aid in the surqical correction and stabilization of the spine.

The CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach.

The CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System implants are provided either in a sterile packaging configuration or non-sterile and requires sterilization prior to use.

CONSTRUX Mini PTC Spacer System - The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that have a PEEK core with integrated porous titanium end plates. CONSTRUX Mini PTC spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another.

The CONSTRUX Mini PTC Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach.

The CONSTRUX Mini PTC implants are provided sterile.

CONSTRUX Mini PTC implants are design to be used with CONSTRUX Mini PEEK Spacer System instrumentation. The CONSTRUX Mini PTC implants are not compatible with components or metal from any other manufacturer's system.

CONSTRUX Mini Ti Spacer System - The CONSTRUX Mini Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure. CONSTRUX Mini Ti spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another.

The CONSTRUX Mini Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach.

The CONSTRUX Mini Ti implants are provided sterile.

CONSTRUX Mini Ti implants are design to be used with CONSTRUX Mini Spacer System instrumentation. The CONSTRUX Mini Ti implants are not compatible with components or metal from any other manufacturer's system.

FORZA PEEK Spacer System - The FORZA Spacer System consists of implants, trials and instruments. The system is comprised of a variety of implants fabricated and manufactured from polvetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants both intraoperatively and postoperatively.

FORZA Spacer System implants are offered in two geometric shapes – straight and curved, and offered in parallel and lordotic profiles to restore the natural curvature of the implants can be used in single placement or in pairs. Both the curved and straight implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA Spacer System is intended for intervertebral body fusion to aid in the surgical correction and stabilization of the spine and are implanted using a posterior approach.

The FORZA Spacer System is not intended to be used as a stand-alone device. The FORZA Spacer System must be used with a supplemental fixation system. The implants are provided sterile but the instruments are provided non-sterilization prior to use.

FORZA PTC Spacer System - The FORZA PTC Spacer System is comprised of a variety of implants that have a PEEK (OPTIMA LT1) core with integrated porous titanium (Ti-6Al-4V) end plates as well as a tantalum marker that acts as a visual aid for the surgeon in determining the location of the implant both intraoperatively and postoperatively.

FORZA PTC Spacer System implants are offered in two geometric shapes - straight and curved, and offered in parallel and lordotic profiles to restore the natural curvature of the spine. The implants can be used in single placement or in pairs. Both the curved and straight implants feature a bulleted nose for ease of insertion and a roughened surface on both the inferior and superior faces of the implant to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA PTC Spacer System is intended for intervertebral body fusion to aid in the surgical correction of the spine and are implanted using a posterior approach.

The FORZA PTC Spacer System is not intended to be used as a standalone device. The FORZA PTC Spacer System must be used with a supplemental fixation system.

The FORZA PTC Spacer System implants are provided sterile.

FORZA PTC implants are designed for use with FORZA PEEK Spacer System instrumentation. The FORZA PTC spacers are not compatible with components or metal from any other manufacturer's system.

FORZA Ti Spacer System - The FORZA Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure.

FORZA Ti Spacer System implants are offered in two geometric shapes - straight and curved, and offered in parallel and lordotic profiles to restore the natural curvature of the spine. The implants can be used in single placement or in pairs. Both the curved and straight implants feature a bulleted nose for ease of insertion and a roughened surface on both the inferior and superior faces of the implant to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA Ti Spacer System is intended for intervertebral body fusion to aid in the surgical correction of the spine and are implanted using a posterior approach.

The FORZA Ti Spacer System is not intended to be used as a standalone device. The FORZA Ti Spacer System must be used with a supplemental fixation system.

The FORZA Ti Spacer System implants are provided sterile.

FORZA Ti implants are designed for use with FORZA PEEK and FORZA PTC Spacer System instrumentation. The FORZA Ti spacers are not compatible with components or metal from any other manufacturer's system.

FORZA XP Expandable Spacer System - The FORZA XP Expandable Spacer System is comprised of an assortment of non-sterile, single use, titanium allov (Ti-6AI-4V ELI per ASTM F136) and Polyetheretherketone (PEEK) Polymer (PEEK OPTIMA® LT1 per ASTM F2026) spacers with height expansion capability. The expandable interbody spacer is inserted into the lumbar disc space and expanded to fit the patient anatomy.

The implants are offered in parallel, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).

The implants feature a bulleted nose for ease of insertion ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device. The system must be used with a supplemental fixation system, is provided non-sterile and requires sterilization prior to use.

Lonestar Cervical Standalone System - The LONESTAR Cervical Stand Alone System is a stand-alone spacer system designed to provide biomechanical strength to a traditional or minimally invasive ACDF procedure with less disruption of patient anatomy and preservation of the anatomical profile. The system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability.

The LONESTAR implant consists of a hybrid PEEK and titanium spacer along with titanium bone screws and a titanium cover plate. The spacers are designed with a zero degree anterior profile and are implanted using an anterior approach.

The LONESTAR Cervical Stand Alone implants and instruments are provided non-sterile and will require thorough cleaning and sterilization prior to each use. The implants are not compatible with components or metal from any other manufacturer's system.

PILLAR PEEK Spacer System - The PILLAR PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone) as described by ASTM F2026 with tantalum markers as described by ASTM F560. The implants are available in a variety of sizes and are offered in parallel and lordotic profiles in order to restore the natural curvature of the spine. The implants are available in various heights in either one or two millimeter increments. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR PEEK Spacer System is intended for intervertebral body fusion or partial vertebral body replacement to aid in the surgical correction and stabilization of the spine.

The PILLAR PEEK Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The system is provided non-sterile and requires sterilization prior to use.

PILLAR SA PEEK Spacer System - The PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone) as described by ASTM F2026 with tantalum markers as described by ASTM F560. The implants are available in multiple footprints, a variety of heights, and two angles of lordosis: 7° and 12°. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent of the device.

The PILLAR SA PEEK Spacer System is provided non-sterile.

PILLAR SA PTC Spacer System - The PILLAR SA PTC Spacer System is comprised of a variety of implants that have a PEEK core with integrated porous titanium end plates. The implants incorporate integrated anterior screw holes to allow for medial placement of bone screws as well as a titanium plate for securing the bone screws once in place. The implants are designed with a roughened surface on the inferior and superior faces of the implant to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR SA PTC Spacer System is intended for intervertebral body fusion to aid in the surgical correction of the spine and is implanted using an anterior approach.

The PILLAR SA PTC spacers are provided sterile. The cover plate, screws and instruments are provided non-sterile and require sterilization prior to use.

The PILLAR SA PTC implants are designed to be used with PILLAR SA PEEK Spacer System instrumentation. The implants are not compatible with components from any other manufacturer's system.

SKYHAWK Lateral Interbody Fusion System - The SKYHAWK Lateral Interbody Fusion System consists of implants, trials, and instruments and is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent property, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the implants, both intraoperatively and postoperatively.

The SKYHAWK Lateral Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device may be implanted using a lateral approach.

The SKYHAWK Lateral Interbody Fusion System implants, trials and instruments are provided non-sterile. They require sterilization prior to use.

The provided text is a 510(k) Summary for multiple spinal implant systems, focusing on the addition of "MR Conditional" labeling. It details the device descriptions and indications for use but does not contain information about acceptance criteria or a study proving clinical effectiveness or device performance in the context of typical medical device evaluation (e.g., diagnostic accuracy, treatment efficacy in patients).

Instead, the "performance data" section (page 26) pertains to the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment to support the MR Conditional labeling. This is a specific type of performance evaluation, not a general study proving the device meets clinical acceptance criteria for its primary function (spinal fusion).

Therefore, most of the requested information regarding acceptance criteria, patient sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information is not available in the provided document.

Here's a breakdown of what can be extracted or inferred:

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

2. Sample sized 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 applicable. The "test set" here refers to the physical devices themselves used for MR compatibility testing, not patient data. The number of devices tested is not specified.
• Data Provenance: Not applicable, as this refers to laboratory testing of physical devices according to ASTM standards, not clinical patient data.

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. Ground truth, in the context of MR compatibility testing, is defined by the ASTM standards and the physical measurements performed, not by expert interpretation of clinical data.

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

• Not applicable. Adjudication is relevant for interpreting ambiguous clinical data, not for laboratory measurements of physical properties.

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 document describes spinal implants, not an AI-assisted diagnostic or treatment system.

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

• Not applicable. This document describes spinal implants, not an algorithm.

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

• For MR Conditional Labeling: Ground truth is established by the specified ASTM standards and physical measurements.
• For Clinical Efficacy (Spinal Fusion Devices): This information is not provided in the document. Clinical ground truth for spinal fusion devices would typically involve imaging (e.g., CT scans to assess fusion), patient reported outcomes, and potentially re-operation rates or other clinical endpoints from previous studies.

8. The sample size for the training set

• Not applicable. This document describes spinal implants, not an AI/ML algorithm that requires a training set.

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

• Not applicable.

Ask a specific question about this device

The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The FIREBIRD SI Fusion System (formally SambaScrew 3D SI Fusion System) is a temporary multiple component system consisting of non-sterile instruments, sterile 11mm and 12mm FIREBIRD SI Screws and non-sterile 9mm FIREBIRD SI Screws. The FIREBIRD SI Screws are manufactured from medical-grade titanium alloy (Ti-6AI-4V ELI) with lengths ranging from 25mm to 70mm.

The 11mm FIREBIRD SI Screw is a cannulated screw featuring multiple fenestrations along the shaft, with a tapered proximal end and dual-pitch threads. The 12mm FIREBIRD SI Scew is a cannulated screw featuring multiple fenestrations along the shaft, with a single pitch thread on the proximal and distal ends. The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The 9mm FIREBIRD SI Screw features multiple fenestrations along the shaft and maintains a single pitch thread along the proximal and distal ends of the screw.

The FIREBIRD SI Fusion System allows for packing of autograft and allograft materials.

This document is a 510(k) premarket notification for the Orthofix FIREBIRD SI Fusion System. It primarily addresses the addition of nano-scale descriptors to the device labeling and explicitly states that the device's technological characteristics, performance data, and other critical aspects remain unchanged since its prior clearance (K200696). Therefore, there is no new study or new acceptance criteria presented in this document for the FIREBIRD SI Fusion System itself.

The document refers to studies from a predicate device (K200052 – Orthofix Inc. – PTC Systems) to support the nano-surface descriptors. These studies focused on surface characterization and in vitro cellular studies to demonstrate increased proliferation and alkaline phosphatase activity in human stem cells with the PTC modified surface.

Since the core device is unchanged and no new performance studies for the FIREBIRD SI Fusion System are detailed in this 510(k) submission, a table of acceptance criteria and reported device performance directly from this document cannot be created for the FIREBIRD SI Fusion System in the way requested. Instead, I will summarize the information provided regarding the reliance on prior clearances and the nature of the supporting data for the nano-surface descriptors.

Summary regarding Acceptance Criteria and Study for FIREBIRD SI Fusion System (K201664):

This 510(k) submission (K201664) for the FIREBIRD SI Fusion System does not introduce new acceptance criteria for the device's overall function or new studies to demonstrate its performance. The submission's purpose is to add nano-scale descriptors to the labeling.

The document explicitly states:

• "The technological characteristics of the FIREBIRD SI Fusion System are unchanged since the prior clearance K200696."
• "The performance data of the FIREBIRD SI Fusion System are unchanged since the prior clearance K200696. No new mechanical testing was performed for the FIREBIRD SI Fusion System as there are no design changes to the device."
• "The previously cleared indications for use, intended use, design, specifications, contraindications, warnings or precautions remain the same as previously cleared under K200696."

Therefore, the acceptance criteria and supporting studies for the overall device performance would be found in the K200696 submission.

However, the submission does refer to data used to support the nano-surface descriptors, which were previously cleared under predicate K200052. The details on this specific aspect are provided below, but it's important to note these studies are not for the overall performance of the FIREBIRD SI Fusion System as a fusion device, but rather for a specific material characteristic.

1. Table of acceptance criteria and the reported device performance

As no new performance data or acceptance criteria are presented for the FIREBIRD SI Fusion System in this 510(k) submission (K201664), a direct table cannot be provided. The submission relies on prior clearances.

However, regarding the nano-surface descriptors, which is the focus of this particular 510(k) (K201664):

Note: These are derived from the limited information provided in K201664, which heavily references prior 510(k)s (K200696 for the device itself and K200052 for the nano-surface technology). Full details would be in those respective submissions.

Supporting Information for the nano-surface descriptors (based on referenced K200052):

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified in this document. It refers to "in vitro cellular studies using HMSCs and normal human osteoblasts (NHOst) cells." The number of cells, replicates, or experiments is not detailed.
• Data Provenance: In vitro cellular studies. Country of origin not specified, but typically lab-based studies for medical device material properties are conducted by the manufacturer or a contract research organization. Retrospective or prospective is not applicable as it's a lab study, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Experts: Not applicable for in vitro cellular studies. The "ground truth" for such studies would be the objective measurements of cellular activity (proliferation, enzyme activity) quantified by laboratory equipment and interpreted by scientific personnel.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable for in vitro cellular studies. Data would be analyzed statistically, and results would be based on predefined scientific protocols and statistical significance.

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:

• MRMC Study: No. This is an orthopedic implant for physical fixation and fusion, supported by mechanical and in vitro cellular studies. It is not an AI-assisted diagnostic device.

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

• Standalone Performance: Not applicable. This is an implanted medical device, not a software algorithm.

7. The type of ground truth used:

• Ground Truth: For the in vitro cellular studies referenced (from K200052), the "ground truth" would be the quantified biological responses of human stem cells and osteoblasts (e.g., cell counts for proliferation, enzymatic assay readings for alkaline phosphatase activity).

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is an experimental study for material characterization and biological response, not a machine learning model requiring a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned.

Ask a specific question about this device