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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

When used as a cervical intervertebral body fusion device, 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 PTC Spacer System in the cervical spine.

When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Minn 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 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 comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with titanium markers 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 Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PEEK Spacer System must be used with a supplemental fixation system.

The provided document is a 510(k) Premarket Notification from the FDA for the CONSTRUX Mini PEEK Spacer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive clinical trials with an explicit set of acceptance criteria based on device performance in human subjects.

Therefore, the document does not contain the information requested in points 1-9 regarding a study that proves the device meets specific acceptance criteria related to its performance in a clinical setting (e.g., accuracy, diagnostic performance, or human reader improvement with AI assistance).

The "Performance Testing Summary" section indicates that the device was evaluated via mechanical testing (ASTM F2077 and ASTM F2267) to demonstrate substantial equivalence, not clinical performance. These tests assess the physical properties and structural integrity of the implant.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance related to a clinical study.
2. Sample sizes for a test set, data provenance, or details about the retrospective or prospective nature of data.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication methods for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes for human readers.
6. Results of a standalone algorithm-only performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data) for clinical evaluation.
8. Sample size for a training set (as this is not an AI/ML device that requires distinct training and test sets in the traditional sense).
9. How ground truth for a training set was established.

This 510(k) submission primarily relies on bench testing and comparison against predicate devices to establish substantial equivalence for market clearance, rather than the kind of clinical performance study details requested in your prompt.

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CONSTRUX Mini PEEK Spacer System

When used as a cervical intervertebral body fusion device, 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 with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) 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 replaced 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 CONSTRUX Mimi PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

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.

The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.

CONSTRUX Mini PEEK Ti Spacer System

The CONSTRUX Mini PEEK 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 PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

CONSTRUX Mini PEEK Spacer System:

The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in onemillimeter increments. The superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.

CONSTRUX Mini PEEK Ti Spacer System:

The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implant. The implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

This is a 510(k) submission for a medical device (CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a performance study of a diagnostic AI device. Therefore, much of the requested information about acceptance criteria, study design, and AI-specific metrics is not applicable to this document.

However, I can extract the relevant information regarding the basis for substantial equivalence and the "performance data" presented, which primarily focuses on mechanical testing related to the device's physical properties or reference to existing clinical data, rather than a clinical study evaluating diagnostic accuracy.

Here's the breakdown of what can be derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present a table of acceptance criteria and reported device performance in the context of a diagnostic study with specific metrics like sensitivity, specificity, or AUC. The "performance data" refers to the lack of need for new mechanical or clinical testing due to the nature of the submission (expanded indications for an unchanged device substantially equivalent to a predicate).

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This is not a study assessing the performance of a diagnostic device on a test set. The submission is for an intervertebral body fusion device and focuses on substantial equivalence based on material, design, and intended use.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. There is no diagnostic test set with ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. There is no diagnostic test set.

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

Not applicable. This document is not about a diagnostic AI device and does not involve human readers interpreting images with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This document is for a physical medical implant, not a standalone algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no diagnostic study with a ground truth.

8. Sample Size for the Training Set:

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of "Performance Data" from the Document (as it relates to the device):

The document explicitly states:

• Mechanical Testing: "No changes have been made to the actual implants and therefore no mechanical testing was performed to help determine substantial equivalence." This implies that prior mechanical testing results for the original CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System, or the predicate device (Valeo Spacer System), were deemed sufficient and applicable due to no design changes to the implants themselves.
• Clinical Testing: "Published clinical data for the cervical interbody fusion devices similar to the CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System, implants was provided in support of this application. The published clinical outcomes demonstrated that the use of PEEK interbody devices for one or two contiguous levels in anterior cervical fusion procedures, as defined above, poses no new or additional risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional clinical testing was required or performed."

Key Takeaway from the FDA Letter:

The FDA's review for K150619 is a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is different from a PMA (Premarket Approval) which often requires extensive clinical trials to prove safety and effectiveness for novel devices.

The "acceptance criteria" here are aligned with the criteria for demonstrating substantial equivalence to a predicate device (K142264 - Valeo Spacer System and K142152 – CONSTRUX Mini PEEK Spacer System and CONSTRUX Mini PEEK Ti Spacer System). The "study that proves the device meets the acceptance criteria" is the comparison to the predicate device and reference to existing data, rather than a new, independent performance study with specific metrics. The claim is that because the device has not changed in design and has similar intended use and technological characteristics to already cleared devices, it poses no new or additional risks.

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CONSTRUX Mini PEEK Spacer System

When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with desc 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 and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g.: the Ascent™ or Ascent LE™ POCT System.

Patients must have undergone a regimen of at least six (6) 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 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 CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

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.

The CONSTRUX Mini PEEK Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the CONSTRUX Mini PEEK Spacer System is the Orthofix Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.

CONSTRUX Mini PEEK Ti Spacer System

The CONSTRUX Mini PEEK Ti Spacer 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 CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Cervical Stand Alone System

The 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 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 (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

CONSTRUX Mini PEEK Spacer System:

The CONSTRUX Mini PEEK Spacer System is comprised of a variety of implants manufactured from PEEK and with titanium markers. The implants are available in two footprint sizes, a small and a large. The implants are available in various heights, in one-millimeter increments. The superior and inferior surfaces of the implant have a pattern of ridges to provide increased stability and help prevent anterior/posterior movement of the device.

CONSTRUX Mini PEEK Ti Spacer System:

The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The superior and inferior Titanium plate surfaces of the implant provide increased stability for the implants are available in three footprint sizes and various heights. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

Cervical Stand Alone System

The Cervical Stand Alone Spacer system is designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Cervical Stand Alone spacer is manufactured from PEEK and Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.

This document is a 510(k) premarket notification for the CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, and Cervical Stand Alone System. It primarily addresses expanded indications for use, specifically the inclusion of allograft bone.

Based on the provided text, there is no acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML powered medical device. The document is for a medical implant (intervertebral body fusion device) and discusses its substantial equivalence to predicate devices, focusing on materials, design, and indications for use.

Therefore, most of the requested information regarding AI/ML device performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.

However, I can extract information related to the clinical data that supported the expanded indication:

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

• Not Applicable. The document does not define specific performance acceptance criteria for an AI/ML device. It discusses the "substantial equivalence" of the implant system to predicate devices based on design, materials, and intended use, and the safety of using allograft bone.

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

• Sample Size: Not explicitly stated. The document refers to "Published retrospective clinical data," not a specific test set with a defined sample size for this submission.
• Data Provenance: The data was "Published retrospective clinical data." The country of origin is not specified but implicitly relates to the use of similar cervical interbody fusion devices.

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. No ground truth establishment by experts for a specific test set is mentioned in the context of this 510(k) submission. The clinical data referred to supports the safety of using allograft bone.

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

• Not Applicable. No adjudication method is mentioned.

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 is for a physical medical implant, not an AI/ML device, so an MRMC study related to AI assistance is irrelevant here.

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

• Not Applicable. This document is for a physical medical implant, not an AI/ML device.

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

• Not Applicable in the context of an AI/ML ground truth. However, the "Published retrospective clinical data" would have relied on clinical outcomes data related to spinal fusion procedures and the use of allograft. The "outcomes demonstrated that the use of allograft... poses no new risks to patients."

8. The sample size for the training set:

• Not Applicable. No training set is mentioned as this is not an AI/ML device submission.

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

• Not Applicable. No training set or ground truth establishment for a training set is mentioned.

In summary, this 510(k) submission focuses on the substantial equivalence of a spinal implant system with expanded indications for use (specifically regarding bone graft material), rather than the performance of an AI/ML powered device.

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When used as a cervical intervertebral body fusion device, the Construx Mini PEEK 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 Construx Mini PEEK System is intended for use with autograft and supplemental internal fixation, e.g.: the Blackstone Medical Ascent™ or Ascent LETM POCT System.

Patients must have undergone a regimen of at least six (6) weeks of non-operative r attention masterial with the Construx Mini PEEK System in the cervical spine.

The Construx Mini PEEK device is used singly and is implanted using an anterior approach.

When used as a Partial Vertebral Body Replacement (VBR) System, the Construx Mini When used as i Parliated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised replacement of tumors, to achieve anterior decompression of the spinal cord and for the treatment of tumors, to active an arrest aponed vertebral body. The Construx Mini neural issues, and to restore the freigen in a fractures of the thoracic and lumbar spine.

The Construx Mini PEEK System is designed to restore the biomechanical integrity of the The Collistian Minn I EEIN Bysterior spinal column even in the absence of fusion for a prolonged amenor, inidate, and posterier epinal se is intended to be used with autograft or allograft.

The Construx Mini PEEK System is intended for use with internal fixation. The The Collstux Internal fixation system that may be used with the Construx Mini PEEK System is the Blackstone Medical Spinal Fixation System (SFS) or the Firebird Spinal Fixation System.

The Construx Mini PEEK Spacer System components consist of:

1. A PEEK Spacer 2) cp Titanium Markers

The Construx Mini Spacer System is a Cervical IBFD device that is implanted using anterior surgical approach with the intention is to achieve intervertebral spinal fusion. In addition, the Construx Mini is intended to contain autologous bone graft to facilitate intervertebral fusion. The Construx Mini performance data, in combination with a dimensional comparison to predicate devices and testing, has been used to demonstrate substantial equivalence with devices that are cleared for both Cervical IBFD and Partial VBR indications.

Here's a breakdown of the acceptance criteria and the study information for the Blackstone Construx Mini PEEK Spacer System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria (Implied):

The document implicitly states that the acceptance criteria for the mechanical tests (Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, and Subsidence) were adherence to the specified ASTM standards (ASTM F2077-03 and ASTM F2267-04). For a 510(k) submission, meeting these recognized standards is a primary way to demonstrate safety and effectiveness for mechanical performance. The ultimate acceptance criterion is substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for the mechanical tests. However, these types of tests (Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, and Subsidence) typically involve a statistically relevant number of physical devices or representative constructs as per the ASTM standards.
• Data Provenance: The data is from mechanical testing of the device components. It is not patient or clinical data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" do not apply in the context of this specific regulatory submission, which focuses on device design and mechanical performance for substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the "test set" here refers to physical devices undergoing mechanical engineering tests, not a clinical dataset requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods are relevant for clinical studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This 510(k) submission is for a medical device (spinal implant), and the provided text describes mechanical testing and a comparison to predicate devices, not a clinical study involving human readers and AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical spinal implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by engineering standards and direct measurement of mechanical properties. The performance of the Construx Mini PEEK Spacer System was evaluated against the requirements outlined in ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Device Static and Dynamic Cyclic Compression Shear and Torsion Testing) and ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression).

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The testing described is verification and validation of the physical device's mechanical properties.

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

This information is not applicable for the reasons stated above.

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