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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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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 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.

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 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.

The CONSTRUX Mini PEEK Ti Spacer System is not intended to be used as a stand-alone device. The CONSTRUX Mini PEEK Ti Spacer System must be used with supplemental fixation. The CONSTRUX Mini PEEK Ti implants are provided sterile.

The CONSTRUX Mini PEEK Ti Spacer System is a medical device. The information provided does not describe a study involving artificial intelligence (AI) or machine learning. Instead, it details the regulatory submission (510(k)) for a physical medical implant. Therefore, the questions related to AI/ML performance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this document.

The document focuses on demonstrating that the CONSTRUX Mini PEEK Ti Spacer System is substantially equivalent to previously cleared predicate devices based on its design, materials, and mechanical performance.

Below is the relevant information extracted from the provided text, adapted to the requested format where applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to predicate devices through mechanical testing standards. The reported device performance indicates that these standards were met.

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

The document describes non-clinical mechanical testing of the device prototypes, not a study involving a test set of data in the context of AI/ML.

• Sample Size: The document does not specify the exact number of units tested for each mechanical test (e.g., how many spacers were subjected to torsion tests). This information is typically found in detailed test reports, not summary submissions.
• Data Provenance: Not applicable. The "data" refers to the results of in vitro mechanical tests conducted on the physical device, not patient data from a specific country or collected retrospectively/prospectively.

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

This question is not applicable as the submission pertains to a physical medical device and its mechanical performance, not an AI/ML model where "ground truth" is established by human experts reviewing medical data. The "ground truth" for mechanical testing is defined by the performance standards themselves (e.g., ASTM F2077-11 requirements).

4. Adjudication Method for the Test Set

This question is not applicable as the submission pertains to mechanical testing of a physical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML ground truth establishment, not for non-clinical engineering tests.

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

This question is not applicable. The submission is for a physical medical implant and focuses on demonstrating substantial equivalence through mechanical testing, not on assessing human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the document describes a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the CONSTRUX Mini PEEK Ti Spacer System's performance is established by the requirements and methodologies outlined in the referenced ASTM standards (ASTM F2077-11 and ASTM F2267-04). These standards define the acceptable mechanical properties and behaviors (e.g., static and dynamic strength, subsidence resistance) that an intervertebral body fusion device must demonstrate. The device is considered to meet the "ground truth" if its test results comply with these engineering standards and demonstrate equivalence to predicate devices that have already met these standards.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device, not an AI/ML model that requires a training set.

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

This question is not applicable as the document describes a physical medical device, not an AI/ML model.

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