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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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