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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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