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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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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.

Cervical Stand Alone system is designed to provide the biomechanical strength to a traditional or minimal invasive ACDF procedure with less disruption of patient anatomy and preserve the anatomical profile. The Cervical Stand Alone system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability. Cervical Stand Alone is a hybrid PEEK (ASTM F-2026) and Titanium (Ti-6Al-4V) spacer which incorporates Titanium Bone Screws (Ti-6Al-4V) and a Titanium Cover Plate (Ti-6Al-4V). The Cervical Stand Alone spacers are designed with a zero anterior profile and are implanted using an anterior approach.

The provided document describes a medical device, the "Cervical Stand Alone System," and its premarket notification (510(k)) for FDA clearance. However, this document does not contain information about the acceptance criteria or a study proving the device meets the acceptance criteria in the context of an AI/ML medical device.

The document primarily focuses on:

• Regulatory Clearance: It's an FDA 510(k) clearance letter for a Class II medical device (intervertebral body fusion device).
• Device Description: Details about the Cervical Stand Alone System, its materials (PEEK, Titanium), and its intended use for spinal fusion in the cervical spine for patients with degenerative disc disease.
• Predicate Devices: It compares the device to previously cleared predicate devices (K142152 and K150619) to establish substantial equivalence.
• Performance Data (Non-Clinical): It mentions mechanical testing (Static and Dynamic Axial Compression Test, Static Torsion Test, Static Compression Shear Test, Subsidence Test, and Expulsion Test) conducted according to ASTM standards (F2077-14, F2267-04, and ASTM Draft Standard F-04.25.02.02).

There is no mention of:

• An AI/ML component.
• Acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A clinical study involving human readers or AI assistance.
• Ground truth establishment in the context of diagnostic performance.
• Training or test set sizes for an AI model.

Therefore, I cannot populate the requested table and answer the specific questions related to AI/ML device performance and testing. The document describes a traditional medical device's mechanical and material performance testing for regulatory clearance, not the performance of an AI-powered diagnostic or assistive tool.

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