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The NEXXT MATRIXX® Stand Alone Cervical System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical System is intended to be used with the bone screw fixation provided and requires no additional fixation.

NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone Cervical System includes additively manufactured spacer and traditionally machined fixation screw implants. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have 300-700µm pores. The inferior/superior aspects of the spacer incorporates a vertical cavity which can be packed with bone graft material. Each fixation screw is preassembled to a locking collet which secures the spacer and screw components.

This FDA 510(k) summary is for the NEXXT MATRIXX® Stand Alone Cervical System, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of technological characteristics, rather than clinical performance or diagnostic accuracy. Therefore, many of the requested categories related to clinical study design and performance metrics (like sensitivity, specificity, or human reader improvement with AI) are not applicable or detailed in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical performance and technological characteristics. The document implies that the device's performance should be comparable to or exceed that of the predicates in relevant mechanical tests.

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

• Sample Size: The document does not specify a "sample size" in terms of patient numbers, as the primary testing described is mechanical. For mechanical testing, the "samples" would be individual devices or components tested. The exact number of devices tested for each mechanical test is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical patient data. The mechanical testing would have been conducted in a laboratory setting.

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

Not applicable. This device is an implantable medical device, and its approval is based on mechanical performance and design specifications, not on expert interpretation of diagnostic images or clinical outcomes that require ground truth establishment by experts in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of expert review for diagnostic ground truth. The mechanical testing results would be compared against predefined standards (ASTM standards and predicate device performance).

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

No. This is a medical implant, not a diagnostic AI device requiring an MRMC study to compare human reader performance with and without AI assistance.

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

Yes, in the sense that the mechanical tests represent the "standalone" physical performance of the device without human intervention during its function in the body. The tests evaluate the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• ASTM Standards: F2267 (for intervertebral body fusion devices) and F2077 (for intervertebral body fusion device static and dynamic compression shear tests), which set objective mechanical performance requirements.
• Predicate Device Performance: The mechanical performance and technological characteristics (intended use, design, materials, sizes) were assessed for "substantial equivalence" to a primary predicate (Vertu by Spinal Elements, Inc. - K181837) and several additional predicate devices. The performance of these cleared devices establishes a benchmark for safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set.

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