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4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

4CIS® Marlin ACIF cages are hollow, generally rectangular box shape made either from poly-ether-ether-ketone [PEEK-OPTIMA® LT1 (Invibio, Inc., West Conshohocken, PA USA) / VESTAKEEP® i4R (Evonik Industries, Essen Germany)] or Titanium alloy according to ASTM F2026(PEEK), F136(64ELI), F560(Tantalum). The cages are available in a variety of sizes and geometric options to fit the anatomical needs of a wide variety of patients. The device is filled with a bone graft material and inserted into the intervertebral body space of the cervical spine through an anterior cervical approach. As the design requirements, this cage design maintains the spacing between two vertebral bones following discectomy until fusion occurs. Each PEEK cage has three(3) x-ray markers made of tantalum for ease of visualization on the radiographs. Angled shape for lordotic curve and anatomic shape is available to allow maximum preservation of bony endplate with this system and teeth on the surfaces ensure enough contact with bony endplate, which prevents subsidence of the cage into the vertebral body when the teeth increase the anchoring and prevent slipping or expulsion.

This is a medical device 510(k) summary for the "4CIS® Marlin ACIF Cage System," an intervertebral body fusion device. The document describes the device, its intended use, and its comparison to predicate devices for substantial equivalence.

Here's an analysis of the provided text for acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance usually seen in AI/software studies (e.g., sensitivity, specificity, AUC). Instead, it focuses on mechanical performance for this implantable device. The "Performance Specification" section states:

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

This document describes a mechanical device, not an AI/software product requiring a "test set" of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country, retrospective/prospective) are not applicable in the context of this medical device submission. The performance data comes from laboratory mechanical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As this is a mechanical device submission, there is no mention of experts establishing ground truth for a test set in the way it would be for an AI diagnostic algorithm. Ground truth here refers to the physical properties and performance of the device under mechanical stress, evaluated against established ASTM standards.

4. Adjudication Method for the Test Set

Again, this is not applicable as there is no "test set" in the context of clinical interpretation by experts. Mechanical testing results are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and AI assistance. This submission pertains to an implantable surgical device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical intervertebral cage, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by Mechanical Testing Standards (ASTM F2077 and ASTM F2267). This involves objective measurements of physical properties like static and dynamic compression, torsion, subsidence, and expulsion, compared against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI model requiring a training set. The device's design and manufacturing processes are developed through engineering and material science, not machine learning training.

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

Not applicable. See point 8.

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