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The Spine360 Stingray Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to T1 disc levels using autograft bone. The Spine 360 Cervical Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Stingray Cervical Cage was developed as an intercorporal implant for anterior cervical spondylosis. Stingray is a system of wedge-shaped implants and instruments designed for anterior cervical interbody fusion (ACF). In the lateral view, the implant has a 3.5° lordotic form. The Stingray Cervical Cage has a flat top and bottom. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Spine 360 Cervical Interbody Fusion System (K122085), framed according to your requested information.

Please note that this is a medical device submission, not an AI/software device. Therefore, many of the requested fields related to AI performance, human readers, training sets, and ground truth in the context of an algorithm will not be applicable or will need to be reinterpreted in the context of a physical device.

Acceptance Criteria and Study for Spine 360 Cervical Interbody Fusion System (K122085)

This device is a physical medical implant (interbody fusion system) and not an AI or software-based medical device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical and material properties, not algorithmic accuracy or human reader improvement. The "study" refers to non-clinical (mechanical) testing based on ASTM standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating mechanical equivalence or superiority to predicate devices and meeting established biomechanical tissue tolerances for the cervical spine. The performance is reported as meeting or exceeding these criteria.

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

• Test Set Sample Size: The document does not specify the exact number of devices tested for each mechanical test. However, standards like ASTM F2077-11 typically require a minimum number of samples for statistically valid testing (e.g., 5-6 samples per test group). The tests are conducted on manufactured devices, not human data.
• Data Provenance: The data is generated from non-clinical (laboratory) mechanical testing of the physical device. It is not patient data, nor does it have a country of origin in that sense. It's a prospective testing design to evaluate the device against established engineering standards.

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

• This question is not applicable to a physical medical device. "Ground truth" in this context refers to established engineering standards (ASTM standards) and biomechanical properties of the human spine. The "experts" would be the engineers and scientists who developed these standards and conducted the testing, not clinical experts establishing ground truth from patient data.

4. Adjudication Method for the Test Set

• This question is not applicable as there is no human interpretation or adjudication of test results in the clinical sense. The results of the mechanical tests are quantitative measurements against predefined criteria in the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

• This device is a physical medical implant, not an AI or software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

• This device is a physical medical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance relies on established engineering standards (ASTM F2077-11, F2267-04) and recognized biomechanical properties and tolerances of the human cervical spine. The objective is to ensure the device's mechanical integrity and safety when implanted.

8. The Sample Size for the Training Set

• This device is a physical medical implant, not an AI with a training set. Therefore, this question is not applicable.

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

• This device is a physical medical implant, not an AI with a training set. Therefore, this question is not applicable.

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