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Matisse Anterior Cervical Interbody Fusion Cage 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. Matisse Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. Matisse Anterior Cervical Interbody Fusion Cage system is to be used with supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

Matisse Anterior Cervical Interbody Fusion Cage system intended for use as an . interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA®LTlwith marker pins made of Tantalum (ASTMF 560).

The provided document is a 510(k) summary for the Matisse Anterior Cervical Interbody Fusion Cage system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the format of a clinical trial for a novel AI or diagnostic device.

Therefore, many of the requested categories for AI/diagnostic device studies (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of submission.

The "study" in this context refers to non-clinical (mechanical) testing used to demonstrate the device's physical properties are equivalent to devices already on the market.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic AI. Instead, it demonstrates performance by showing the device meets established ASTM standards for interbody fusion cages.

• ASTM F 2077: Specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing.
• ASTM F 2267: Specifically, Static Subsidence testing under Axial Compression.
  The document asserts that "the non-clinical testing conducted on the Lexus predicate [is] applicable to represent the Matisse Anterior Cervical Interbody Fusion Cage system." |
  | Design, materials, and intended use are identical or similar to legally marketed predicate devices. | The Matisse Anterior Cervical Interbody Fusion Cage system is stated to be "exactly identical" to the Lexus Cervical Intervertebral body Fusion Cage System (K120840) and "substantially equivalent" to several other predicate devices regarding design, sizes, manufacturing process, materials (PEEK-OPTIMA® LTi with Tantalum marker pins), and intended use. |

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable in the context of an AI/diagnostic device's test set. For mechanical testing, this refers to the number of physical devices or components tested. The document does not specify the exact number of units tested for each ASTM standard, but implies a sufficient number were tested to satisfy the standards.
• Data Provenance: Not applicable for an AI/diagnostic device's data provenance. The testing was conducted for the Lexus Cervical Intervertebral body Fusion Cage System (K120840) and considered applicable to the Matisse system due to their identical nature. The location of the testing laboratories is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical implant, not an AI or diagnostic device requiring expert interpretation of outputs or ground truth establishment in this manner.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is relevant for studies involving human interpretation or labeling, which is not the case for mechanical testing of an implantable device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This describes an MRMC study for AI/diagnostic devices, which is irrelevant to a spinal implant's 510(k) submission based on substantial equivalence and mechanical testing.

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

Not applicable. This concept applies to AI algorithms, not physical medical devices like the Matisse Anterior Cervical Interbody Fusion Cage system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is compliance with established ASTM mechanical testing standards (F 2077 and F 2267), which define acceptable physical and mechanical properties for intervertebral body fusion devices.

8. The sample size for the training set

Not applicable. This pertains to AI/machine learning models, not physical devices.

9. How the ground truth for the training set was established

Not applicable. As above, this is for AI/ML models.

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