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The Cervical Spine Truss System – Stand Alone (CSTS-SA) Interbody Fusion Device is a standalone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws which accompany the device. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment with the devices.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

The provided text is a 510(k) summary from the FDA for a medical device called the Cervical Spinal Truss System-Stand Alone (CSTS-SA). It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove performance against specific acceptance criteria for an AI/software device.

Therefore, many of the requested categories for AI/software device studies are not applicable or cannot be extracted from this document, as this is a hardware device submission.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in the typical sense for an AI/software device (e.g., sensitivity, specificity, AUC thresholds). Instead, it refers to performance standards for a physical medical implant.

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

Not applicable for this type of device and submission. The "test set" would refer to the physical devices tested according to the ASTM standards. The document doesn't provide details on the number of devices or units tested for each standard. Data provenance is not relevant in the context of device mechanical testing.

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

Not applicable. Ground truth, in this context, would be the physical properties and structural integrity of the device, established through standardized engineering tests, not expert human review of data.

4. Adjudication method for the test set

Not applicable. Testing is based on objective measurements against engineering standards.

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 is a physical interbody fusion device, not an AI/software product that assists human readers.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

The "ground truth" for the device's performance is established by the specified ASTM and industry standards for mechanical and MR conditional testing. Compliance with these standards indicates the device performs as expected for its intended physical function.

8. The sample size for the training set

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

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

Not applicable.

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