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The Spineway Blue Mountain Cervical Plate System is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Spineway Blue Mountain Cervical Plate System is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

The Spineway Blue Mountain Cervical Plate System that includes titanium alloy (per ASTM F136 and ISO 5832-3) plates and screws that are intended to stabilize the spine during the fusion process. The plates and screws are available in various sizes to accommodate patients' anatomy. The plates are contoured to follow the curves of the cervical spine.

Based on the provided text, the document is a 510(k) summary for the Spineway Blue Mountain Cervical Plate System. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data like one would expect for an AI/ML medical device.

Therefore, the information required to populate the requested table and answer the study-related questions is not present in this document. The document explicitly states:

• "Spineway determined that the changes made to the device did not present a new worst case, and therefore, no new testing was conducted." (Page 4)

This indicates that no new performance data or studies were performed for this particular 510(k) submission to demonstrate the device meets specific acceptance criteria. Instead, the submission relies on the substantial equivalence to a predicate device, which would have had its own performance data and acceptance criteria established during its clearance process.

Here's a breakdown of why the requested information cannot be extracted from this document, followed by what could be inferred about the predicate device if it were an AI/ML device (which it is not in this case):

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

• Not Available: The document states "no new testing was conducted." Thus, there are no reported device performance metrics against specific acceptance criteria for this K150036 submission.

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

• Not Available: No new test sets were used as no new testing was conducted.

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

• Not Available: No new test sets or ground truth establishment processes are described.

4. Adjudication method for the test set:

• Not Available: No new test sets are described.

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 device (Cervical Plate System) is a physical implant, not an AI/ML diagnostic or assistive device, so MRMC studies are not relevant.

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

• Not Applicable: This is a physical device, not an algorithm.

7. The type of ground truth used:

• Not Applicable: For an implantable device like a cervical plate, "ground truth" as typically discussed for AI/ML devices is not relevant. Its performance is assessed through biomechanical testing, material properties, and clinical outcomes.

8. The sample size for the training set:

• Not Applicable: This is a physical device, not an AI/ML model, so there is no "training set."

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

• Not Applicable: This is a physical device, not an AI/ML model.

Summary based on the provided text:

The document focuses on demonstrating that the "Blue Mountain Cervical Plate System" is substantially equivalent to a previously cleared predicate device (Qualgenix Blue Mountain Cervical Plate System, K112809). The equivalence is based on materials, screw type, screw diameters, screw locking mechanism, and the fact that new plate sizes and instruments for the current device did not introduce new worst-case scenarios, negating the need for new performance testing.

Therefore, this document does not contain the information requested about acceptance criteria and study data for the device's performance, as no such new studies were part of this 510(k) submission.

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