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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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The Qualgenix Blue Mountain Cervical Plate is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Qualgenix Blue Mountain Cervical Plate 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 with degeneration of the disc), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, 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 Qualgenix Blue Mountain Cervical Plate is a system that includes titanium alloy (ISO 5832-3) plates and screws that are intended to stabilize the spine during the interbody fusion process.

The provided text describes a 510(k) summary for the Qualgenix Blue Mountain Cervical Plate, a spinal fixation device. However, this document does not describe an AI medical device or a study involving AI performance. It details a traditional medical device submission, focusing on substantial equivalence to predicate devices through material and mechanical testing.

Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies cannot be extracted from this document, as it pertains to a different type of medical device evaluation.

Below is a partial response based on the information that is available, specifically for mechanical testing.

Acceptance Criteria and Study for Qualgenix Blue Mountain Cervical Plate

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing indicates the device is "substantially equivalent to predicate devices" and was performed "per ASTM F1717-10". This implies that the device's performance results met or exceeded the established benchmarks derived from the predicate devices under the specified ASTM standard.

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

This information is not provided in the document. For mechanical testing, sample sizes would refer to the number of physical devices or components tested. The document does not specify these numbers or the provenance of any data beyond indicating "testing performed on this device."

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

This is not applicable to this type of device and study. The study involves mechanical performance testing against an ASTM standard, not clinical data requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and study. Mechanical tests follow predefined protocols and objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. This study concerns the mechanical equivalence of a spinal implant, not the diagnostic or interpretative performance of an AI system or human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical performance study, the "ground truth" or benchmark was established by testing per ASTM F1717-10 and demonstrating substantial equivalence to predicate devices. This means the performance of the predicate devices under this standard served as the reference.

8. The Sample Size for the Training Set

This is not applicable as this study does not involve an AI algorithm or a "training set" in the context of machine learning.

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

This is not applicable as this study does not involve an AI algorithm or a "training set."

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