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The golden gate™ anterior plate system is intended to provide stabilization during the development of a spinal fusion. The golden gate™ System is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of: DDD (back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), Spondylolisthesis, Spondylolysis, Fracture (including dislocation or subluxation), Spinal stenosis, Deformities (i.e., scoliosis, kyphosis, lordosis), Tumor, Pseudarthrosis, Revision of previous surgery.

The golden gate™ anterior plate system is used for the surgical stabilization and fixation of the thoracolumbar spine to provide a suitable environment for fusion to occur. The fixation components of the system include plates, screws and connectors (hex nuts and inlays). These are available in a variety of sizes and lengths to accommodate differing patient anatomy.

The provided text describes a 510(k) premarket notification for a medical device called the "golden gate™ System," a spinal intervertebral body fixation orthosis. The notification focuses on establishing substantial equivalence to previously cleared predicate devices through performance data, specifically mechanical testing.

Here's an analysis of the acceptance criteria and study information based on your request:

1. Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria (e.g., minimum load bearing capacity in Newtons, or maximum displacement in millimeters). Instead, it relies on a comparative standard: performing as well as or better than the predicate devices when tested against the ASTM F1717 standard. This is a common approach for 510(k) submissions demonstrating substantial equivalence.

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

• Sample Size: The document does not specify a numerical sample size for the "worst case golden gate™ construct" tested. It refers to a "worst case" construct, implying that representative configurations of the device were tested. For mechanical testing, this typically involves a limited number of samples for each configuration to demonstrate compliance with a standard.
• Data Provenance: The study was a prospective mechanical laboratory study. The document does not provide details on the country of origin of the data beyond the sponsor being a German company (ulrich GmbH & Co. KG) with a US subsidiary (ulrich medical USA, Inc.). The testing was performed in accordance with ASTM F1717, an international standard.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable to this submission. The device is a mechanical implant, and its performance is evaluated through objective mechanical testing against a recognized standard (ASTM F1717), not through subjective interpretation by human experts or clinical ground truth.

4. Adjudication Method for the Test Set

This section is not applicable. The "test set" in this context refers to the physical devices undergoing mechanical stress tests. There is no human adjudication involved in interpreting these objective mechanical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable. An MRMC study is relevant for diagnostic devices or AI systems where human reader performance is being evaluated or compared. This submission pertains to a surgical implant, and its effectiveness is determined by mechanical stability and successful fusion, not diagnostic accuracy.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This section is not applicable. The "golden gate™ System" is a physical medical device (spinal implant), not a software algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective mechanical test results directly measured during the tests (e.g., load-to-failure, displacement, fatigue cycles) compared against the benchmark performance of predicate devices as per the ASTM F1717 standard.

8. Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This section is not applicable, as there is no training set for this device.

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