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The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The ORION® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy, with certain subcomponents manufactured from shape memory alloy (Nitinol - Niti). The devices may be supplied either sterile or non-sterile. The purpose of this 510(k) is to include modified plates to the ORION® Anterior Cervical Plate System.

This 510(k) summary for the ORION® Anterior Cervical Plate System focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one would for a novel AI/software medical device.

Therefore, much of the requested information (like expert qualifications, adjudication methods, multi-reader studies, standalone performance, and training set details) is not applicable or present in this type of submission. This document pertains to a physical medical device (an anterior cervical plate system) and its modifications, not a software algorithm.

However, I can extract the relevant information that is present:

1. Table of "Acceptance Criteria" and Reported Device Performance:

For a physical device modification like this, "acceptance criteria" are typically related to mechanical performance, biocompatibility, and substantial equivalence to a predicate device. The "reported device performance" is a demonstration that these criteria are met through testing or comparison.

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

This document does not describe a clinical study with a "test set" in the context of AI/software performance. Instead, the "test set" would refer to mechanical testing or material characterization samples. The document does not specify the sample sizes for these tests. Data provenance is not described in detail, but it would typically originate from in-vitro biomechanical testing laboratories.

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

Not applicable. For a physical device, "ground truth" would be established by engineering specifications, material and mechanical properties testing, and clinical outcomes of the predicate device. These typically do not involve a "number of experts" in the same way an AI diagnostic study would.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically for evaluating human or AI interpretations of data. For a physical device, compliance is determined by meeting engineering standards and comparative data to predicates.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, this type of study was not done. An MRMC study is relevant for comparing diagnostic performance, often involving human readers with and without AI assistance. This submission is for a physical implant.

6. If a Standalone (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:

The ground truth used for this submission is substantial equivalence to legally marketed predicate devices. This is established by comparing:
* Materials (Titanium alloy, Nitinol)
* Intended Use
* Design principles (anterior cervical plate for interbody screw fixation)
* Performance (implied through risk analysis and comparative data, likely mechanical testing data)
* Safety profile (implied by equivalence to predicates)

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical device.

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

Not applicable. No training set for an AI model.

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The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The ORION® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy and may be supplied either sterile or non-sterile. The purpose of this 510(k) is to include modified screws to the ORION® Anterior Cervical Plate System.

The provided text is a 510(k) summary for the ORION® Anterior Cervical Plate System, focusing on the inclusion of modified screws into an existing system. This document is a regulatory submission for a medical device and describes its intended use and claims of substantial equivalence to a predicate device.

It does not contain any information regarding clinical studies, acceptance criteria for device performance (such as sensitivity, specificity, or accuracy), sample sizes for test or training sets, expert qualifications, or details about ground truth establishment.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria and study details based on the provided text. The document focuses on regulatory approval based on equivalence to a previously cleared device, not on new clinical performance data from a standalone study.

Ask a specific question about this device