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The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have manual locking mechanisms to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters from 4.0mm to 5.0mm (rescue) and lengths from 14mm to 16mm.

The provided document is a 510(k) summary for the Asfora Anterior Cervical Plate System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with acceptance criteria in the manner of AI/software devices. Therefore, much of the requested information regarding AI device evaluation is not explicitly available in this document.

Here's an attempt to extract and interpret the information based on the context of a medical device submission for a spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

For mechanical implants like the Asfora Anterior Cervical Plate System, "acceptance criteria" and "reported device performance" are typically defined by compliance with recognized ASTM standards for spinal implants. The document states:

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

• Sample Size for Test Set: Not applicable in the context of this type of mechanical device evaluation. The "test set" would refer to the physical samples of the device and its components used for mechanical testing. The document does not specify the number of individual plates, screws, or constructs tested.
• Data Provenance: The mechanical testing data would be generated from laboratory tests conducted on the physical device prototypes. The country of origin for the testing itself is not specified but would typically occur at the manufacturer's facility or a contract testing lab. This is a prospective evaluation in the sense that the device prototypes were specifically manufactured and tested for this submission.

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

• Number of Experts & Qualifications: Not applicable. For mechanical testing of an orthopedic implant, "ground truth" is not established by human experts in the same way as, for example, image interpretation for an AI algorithm. The "ground truth" would be the engineering specifications and performance standards defined by the ASTM F 1717 standard itself. The engineers and technicians conducting the tests are qualified in mechanical testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical test results are typically objective measurements (e.g., load at failure, displacement). There is no "adjudication" in the sense of reconciling differing expert opinions. The test results are compared directly against the performance requirements of the relevant ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• MRMC Study: No. This is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool. MRMC studies are specific to evaluating AI algorithms that assist human readers (e.g., radiologists, pathologists).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: No. This is not an AI algorithm.

7. The Type of Ground Truth Used

• Ground Truth: For the mechanical testing, the "ground truth" is the performance specifications and requirements defined by the ASTM F 1717 standard for spinal intervertebral body fixation orthoses. The device is expected to meet or exceed these established engineering benchmarks.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device. The design and manufacturing processes are based on established engineering principles and materials science, not machine learning.

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

• Ground Truth for Training Set: Not applicable. As there's no training set, there's no ground truth needing to be established for it. The design of such a device relies on accepted biomechanical principles, material properties, and clinical experience, rather than data-driven "ground truth" in the AI sense.

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