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The Eagle Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.

The Eagle Anterior Cervical Plate System consists of an assortment of plates and screws. The Eagle Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Eagle Anterior Cervical Plate System.

It's important to note that the provided documents (sections {0} through {4}) are a 510(k) Summary and an FDA clearance letter for a medical device (Spinal Intervertebral Body Fixation Orthosis). Such documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with explicit performance criteria, sample sizes, and expert review methodologies as would be found in a clinical trial report for an AI/software as a medical device (SaMD).

Therefore, much of the requested information (especially regarding AI-specific criteria, ground truth, expert adjudication, MRMC studies, and detailed performance metrics) is not present in these documents because they describe a physical implant, not an AI-driven diagnostic device.

Revised Analysis Based on Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Performance data were submitted to characterize the Eagle Anterior Cervical Plate System." However, the specific details of these performance data (e.g., in vitro mechanical testing results, specific values for strength, fatigue, etc.) are not included in this 510(k) summary. The summary only implies that such data were submitted and found acceptable by the FDA to demonstrate substantial equivalence to the predicate device. For mechanical devices like this, the "study" would primarily involve bench testing (e.g., static and dynamic load testing, pull-out strength, torque tests) and material characterization, rather than clinical trials with human subjects in the typical sense of showing diagnostic accuracy.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) summary for a physical implant. The "test set" would primarily refer to the physical specimens (e.g., number of plates or screws tested) for mechanical characterization. This information is not provided in the summary.
• Data Provenance: Not applicable in the context of this 510(k). The data would be from laboratory bench testing.

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

• This is not applicable. For a physical implant, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM F-136 for titanium alloy), and mechanical testing results compared against predefined thresholds or predicate device performance, not by expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human interpretation of data (e.g., medical images). For mechanical testing, the "adjudication" is typically the comparison of quantitative test results against acceptance criteria.

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

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially AI in medical imaging) to assess how human readers perform with and without AI assistance. This device is a physical implant, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone study was not done. This concept applies to AI algorithms. The Eagle Anterior Cervical Plate System is a physical medical implant.

7. Type of Ground Truth Used

• Engineering specifications, material standards, and mechanical test results. For a physical implant, the "ground truth" relates to its material properties, structural integrity, and functional performance under simulated physiological stresses, all measured against established engineering benchmarks and comparisons to the predicate device's known performance.

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant. The concept of a "training set" is relevant for machine learning algorithms.

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

• Not applicable. As above, this concept does not apply to a physical implant.

In summary: The provided 510(k) documentation focuses on demonstrating the substantial equivalence of a physical medical implant (Eagle Anterior Cervical Plate System) to a previously cleared predicate device. It highlights the device's material, intended use, and general statement about performance data, but does not contain the detailed clinical study information relevant to AI/SaMD, such as specific acceptance criteria for diagnostic accuracy, expert review methodologies, or training/test set details.

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