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The NuVasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.

Indications for the use of the implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. Additionally, the three-hole version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomies for the treatment of tumors and burst fractures.

WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The NuVasive Archon Anterior Cervical Plate System is an anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, with a nickel-cobalt-chrome-molybdenum (MP35N) lock screw option conforming to ASTM F562.

The provided text describes a 510(k) submission for the "NuVasive Archon Anterior Cervical Plate System." This is a medical device for spinal fixation, and the marketing clearance is based on substantial equivalence to previously cleared predicate devices, rather than a de novo study with specific acceptance criteria that an AI device would typically have (e.g., sensitivity, specificity, AUC).

Therefore, the information requested, such as a table of accuracy data, sample sizes for test/training sets, expert qualifications, and details about MRMC studies or standalone algorithm performance, is not applicable to this type of submission. This document describes a traditional medical device (spinal implant), not an AI/ML-based diagnostic or assistive device.

However, I can extract information related to the device's "performance data" as described in the document, which serves a similar purpose of demonstrating safety and effectiveness based on equivalence.

Here's a breakdown based on the closest applicable information in the text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are not reported as specific performance metrics (like accuracy, sensitivity) against a clinical gold standard. Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices in terms of design, intended use, material composition, function, and range of sizes, and showing that the technological characteristics do not raise new questions of safety or effectiveness.

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

• Test Set Sample Size: Not applicable. This device does not use a "test set" in the context of an AI/ML diagnostic or predictive model. Its safety and effectiveness are demonstrated through engineering analysis (FEA), comparative methods, and literature review against predicate devices.
• Data Provenance:
  • Engineering Data: Finite Element Analysis data would be generated in-house.
  • Clinical Literature Review: Retrospective, provenance of studies would be global from medical literature.

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

• Not applicable. No "ground truth" was established by experts in the context of a diagnostic test set for this spinal implant. The evaluation relies on engineering principles and regulatory comparison.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" requiring adjudication by experts.

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

• Not applicable. This is not an AI-assisted diagnostic or imaging interpretation device, so an MRMC study is not relevant. The study performed involved engineering analysis and a literature review for comparison to predicates.

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

• Not applicable. This is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• Not applicable in the typical sense of a diagnostic device. The "ground truth" for this submission is effectively established by:
  • Predicate Device Performance: The known safe and effective performance of comparable, legally marketed devices.
  • Engineering Principles: Finite Element Analysis and mechanical testing data, which demonstrate structural integrity and performance in vitro.
  • Clinical Literature: Retrospective review to support the safety and effectiveness of the intended use and similar plate systems.

8. Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for this type of device submission.

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

• Not applicable. No "training set" for AI/ML was involved.

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The NuVasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.

WARNING: The NuVasive Archon Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The NuVasive Archon Anterior Cervical Plate System is an anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, with a nickel-cobalt-chrome-molybdenum (MP35N) lock screw option conforming to ASTM F562.

The information provided describes a medical device, the NuVasive Archon Anterior Cervical Plate System, which is an anterior cervical plating system. The 510(k) summary and associated FDA correspondence confirm its substantial equivalence to existing predicate devices.

Here's an analysis of the provided text with respect to your questions regarding acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document describes nonclinical testing (mechanical testing) rather than clinical studies using patient data. Therefore, questions regarding "test set," "data provenance," and "country of origin" are not directly applicable in the context of clinical data. For the mechanical tests, the "samples" would refer to the physical specimens of the Archon Anterior Cervical Plate System that underwent testing. The exact number of samples tested for each mechanical test (static/dynamic compression, static torsion) is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for nonclinical mechanical testing is typically established by the physical testing and measurements according to standardized protocols (e.g., ASTM F1717), not by expert consensus or interpretations of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the studies were nonclinical mechanical tests, not studies involving human interpretation or adjudication of patient data for establishing ground truth.

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

No such study was conducted or described. This device is a mechanical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. This device is a mechanical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the nonclinical mechanical testing was based on the objective measurements derived from standardized mechanical test methods (ASTM F1717). The performance of the test samples was compared directly against the performance of predicate devices under these conditions.

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is a mechanical device, not a machine learning model.

9. How the ground truth for the training set was established

This question is not applicable. There is no training set involved for this type of mechanical device submission.

Summary of the Study:

The study was a series of nonclinical mechanical tests designed to demonstrate the physical performance and substantial equivalence of the NuVasive Archon Anterior Cervical Plate System to predicate devices.

Tests Performed:

• Static and dynamic compression testing per ASTM F1717
• Static torsion testing per ASTM F1717

Purpose of the Study:

To demonstrate that the subject device "meets or exceeds the performance of the predicate device" under these mechanical loads, thereby supporting the claim of substantial equivalence in its technological characteristics, function, and safety for its intended use.

Conclusion:

Based on these tests, the device was found to be "substantially equivalent" to legally marketed predicate devices and "safe and effective for its intended use."

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