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The Magnes-C™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

The Magnes-C™ Anterior Cervical Plate System components are intended for anterior screw fixation and stabilization of the cervical spine during the development of cervical interbody spinal fusion. The Magnes-C™ Anterior Cervical Plate System consists of one through three-level plates and fixed and variable screws, in a variety of sizes to accommodate individual patient anatomy. The Magnes-C components are provided nonsterile. Instruments to facilitate unilateral anterior fixation are included.

The provided text describes a medical device, the Magnes-C Anterior Cervical Plate System, and its clearance by the FDA. However, it does not include information about acceptance criteria for an AI/ML powered device, nor a study proving meeting such criteria. Instead, it details the indications for use, device description, materials, and mechanical testing results to demonstrate substantial equivalence to predicate devices for a spinal implant.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study for an AI-powered device based on the given text.

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The Aggeris™-C device is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
2. Spondylolisthesis
3. Spinal stenosis
4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
5. Pseudoarthrosis
6. Revision of previous surgery

The Aggeris™-C is designed for use as a cervical plate. The device is manufactured from medical grade Titanium alloy. The device has a shape which restores the intervertebral height and lordosis. The device consists of a variety of bone screws and cervical plates provided in a variety of shapes and sizes of with rounded corners, bone screw holes, and a screw locking system. The plates are provided in a variety of lengths, allowing treatment from 1 to 5 levels. The Aggeris™-C plates, as well as the bone screws, are made from Ti alloy conforming to ASTM F136.

This document describes the Clariance Aggeris™-C device, specifically a spinal intervertebral body fixation orthosis. However, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based medical devices or AI/ML components.

The text focuses on hardware-related regulatory submission details for a physical medical device (spinal implant), including:

• Device name, classification, and regulation details.
• Indications for use for a cervical plate.
• Technological characteristics (materials, design).
• Performance data related to biocompatibility, sterility, cleaning, and mechanical testing (static and dynamic axial compression, static torsion) of the physical implant.
• Comparison to a predicate device for substantial equivalence, again for the physical implant.

There is no mention of an AI/ML component, software, or any study involving human-in-the-loop performance, standalone algorithm performance, or ground truth establishment for diagnostic or predictive purposes.

Therefore, I cannot provide the requested information based on the provided text. The questions posed in your prompt (e.g., sample size for test/training set, number of experts for ground truth, MRMC study, standalone performance) are relevant to AI/ML medical devices, not to the type of physical device and regulatory submission described here.

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The ACP 1™ Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The ACP 1™ system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
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
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy
Spondylolisthesis
Spinal stenosis

The ACP 1TM Anterior Cervical Plating System are one-, two-, three- and four-level plate configurations ranging in lengths 10mm to 22mm for the one-level plates, 24mm to 46mm for the two-level plates, 39mm to 69mm for the three-level plates and 56mm to 96mm for the four-level plates. A locking screw is utilized as an anti-backout mechanism to lock the bone screws in place. The bone screws are provided with either fixed or variable angles available in self-tapping or self-drilling designs. The variable angle bone screws allow the screw to be placed into bone at various degrees of angulation, while the fixed bone screws are inserted at a defined angle. Any combination of bone screws can be used to secure the cervical plate. The bone screws are offered in 4.0mm and 4.5mm diameters in lengths 10mm - 20mm. The implants (bone screws and cervical plates) are provided as single-use, sterile devices manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

This document is a 510(k) summary for the Stryker Corporation's ACP 1™ Anterior Cervical Plating System. The information provided heavily emphasizes the substantial equivalence of the new device to previously cleared predicate devices, rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.

Therefore, the response below is structured to reflect the information available in the provided text, primarily focusing on the comparison to predicate devices and the mechanical testing performed, as a direct AI-style acceptance criteria and study section isn't explicitly present.

Acceptance Criteria and Study for the ACP 1™ Anterior Cervical Plating System

The ACP 1™ Anterior Cervical Plating System's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to existing predicate devices through risk analysis and mechanical testing, rather than a clinical performance study with specific diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The provided document describes a "510(k) Summary" process which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "study" in this context refers to the assessment performed to support this claim.

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

• Sample Size for Mechanical Testing: The document does not specify the exact number of test samples (e.g., number of plates or constructs) used for the static and dynamic mechanical tests per ASTM F1717-14.
• Data Provenance: The data provenance for the mechanical testing is not explicitly stated (e.g., country of origin, specific lab). It is implicitly prospective testing conducted by the manufacturer to support the 510(k) submission. There is no patient data involved in this assessment as it's a mechanical device.

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

This type of information is not applicable for the ACP 1™ Anterior Cervical Plating System as described in this document. The assessment is for a physical implantable medical device and relies on engineering principles and mechanical testing standards (ASTM F1717-14), not on expert clinical interpretation of data or diagnostic accuracy.

4. Adjudication Method for the Test Set:

This is not applicable. There is no "test set" in the sense of a dataset requiring expert adjudication, as the study involves mechanical performance testing of a physical device against predefined engineering standards.

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

An MRMC study is not applicable here. This study type is typically used for diagnostic devices (e.g., AI in radiology) to evaluate the performance of human readers with and without AI assistance. The ACP 1™ System is an implantable surgical device, not a diagnostic tool.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This concept is not applicable to the ACP 1™ Anterior Cervical Plating System. The device is a physical implant, not an algorithm. Its performance is evaluated through mechanical testing and comparison to predicate devices, not as a standalone AI system.

7. Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the ACP 1™ System is based on established engineering standards and requirements for spinal intervertebral body fixation orthoses, specifically the ASTM F1717-14 standard for static and dynamic compression and torsion testing. The ultimate "ground truth" for regulatory clearance is substantial equivalence to legally marketed predicate devices, meaning the new device performs as safely and effectively as the existing ones.

8. Sample Size for the Training Set:

This is not applicable. The ACP 1™ System is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.

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

This is not applicable, as there is no "training set."

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