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This 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 from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

The Life Spine Cam Lock Anterior Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.

The Life Spine Cam Lock Anterior Cervical Plating System implant components are made from titanium alloy described by ASTM F136. Stainless steel and titanium implant components must not be used together in a construct.

Do not use any of The Life Spine Cam Lock Anterior Cervical Plating System components with the components from any other system or manufacturer.

This looks like a 510(k) premarket notification for a medical device called the "Cam Lock Plating System." The provided document does not contain information about acceptance criteria and study data in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC, or reader studies).

The document is for a spinal intervertebral body fixation orthosis and focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, sizing, and mechanical performance.

Therefore, I cannot provide the requested information as it pertains to AI/ML device performance metrics and studies.

Here's an explanation of why the requested information is not present in the provided text:

• Type of Device: The "Cam Lock Plating System" is a physical implant (spinal plating system) used for spinal fixation. It's not an AI/ML-driven diagnostic or prognostic software device.
• Regulatory Pathway: The document describes a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device. For mechanical devices like this, substantial equivalence is typically shown through:
  • Indications for Use comparison.
  • Technological characteristics comparison (materials, design, sizing).
  • Performance data (which for this device are mechanical tests, not clinical performance metrics related to diagnostic accuracy).
• Acceptance Criteria & Study: The "acceptance criteria" for this type of device would generally revolve around meeting established mechanical performance standards (e.g., ASTM F1717 for spinal implants) and demonstrating that the device performs as intended in terms of its structural integrity and fixation capabilities. The study mentioned ("Mechanical testing was included to demonstrate the substantial equivalency... The testing included static compression, dynamic compression and static torsion testing per ASTM F1717 in addition to a benchtop screw push-out test") is accordingly focused on these mechanical aspects.

In summary, there is no information in the provided document about:

• AI/ML performance metrics (sensitivity, specificity, etc.)
• Test set sample size or provenance for AI/ML evaluation
• Experts used to establish ground truth for AI/ML evaluation
• Adjudication methods for AI/ML evaluation
• Multi-reader multi-case (MRMC) studies with AI assistance
• Standalone AI algorithm performance
• Ground truth type, training set size, or ground truth establishment for an AI/ML model.

The document is entirely focused on the mechanical and material equivalence of a physical medical implant.

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The XTEND™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for 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, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The XTEND™ Anterior Cervical Plate System consists of standard plates, Extender plates and Universal Extender plates. Extender plates may be used for revision surgery in which additional stabilization is required. Extender plates are attached to an adjacent XTEND™ plate, and Universal Extender plates are inserted adjacent to other plates. XTEND™ plates are available in various lengths to be used with either variable angle screws or fixed angle screws. Each XTEND™ plate is attached to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The XTEND™ Anterior Cervical Plate System implants are composed of titanium allov, as specified in ASTM F136 and F1295.

The provided text is a 510(k) summary for the XTEND™ Anterior Cervical Plate System. This document focuses on demonstrating substantial equivalence to previously approved devices through engineering and mechanical testing, rather than clinical studies involving human or animal subjects or AI/algorithm performance. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the XTEND™ Anterior Cervical Plate System are based on mechanical testing in accordance with FDA guidance. The "reported device performance" is the successful meeting of these criteria, which is implied by the 510(k) clearance.

The Study that Proves the Device Meets the Acceptance Criteria:

The submission explicitly states: "Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented."

This indicates that a series of in vitro mechanical tests were conducted on the XTEND™ Anterior Cervical Plate System. The purpose of these tests was to demonstrate that the device's performance characteristics (e.g., strength, durability, fatigue resistance) are equivalent to or better than those of the predicate devices. By meeting the benchmarks established in the FDA guidance and through comparison with predicate devices, the XTEND™ system was deemed substantially equivalent.

Non-Applicable Categories based on the provided text:

The following information is not present in the provided 510(k) summary because this type of premarket submission for a spinal implant device typically relies on engineering and material equivalence, rather than clinical trial data or AI performance metrics.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This refers to test samples for mechanical testing, not patient data. No human or animal data is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" is not established by human experts in the context of mechanical testing for substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a physical spinal implant, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is established by standardized mechanical testing protocols and material specifications, as well as the performance of predicate devices.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of a 510(k) submission for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

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