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The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: 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 FORTIS and HANA Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for HANA and one, two, three, and four level procedures for FORTIS. Main plate is available from 13mm to 46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The FORTIS and HANA Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136.

This document is related to a 510(k) premarket notification for a medical device called the "Fortis and Hana Anterior Cervical Plate System." This is a spinal implant, and the FDA letter indicates that the device has been found substantially equivalent to previously marketed devices.

Based on the provided text, the document describes performance testing for mechanical properties, not a clinical study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria as typically understood for AI/ML radiology devices is not present.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed." However, it does not provide specific acceptance criteria values or the reported performance values from these mechanical tests. It only states that the testing was done and that the device was found substantially equivalent, implying that it met the necessary performance standards to be considered equivalent to the predicate devices.

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

Not applicable. This was mechanical testing, not a study on a test set of data (e.g., medical images). The testing was performed on the physical device components.

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

Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts. This document describes mechanical testing of a physical implant.

4. Adjudication Method:

Not applicable for a mechanical test.

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

Not applicable. This is not an AI/ML device for diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an AI/ML algorithm.

7. Type of Ground Truth Used:

For this type of device, the "ground truth" for mechanical testing would be the engineering specifications and performance values derived from validated test methods (e.g., ASTM F1717). The document implies that the device met these engineering standards by stating "Mechanical testing (Static compression bending, Dynamic compression bending, and Static torsion test) in accordance with the ASTM 1717 was performed" and that the device was found "substantially equivalent."

8. Sample Size for the Training Set:

Not applicable. This is a physical implant, not an AI/ML model that requires a training set.

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

Not applicable.

Summary of Device and Study Information:

• Device: FORTIS and HANA Anterior Cervical Plate System (spinal intervertebral body fixation orthosis)
• Purpose: Anterior fixation to the cervical spine C2-C7 for various indications (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, failed previous fusion).
• Study Type: Mechanical testing.
• Tests Performed: Static compression bending, Dynamic compression bending, and Static torsion test.
• Standard Followed: ASTM F1717.
• Result: The device demonstrated substantial equivalence to predicate systems based on technical characteristics, performance, and intended use, implying it met the necessary mechanical performance criteria.

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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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