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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 IVA Cage (ACIF, Ti ACIF) are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage

The IVA Cage (PLF, TLIF, DLIF, Ti PLIF, Ti TLIF, Ti DLIF and Ti ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level of two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA Cage Ti (ACIF, PLIF, TLIF, DLIF and ALIF) is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine.

The provided text does not contain information about the acceptance criteria and performance of a device based on a study with AI in the loop. The document is a 510(k) premarket notification for an intervertebral body fusion device (IVA Cage Ti) and focuses on demonstrating substantial equivalence to a legally marketed predicate device.

The document discusses:

• Device Name: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
• Regulation Number: 21 CFR 888.3080
• Regulatory Class: Class II
• Product Code: MAX, ODP
• Indications for Use: Intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical and lumbar spine, with specific disc levels mentioned.
• Performance Data: States "The addition of components to the system did not introduce a new worst case construct as evaluated based on an engineering analysis. Dynamic axial compression test per ASTM F2077 was performed."
• Predicates: IVA (ACIF, PLIF, TLIF, DLIF, and ALIF) Cage (K162220) and SUSTAIN® & SUSTAIN® - R (K130478).
• Substantial Equivalence Determination: Based on technical characteristics, performance, and intended use to the predicate system(s).

There is no mention of:

• Acceptance criteria for an AI-powered device.
• A study evaluating AI performance (standalone or with human-in-the-loop).
• Sample sizes for test or training sets related to AI.
• Experts or ground truth establishment for AI.
• MRMC comparative effectiveness study or related effect sizes.

Therefore, I cannot provide the requested information based on the given input text.

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The Nexus Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. 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 Nexus Anterior Cervical Plate System consists of a variety of shapes and sizes of main plates, screws, sub-plates, rivets and associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion.

The rivets are pre-assembled to the main plate, which firmly attach the sub-plate component to the main plate. Each component is color anodized to differentiate the screw type and diameter and to facilitate the surgical process.

The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are provided in fixed self-tapping, variable self-tapping, fixed self-drilling and variable self-drilling configurations.

This document describes a 510(k) submission for the Nexus Anterior Cervical Plate System. This is a medical device for spinal fixation, not an AI/ML device, and therefore the requested information regarding acceptance criteria and studies (like sample size, ground truth, expert opinions, MRMC studies, standalone performance, training set) is not applicable in the context of this submission.

The core of this submission is a demonstration of substantial equivalence to a previously cleared predicate device (Dio Medical Rex Anterior Cervical Plate System, K121862). This means the device is being cleared because it is deemed to be as safe and effective as a device already on the market, not through a process involving performance metrics against acceptance criteria tested in a clinical or AI performance study.

Here's why the AI/ML specific questions are not applicable:

• No AI/ML Component: The Nexus Anterior Cervical Plate System is hardware (plates, screws, sub-plates, rivets) used for physical fixation in cervical spine surgery. It is a traditional medical device, not a software algorithm, diagnostic tool, or any other device that would typically involve AI/ML.
• Substantial Equivalence (Predicate Device): The submission explicitly states: "The subject device is identical to the previously cleared Rex System in terms of indications for use, device dimensions instrumentation, manufacturing process, cleaning/sterilization process and labeling." And "Non-clinical testing was not performed as part of this submission." This indicates that the approval relies on the fact that the new device is essentially the same as one already approved, and therefore, extensive new testing (especially AI/ML performance testing) is not required.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer questions 2-9 from your prompt because they relate to the evaluation of AI/ML models or clinical studies that were not performed or required for this type of 510(k) submission.

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