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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 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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The uNion™ Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of 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), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

uNion™ is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips, one- through four-level standard plates having lengths from 10mm to 84mm and one- and two-level midline plates having lengths from 10mm to 46mm. Both the standard and the midline plates incorporate a pivoting insert which functions as an anti-back out mechanism. The devices are sold non-sterile.

The provided text describes a 510(k) Pre-market Notification for the uNion™ Cervical Plate System, focusing on its substantial equivalence to predicate devices based on mechanical testing. It does not contain information about an AI/ML device or its performance study against acceptance criteria in the way described in the prompt. Therefore, I cannot extract the requested information.

The document discusses:

• Device: uNion™ Cervical Plate System (a medical implant for spinal fixation).
• Regulatory Category: Class II, Spinal intervertebral body fixation orthosis.
• Purpose of filing: 510(k) Pre-market notification to demonstrate substantial equivalence to legally marketed predicate devices.
• Performance Data: Mechanical testing of worst-case uNion™ constructs (static and dynamic compression bending, static torsion) according to ASTM F1717.
• Conclusion: The mechanical test results showed that the uNion™ performance is substantially equivalent to the predicate devices.

None of the requested information regarding acceptance criteria, AI/ML performance study, sample sizes for test/training sets, ground truth establishment, or expert adjudication is present in the provided text, as it pertains to a traditional medical device, not an AI/ML system.

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The Stryker Spine Reflex® Translational Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

The Reflex® Translational Anterior Cervical Plating 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)
• 피 Trauma (including fractures)
• Tumors
• E Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
• 트 Pseudarthrosis
• 트 Failed previous fusion
• Decompression of the spinal cord following total or I partial cervical vertebrectomy
• 트 Spondylolisthesis
• Spinal stenosis

WARNING: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

This Special 510(k) premarket notification is intended to introduce the following line extensions to the Reflex Hybrid Plates approved under K000742 and K000536: Translational plates in 1-level, 2-level, 3-level, and 4-level configurations and in lengths ranging from 14mm through 96mm.

The subject system consists of various length plates that have Titanium clips which hold the plate in the "fully open" position. After the plate is placed and secured, Titanium clips are removed allowing the plate to decrease in size up to 2mm per level treated. This translational plate design uses the same screws and locking mechanism used in the predicate Stryker Spine Reflex® Hybrid ACP System.

The provided text describes a Special 510(k) premarket notification for a medical device, the Stryker Spine Reflex® Translational Anterior Cervical Plating System. This notification is for a line extension to an existing product and, therefore, focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and performance testing, rather than a clinical study evaluating diagnostic or prognostic performance.

As such, the information typically requested for AI/diagnostic device studies (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets) is not applicable to this type of submission. This device is a mechanical implant, not an AI or diagnostic tool.

The document explicitly states: "Engineering analysis and performance testing verify that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device systems." This indicates that the "study" proving the device meets acceptance criteria was based on engineering and performance benchmarks, rather than a clinical trial with human subjects.

Therefore, I cannot provide the requested table and details because the submission is not focused on an AI or diagnostic device that would involve such criteria and studies.

However, I can extract the acceptance criteria (implied by the substantial equivalence claim) and the general nature of the "study" reported:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This was an engineering and performance testing study, not a clinical study on human subjects where a "test set" and "data provenance" (e.g., country of origin, retrospective/prospective) would be relevant. The "test set" would refer to mechanical test specimens.

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

• Not applicable. Ground truth, in the context of clinical expert consensus, is not relevant for this type of engineering and performance study. The "ground truth" here would be established by validated engineering standards and test methods.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are used in clinical studies or image interpretation, not in mechanical engineering verification.

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 surgical implant, not an AI tool.

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

• Not applicable. This device is a surgical implant, not an AI algorithm.

7. The type of ground truth used

• Engineering specifications and validated performance testing methods. The "ground truth" for this submission is based on established engineering and material science principles, biomechanical testing standards, and direct comparison to the performance characteristics of legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

• Not applicable. As there is no training set, this question is not applicable.

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