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The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization 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), tumor, pseudarthrosis or failed previous fusion.

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

The provided text is a 510(k) summary for the Zavation Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance metrics, or any study results for performance validation.

The document explicitly states: "Biomechanical testing was not repeated, as the basis for this submission is the addition of sterile packaged options for the predicate device." This indicates that the current submission (K181244) is not based on new performance testing but rather on the equivalence of sterilized versions of a previously cleared device.

Therefore, I cannot provide the requested information. The document is missing:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, number of experts, and adjudication methods.
3. Information on multi-reader, multi-case comparative effectiveness studies.
4. Information on standalone algorithm performance.
5. Details on the type of ground truth used or how it was established.
6. Sample size for a training set.

The document is primarily a regulatory filing asserting substantial equivalence based on technological characteristics and intended use being the same as predicate devices (K112533 and K130030), with the current 510(k) specifically addressing the addition of sterile packaged options.

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The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of 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), tumor, pseudarthrosis or failed previous fusion.

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

This document describes the Zavation Cervical Plate System, a medical device. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does not contain information typically found in a study for an AI/ML diagnostic device, such as acceptance criteria based on metrics like sensitivity/specificity, nor does it discuss ground truth establishment, expert adjudication, or reader studies.

Therefore, many of the requested categories related to AI/ML device studies are not applicable to this submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified. The submission refers to "a worst-case, cervical plate construct" being tested, implying a limited number of constructs rather than a large clinical test set.
• Data provenance: Mechanical testing was performed according to ASTM F1717. This is laboratory-based testing, not human data.

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

Not applicable. Ground truth for mechanical performance is established by standardized testing protocols (ASTM F1717) and engineering measurements, not by expert medical review.

4. Adjudication method for the test set

Not applicable. See point 3.

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 is a spinal implant device, not an AI/ML diagnostic device requiring a reader study.

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

Not applicable. This is a spinal implant device, not an AI/ML diagnostic device.

7. The type of ground truth used

"Ground truth" was established through standardized mechanical testing (ASTM F1717) on physical device constructs, measuring parameters like bending strength, torsion stability, and fatigue resistance.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML system that requires a training set. Development and validation rely on engineering design principles and physical testing.

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

Not applicable. See point 8.

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The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of 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), tumor, pseudarthrosis or failed previous fusion.

The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

The provided text describes a 510(k) submission for the Zavation Cervical Plate System, a medical device. This type of submission is for establishing substantial equivalence to a predicate device, not for proving novel clinical effectiveness through extensive studies as one might see for a new drug or a highly innovative device.

Therefore, many of the typical acceptance criteria and study elements listed in the prompt (like sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific effect sizes) are not applicable to this type of regulatory submission for this device.

The study presented here is a mechanical performance study comparing the new device against a predicate device.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as human or animal subjects as this was a mechanical bench test. The "worst-case, cervical plate construct" was used for testing. The number of constructs tested for each mechanical test (static and dynamic) is not specified.
• Data Provenance: Not applicable in the context of human data. The tests were performed according to ASTM F1717, an established standard for spinal implant testing. These are laboratory-generated data.

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

• Not applicable. Ground truth in this context refers to the pass/fail criteria of the ASTM F1717 standard and comparison of mechanical output values against the predicate device's performance. No human experts were used to establish "ground truth" for the mechanical characteristics of the device in the way a radiologist reviews images.

4. Adjudication Method for the Test Set

• Not applicable. This was a mechanical study, not a clinical study requiring human adjudication of outcomes or diagnoses. The "adjudication" was based on objective measurements adhering to ASTM F1717 and comparison to predicate device data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This was a mechanical performance study, not a clinical study involving human readers or comparative effectiveness in a clinical setting.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Not applicable. This device is a physical implant, not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on engineering standards (ASTM F1717) and the performance data of legally marketed predicate devices. The new device's mechanical performance in specific tests (static compression bending, torsion, and dynamic compression bending) was compared to that of the predicate devices. The aim was to demonstrate equivalent or superior performance.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of a mechanical performance study for a physical medical device. This term is relevant for machine learning or AI models.

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

• Not applicable. As there is no training set, there is no ground truth for it to be established.

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